AC 14.6.2018
Item Number : 4.53
UNIVERSITY OF MUMBAI
Bachelor of Pharmacy
B. Pharm. Choice Based Credit System (CBCS)
Third Year B. Pharm. and Final Year B. Pharm
( Semester V to Semester VIII ),
from Academic Year 201 8 -19 and 2019 -20
(As per Choice Based Credit and Grading System with
effect from the academic year 2016 –2017)
From Coordinator’s Desk:
To meet the challenge of ensuring excellence in engineering education, the issue of quality needs to be addressed, debated
taken forward in a systematic manner. Accreditation is the principal means of quality assurance in higher education. The
major emphas is of accreditation process is to measure the outcomes of the program that is being accredited. In line with this
Faculty of Technology of University of Mumbai has taken a lead in incorporating philosophy of outcome based education
in the process of curric ulum development.
Faculty of Technology, University of Mumbai, in one of its meetings unanimously resolved that, each Board of Studies
shall prepare some Program Educational Objectives (PEO’s), give freedom to affiliated Institutes to add few (PEO’s) cour se
objectives course outcomes to be clearly defined for each course, so that all faculty members in affiliated institutes
understand the depth approach of course to be taught, which will enhance learner’s learning process. It was also resolved
that, maximu m senior faculty from colleges and experts from industry should to be involved while revising the curriculum.
I am happy to state that, each Board of studies has adhered to the resolutions passed by Faculty of Technology, developed
curriculum accordingly. In addition to outcome -based education, Choice Based Credit and Grading System is also
introduced to ensure quality of engineering education.
Choice Based Credit and Grading System enables a much -required shift in focus from teacher -centric to learner -centric
education since the workload estimated is based on the investment of time in learning not in teaching. It also focuses on
continuous evaluation which will enhance the quality of education. University of Mumbai has taken a lead in implementing
the syst em through its affiliated Institutes. Faculty of Technology has devised a transparent credit assignment policy
adopted ten points scale to grade learner’s performance. Credit grading -based system was implemented for First Year of B.
Pharmacy from the acad emic year 2016 -2017. S ubsequently this system was carried forward for Second Year B. Pharmacy
in the academic year 2017 -2018, Third Year in the academic years 2018 -2019 and Final Year B. Pharmacy in the academic
year 2019 -2020.
Dr. S. K. Ukarande
Dean – Faculty of Science and Technology,
Member - Academic Council
University of Mumbai, Mumbai
B. Pharm. Choice Based Credit System (CBCS)
Scheme Examination Semesters V to VIII
&
Syllabus Semesters V to VIII
EXAMINATION SCHEME FOR THE
CHOICE BASED CREDIT SYSTEM (CBCS)
SEMESTER V
Course Code Name Credits Hr/Wk Weightage
Internal Weightage
End Semester
Exam Total Marks
BPH_C_501_T Organic Chemistry
III 4 4 20 80 100
BPH_C_502_T Pharmaceutics II 4 4 20 80 100
BPH_C_503_T Pharmaceutical
Biotechnology 4 4 20 80 100
BPH_C_504_T Pharmacology II 4 4 20 80 100
BPH_E_5xx_T Choice Based
Course I 2 2 10 40 50
BPH_E_5xx_T Choice Based
Course II 2 2 10 40 50
TOTAL Theory 20 20 100 400 500
BPH_C_505_L Organic Chemistry
Lab II 2 4 10 40 50
BPH_C_506_L Pharmaceutics Lab II 2 4 10 40 50
BPH_C_507_L Experimental
Techniques in
Microbiology and
Biotechnology Lab 2 4 10 40 50
TOTAL Lab 6 12 30 120 150
TOTAL SEM V 26 32 130 520 650
SEMESTER VI
Course Code Name Credits Hr/Wk Weightage
Internal Weightage
End Semester
Exam Total Marks
BPH_C_601_T Pharmaceutical
Chemistry I 4 4 20 80 100
BPH_C_602_T Pharmaceutics III 4 4 20 80 100
BPH_C_603_T Pharmaceutical
Analysis II 4 4 20 80 100
BPH_C_604_T Pharmacognosy II 4 4 20 80 100
BPH_E_6xx_T Choice Based
Course III 4 4 20 80 100
BPH_E_6xx_T Choice Based
Course IV 2 2 10 40 50
TOTAL Theory 22 22 110 440 550
BPH_C_605_L Pharmaceutical
Chemistry Lab I 2 4 10 40 50
BPH_C_606_L Pharmaceutics Lab
III 2 4 10 40 50
BPH_C_607_L Pharmaceutical
Analysis Lab II 2 4 10 40 50
TOTAL Lab 6 12 30 120 150
TOTAL SEM VI 28 34 140 560 700
SEMESTER VII
Course Code Name Credits Hr/Wk Weightage
Internal Weightage
End Semester
Exam Total Marks
BPH_C_701_T Pharmaceutical
Chemistry II 4 4 20 80 100
BPH_C_702_T Pharmacognosy III 4 4 20 80 100
BPH_C_703_T Pharmaceutical
Analysis III 4 4 20 80 100
BPH_C_704_T Pharmacology III 4 4 20 80 100
BPH_C_705_T Pharmaceutical
Jurisprudence 3 3 20 80 100
BPH_E_7xx_T Choice Based
Course V 2 2 10 40 50
TOTAL Theory 21 21 110 440 550
BPH_C_706_L Pharmacognosy Lab
II 2 4 10 40 50
BPH_C_707_L Pharmaceutical
Analysis Lab III 2 4 10 40 50
BPH_C_708_L Pharmacology Lab II 2 4 10 40 50
TOTAL Lab 6 12 30 120 150
TOTAL SEM VII 27 33 140 560 700
SEMESTER VIII
Course Code Name Credits Hr/Wk Weightage
Internal Weightage
End Semester
Exam Total Marks
BPH_C_801_T Pharmaceutical
Chemistry III 4 4 20 80 100
BPH_C_802_T Pharmaceutics IV 4 4 20 80 100
BPH_E_8xx_T Choice Based
Course VI 4 4 20 80 100
BPH_E_8xx_T Choice Based
Course VII 4 4 20 80 100
TOTAL Theory 16 16 80 320 400
BPH_C_803_L Pharmaceutical
Chemistry Lab II 2 4 10 40 50
BPH_C_804_L Pharmaceutics Lab
IV 2 4 10 40 50
BPH_E_805_D Project 6 12 - 200 200
TOTAL Lab 10 20 20 280 300
TOTAL SEM VIII 26 36 100 600 700
SYLLABUS FOR T. Y. B. Pharm.
SEMESTER -V
BPH_C_501_T – Organic Chemistry III - (4 Hr/Wk)
Course Objective
Organic chemistry provides a foundation for understanding:
1) synthesis, nature, nomenclature of various heterocycles and their importance in medicinal chemistry,
2) nomenclature, nature and significant role of biomolecules like steroid hormones, peptide and DNA molecules in the organic and
pharmaceutical chemistry and
3) To learn the basic concepts of polymers. Polymerization methods, measurement of molecular weig ht and its application in
pharmaceutical industries
Course Outcomes
1. Upon successful completion of this course, a learner will be able to
2. Identify, nomenclate, and to employ fundamental heterocyclic organic reactions in the synthetic design of biolog ically active
molecules containing heterocyclic nucleus
3. Recognize the steroid molecules, synthetic methods, nature and their role in our body.
4. Outline the synthesis, chemical reactions of steroids, conversion of cholesterol to progesterone, estron e and testosterone and
elucidation of structure of cholesterol.
5. State basic terminologies in polymers, different mechanisms involved in the polymer preparation, different polymerization
techniques, details about the glass transition temperature and the factors affecting it and the types of polymers with some specific
examples of each
No. Details Hours
1 1 Heterocyclic Chemistry
1.1
Nomenclature of mono, bi - and tri -cyclic hetero -aromatic, fused heterocyclic ring and bridge head
system of the drug molecules along with drug examples.
Synthesis, Discussion of aromaticity, resonance, properties of heterocycles, acidity and basicity and
reaction of the following heterocycles
1.2
Five membered Heterocycles with One Heteroatom:
a. Furan: Synthetic methods including synthesis using carbohydrates, Paal -Knorr synthesis
b. Pyrrole: Synthetic methods including synthesis using furan, Knorr synthesis, Paal -Knorr synthesis,
Hantzsch synthesis.
c. Thiophene: Synthetic methods including synthesis using Paal -Knorr synthesis.
Reactions of Furan, Pyrrole and Thiophene: With acids, Electrophilic Aromatic Substitution (EAS),
Nucleophilic Aromatic substitution (NAS) reaction, oxidizing and reducing agents.
1.3.
Five membered heterocycles with Two heteroatoms :
a. Imidazole: Synthetic methods including synthesis from imidazolines, α -haloketones, Radiszewskii
reaction.
b. Oxazole: reaction between acid amides and α -halogenoketones eg. Acetamide and bromoacetone form
2,4-dimethyloxazole, Robinson –Gabriel synthesis by d ehydration of 2 -acylaminoketones, Reaction with
Tosylmethyl isocyanide and aldehydes (The Van Leusen reaction)
c. Thiazole: preparation α -chlorocarbonyl compound and thioacid amide – Hantzsch synthesis, Gabriel
synthesis by reaction of a -Acylamino Ketones w ith Phosphorus Pentasulfide, Cook -Heilborn’s synthesis
from a -Aminonitriles, Reactions of Imidazole, Thiazole, Oxazole with acids, Electrophilic Aromatic
Substitution (EAS), nucleophilic aromatic substitution (NAS), oxidizing and reducing agents,.
1.4
Six membered heterocycles with One and Two heteroatoms :
a. Pyridine: Synthetic methods including synthesis using 1,5 -diketones and Hantzsch synthesis.
b. Pyrimidine: Synthesis using malonic ester; 2,4 -dichloropyridine, amidine and maleic acid, Reactions
of pyridine and pyrimidine with acids, Electrophilic Aromatic Substitution (EAS), nucleophilic aromatic
5
4
5
4
substitution (NAS), Hetaryne formation, oxidizing and reducing agents and Reactions of pyridine -N-
oxide
1.5
Fused heterocycles with One heteroatoms
a. Quinoline: Synthetic methods including Skraup synthesis, Doebner -Miller synthesis, Friedlander
synthesis, Conrad -Limpach synthesis. Reactions with acids, Electrophilic Aromatic Substitution (EAS),
nucleophiles, oxidizing and reducing agents
b. Isoquinoline: Synthetic methods including Bischler -Napieralski and Pomeranz -Fritsch, Reactions
including EAS, nucleophiles, oxidizing and reducing agents.
c. Indole: Synthesis by Fischer indole synthesis, Madelung synthesis. Reactions with acids, EAS,
Metallic K, Mannich reaction, oxidizing and reducing agents.
1.6
Non-aromatic heterocyclic chemistry : Synthesis and properties of the following heterocycles -
Morpholine s, Piperazines, Piperidine
5
4
2 Biomolecules:
I. Chemistry of Steroids
2.1 Definition of steroids and sterols, numbering and ring letters, orientation of projection formulae,
stereochemistry of ring junction and side chain attachments, stereochemistry of substituents in the side
chain.
2.2 Types of steroid hormones: androgens, estrogens, progestins, corticosteroids. Structure and
biosynthesis of steroids from cholesterol. Conformation and chemical rea ctivity, steroid specific
reactions of A and B rings, Addition -elimination, epoxide opening, relative rates of esterification,
oxidation of epimeric alcohols, reduction of ketones.
II. Peptides:
Isoelectric point, synthesis of alpha amino acids (Strecker synthesis and amidomalonate and reductive
amination of alpha keto acids), co -valent bonding in peptides, structure determination of peptides,
sequencing of peptides (Edman synthesis, C -terminal residue determination - carboxy peptidase), partial
hydrolysis of peptides using chemical (aq. Acids) and enzymatic methods (trypsin and chymotrypsin),
synthesis of peptides – protection and deprotection of N and C -terminal amino acids, solution phase and
solid phase (Merrifield) peptide synthesis.
III. DNA: Merrifie ld solid phase synthesis of DNA
IV. Polymers
Chain growth polymers (free radical polymerization)
Stereochemistry of polymerization Ziegler Natta catalyst, co -polymer, step growth polymers, co -
polymers, polymer structure and physical properties, biodegrad able polymers, characterization of
molecular weight – average molecular weight, molecular weight distribution, size exclusion
chromatography
7
5
3
6
TOTAL 48
Books:
Latest editions of following books to be adopted.
1. I. L. Finar: Organic chemistry - Volumes 1 and 2, Pearson Education, Ed:5
2. Morrison and Boyd, Organic chemistry, Prentice Hall.
3. Clayden and Greeves, Organic chemistry, Oxford University Press.
4. S. H. Pine et al, Organic chemistry, McGraw -Hill Science/Engineering/Math.
5. D. Lednicer: Steroid chemistry at a glance, Wiley.
6. Heterocyclic Chemistry, Volume I, Volume II, Volume III by R. R. Gupta, M. Kumar, V. Gupta, Publisher: Springer Nature (SIE)
(2009)
7. Fundamental Principles of Polymeric ma terial, Stephen L. Rosen, Second edition, John Wiley and sons, Inc. (1993)
BPH_C_502_T – Pharmaceutics II - (4 Hr/Wk)
Course Objectives
To provide knowledge to the students related to dosage forms such as biphasic liquid dosage forms, Semisolids, Suppositories and
Aerosols with emphasis on their formulation and evaluation, and an introduction to cosmetics
Course Outcomes
Upon completion of the course, the learner shall be able to:
1. Understand the formulation of liquid biphasic, semisolid, suppos itory and aerosol dosage forms
2. Describe the evaluation of such dosage forms
3. Summarize the packaging of liquid biphasic, semisolid, suppository and aerosol dosage forms
4. Explain the basic concepts of cosmetic science
Books:
Latest
Editions
1. Lachman
Leon,
Liberman
Herbert A.,
Kaing
Joseph L.,
“Theory
and practice
of Industrial
Pharmacy” No. Details Hours
1 Biphasic Systems: Suspensions and Emulsions 15
1.1 Physicochemical aspects: surface & interfacial tension, surface free energy, Gibb’s equation,
thermodynamic & kinetic stability of disperse systems
Definition, advantages and disadvantages, desirable features and pharmaceutical dispersions 1
1.2 Suspensions
Wetting phenomenon, particle ‐particle
interactions, DLVO theory, flocculated and deflocculated systems, Schulze Hardy rule, Sedimentation
process, Ostwald ripening and crystal factors, rheology 3
1.3 Formulation of suspensions: Excipients & additives
Methods of preparation, Large scale manufacture (including equipment), filling and packaging, Layout
of manufacturing area 3
1.5 Quality evaluation and stress testing, Official formulation examples 1
1.6 Emulsions
Emulsifiers ‐ need and mechanisms, droplet stabilization, classification,
Selection of emulsifiers ‐HLB method, Davies method, PIT method,
Cloud point method
3
1.7 Preparation of Emulsions ‐formulation additives, rheological aspects,
physical stability of emulsions, symptoms of instability. 2
1.8 Methods of preparation, Large scale manufacture (including equipment), filling and packaging, Layout
of manufacturing area. Concept of low energy emulsification. 1
1.9 Quality evaluation and stress testing, Examples of Official formulations 1
2 Semisolids: Ointments, Creams, Pastes and Gels 10
2.1 Factors influencing skin penetration ‐physiological and physicochemical factors, vehicles and
penetration enhancers, methods to evaluate skin penetration. 3
2.2 Raw materials for semisolids, types of vehicles, ointment bases, creams, pastes, gels: Formulation
additives; Rheological aspects. 4
2.4 Large scale manufacture with equipment involved in each step and layout.
Quality evaluation, Examples of Official formulations. 3
3 Suppositories 6
3.1 Suppositories:
Introduction, definition, advantages and disadvantages, desirable features of suppositories, factors
affecting rectal absorption. 1
3.2 Suppository bases ‐ specifications and desired features, classification and selection of suppository bases,
special bases. 2
3.3 Formulation and specific problems involved in formulating suppositories, large scale manufacture with
equipment, packaging. 2
3.4 Quality control tests, Examples of official formulations. 1
4 Pharmaceutical Aerosols 9
4.1 Definition, advantages & disadvantages, desirable features. Components of aerosol package, Two phase
& three phase aerosol systems 1
4.2 Components in detail -Propellants -types – Liquefied propellants and Gaseous propellants, selection of
propellants.
Containers – Tin Plate, Aluminium, Glass, Plastics
Valve and Actuator, Metered dose valve
Product concentrate - Different formulation system s- solution, dispersions, foams.
Dry Powder Inhalations -concept. 6
4.3 Manufacture of Aerosols -Cold filling and Pressure filling.
Quality Control testing, Stability studies 2
5 Introduction to Cosmetics 8
5.1 Definition of cosmetics, classification. 1
3rd
edition,1987, Varghese Publishing house,Mumbai.
2. Liberman Herbert A., rieger, “Pharmaceutical dosage Forms -Disperse Systems”, vol 1/2/3, 2nd edition,2005 , Marcel Dekker Inc.,
New York.
3. Allen, Loyd v V.Jr, “Remingtons - the Science and Practice of Pharmacy, Vol 1 / 2, 22nd edition, Pharmaceutical Press
4. Patrik Sinko Ed.”Martin’s Physical Pharmacy and Pharmaceutical Sciences”, 6th edition, 2010,Lippincot t Williams and Wilkins.
5. M.E. Aulton Ed.,”Pharmaceutics -The Science of Dosage Form Design”3rd edition,2007,
Churchill livingstone Elsevier Ltd., UK.
6. E.A. Rawlins Ed.,”Bentley’s Textbook of Pharmaceutics”, 2010, Elsevier Publications.
7. S.J.Carter Ed.,”Tutorial Pharmacy -Cooper & Gunn”, 6th edition,1986, CBS Publishers & distributors, India.
8. Pharmacopeias -IP, BP, USP -latest editions
9. Harry’s Cosmeticology Edited by J. B. Wilkinson and R. J. Moore, Longman Scientific & Technical Publishers
10. Co smetics Science and Technology, Edited by M. S. Balsam, E. Sagarin, S. D. Gerhon, S. J. Strianse and M. M. Rieger, Volumes
1,2 and 3.Wiley -Interscience, Wiley India Pvt. Ltd.
11. Poucher’s Perfumes, cosmetics & Soaps, Editor - Hilda Butler, Klewer Academic Publishers,Netherlands
12. Cosmetic Technology, Ed. By S. Nanda, A. Nanda and R. Khar, Birla Publications Pvt. Ltd., New Delhi
13. Encyclopedia of Pharmaceutical Technology, Vol. 6, Eds. James Swarbrick, James C. Boylan, Marcel Dekker Inc.
14. BIS Guidelin es for different cosmetic products.
15. Formulation and function of cosmetics by Jellinek Stephan, Wiley Interscience.
16. Remington: The Science and Practice of Pharmacy, Lippincott Williams & Wilkins, 2006 .
BPH_C_503_T – Pharmaceutical Biotechnology - (4 Hr/Wk)
Course Objectives
On completion of following theory topics, learner should be able to understand basic of modern biotechnology, fermentation te chnology,
enzyme technology and immunology, working of tools used in molecular biotechnology, applicatio ns of conventional, modern
biotechnology in pharmaceutical industries.
Course Outcomes
1. To discuss the tools, techniques, ethics and environmental safety involved in gene cloning, and the applications of Recomb inant DNA
technology
2. Discuss basics of immunology and explain the antigen -antibody interactions and defense mechanism and explain technique of
monoclonal antibodies production for treating the human diseases
3. Study fermentation technology and understanding the basic concepts for production of safer vaccines and antibiotics
4. To study different techniques and applications of microbiological assay, enzyme immobilization and cell culture
No. Details Hours
1 Introduction to Biotechnology 1
1.1 Definitions, scope, relevance to Pharma Industry.
1
2 Fermentation Technology 5
2.1 Types of fermenters (mechanically stirred, air -lift, tray), Batch and continuous
fermentation, design of fermenter, factors affecting fermentation (innoculum
preparation, temperature, pH, media composition, aeration, agitation, antifoam agents,
strain optimization, growth kinetics), Example of products of fermentation (microbial,
animal and plant), and downstream process. 4
2.2
Production of penicillin
Self-study: Production of dextran, Vitamin B12 1 5.2 Raw materials including water, Oils, Fats, Waxes, Emulsifiers, Thickeners and Gums, colours,
antioxidants, preservatives, perfumes, Fragrance selection, stability and Testing 3
5.3 Microbiological aspects of cosmetics. 1
5.4 Safety testing and toxicology, Efficacy Testing
Instrumental and Sensorial Evaluation of cosmetics 2
5.5 Labelling, Legislation and regulations for cosmetics (Drug and Cosmetics Act, 1940 & Rules 1945), BIS
specifications 1
TOTAL 48
3 Recombinant DNA technology 10
3.1 Steps involved in rDNA technology, Enzymes involved in DNA technology, Cloning
vectors (Plasmid, Cosmid, YAC), Gene expression System 7
3.2 Application of rDNA technology and genetic engineering for production of
pharmaceutical products e.g. Hormone (Insulin), Hepatitis B (Vaccines) and Interferon.
Self-study: Preparation of a list of approved biotech derived products. 3
4 Techniques used in molecular biology 7
4.1 Introduction to following molecular biology tools.
Polymerase chain reaction, DNA sequencing (Sangers dideoxynucleotide method and
Maxam and Gilbert method), Restriction Fragment Length Polymorphism, cDNA
library, Blotting techniques (Southern, Northern and Western blotting), Gene therapy. 6
4.2 Transgenic animal, transgenic plants, ethics in Biotechnology and disposal of biological
waste
Self-study: SDS - PAGE. 1
5 Enzyme and cell immobilization. 5
5.1 Methods for enzyme immobilization (adsorption, covalent binding, entrapment,
microencapsulati on) with examples and its applications in Pharmaceutical Industries. 2
5.2 Biosensor - Working and applications in Pharmaceutical Industries e.g. glucose oxidase,
penicillinase. 2
5.3 Use of microbes in industry. Production of Enzymes -General consideration e.g Amylase 1
6 Immunology 11
6.1 a) Host -microbe interactions, Introduction to terms -infection, infestation, pathogen,
resistance, susceptibility etc.
b) Factors affecting pathogenicity and infection,
c) Innate defense mechanism – first line of body defense, physiological phenomena -
inflammatory response, fever, cellular, mediators; soluble (humoral) mediators,
phagocytosis.
d) Specific defense Mechanism – Characteristics, Antigen, Cell -mediated immunit y,
humoral immunity.
e) Antibody structure and types, pathways of immune response, clonal selection theory.
Self-study: Innate defense mechanism, Specific defense Mechanism, organization of
immune system -organs & cells involved. 5
6.2 Serology -Precipitation, agglutination, complement fixation tests, immunofluorescence,
RIA, ELISA. 2
6.3 Introduction to Hypersensitivity & Allergy. Immunodeficiency states - Primary &
acquired, autoimmunity.
Hybridoma technology – Production and application of mo noclonal antibodies. 4
7 Vaccines & Sera 4
7.1 Definitions and classification, outline of general method of preparation of bacterial &
viral vaccines, typical examples of each type (diphtheria, TAB, polio), antisera (anti -
tetanus sera) 2
7.2 Q. C. aspects, Storage conditions and Stability of official vaccines, recent trends in
vaccines (recombinant vaccines)
Self-study: Outline of general method of preparation of BCG and rabies vaccine 2
8 Cell culture (plant and animal) 2
8.1 Tissue cultur e media, primary cell culture, continuous cell culture, pharmaceutical
applications of animal cell culture. 2
9 Microbial biotransformation 1
9.1 Introduction to Microbial biotransformation and Applications. 1
10
10.1 Introduction to Bioinformatics
Definition, History and Application of Bioinformatics in Pharmaceutical Industry. 2
TOTAL 48
Books:
Latest editions of the following books to be adopted.
1. R. C. Dubey, A textbook of biotechnology
2. B. D. Singh, Biotechnology.
3. S. P. Vyas and Dixit, Pharmaceutical Biotechnology, CBS publisher & distributers.
4. S. S. Kori, Pharmaceutical Biotechnology.
5. H. D. Kumar, Biotechnology, Affiliate East -West press Pvt. Ltd New Delhi.
6. Ananthnarayan, A textbook of microbiology, Orient Longman Pvt. Ltd.
7. W. B. Hugo and A. D. Russell, Pharmaceutical Microbiology, Blackwell Science.
8. David, Nelson, Lehninger - Principle of Biochemistry, W. H. Freeman & Co.
9. Pelezar, Chan & Krieg, Microbiology -Concepts and Applications, International Edn., McGraw Hill, Inc.,
10. Weir Stewart: Immunology, Churchill Livingstone.
11. Chandrakant Kakote, Pharmaceutical Biotechnology.
12.Desmond S.T. Nicholl, An introd uction to genetic engineering, Panima Publishing Corporation, New Delhi.
13. Stanbury F. P., Whitakar A., and Hall J.S. Principles of fermentation technology,2nd edition. Aditya books LTD., New Delhi.
BPH_C_504_T – Pharmacology II - (4 Hr/Wk)
Course Prerequisites
Basic knowledge of receptors and their physiological role in the human body.
Understanding of concepts of immunology and endocrinology.
Basic knowledge about blood and blood components.
Course Objectives
1. Study of drugs used in treatment of Ba cterial, fungal, viral and microbial infections, cancer, HIV, endocrine and hematological
disorders.
Course Outcomes
1. Discuss pharmacology of drugs used in chemotherapy and justify the need for rational use of antimicrobials.
2. Explain pharmacology of drugs used as immunomodulators.
3. Explain pharmacology of drugs used in endocrine disorders & haematological disorders.
No. Details Hours
1 Chemotherapy 28
1.1 Introducti on to che mother apy including drug resistanc e. 2
1.2 Sulfonamides, trimethopri m, fluoroquinolones, nitrofurantoin. 3
1.3 Penicillins, cep halosporins and cephamycins. 3
1.4 Tetracyclines, chlora mpheni col, macrolides, clinda mycin, linezoli d, streptogramins and
fusidic acid. 3
1.5 Aminogl ycosides. 2
1.6 Antifungal agents. 2
1.7 Antiviral agents. 3
1.8 Chemotherapy of tuberculosi s and leprosy. 3
1.9 Chemotherapy of malaria and a moebiasis. 3
1.10 Anthelmintic dru gs. 1
1.11 Chemotherapy of neoplastic diseases (Antic ancer drugs). 3
2 Immuno modulators 3
2.1 Immunology: Regulation of immune syste m, signaling pathways for its activation and
inhibition. 1
2.2 Immunost imulants and immuno suppressants. 2
3 Drugs in Endocrine Diso rders 11
3.1 Thyroid and anti-thyroid drugs. 2
3.2 Insulin, anti-diabetic a gents incl uding DPP -IV in hibitors. 3
3.3 Agents affecti ng bone mineral homeostasis. 2
3.4 Oxytocics. 1
3.5 Oral contrac eptives. 1
3.6 Corticosteroids 2
4 Drugs in Haematological Disorders 6
4.1 Drugs used in anemia. 2
4.2 Coagulants and anti-coagulants. 2
4.3 Thrombolytics and anti-platelet agent s. 2
TOTAL 48
Books:
Latest e ditions of the following books to be adopted
1. Good man & Gil man’s Ph armacological Basis of Therapeutics, McGraw H ill Companies Inc.
2. Sato skar R.S. Bhandarkar S.D. & Rege N. N. Pharmacology & Therapeutics, Pop ular Prakashan.
3. Ra ng & Dale P harmacology, Churchill Li vingstone.
4. Lipp incott’s Illustrated Revi ews: Pharmacolog y- Lippincott-Raven Howland & Nyeets Publishers NY.
5. La urence D. R. & Be nnett Cli nical Pharmacology, Elsevier NY.
6. Ku lkarni S. K. Handbook of Experimental Phar macolog y, Vallabh Prakashan, N ew Del hi.
7. Katz ung B. G. -Basic a nd Clinical Ph armacology, Appleton and Lange publicati ons.
8. Ghosh M. N. Fundamentals of E xperimental Ph armacology Hilton & Company, Kolkata.
BPH_C_505_L – Organic Chemistry Lab II - (4 Hr/Wk)
Course Objectives
1. To introduce the learner to the basic techniques of separation of compound mixtures.
2. To introduce the learner to the procedure for identification of organic compounds
3. To introduce the learne r to the methods for recrystallization of compounds
Course Outcomes
The learner will be able to:
1. To carry out the separation of simple compound mixtures.
2. To identify organic compounds based on simple tests
3. To recrystallize compounds use single solvent and binary solvent mixtures
List of Experiments:
1) Separation and quantification of binary mixtures by physical and chemical methods.
Identification of one component and confirmation by preparation of a suitable derivative.
Minimum eight binary mixtures, covering a wide variety of types to be studied
2) Theoretical aspects of recrystallization
3) Recrystallization of organic compounds: at least two with the use of different solvents.
Books:
Latest editions to be adopted
1. A laboratory handbook of organic qualitative analysis and separation, V.S. Kulkarni, S. P. Pathak, D.
Ramchandra & Co., Pune.
2. Text book of organic practical chemistry, V.S. Kulkarni, S. P. Pathak, D. Ramchandra & Co., Pune.
3. R. L. Shriner, R. C. Fuson and D. Y. Curtin, The systematic Identification of Organic compounds, 6th
Ed., Wiley, New York, 1980.
4. A. I. Vogel, A textbook of practical organic chemistry, 4th edition, Wiley New York, 1978.
5. Comprehensive Practical Organic Chemistry: Qualitative Analysis, V. K. Ahlu walia, S. Dhingra,
Universities Press (India) Limited, 2000.
6. Comprehensive Practical Organic Chemistry: Preparation and Quantitative analysis, V.K. Ahluwalia,
Renu Aggarwal, Universities Press (India) Limited, 2000.
BPH_C_506_L – Pharmaceutics Lab II - (4 Hr/Wk)
Course Objectives
To teach the learner the practical aspects of preparation and evaluation of biphasic suspensions and emulsions, semisolid oin tments
and creams, suppositories and aerosols formulations for pharmaceutical and cosmetic applications.
Course Outcomes
Upon completion of the course, the learner shall be able to:
1. Understand the formulation aspects of biphasic and semisolid dosage forms
2. Explain calculations involved in formulations
3. Describe the importa nce of quality evaluation of biphasics, semisolids, suppositories, aerosols
No. Details
Formulation and Preparation of the following:
1 Biphasics: Suspensions and Emulsions
1. Paracetamol Paediatric Oral Suspension IP
2. Dry suspension for reconstitution (any one)
3. Antacid Suspension
5. Liquid Paraffin Emulsion IP
6. White Liniment BPC/ Turpentine Liniment IP
7. Evaluation of any one suspension & one emulsion
Evaluation Parameters: Organoleptic Properties, Particle/droplet size, Sedimenta tion/Creaming volume ,
pH, stability studies, rheology of any one preparation
2 Semisolids
1. Compound Benzoic acid Ointment IP
2. Aqueous Calamine Cream IP
3. Cetrimide Cream IP
4. Diclofenac Gel BP
Evaluation of any one Ointment / Cream
3 Suppositories
1. Glycerin Suppositories USP
2. Paracetamol Suppositories BP/Indomethacin Suppositories IP /
Bisacodyl suppositories IP/ Aspirin Suppositories USP
Evaluation of any one suppository
4 Pharmaceutical Aerosols
Introduction to different devices for inhalation and demonstration of evaluation of a suitable commercial
product for simple tests related to spray and weight / drug content per discharge
5 Cosmetics: Preparation & Evaluation
1. Toothpaste
2. Clear liquid Shampoo
3. Lipstick/ Nail lacquer
4. Vanishing Cream/Cold cream
Books:
Latest Editions
1. Indian Pharmacopoeia, Indian Pharmacopoeia Commission, Government of India, Ministry of Health and Family Welfare.
2. The United States Pharmacopoeia
3. British Pharmacopoeia
4. Theory and Practice of Industrial Pharmacy by Liberman & Lachman
5. Pharmaceutical dosage form disperse system by Liberman & Lachman
6. Remington: The Science and Practice of Pharmacy, Lippincott Williams & Wilkins, 2006 .
7. Pharmaceutics - The science of dosage form design by M.E.Aulton, Churchill Livingston
8. Introduction to Pharmaceutical Dosage Forms by H. C.Ansel, Lea & Febiger, Philadelphia
9. Cosmetic formularies
BPH_C_507_L – Experimental Techniques in Microbiology and Biotechnology Lab - (4 Hr/Wk)
Course Objectives
To introduce the learner to some of the common techniques used in microbiological work and biotechnology experiments.
Course Outcomes
1. Characterization and identification of bacteria using various staining techniques (morphological study), colony characteri zation,
serological and biochemical characteristics
2. Analyze quality of raw material, food and water and assessment of extent of microbial contamination using counting tech nique and
Evaluate sterility of products.
3. To impart the knowledge of bioas say of antibiotic and test antibiotic sensitivity of few antibiotics.
LIST OF EXPERIMENTS:
1. Study of microscope and common laboratory equipment e.g., B.O.D. incubator, laminar air flow unit, aseptic hood, autoclave, hot -
air sterilizer, deep freezer, refrig erator.
2. Sterilization of glassware and preparation and sterilization of nutrient broth, agar slants, plates and inoculation techniques.
3. Isolation of pure culture by T plate, pour plate and streak plate methods. Colony characterization and growth patterns in broth,
slant.
4. Study various staining techniques such as Gram Staining, Spore, Negative staining, Cell wall staining, Capsule,
Motility by hanging drop technique.
5. Bacteriological analysis of water (IMVIC and MPN)
6. Test for sterility as per IP (Injection water/ nonabsorbent cotton/soluble powder/ear drops).
7. Antimicrobial assay of antibiotic using cup plate method, introduction to zone of inhibition and calculation.
8. Study drug resistance using antibiotic sensitivity testing
9. Biochemical tests (Catalase, Ox idase, Urease, Nitratase, Protease, Gelatinase, Phosphatase, Amylase).
10. Demonstration experiments
a. Thermal death time and thermal death point.
b. Effect of Ultra -Violet exposure on growth of E. coli.
c. Selection and isolation of bacteria by replica plating.
d. Widal test
e. Counting of bacteria by total count, viable count, and biomass determination methods
Books:
1. C. R. Kokare “Pharmaceutical Microbiology Experiments and Techniques”, Career Publication, Nashik.
2. R. S. Gaud and G. D. Gupta “Practical Microbiol ogy”, Nirali prakashan, Pune.
3. C. H. Collins, Patricia M. Lyne, J. M. Grange “Microbiological Methods “7th Edn. Butterworth ‐Heinemann Ltd, Oxford, London
ANY TWO SUBJECTS FROM THE FOLLOWING 2 CREDIT SUBJECTS TO BE CHOSEN AS
ELECTIVES FOR A TOTAL OF 4 CR EDITS
BPH_E_508_T – Nutraceuticals and Dietary Supplements -(2 Hr/Wk)
Course Objectives
1. To make the learner understand the concept of nutraceuticals and dietary supplements along with the classification with re spect to
health benefits, chemical nature and mechanism of action
2. To expose the learner to the health benefits of various class es of phytochemicals along with their salient chemical features,
pharmacokinetics, doses and marketed preparations
3. To introduce to the learner the formulation challenges of nutraceuticals and health supplements and the importance of the safety and
stabi lity of nutraceutical formulations
4. To make the learner aware of the regulatory aspects of nutraceuticals in India and major countries
Course Outcomes
Upon completion of the course student will be able to –
1. Explain concept of nutraceuticals and diet ary supplements, classify these based on chemical nature, health benefits and mechanism
of action
2. Discuss the chemistry of phytochemicals, their health benefits, pharmacokinetics, interactions with food and recommended d oses
along with the marketed preparations
3. Explain the challenges in formulating nutraceuticals
4. Understand the significance of safety and stability studies of nutraceuticals
5. Describe the labeling and regulatory aspects for manufacture and sale of nutraceutical products.
No. Details Hours
1 Introduction to Nutraceuticals
Definitions of Nutraceuticals, Functional foods, and Dietary supplements, Nutrigenomics. Link between Food and
Medicine. Food and No - food sources of nutraceutical factors, Nutraceutical factors in specific f oods. Classification
of Nutraceutical. Factors based on chemical nature and mechanism of action. Safety, Scientific evidence and market
trends: Local and Global.
Self-study: Public health nutrition, maternal and child nutrition, nutrition and ageing, nut rition education in
community, Limitations of Nutraceuticals 3
1
2 Phytochemicals as Nutraceuticals :
Occurrence, Structure, Properties, Metabolism and Pharmacokinetics, Therapeutic uses, Recommended Doses and
Marketed Preparations of following
a) Carotenoids - Lycopene, Lutein, Zeaxanthene, Astaxanthene
b) Phenolics and Polyphenolics as Antioxidants - - Reservetrol , Grapeseed
extract, Tea, Pycnogenol, Avenanthramides from Oats, Rutin, Soy Isoflavones,
Curcumin
c) Sulphur Compounds - Glucosinates
d) Prebiotics / Probiotics -Fructo -oligosaccharides, Lactobacillum.
e) Dietary fibres – Soluble and insoluble any two examples each.
f) Lignans – Flax Lignans
g) Essential Fatty acids - Fish oils, α - Linolenic acid from Flax.
h) Quinones - Tocopherol.
i) Prot eins and Minerals - Melatonin, Glutathione, Shilajit, Carnitine.
j) Marine nutraceuticals – Collagen from fish skin 9
3 Formulations and Challenges
Challenges involved in processing, extraction and concentration of nutraceutical constituents, formulations and
delivery systems, safety, storage and stability evaluation of formulations.
Labeling of Nutraceuticals 4
4 Safety and Toxicity of Nutraceuticals
Adverse Effects, Interactions, Adulteration - Intentional, counterfeiting, undeclared labeling, toxic cont aminants 3
5 Regulatory issues of Nutraceuticals and Dietary Supplements
a) EU, US and Indian guidelines.
b) Regulatory Aspects; FSSAI, FDA, FPO, MPO, AGMARK. HACCP and
GMPs on Food Safety. Adulteration of foods.
c) Pharmacopoeial Specifications for dietary supplements and nutraceuticals 4
TOTAL 24
Books:
1. Handbook of Nutraceuticals and Functional Foods, Second Edition, Eds Robert E.C. Wildman, CRC Press, Taylor and Francis
2. Nutraceuticals: A Guide for Healthcare Professionals, Brian Lockwood
3. Nutraceuticals in Health and Disease Prevention edited by Klaus Kramer, Peter -Paul Hoppe, Lester Packer, Marcel Decker New
York
4. Nutraceuticals: Efficacy, Safety and Toxicity edited by Ramesh C. Gupta Academic Press, Elsevier Publication
5. Handbook of Nutraceuticals Volume I: Ingredients, Formulations, and Applications edited by Yashwant Vishnupant Pathak, CRC
Press, Taylor and Francis
6. Nutraceuticals edited by Alexandru Grumezescu, Academic Press Elsevier
7. Nutraceuticals, Glycemic Health and Type 2 Diabetes, Eds Vijai K. Pasupuleti, James W. Anderson, Wiley Blackwell Publications
8. Regulation of Functional Foods and Nutraceuticals: A Global Perspective, Ed Clare M. Hasler, Blackwell Publishing
9. Developing New Functional Food an d Nutraceutical Products edited by Debasis Bagchi, Sreejayan Nair, Academic Press, Elsevier
Publishing
10. Phytosterols as Functional Food Components and Nutraceuticals, Ed Paresh C. Dutta, Marcel Decker Publishing
11. Phenolics in Food and Nutraceuticals, Fereidoon Shahidi, Marian Naczk, CRC press
12. Bioactive Proteins and Peptides as Functional Foods and Nutraceuticals, Eds Yoshinori Mine, Eunice Li -Chan, Bo Jiang, Wiley
Blackwell
13. Marine Nutraceuticals and Functional Foods, Ed Colin Barrow, Fereidoo n Shahidi, CRC press
14. Role of dietary fibres and nutraceuticals in preventing diseases, K. T Agusti and P.Faizal, B S Publication
15. Goldberg, I. Functional Foods . Chapman and Hall, New York.
16. Labuza, T.P. Functional Foods and Dietary Supplements: Safety, Good Manufacturing Practice (GMPs) and Shelf Life Testing in
Essentials of Functional Foods, Eds M.K. Sachmidl and T.P. Labuza, Aspen Press.
BPH_E_509_T – Microbial Genetics -(2 Hr/Wk)
Course Objectives:
1. To introduce the learner to the conceptual and practical tools for generating, processing and understanding biological genetic
information.
2. To develop a knowledge of the underlying theories of genetics and understanding of genetic exchange among prokaryotes.
3. To give the learner com petence in fundamental molecular biology theories and laboratory techniques.
Course Outcomes:
The learner should be able to -
1. Understand basic concepts of homologous recombination and genetic exchange among prokaryotes.
2. Understand natural plasmids an d transposons present in prokaryotes
3. Give an account of prokaryotic gene structure and the mechanisms controlling gene expression
No. Details Hours
1 GENETIC EXCHANGE - Gene transfer mechanisms in bacteria & homologous recombination
1.1. Transformation
i. Introduction and History
ii. Types of transformation in prokaryotes --Natural transformation in Streptococcus pneumoniae, Haemophilus
influenzae, and Bacillus subtilis
iii. Mapping of bacterial genes using transformation.
iv. Problems based on transformation.
1.2. Conjugation
i. Discovery of conjugation in bacteria
ii. Properties of F plasmid/Sex factor
iii. The conjugation machinery
iv. Hfr strains, their formation and mechanism of conjugation
v. F’ factor, origin and behavior of F’ strains, Sexduction.
vi. Mapping of bacterial genes using conjugation
(Wolman and Jacob experiment).
vii. Problems based on conjugation
1.3. Transduction
i. Introduction and discovery
ii. Generalised transduction
iii. Use of Generalised transduction for mapping genes
iv. Specialised transduction v. Problems based on transduction
1.4. Recombination in bacteria
General/Homologous recombination
i. Molecular mechanism
ii. Holliday model of recombination
Site –specifi c recombination 12
3
3
3
3
2 PLASMIDS, TRANSPOSONS & OPERONS (REGULATION)
2.1. Plasmids
a. Physical nature
b. Detection and isolation of plasmids
c. Plasmid incompatibility and Plasmid curing
d. Cell to cell transfer of plasmids
e. Types of plasmids
i. Resistance Plasmids,
ii. Plasmids encoding Toxins and other Virulence characteristics 12
3
iii. col factor
iv. Degradative plasmids
2.2. Transposable Elements in Prokaryotes
a. Insertion sequences
b. Transposons
i. Types
ii. Structure and properties
iii. Mechanism of transposition
iv. Transposon mutagenesis
c. Integrons
2.3. Lac operon and problems on Lac operon, Trp operon
3
6
TOTAL 24
Books:
1. Peter J. Russell (2006), “Genetics -A molecular approach”, 2nd ed.
2. Benjamin A. Pierce (2008), “Genetics a conceptual approach”, 3rd ed., W. H. Freeman and company.
3. R. H. Tamarin, (2004), “Principles of genetics”, Tata McGraw Hill.
4. D. Nelson and M. Cox, (2005), “Lehninger’s Principles of biochemistry”, 4th ed., Macmillan worth Publishers.
5. M. Madigan, J. Martinko, J. Parkar, (2009), “Brock Biology of microorganisms”, 12th ed., Pearson Education International.
6. Fairbanks and Anderson, (1999), “Genetics”, Wadsworth Publishing Company.
7. Prescott, Harley and Klein, “Microbiology”,. 7th edition Mc Graw Hill international edition.
8. Robert Weaver, “Molecular biology”, , 3rd edn. Mc Graw Hill international edition.
9. Nancy Trun and Janine Trempy, (2004), “Fundamental bacterial genetics”, Blackwell Publishing
10. Snustad, Simmons, “Prin ciples of Genetics”, 3rd edn. John Wiley & sons, Inc.
BPH_E_510_T – Biochemistry III - (2 Hr/Wk)
Course Prerequisites
Basic knowledge of Cell Biology, Microbiology
Course Objectives
To introduce the learner to the details of DNA replication, DNA transcription and RNA translation, Gene regulation, DNA mutation,
and DNA repair
Course Outcomes
The learner will be able to:
1. Explain how DNA topology and chromatin structure affects the processes of DNA replication, repair, and transcription
2. Compare and contrast the mechanisms of bacterial and eukaryotic DNA replication, transcription, and translation.
3. Describe mechanisms by which DNA can be damaged, mutated and describe the molecular mechanisms by which protein complexes
repair different forms o f DNA damage
4. Explain the molecular mechanisms behind different modes of gene regulation in bacteria
No. Details Hours
1 Genome organization in prokaryotes and eukaryotes: Structure of DNA, RNA, Chromosome, chromatin,
mitochondrial genome. Justification of the large nature of the genome, genome complexity, tandem
repeats, micro and mini satellites 2
2 Replication of DNA: Details of DNA replication, differences between prokaryotes/eukaryotes. Semi -
conservative DNA replication, DNA Polymerases and its role, E. coli Chromosome Replication,
Bidirectional Replication of Circular DNA molecules. Rolling Circle Replication, D -Loop model for
replication.
DNA Replication in Eukaryotes and differences with respect to prokaryotes.
DNA Recombi nation – Holliday Model for Recombination Transformation. Examples of drugs
modulating these pathways (polymerase inhibitors, telomerase inhibitors, topoisomerase inhibitors) and 8
polymorphisms involved in disease states. Brief description of telomeres and telomerase activity. DNA
polymorphisms and SNPs.
3 Transcription in prokaryotes and eukaryotes, (role of proteins and factors of transcription), RNA splicing
and RNA 2
4 Translation in Prokaryotes and Eukaryotes: Steps of translation, Initiation of translation, initiation factors,
role of Met -tRNA, elongation and its factors, termination and protein stability. Drugs modulating
translation. 2
5 Transcriptional and translational differences in prokaryotes and eukaryotes especially with respect to post ‐
transcriptional and post ‐translational modifications. Examples of drugs modulating these pathways with
emphasis on protein synthesis inhibitors used as drugs. Discussion of solid phase peptide synthesis,
peptide synthesizers and comparison between biosynt hesis and chemical synthesis 4
6 DNA Repair: Photo repair, Base Excision Repair, Nucleotide Excision Repair, Mismatch Repair, SOS
Repair and Recombination Repair 2
7 Definition and Types of Mutations. Mutagenesis and Mutagens. (Examples of Physical, Chemical and
Biological Mutagens) 2
8 Gene regulation in prokaryotes, operon models, Gene regulation in eukaryotes, gene activators,
enhancers and silencers, Lac Operon and Catabolite repression 2
TOTAL 24
Books:
1. Meyers, R. A., Molecular Biology and Biotechnology, Wiley -VCH, 2000.
2. Lodish, H. Molecular Cell Biology, 6th Edition, W. H. Freeman and Co., NY, USA.
3. Rose, P. Molecular Biotechnology, Panima, 2000.
4. Brown, T. A., Molecular Biology, Vol. I and II, Academic Press, 2000.
5. B. Lewin, Genes IX, 9th Edition, Jones and Barlett Pub., USA, 2007.
6. Watson J. D. Molecular Biology of the Gene, Benjamin Cummings; 6th Edition, 2007.
7. D,.Nelson and M.Cox, (2005), “Lehninger’s Principles of biochemistry”, 4th ed., Macmillan worth Publishers.
BPH_E_511_T – Synthon Approach - (2 Hr/Wk)
Course Objectives
1. To teach the learner to analyse a target structure in order to design a synthetic scheme.
2. To acquire the expertise toward synthesis by the manipulation of both activation methods and selectivity control.
Course Outcomes
1. Learner will also gain confidence for drawing the schematic retrosynthetic pathway from the course.
2. Learner will b e able to analyze the retrosynthetic scheme synthesis planning and route analysis for any given target molecule.
No. Details Hours
1.
Definition of retrosynthesis or disconnection approach, synthon, disconnection, synthetic
equivalent, functional group interconversion, functional group addition, functional group
removal. 1
2.
Guidelines for disconnection
a. Order of events
b. Reversal of polarity
c. Protecting groups 4
3.
3.1
3.2
3.3
Disconnection of simple alcohols, alkyl halide, ethers, olefins, esters, carboxylic acids,
aldehydes, ketones and amines.
Two group disconnections – 1,2-, 1,3-, 1,4- difunctionalized compounds
Strategies for synthesis of aromatic heterocycles pyrrole, thiophene, furan, pyridine,
pyrimidine 8
3
3
2
4 Design of retrosynthesis of drugs: Paracetamol, benzocaine, sulfadiazine, ibuprofen,
propranolol, nifedipine, isoniazid, ranitidine, diphenhydramine 4
TOTAL 24
Books:
1. Designing organic syntheses: A programmed introduction to the synthon approach, Stuart Warren; Wiley India Pvt Ltd., 2012
2. Designing Organic Syntheses: A Programmed Introduction to the Synthon Approach; Stuart Warren ; ISBN: 978 -0-471-99612 -5,
285 pages, January 1991
3. Organic Synthesis the Disconnection Approach, Stuart Warren , 391pages, ISBN 0 471 10161 3 Paper 1982 by John Wiley and Sons
LTD
4. Synthesis of Drug, A synthon approach by Radhakrishnan P. Iyer & Anant v. prabhu, 1st Edition, (1985) Sevak Publications,
Mumbai.
5. Clayden and Greeves, Organic Chemistry, Oxford University Press (2001)
6. site for solving synthon problems
http://highered.mheducation.com/sites/0073375624/student_view0/chapter22/synthesis_problem_1 -2.html
BPH_E_512_T – Cosmeticology - (2 Hr/Wk)
Course Objectives
To provide the learner with knowledge of cosmeticology with respect to the types of formulations, evaluation and regulatory aspects
Course Outcomes
Upon completion of the course, the learner shall be able to:
1. Discuss the various raw materials for cosmetics
2. Understand the toxicological aspects and toxicity testing for cosmetics.
3. Discuss the various cosmetics products w.r.t. raw materials, large scale manufacturing and functional and physicochemical
evaluation
4. Know the regulatory guidelines and sensorial assessment for cosmetics
No. Details Hours
1. General Aspects of Cosmeticology 5
1.1 Definition of Cosmetics, historical background, classification
Structure of skin, hair, nails, teeth; Regulatory aspects - Schedules to Drug and
Cosmetics Rules - M II, S, Q; BIS specifications, Marketing aspects of Cosmetics 2
1.2 Raw materials including oils, fats, waxes, colours, perfumes, antioxidants, preservatives,
surfactants, and water, herbal ingredients (Self study and follow up) 1
1.4 Toxicology of cosmetics -irritation and sensitization reactions to cosmetics, sensitivity
testing and safety aspects 2
2. Cosmetic formulations: Raw materials, formulation, and functional evaluation of:
a) Skin creams -- Cleansing, cold, vanishing, moisturizing, hand and body
products, Face packs, antiacne, antiwrinkle, bleach products
b) Protective preparations - Barrier products; sunscreen, suntan & anti -sunburn
products, insect repellants.
c) Coloured cosmetics -Foundation products, face powders, lipsticks, rouge, eye
cosmetics (Large scale manufacture of lipsticks and face powders, including
compact face pwder)
d) Nail specialty products -cuticle softener, nail bleach, nail strengthener, nail
whites, nail lacquer
e) Hair care products -Shampoos (including antidandruff & anti lice), hair
grooming products [hair setting products, hair sprays, hair tonics, hair
conditioners, hair rinses, hair waving & hair straightening products (principles),
hair colorants]
f) Depilatories & Shaving products (Wet, Dry & After shave)
g) Oral and personal hygiene preparations -tooth powder, tooth paste, mouth
washes, denture cleansers, bath products (soaps, bath salts, bubble baths,
shower gels, body washes, anti -perspirants &deodorants
h) Baby toiletr ies-oils, creams, lotions, shampoos, powders 17
3
2
4
1
3
1
2
1
6. Sensorial evaluation of cosmetics - concept and need, sensory perception, requirements
for sensory testing, methods used, interpretation and documentation/representation. 2
TOTAL 24
Books :
Latest editions
1. Harry’s Cosmeticology Edited by J.B. Wilkinson and R. J. Moore, Longman Scientific & Technical Publishers
2. Cosmetics Science and Technology, Edited by M.S. Balsam, E. Sagarin, S.D. Gerhon, S.J.Strianse and M.M.Rieger, Volumes 1,2
and 3.Wiley -Interscience, Wiley India Pvt. Ltd.,2008
3. Poucher’s Perfumes, Cosmetics & Soaps, 10th Ed, Editor - Hilda Butler, Klewer Academic Publishers, Netherlands, 2000
4. Cosmetic Technology, Ed. By S.Nanda, A. Nanda and R. Khar , Birla Publications Pvt. Ltd., New Delhi, 2007
5. Handbook of Cosmetic Science and Technology, edited by M. Paye, A.O.Barel, H. I. Maibach, Informa Healthcare USA,Inc. 2007 .
6. Encyclopedia of Pharmaceutical Technology, Vol. 6, Eds. James Swarbrick, James C. Boylan, Marcel Dekker Inc., 1992
7. Kemp S.E., Hollowood T, Hort J., “Sensory evaluation -A practical handbook,” John Wiley & Sons, 2009.
8. Sensory Evaluation Techniques, Fourth Edition , Morten C. Meilgaard , B. Thomas Carr , Gail Vance Civille , CRC Press
9. ISO 13299:2016(en) Sensory analysis — Methodology — General guidance for establishing a sensory profile
10. BIS Guidelines for different cosmetic products.
11. Formulation and function of cosmetics by Jellinek Stephan, Wiley Interscience.
BPH_E_513_T – Packaging of Pharmaceuticals - (2 Hr/Wk)
Course Objectives
To provide the learner with knowledge of types of packaging materials, and packaging methods for Pharmaceuticals, evaluation and
regulatory guidelines for the same.
Course Outcomes
Upon completion of the course, the learner shall be able to:
1. Classify Packaging materials and explain the functions and design aspects
2. Discuss the different primary and ancillary packaging materials, their functions and evaluation
3. Elaborate on labelling aspects of pharmaceuticals
4. Discuss sterilization and stability of packaging materials.
No. Details Hours
1.0 Introduction to Packaging, Classification of Packaging materials into Primary & secondary
packaging, Essential Requirements, Functions of Packaging, Properties of Ideal Package,
Packaging formats in Pharma Industry, Packaging recycling symbols, FDA Definit ion;
Approach to package design. 3
2.0 Packaging Materials 21
2.1 Glass : Glass types, their manufacture, chemical composition, Performance testing and quality
control, Defects. 2
2.2 Plastics & polymers: Classification, physio -chemical, mechanical and biological properties,
Additives and fabrication processes, Plastic containers for Parenteral and transfusion sterile
drip kits, ophthalmic products; disposable devices. Quality control testing and issues related
to leachables, biocompatibility, biodegrada tion, environmental safety; evaluation aspects -
performance and toxicity 3
2.3 Metals: Aluminum and tinplate cans, drums and collapsible tubes. Aerosol containers,
Lacquering, coating and lining 2
2.4 Flexible packaging: Materials and laminates, Co -extrud ed films, foils, coating and laminates,
shrink and stretch films, blisters including ALU - ALU blisters and Strip Packaging. 2
2.5
Strip and Blister Packaging -
Strip Packs - High Barrier Laminates, Strip Packaging Process, Properties of Materials, Child -
resistant strip package, Strip Sealing Machine, Strip Packing Machinery, Multi -Dose
Strip Packaging
Blister packs - Design parameters, Materials, Formation, Types of Blisters, Advantages and
disadvantages of Blister Packaging, Types of Problems/ Defe cts, Blister Packing
Machine, Other packages -shrink wrapping and stretch wrapping, sachets. 3
2.6 Caps and Closures: Types of caps, closures, liners, child resistant caps.
Elastomeric closures for parenterals, classification of Elastomers, physical chemical and
biological properties and their quality control. 2
2.7 Corrugated and solid fibre boards and boxes, Paper and paperboard
and Quality control, Common defects 1
3.0 Ancillary materials in packaging - 1
Cushioning materials -applications for impact, vibration, temperature & humidity protection
Fasteners, tapes
4.0 Sterilization of containers and closures 1
4.0 Labels and labelling :
Types of labels, adhesives,
Printing of labels - printing inks, toxicity and safety of printing inks, inject and bar coding and
printing of labels,
Quality control and common defects in printing of labels 2
5.0 Stability of Packages
Introduction, Legislation, Regulation, Pharmaceutical Stability Testing in Climatic Cabinets,
Pharmaceutical Stability Testing Conditions, Photo -Stability Testing, Review of
Pharmaceutical Product Stability, Packaging and the ICH Guidelines 2
TOTAL 24
Books:
Latest editions
1. D. A. Dean, Roy Evans, Ian Hall. Pharmaceutical packaging technology. Tylor and Francis, London.
2. Edward J. Bauer, Pharmaceutical Packaging Handbook. Bausch and Lomb, Rochester, New York, USA.
3. Wilmer A. Jenkins, Kenton R. Osborn. Packaging drugs and pharmaceuticals.
4. Salvatore J. Turco, Sterile dosage forms : their preparation and clinical applications
5. Remington: The Science and Practice of Pharmacy, Lippincott Williams & Wilkins, 2006 .
6. Michael E. Aulton, Kevin Tylor (Ed.). Aulton’s Pharmaceutics: The design and Manufacture of Medicine.
7. Gilbert Banker and Christopher Rhodes. Modern Pharmaceutics.
8. Leon Lachman; Lieberman Herbert A.; Kanig, Jose ph L. The theory and Practice of Industrial Pharmacy.
9. Hanlon J., Robert J. Kelsey, “Handbook of Package Engineering” 2nd Edition, McGraw -Hill, New. York. 1984
10. Paine A., “Packaging User's Handbook”, Springer, 1990
11. K. Avis, Liberman and Lachman, Pharmaceutical Dosage Forms: Parenterals, Vol. I, Marcel Dekker, Expanded ad revised edition,
2008.
SEMESTER -VI
BPH_C_601_T – Pharmaceutical Chemistry I - (4 Hr/Wk)
Course objectives
1. Learn about pharmacodynamic attributes like drug targets, drug -recepto r binding, proteins as drug targets, receptors and enzyme as
drug targets, nucleic acids as drug targets and metabolism of drugs
2. Learn how physicochemical properties / QSAR play role to design and optimize the structure of leads
3. Learn about the Drug Metabolism, types of Phase I and Phase II Reactions by taking suitable drug examples
4. Learn structure including stereochemistry, chemical name, SAR, metabolism, mechanism of action and selected synthesis of a nti-
infective agents like antibiotics, sulfon amides and fluoroquinolones
5. Learn structure including stereochemistry, chemical name, SAR, metabolism, mechanism of action and selected synthesis of
antiparasitic agents like antimalarials, antitubercular, anthelmintics, amoebiasis, giardiasis, trichomo niasis, pneumocystis,
trypanosomiasis, leishmaniasis and fungi
Course outcomes
Learner will be able to :
1. Identify and study the suitable drug targets for treatment of disorders
2. Identify the relationship between the physicochemical properties of the chemical entity and biological response
3. Draw a schematic metabolic pathway for any given drug
4. Identify the SAR of all the classes of antimalarial, antitubercular, anti -infective, antibiotic, antiparasitic disorders
No. Details Hours
1 Pharmacodynamics
1.1 Drug Targets at Molecular Level –
Lipids, Carbohydrates, Proteins and Nucleic Acids as drug targets 2
1.2 Intermolecular Bonding Forces like Electrostatic, Hydrogen Bonding, van der Waal’s
Interactions, Dipole -dipole and Ion -dipole Interactions and Hydrophobic Interactions 3
2 Proteins as Drug Targets
2.2 Proteins as Drug Targets / Drugs
Monoclonal Antibodies, Peptides
Introduction to Proteomics 2
2.3 Enzymes as Drug targets
2.3.1 Enzyme Inhibitors – Reversible and Irreversible (Self Study) 1
2.3.2 Enzyme Inhibitors against microorganisms, viruses, body’s own enzymes 1
2.4 Receptors as Drug Targets
2.4.1 Types of Receptors and signal transduction - Ion Channels, G -Protein Coupled Receptor
(GPCR), Kinases, Nuclear Receptors 6
2.4.2 Concept of Agonist, Antagonist, Partial agonist, Inverse agonist, Concept of
desensitization/sensitization, Tolerance, Affinity, Efficacy, Potency (Self Study) 1
3 Nucleic Acids as Drug target
3.1 Primary, Secondary and Tertia ry Structure of DNA (Self Study) 1
3.2 DNA Intercalation, DNA Alkylation, Antisense Therapy 1
4 Pharmacokinetics and Physicochemical Properties of Drug Action
4.1 Solubility, Partition Coefficient, Acidity -Basicity, pK a, Bioisosterism, Stereochemistry
(geometrical, optical and conformational), Protein Binding 2
4.2 Drug Metabolism – Phase I and Phase II Reactions 6
Discussion on the following classes of drugs including classification, chemical nomenclature, structure including
stereochemistry, generic names, chemistry, SAR, metabolism, molecular mechanism of action, introduction to
rational development, drug resistance, if any, of following classes of drugs
5. Anti -infective Agents
5.1 Antibiotics
Penicillins (natural and semisynthetic penicillins like Penicillins G, Penicillins V,
ampicillin*, amoxicillin, cloxacillin*, oxacillin, naficillin, methicillin and ampicillin
prodrugs like bacampicillin and hetacillin);
β-lactamase inhibitors like clavulinic acid, (self study – tazobactam)
Cephalosporins (cephalexin, cefadroxil, cefazolin, cefamandole, cefoxitin, cefuroxime,
cefotaxime, ceftriaxone, cefpodoxime proxetil)
Tetracyclines (tetracycline, chlortetracycline, oxytetracycline, doxycycline, and
minocycline and its prodrug – rolitetracycline); Macro lides, (erythromycin,
roxithromycin, azithromycin - only highlights of structure to be discussed); 7
Aminoglycosides (gentamicins, and neomycins, - only highlights of structure to be
discussed);
Only highlight the structures of the following compounds: Carb apenems (Emepenem,
Meropenem) Monobactams (Aztreonam, Tigemonam) Linezolid,
5.3 Fluoroquinolones
Norfloxacin, ciprofloxacin*, sparfloxacin, gatifloxacin, levofloxacin, lomefloxacin 2
6 Antiparasitic Agents
6.1 Antimalarial Agents
Natural products lik e cinchona alkaloids (with stereochemistry and drug action) and
artemisinin and its derivatives like artether, artemether and artesunate, Synthetic
antimalarials such as 8 - aminoquinolines eg. primaquine*, 4 - aminoquinilines eg.
chloroquine*, Quinoline met hanols eg. mefloquine; misc like halofantrine, lumefantrine
and; DHFR inhibitors like pyrimethamine* and proguanil, cycloguanil, atovaquone,
sulfadoxine
Combination therapy. 3
6.2 Drugs for treatment of amoebiasis, giardiasis and trichomoniasis (Self Study)
Metronidazole*, tinidazole, secnidazole, diloxanide furoate*, nitazoxanide 1
6.3 Anthelmintics (Self Study)
Albendazole, Mebendazole*, Thiabendazole, Diethylcarbamazine, Ivermectin,
Praziquantel, Pyrantel Pamoate 1
7 AntiMycobacterial Agents
Antitubercular drugs
PAS*, ethionamide, isoniazid, pyrazinamide, ethambutol*, antitubercular antibiotics
(streptomycin, rifampin, rifapentine, capreomycin, cylcoserine – the first four only
highlights of structure to be discussed), fluoroquinolones, bedaquiline, Antileprotic drugs
Dapsone*, clofazimine, rifampin, Combination therapy 4
8 Antifungal Agents
Natural products like griseofulvin, amphotericin B and nystatin (later two only general
aspects of structure related to activity)
Antifungal azoles like clotrimazole*, ketoconazole, fluconazole, and itraconazole
Allyl amines like naftifine, and terbinafine,
Flucytosine
Miconazole, econazole, flutrimazole, sulconazole, sertaconazole, voriconazole, butenafine
and tolnaftate (Self -Study) 3
1
TOTAL 48
Books:
Latest Editions of the following books should be used.
1. ‘An Introduction to Medicinal Chemistry’, Graham L. Patrick, Oxford University Press, (Latest Edition)
2. ‘Fundamentals of Medicinal Chemistry’, Gareth Thomas, Wiley, New York, (Latest Edition)
3. ‘The Organic Chemistry of Drug Design and Drug Action’, Richard B.Silverman, Academic Press
4. ‘Foye’s Principles of Medicinal Chemistry’, Thomas L. Lemke, David A Williams, Lippincott Williams & Wilkins
5. ‘Wilson and Gisvold’s Textbook of Organic Medi cinal and Pharmaceutical Chemistry’, John M. Beale, John H. Block,
Lippincott Williams & Wilkins.
6. ‘Medicinal Chemistry’, Ashutosh Kar, New Age International Publishers
7. ‘Introduction to Medicinal Chemistry’, Alex Gringauz, Wiley
8. ‘The Organic Chemistry of D rug Synthesis’, Daniel Lednicer, Lester A. Mitscher, John Wiley and Sons
9. Pharmaceutical Chemistry, Volume 1, Organic Synthesis, H. J. Roth & A. Kleemann, Ellis Horwood Series in
Pharmaceutical Technology, Halsted Series.
10. ‘Synthesis of Essential Drugs’, Ruben Vardanyan and Victor Hruby, Elsevier
11. ‘Pharmaceutical Substances: Syntheses, Patents, Applications’, Kleemann & Engel, Thieme Publications.
BPH_C_602_T – Pharmaceutics III - (4 Hr/Wk)
Course Objectives
To familiarize the learner with various aspects of formulation development, large scale manufacturing and evaluation of solid oral
dosage forms. Also to teach the learner the important aspects of stability, quality control and quality assurance.
Course Ou tcomes
Upon completion of the course, the learner shall be able to:
1. Know the various solid oral dosage forms and their manufacturing techniques
2. Know various considerations in development of pharmaceutical dosage forms including stability
3. Formulate solid d osage forms and evaluate them for their quality
4. Understand the responsibilities of quality assurance & quality control departments
5. Appreciate the importance of documentation
Books: No. Details Hours
1 TABLETS 15
1.1 Definition, advantages and limitations, ideal characteristics of tablets
preformulation aspects;
Types of tablets -Effervescent, buccal, chewable, sublingual,
dispersible, soluble, orodispersible, compression coated and layered tablets.
2
1.2 Tablet formulation and design, additives, excipients with examples. 3
1.3 Manufacture of tablets -
Direct compression, wet granulation, dry granulation;
Characterization and evaluation of granules
Large scale manufacturing process and equipment for: Mixing, drying,
wet granulation, slugging and roller compaction. T ablet tooling
Compression – (Single station tablet press and Rotary press), physics of tablet
compression (brief. Only the steps. No equations)
Layout of tablet section 6
1.4 Processing problems in tableting and tablet defects. 1
1.5 Packaging & labelling of solid dosage forms (tablets & capsules) - strip, blister & bulk packaging, including
flexible packaging materials (laminates), and equipment used (schematic). 1
1.6 In process quality control tests for tablets. Evaluation of tablets as per
IP, BP, USP
2
2 COATING OF TABLETS 8
2.1 Need for tablet coating, tablet core properties. 1
2.2 Types of tablet coating: Sugar, Film & Enteric coating., compression coating
Materials, and processes employed 3
2.3 Coating equipment – Conventional & modified pans, coating columns (fluidized bed coating), Spray equipment & other accessories.
Equipment for compression coating (schematic) 2
2.4 Problems encountered in coating, coating defects & remedies (in all types of coatings) 1
2.5 Evaluation of coated tablets 1
3 CAPSULES 9
3.1 Definition, types of capsules, advantages and limitations, and raw materials including gelatin and HPMC.
Manufacture of gelatin & HPMC (Schematic representation of steps) 2
3.2 Hard capsule shells: Manufacturing of empty capsule shells (gelatin & HPMC) -schematic representation of
steps only ; Additives, size, sealing, size selection, storage, defects of shells, Quality evaluation of 1
of empty shells.
3.3 Hard capsule fill formulation aspects: , types of fill and excipients;
Large scale manufacturing steps with detailed study of Filling of hard capsule shells;
Filling equipments : classification -volumetric, dosator type and tamping type.
(one example of each type of equipment -schematic representation only).
Problems in caps ule filling & remedies
Layout of capsule section. Humidity control in capsule manufacturing and filling area.
Quality control aspects of hard capsules.
4
3.4 Soft gelatin capsules: Properties, nature of shell and contents,
Formulation aspects - types of fills and excipients, Concept (minim/gm)
Large scale manufacturing - Rotary Die Process, Quality control aspects of soft capsules 2
4 Stability Studies 7
4.1 Importance of stability studies, kinetic principles, Arrhenius equation and derivation of shelf life based
on Arrhenius equation, limitations and advantages of Arrhenius equation, 3
Latest
Editions
1. Pharmaceutical dosage forms - Tablets, volume 1 -3 by H.A. Liberman, Leon Lachman & J. B. Schwartz
2. Modern Pharmaceutics by Gilbert S. Banker & C.T. Rhodes.
3. Remington: The Science and Practice of Pharmacy, Pharmaceutical Science (RPS)
4. Theory and Practice of Industrial Pharmacy by Liberman & Lachman
5. Pharmaceutics - The science of dosage form design by M.E. Aulton, Churchill Livingstone.
6. Cole, Graham, “Pharmaceutical Production Facilities: Design and Applications”.
7. Drug stability - Principles and practice by Cartensen & C.J. Rhodes, Marcel Dek ker Series, Vol 107.
8. Quality Assurance Guide by organization of Pharmaceutical Products of India.
9. Quality Assurance of Pharmaceuticals - A compendium of Guide lines and Related materials Vol I, WHO Publications.
10. How to Practice GMP’s - P. P. Sha rma.
11. GMP for Pharmaceuticals, Sidney H. Willing, Marcel Decker Series
Note : References to latest amendments of Schedule M and Schedule U of Drugs and Cosmetics Act 1940 to be made wherever it is
appropriate
BPH_C_603_T – Pharmaceutical Analysis II - (4 Hr/Wk)
Course Objectives
On completion of following theory topics, learner should be able to describe the working principle, instrumentation and appli cations of
instrumental techniques useful for obtaining qualitative and quantitative information of an analyte and apply statistics for data analysis.
Course Outcomes
The students will be able to:
1. Comprehend underlying principle, instrumentation, application and limitations in instrumental techniques involving molecul ar as well
as atomic absorption and emission techniques such as UV -Visible, Fluorescence, Infra -Red, Raman, Atomic absorption spectroscopy
and Atomic emission spectroscopy.
2. Explain fundamentals, working principle and applications of X -ray diffraction techniqu e, potentiometric titrations and thermal
methods of analysis like TG, DSC and DTA.
3. Generalize the concepts and quality control aspects related to radiopharmaceuticals.
4. Calculate and interpret the results for spectral analysis and statistical data ana lysis.
No Details Hours
1 UV-Visible spectroscopy 10
1.1 Terms - Electromagnetic radiation, Visible light, electromagnetic spectrum, molecular spectra, absorption
spectroscopy, wavelength, wave number, frequency, absorbance, transmittance, auxochrome, bathochromic shift,
hypsochromic shift, hyperchromism, hypochromism, wavelength maxima, specific absorbance, molar
absorptivity, cut -off wavelength for solvents, isoabsorptive point, spectral bandwidth 2
1.2 Concepts -Types of absorbing electrons, electronic transitions.
• Beer -Lambert’s law -statement, derivation of mathematical expression, limitations
• Choice of solvents
• Chemical derivatization 2 4.2 Degradation pathways - hydrolysis, oxidation, photolytic degradation, methods to enhance stability of drugs
- Self-study with follow up. 1
4.3 Accelerated stability studies, introduction to ICH guidelines 2
4.4 Interactions with containers and closures 1
5.0 Quality Assurance: 6
Concepts of Quality Assurance & Quality Control, Responsibilities of Q.A. department.
Raw material control, actives and inactive, Q.C. standards for raw materials. (identity, purity,
quality and potency
Sanitization, environmental and microbiological control, packaging and labeling control, finished
product control,
Statistical Quality control -concept, Q.C. charts, sampling & Sampling Plans, Sampling tools.
6.0 Documentation
Documentation – need/importance, master formula records, batch manufacturing records, SOPs, Maintenance
& Retrieval of Documents. 3
TOTAL 48
1.3 Instrumentation of UV -VIS spectrophotometer:
Sources of UV -VIS radiation
Monochromators (Filters, prisms, gratings)
Sample cells
Detectors
Colorimeter and UV -VIS spectrophotometer (single beam and double beam with diagram) 3
1.4 Applications of UV -VIS spectrophotometry:
Application of Beer’s law in quantitative spectrophotometric assays -Single component assays -use of a
standard absorptivity value - use of a calibration graph -single and double point standardization
Measurement of Equilibria constant.
Measurement of rate c onstant. 2
1.5 Numericals based on Beer -Lambert’s law. 1
2 Fluorescence spectroscopy 4
2.1 Terms -singlet state, triplet state, fluorescence, phosphorescence and energy transitions, molecular emission
spectroscopy. 0.5
2.2 Origin of fluorescence and phosphorescence spectra
Fundamental equation for fluorescence intensity, factors affecting fluorescence intensity (intensity of radiation
source, quantum yield, molecular structure and rigidity, temperature, solvents, pH, dissol ved oxygen, quenchers
& concentration) 1.5
2.3 Instrumentation of fluorimeter:
Filter fluorimeter and Spectrofluorimeter (including Block diagram)
Sources of radiation
Monochromators (Filters, gratings)
Sample cells
Detectors
Quantitative applications: Fluorescent compounds and non -fluorescent compounds (Chemical derivatization to
fluorescent compound, e.g. use of Dansyl chloride, Fluoresamine, o -phthalaldehyde) & Choice of fluorimetry
over UV -Vis spectroscopy with respect to Sensitivity an d Specificity. 2
3 Infrared / Near IR spectroscopy 6
3.1 Theoretical concepts:
I.R regions, requirements for I.R. absorption, vibrational and rotational transitions, dipole changes, types
of molecular vibrations, potential energy diagrams (harmonic oscillator and anharmonic oscillator),
Vibrational frequency, factors influencing vibrational frequencies, force constants, vibrational modes
(normal mode, combination bands and overtone bands), fingerprint region
Instrumentation of FTIR
2
3.2
Sample preparation & applications of I.R. spectroscopy:
Sample preparation for I.R spectroscopy -Solids (mulling, pelleting and thin film deposition, and in
solution form), Liquids (Neat and in solution form).
Sample handling: Attenuated Total Reflectance and Dif fuse Reflectance.
Pharmaceutical applications of IR spectroscopy (including characteristic IR absorption frequencies of
some common bond types such as hydroxyl stretch, nitrile stretch and carbonyl stretch of aldehydes and
ketones, aliphatic and aromatic C -H stretch)
Pharmaceutical applications of Near IR spectroscopy including PAT (Process Analytical Techniques) 4
4 Raman Spectroscopy 4
4.1 Principle of Raman scattering
Comparison between I.R Spectroscopy and Raman Spectroscopy
Raman instrumentation -Sources of light, Sample illumination system (Liquid, solid and fiber optic
sampling), Block diagram of Raman spectrometer.
Applications 4
5 Atomic absorption spectroscopy (AAS) and Atomic emission spectroscopy (AES) 4
5.1 Terms: Atomic spectra, atomic absorption spectroscopy, atomic emission spectroscopy 0.5
5.2 Instrumentation:
For AAS: Radiation sources (Hollow cathode lamp, Electrode discharge lamps)
Plasma sources: Inductively coupled plasma and Direct current plasma source
For AES - Flame atomization (types of flames, flame structure, flame atomizers) 1.5
5.3 Interferences & Applications:
Cationic, Anionic and Physical interferences in Flame photometry
Spectral Interferences and Chemical Interferences in AAS.
Pharmaceutical applications 2
6 X-Ray Diffraction Technique 4
6.1 Fundamentals & Applications:
Fundamentals - Origin of X -ray, Bragg’s law and its mathematical derivation, Bravais lattices and Miller
indices
Pharmaceutical applications - Crystal structure determination, polymorphism 2
6.2 Instrumentation & working principle:
X-Ray source (X -ray tube source)
X-ray monochromator and detector 2
7 Radiochemistry and Radiopharmaceuticals 4
7.1 Terms: Properties of radionuclide, Radioisotope, Radioactive decay, half -life of radioactivity, specific
activity, Becquerel, curie, Sievert and Gray
Relative biological effectiveness, Radionuclidic purity, Radiochemical purity
Safety aspects of radiopha rmaceutical laboratory 1
7.2 Measurements of radioactivity - Geiger -Muller Counting, liquid Scintillation Counting
Requirements of radiopharmaceuticals - Properties of radionuclides, Pharmaceutical properties,
chemical properties
Radionuclide generator - 99m Tc generator
Quality control of radiopharmaceuticals: Physical, Chemical (Radionuclidic purity, Radiochemical
purity)
Radiochemical methods in analysis: Isotope dilution analysis (Direct and Inverse), Radioimmunoassay 3
8 Potentiometric titration 3
8.1 Construction and working of reference electrode (only Silver - silver chloride electrode to be studied)
Indicator electrode (only glass electrode to be studied)
Rejuvenation of glass electrodes
Potentiometric titrations (Only aqueous acid -base titrations -Strong acid vs strong base, strong acid vs
weak base, weak acid vs strong base, weak acid vs weak base)
Calibration of pH meter and measurement of pH
Determination of pKa by potentiometric titration 3
9 Thermal methods of analysis 4
9.1 Principle, Instrumentation, working and applications of:
a) Thermogravimetry (TG)
b) Differential thermal analysis (DTA)
c) Differential scanning calorimetry (DSC)
Factors affecting the above thermal methods of analysis 4
10 Statistical data handling 5
10.1 Norma l Distribution numerical based on:
Confidence limits and Tests of significance (F -test, Student t -test-paired and unpaired)
Linear regression analysis and correlation coefficient
Rejection of results (Q -test) 5
TOTAL 48
Books:
Latest editions of the following books to be adopted
1. D. A. Skoog, F. J. Holler and S. R. Crouch, Principles of Instrumental Analysis, Saunders College Publishing, USA.
2. K. A. Connors, A Textbook of Pharmaceutical Analysis, John Wiley and Sons, Canada.
3. A. H. Beckett and J. B. Stenlake, Practical Pharmaceutical Chemistry, Part I and II, CBS Publishers and Distributors, Indi a.
4. D. A. Skoog, D. M. West, F. J. Holler and S. R. Crouch, Fundamentals of Analytical Chemistry, Saunders College Publis hing,
USA.
5. G. D. Christian, Analytical Chemistry, John Wiley & Sons, Singapore, reprint by Wiley India Pvt. Ltd.
6. H. H. Willard, L. L. Merrit and J. A. Dean, Instrumental Method of Analysis, CBS Publishers and Distributors, New Delhi.
7. Ashutosh Ka r, Pharmaceutical Drug Analysis, New Age International (P) Ltd. Publishers, India.
8. S. S. Mahajan, Instrumental Methods of Analysis, Popular Prakashan Pvt Ltd., India.
9. G.R. Chatwal and S. K. Anand, Instrumental methods of chemical analysis, Revised a nd enlarged, Himalaya Publishing House Pvt.
Ltd.
10. Indian Pharmacopoeias, The Indian Pharmacopeia Commission, Ghaziabad, Government of India.
11. United States Pharmacopoeia.
12. J. Mendham, R. C. Denney, J. D. Barnes, M.J. K. Thomas, Vogel’s Textbook of Quantitative Chemical Analysis, 6th Ed., Pearson
Education Ltd.
13. D.G. Watson, Pharmaceutical Analysis –A textbook for pharmacy students and pharmaceutical chemists, Churchill Livingstone
Elsevier.
14. J.W. Robinson, E. M. S. Frame and G. M. Frame II , Undergraduate Instrumental Analysis, Marcel Dekker, New York, USA.
15. R. Kellnar, J. M. Mermet, M. Otto, M. Valcarceland, H. M. Widmer, Analytical Chemistry: A modern approach to analytical
science, Wiley -VCH, USA.
16. J. W. Munson, Pharmaceutical Anal ysis: Modern methods (in two parts), Marcel Dekker Inc., USA.
17. W. Kemp, Organic Spectroscopy, Reprinted, Palgrave Publishers Ltd., New York, USA.
18. R. M. Silverstein, F. X. Webster and D. J. Kiemle, Spectrometric identification of organic compounds, John Wiley & Sons, Inc.
(Indian edition), New Delhi.
19. D.B. Troy and P. Beringer, Remington -The Science and Practice of Pharmacy, Vol. I & II, Walters Kluwer/ Lippincott Williams
& Wilkins (Indian edition), New Delhi.
20. J.W. Robinson, E. M. S. Frame and G. M. Frame II, Undergraduate Instrumental Analysis, 6th Ed., Marcel Dekker, New York,
USA.
21. J.R. Dyer, Applications of Absorption Spectroscopy of Organic Compounds, Prentice - Hall of India Pvt. Ltd, New Delhi, India.
BPH_C_604_T – Pharmacognosy II - (4 Hr/Wk)
Course Objectives
1. To make the learner understand
a. Extraction of phytoconstitutents, concept of adulteration and substitution
b. Utility of natural products as excipients utilized in pharmaceutical preparations
c. Applications of plant tissue culture techniques for production of secondary metabolites and edible vaccines
2. To introduce the learner to the chemistry, sources, cultivation and collection of crude drugs containing phytoconstituents li ke
volatile oils, resins and tannins
3. To introduce the learner to the biosynthesis of volatile oil constituents belonging to the classes of monoterpenoids and
phenylpropanoids
4. To make the learner understand the chemistry of phytoconstituents belonging to the classes of iridoids, sesquiterpenes,
diterpenes, tetraterpenes and sulphur containing compounds along with sources and utility of representative examples of crude
drugs in therapeutics.
Course Outcomes
Upon completion of the course the learner will be able to –
1. Explain the concept of adultera tion and substitution in crude drugs, extraction process for phyto -constituents using different
methods and principles.
2. Write the source, composition, general methods of extraction, evaluation, chemical tests, therapeutic uses of crude drugs
containing vol atile oils, resins and tannins
3. Write the biosynthesis of monoterpenoids and phenypropanoid constituents of volatiles
4. Understand the chemistry of phytoconstituents belonging to the classes of terpenoids, sulfur containing constituents and
quinones and write source composition and structures of phytoconstituents of crude drugs belonging to these classes
5. Write the significance of excipients of natural origin, used in pharmaceutical formulations and describe various classes of
excipients like binders, colours, sweetners and flavorants along with the examples of their utility.
6. Describe the applications of plant tissue culture techniques with respect to production of secondary metabolites and edible
vaccines.
No. Details Hours
1 Evaluation of commercial crude drugs intended for use.
Adulteration &Substitution of drugs of natural origin.
Case Studies: Adulteration & Substitution with 4 examples
Evaluation by organoleptic, microscopic, physical, chemical and biological methods and properties as per WHO
guidelines for quality control of herbal drugs 6
2 Extraction : Basic principles of extraction with two examples each of extraction using physical (Solubility)
and chemical properties, general solvents to be used, Successive and exha ustive extraction, Soxhlet extraction,
microwave, supercritical extraction. 5
3 Volatile Oils: Source, Composition, chemistry, general methods of extraction, evaluation, chemical test,
therapeutic uses of volatile oils listed below.
Introduction and app lication of terpeneless volatile oils.
a. Umbelliferous fruits (Dill, Fennel, Coriander, Cumin, Caraway).
b. Alcohol – Peppermint, Cardomom
c. Aldehyde volatile oil –Lemongrass, Vanillin
d. Ketone volatile oil - Spearmint (mint oils)
e. Ester volatile oil - Oil of Wintergreen 8
f. Ether volatile oil - Eucalyptus oil
g. Miscellaneous - Sandalwood, Jatamansi.
h. Phenylpropanoids - Cinnamon, Clove, Nutmeg.
Salient features of cultivation, collection, preparation of Umbelliferous fruits, Clove, Cinnamon
Isolation , Identification and Analysis of Phytoconstituents
Terpenoids: Menthol, Citral
Interactive session
• Comparative study of Umbelliferous fruits (Dill, Fennel, coriander, cumin, caraway).
• Commercially significant volatile oils, eg. Palmarosa Oil, Citrus Peel Oil, Patchouli Oil, Primrose Oil, Tea
Tree Oil.
1
1
4 Biosynthetic Pathways: Acetate mevalonate pathway, shikimic acid pathway,
Biosynthesis of Menthol, citral, cinnamaldehyde 3
5 Resins and resin combinations
Study of occurrence, preparation, composition, uses and specific tests for identification of the following
a. Natural resins - Colophony, Benzoin, Asafoetida, Boswellia
b. Prepared resins - Turmeric, Ginger,
Separation, Identification and Analysis of Ph ytoconstituents –
Resin – Curcuminoids
Interactive Session:
Processing and Preparations for market - Ginger, Turmeric and Asafoetida 3
1
1
6 Study of the following Classes of Phytoconstituents with respect to sources, chemistry and therapeutic
uses.
a. Iridoids
Study of piccrohiza, gentian
b. Sesquiterpenes and Diterpenes
Artemisia, Andrographis.
c. Tetraterpenoids - carotenoids - lutein, crocin,
d. Organo sulphur - Allium cepa, Allium sativa
e. Quinones: Napthoquinones - Chitrak , Henna and Benzoquinone - Vidang 5
7 Tannins
Introduction of tannins and their definition, classification, Study of sources, composition, extraction and
applications of
Galls, Amla, Harda, Behra, Catechu (Pale & Black, Arjuna, Green Tea, Pomegranate Peel.
Isolation, Identification and Analysis of Phytoconstituents
Ellagic acid from Myrobalan
Interactive Session
Preparation containing tannins in healthcare with suitable examples
Commercial Application of tannins in synthesis of drugs eg. Trimethoprim
Abuse of Ta nnins 4
1
1
8 Plant Tissue Culture :
Different methods of manipulation of secondary metabolites
Introduction and application of transgenic plants with special reference to
Edible vaccines 4
9 Excipients of natural origin – Significance of substances of natural origin as excipients
a. colorants – bixin, saffron,
b. Sweeteners - thaumatin, stevia
c. binders, diluents, viscosity builders, disintegrants
d. Flavors & Perfumes with two suitable examples each from the class of volatile o ils.
Interactive Session
Study of two examples of each type of excipient (binders, diluents, viscosity builders, disintegrants) from
natural sources and its applications in pharmaceutical formulations. 3
1
TOTAL 48
Books:
Latest editions of the following books to be adopted.
1. Trease D. & Evans W.C.: Text Book of Pharmacognosy: W.B. Saunders.
2. Tyler V. E. Brady L. R. & Robbers J. E.: Pharmacognosy; Lea Feibger, USA.
3. Wallis T. E.; Text Book of Pharmacognosy; CBS Publishers, Delhi.
4. Kokate C. K., Purohit A. P. & Gokhale S. B.: Pharmacognosy; Nirali Publications, Pune.
5. Harbone J. B.: Phytochemical Methods: A guide to modern techniques Analysis: Chapman & Hall, London.
6. Bruneton J.: Pharmacognosy, Phytochemistry, Medicinal Plants: Interce pt Limited.
7. Vasudevan T. N. & Laddha K. S.: A Textbook of Pharmacognosy, Vrinda Publication House, Jalgaon.
8. The Indian Pharmacopeia: The Controller of Publication; Delhi.
9. R. S. Guad, S. J. Surana, G. S. Talele, S. G. Talele, Mr. S. B. Gokhale . Natural Excipients, Pragati Books Pvt. Ltd., 2006
10. Biren Shah , Avina sh Seth , Textbook of Pharmacognosy and Phytochemistry , Elsevier Health Sciences,
11. Ashutosh Kar , Pharmacognosy And Pharmacobiotechnology, New Age International, 2003
12. Quality Control Methods for Medicinal Plant Materials, World Health Organization World Health Organization, 1998 - Botanical
drug industry
13. WHO Monographs on Selected Medicinal Plants, World Health Organization World Health Organization, 199 9
14. ESCOP Monographs : The Scientific Foundation for Herbal Medicinal Products, ESCOP , European Scientific Cooperative on
Phytotherapy , Thi eme, 2003 -
15. Herbal Drugs and Phytopharmaceuticals : A Handbook for Practice on a Scientific Basis, Max Wichtl CRC Press, 2004 - Health &
Fitness
16. Pulok K. Mukherjee Evidence -Based Validation of Herbal Medicine, Elsevier, 17-Feb-2015
17. Adverse Effects of Herbal Drugs 2, Springer Science & Business Media, 06-Dec-2012
18. Quality Control of Herbal Drugs : An Approach to Evaluation of Botanicals, Pulok K. Mukherjee Business Horizons, 2002
19. Brain K. R. & Turner T. D.: The Practical Evaluation of Phytopharmaceuticals: Wright, Scientica, Bristol.
20. Iyengar M. A. & Nayak S. G.: Anatomy of Crude Drugs: Manipal Power Press, Manipal
21. Iyengar M. A.: Pharmacognosy of Powdered Drugs; Manipal Power Press, Manipal
BPH_C_605_L – Pharmaceutical Chemist ry Lab I - (4 Hr/Wk)
Traditional methods of synthesis to be followed for each of the Unit Operations in addition to specific methods as indicated.
1. Acetylation - Synthesis of aspirin using Microwave Procedure or Synthesis of Acetanilide as per Green Chemistry DST Monograph
2. Halogenation – Synthesis of p -bromoacetanilide as per Green Chemistry, DST Monograph
3. Esterification of PABA to benzocaine
4. Oxidation - Synthesis of benzoic by oxidation of toluene or benzyl alcohol with alkaline potassium
permanganate.
5. Hydrolysis of methyl benzoate.
6. Reduction - synthesis of m -nitroaniline by partial reduction of m - dinitrobenzene with sodium polysulfide.
7. Nitration: Synthesis of p -nitroacetanilide as per Green Chemistry, DST Monograph.
8. Synthesis of benzimidazole.
Books:
1. Vogel’s A Text book of Practical Organic Chemistry by Vogel, Longman group limited, London.
2. Practical Organic Chemistry by Mann FC & Saunders BC, Longman Group Limited, London.
3. Labor atory Techniques in Organic Chemistry, Ahluwalia V.K. I.K. Publishers.
4. Green Chemistry, V. K. Ahluwalia.
5. New Trends in Green Chemistry, V K Ahluwalia and M Kidwai, KluwerAcademic Publishers
6. Monograph on Green laboratory Experiments, Grenn Chemistr y Task Force Committee, DST.
7. Practical Organic Synthesis: A Student's Guide - Reinhart Keese, Martin Brändle, Trevor Toube.
8. Advanced practical Medicinal Chemistry by Ashutosh Kar, New Age International Publications.
BPH_C_606_L – Pharmaceutics Lab III - (4 Hr/Wk)
Course Objectives
To teach the learner the practical course dealing with the various aspects of formulation and evaluation of solid oral dosage forms. To
familiarize the learner with the important aspects of accelerated stability testing and shelf life calculations.
Course Outcomes
Upon completion of the course, the learner shall be able to:
1. Formulate solid dosage forms like tablets and capsules and evaluate them for their quality.
2. Understand the tablet coating process.
3. Learn the concepts of accelerated stability testing and shelf life calculations.
No. Details
1. Evaluation of excipients
a. Bulking agents: Comparison of at least one excipient in conventional and directly compressible
form for: Flow properties, Bulk density, Tapped density, Carr’s index, Hausner’s ratio and particle
size by microscopy and sieve analysis.
b. Disintegrating agents -Swelling index
c. Lubricants and glidants: Influence on flow properties of granules.
2. Preparation and evaluation of any one tablet formulation based on each of the following:
a) Direct compression technique
b) Non -aqueous wet granulation technique
c) Aqueous wet granulation technique
3. Preparation and evaluation of any one formulation of the following types of tablets:
a) Mouth dissolving tablet
b) Chewable tablet
4. Filling and evaluation of any one hard gelatin capsule formulation
5. Evaluation of anyone marketed immediate release tablet formulation including dissolution testing as per IP.
6. Accelerated stability testing of any suitable drug/ formulation. Problems based on Arrhenius equation for
shelf life calculations.
7. Demonstration of film coating of tablets
Books:
All books listed in the theory syllabus as well as current editions of IP, BP and USP.
BPH_C_607_L –Pharmaceutical Analysis Lab II - (4 Hr/Wk)
Course Objectives
On performing the following experiments, learner should be able to operate the instruments, understand its instrumentation, p repare
solutions with accurate concentrations, measure the readings, calculate and interpret the results obtained.
Course Outcomes
1. Record the absorbance and calculate concentration of analyte in formulation or as an API by use of A(1%, 1cm), single poin t and
double point standardisation by UV spectrophotometer.
2. Relate and construct linear regression analysis data for colorimetr ic assays and operate a colorimeter instrument.
3. Record and calculate the concentration of an analyte by measure of fluorescence of an analyte in absence and presence of q uenching
agent.
4. Operate a pH meter, measure equivalence point by potentiometric titration, calculate pKa and normality for a given acid or mixture
of acids.
5. Understand the sample preparation technique for FTIR spectroscopy, interpret the IR spectra to identify the functional gro ups of an
analyte, and understand the working of a fla me photometer.
No. Experiments
1 Assay of finished products by UV spectroscopy, using A (1%, 1 cm) -
Minimum assay of 5 formulations:
Paracetamol tablets
Propranolol tablets
Atenolol tablets
Hydrochlorothiazide tablets
Frusemide tablets
Albendazole tablet
Rifampicin capsules
2 Assay of drug by UV spectroscopy.
Use of single point and double point standardization method e.g. Paracetamol
3 Colorimetric assay
(Construction of calibration curve using linear regression analysis)
A. Assay of streptomycin injection
B. Assay of salicylic acid.
4 Fluorimetric analysis
A. Assay of quinine sulphate
B. Effect of different concentrations of iodide ions on fluorescence of quinine sulphate.
5 Potentiometric aqueous acid -base titrations using pH m eter
(All experiments must be performed by use of titration curve and calculations based on equivalence
point determination)
A. Determination of pKa and normality of phosphoric acid (First & Second end -point)
B. Determination of normality of individual acids in a mixture of acids. (e.g: HCl and H 3PO 4)
C. Determination of normality of strong acid (HCl)Vs standard solution of strong base (NaOH)
as a titrant
D. Determination of Normality of weak acid (acetic acid) Vs standard solution of strong Base
(NaOH) as a titrant
6 Demonstration experiments:
A. Determination of Na+ /K+ by Flame photometry.
B. Working of FTIR and Interpretation of IR spectra of any one drug.
Books:
Latest editions of books to be adopted
1. Indian Pharmacopoeia, The Indian Pharmacopoeia Commission, Ghaziabad, Government of India.
2. G. D. Christian, Analytical Chemistry, John Wiley & Sons, Singapore, reprint by Wiley India Pvt. Ltd.
3. A. H. Beckett and J. B. Stenlake, Practical Pharmaceu tical Chemistry, Part I and II, CBS Publishers an d Distributors, India.
4. United States Pharmacopoeia.
5. J. Mendham, R. C. Denney, J. D. Barnes, M. J. K. Thomas, Vogel’s Textbook of Quantitative Chemical Analysis, Pearson Educa tion
Ltd.
6. D. G. Watso n, Pharmaceutical Analysis –A textbook for pharmacy students and pharmaceutical chemists, Churchill Livingstone
Elsevier.
7. R. M. Silverstein, F. X. Webster and D. J. Kiemle, Spectrometric identification of organic compounds, John Wiley & Sons, I nc.
(Indi an edition), New Delhi
ANY TWO SUBJECTS (ONE EACH OF 4 CREDIT AND 2 CREDIT SUBJECT) FROM THE
FOLLOWING SUBJECTS TO BE CHOSEN AS ELECTIVES FOR A TOTAL OF 6 CREDITS
BPH_E_608_T – Pharmaceutical Management - (4 Hr/Wk)
Course Objectives
1. To introduce the learner to the pharmaceutical industry with emphasis on Indian Market.
2. Give the learner an understanding of companies’ financial statements & its components.
3. To enhance the knowledge about marketing and its importance to a learn er’s career.
4. To provide knowledge of management & its importance.
5. To introduce the importance of management in quality control & government regulation.
Course Outcomes
The learner will be able to
1. Study and interpret companies’ financial statemen ts & its components.
2. State the importance of marketing in the pharma industry.
3. Outline the basic principles of management
4. Discuss the importance of management in quality control & government regulation.
Books:
1. Sachin
Itkar:
Pharmaceutical Organisation No. Details Hours
1.1 Indian Pharmaceutical Industry 6
a) Structures
b) Components
c) Present Scenario
d) Foreign Trade
e) Future
1.2 Government Policy 2
a) Growth & Investment
b) Employment
c) Taxes & Subsidies
1.3 Share of Pharmaceutical Industry in the Economy
2 Financial Management 4
3 Management 4
a) Management Thoughts
b) Management Function
c) Organization
d) Motivation
e) Leadership
f) Conflicts & Measures to Solve it.
4 Marketing 8
a) Brand & Branding & Brand Plan
b) Market Segmentation
c) Product Positioning
d) Marketing Mix
e) Packaging
5.1 Product Life Cycle 4
5.2 New Product Development
5.3 Marketing Models (BCG & Porter’s 5 Force)
6 Production Management 8
a) Quality Control
Concepts of Quality Assurance & Quality Control, Responsibilities of Q.A. department.
Raw material control, actives and inactive, Q.C. standards for raw materials. (identity, purity,
quality and potency)
QA before start up - environmental and microbiological control, manufacturing working formula
procedur es, cleaning, sanitization, in process control packaging and labelling control, finished
product control.
Specimen documents -formats
cGMP
Statistical Quality Control -Q. C. Charts, sampling and sampling plans, sampling tools.
b) Six Sigma’s
c) Quality Control Methods & Regulations
d) Inventory Management
e) Production Management & Control
f) Quality Control Standards in Pharmaceutical Industries
g) FDA & Other Regulations
7 Market 5
a) Perfect and Imperfect Competition
b) Mergers & Collaborations
c) Investments Trends in Pharmaceutical Industries
d) Distribution
Distributors, direct distribution, direct home delivery, dispensing, scheme, etc.
8 Costing & Pricing 4
a) Different types of costs including production cost, selling cost and overhead costs
b) Pricing of Products - Government Regulations including DPCO
9 Industrial Psychology 3
a) Human Relation
b) Stress & its Management
c) Present Life, Pharmaceutical Industry, Its Impact on Employees & health measures
d)
2. Vidya
Sagar:
Pharmaceutical Industry & Organisation
3. I.M. Pandey or Prasanna Chandra: Financial Management
4. L.M. Prasad: Principle & Practice of Management
5. Philips Kolter: Principle of Marketing
6. Rama Swamy & Nama Kumari: Marketing Management
7. I.M. Juram & F.M. Gryna: Quality Planning & Analysis (Tata Mcgraw Hill)
BPH_E_609_T – Biopharmaceutics and Pharmacokinetics - (4 Hr/W k)
Course Objectives
To provide knowledge of basic concepts of Biopharmaceutics and Pharmacokinetics and corelate these concepts
to properties of drugs and dosage form design.
Course Outcomes
Upon completion of the course, the learner shall be able to:
1. Explain the basic terms used in Biopharmaceutics and Pharmacokinetics
2. Understand the concept of pharmacokinetics models and significance of various pharmacokinetic parameters
3. Understand BCS Classification, theories of Dissolution and methods of diss olution testing
4. Explain the concepts of Bioavailability and Bioequivalence and IVIVC
5. Solve problems based on principles of Pharmacokinetics
No. Details Hours
1. Introduction to Biopharmaceutics and Pharmacokinetics. Fate of drugs in the body.
Definitions of ADME, Bioavailability, Bioequivalence, Pharmacokinetics, Clinical
Pharmacokinetics. Different models to study the processes of ADME 2
2 ABSORPTION 6
2.1 Physiology of cell membrane and passage of drugs across cell membrane 1
2.2 Different Mechanisms of drug absorption 1
2.3 Factors affecting drug absorption -Physicochemical properties, formulation and dosage form
features, physiological conditions and parameters. 2
2.4 Absorption of drugs from extravascular routes 2
3 DISTRIBUTION 4
3.1 Factors affecting distribution, Physiological barriers, Tissue permeability and perfusion
limited distribution. 2
3.2 Volume of Distribution – Concept, significance of apparent volume of distribution, real
volume of distribution 1
3.3 Protein Binding of drugs and its significance 1
4 METABOLISM/BIOTRANSFORMATION 7
4.1 Phase I and Phase II reactions 3
4.2 Factors affecting drug metabolism: Age, species difference, genetic difference, induction
and inhibition, drug -drug interaction 2
4.3 First pass metabolism, concept of clearance, hepatic clearance and factors affecting hepatic
clearance, Hepatic extraction ratio, limits of values of organ clearance 2
5 EXCRETION 4
5.1 Renal excretion, Renal clearance, factors affecting renal clearance, renal function and
excretion ratio 2
5.2 Non-renal routes of excretion 2
6 DISSOLUTION 4
6.1 Introduction to Biopharmaceutical Classification System of drugs 1
6.2 Theories of dissolution,
Dissolution rate and methods of enhancing dissolution rate -Self-study with follow up 1
6.3 Official and nonofficial methods of dissolution rate testing. Application to different dosage
forms 2
7 PHARMACOKINETICS 17
7.1 Pharmacokinetics: Introduction to compartmental and physiological models.
Introduction to the one compartmental open model and its assumptions. Concept of zero
order and first order rate kinetics 2 TOTAL 48
7.2 Mathematical treatment of pharmacokinetics upon One compartment open model IV bolus
dosing: Importance of volume of distribution, Clearance, elimination rate constant, half - life,
area under the curve (trapezoid rule). 4
7.3 Mathematical treatment of pharmacokinetics upon One compartment open model
extravascular dosing; Absorption rate constant, absorption half - life, bioavailability, Area
under the curve and the method of residuals, concept of C max and t max.
Introduction to Rate of excretion method and Sigma minus method for urine analysis after
IV administration. 3
7.4 Mathematical treatment of pharmacokinetics upon multiple IV bolus dosing, concept of
accumulation, fluctuation and steady state levels 3
7.5 Linear and non -linear kinetics and description of factors resulting in non - linear kinetics. 2
7.6 Application of PK principles through simple problem solving (for i.v. bolus, mul tiple i.v.
and oral). 3
8 BIOAVAILABILITY AND BIOEQUIVALENCE 4
8.1 Concept of absolute and relative bioavailability 1
8.2 Method of assessment and enhancement of bioavailability 1
8.3 Bioequivalence: Study design, IVIVC, introduction to the concept of biowaiver 2
TOTAL 48
Books:
Latest Editions to be adopted
1. Leon Shargel, Susanna Wu – Pong, Andrew B.C., Applied Biopharmaceutics and Pharmacokinetics, Singapore.
2. Brahmankar D.M. and Jaiswal Sunil B, Biopharmaceutics and pharmacokinetics – A Treatise, Vallabh Prakashan.
3. Robert E. Notari, Biopharmaceutics and Pharmacokinetics – An Introduction, Marcel Dekker Inc., New York.
4. Milo Gibaldi, Biopharmaceutics and Clinical Pharmaco kinetics, USA
5. Malcom Roland, Thomas Tozer, Clinical Pharmacokinetics: Concept and Applications, A Lea – Febiger book, USA.
6. Banakar Umesh, Pharmaceutical Dissolution Testing, Volume 49, Marcel Dekker Inc, New York.
BPH_E_610_T – Basic Principles of Toxicology - (2 Hr/Wk)
Course Prerequisites
Understanding of Anatomy, Physiology, Pharmacology and its applications.
Course Objectives
1. To define basic toxicological terminologies and explain mechanisms and factors behind the toxic effects.
2. To describe modes of action by which different chemicals produce toxic effects on different organs and systems of human body.
3. To explain different te sts and their importance to discover toxic potential of drugs.
4. To introduce to regulatory toxicological frameworks within the professional disciplines and different risk assessment criteri a.
Course Outcomes
1. Define toxicological terms mentioned in the cours e.
2. Discuss mechanism of toxicity, factors influencing toxicity and management of poisoning.
3. Explain metal poisoning and basic principles with suitable example of drug induced toxicity.
4. Discuss in brief about different types of toxicity test.
5. Demonstrate the knowledge of regulatory toxicology and able to apply this knowledge for design of nonclinical toxicology and
clinical development of drugs.
No. Details Hours
1 Introduction to toxicology 5
1.1 Definitions: Toxicology, Poisons, Hazards, Risk
Classification of toxicity 1
1.2 Factors influencing toxicity 1
1.3 Mechanisms of toxicity 2
1.4 General Management of poisoning 1
2 Drug induced toxicities 6
2.1 Introduction to the terms with suitable examples of drugs and its clinical repercussions:
genotoxicity, carcinogenicity, teratogenicity, mutagenicity, hepatotoxicity, nephrotoxicity,
cardiotoxicity, neurotoxicity, haematotoxicity and local toxicity 3
2.2 Clinical symptoms and management of alcohol, barbiturate and morphine poisoning. 3
3 Toxicity testing 5
3.1
3.2 Types of toxicological testing: Acute, Sub acute and Chronic toxicity studies
Brief introduction to alternatives to Animal Models for toxicological testing 4
1
4 Regulatory toxicology 8
4.1 Overview of regulatory laws and agencies: Local Drug Regulatory Agencies, OECD and ICH 3
4.2 Schedule Y: Design of non -clinical toxicity studies and clinical development 3
4.3 Risk assessment and management of toxicological risks 2
TOTAL 24
Books:
Latest e dition of the following books to be adopted:
1. General and applied toxicology by Bryan Ballantyne, Timothy Marrs, Paul Turner, Stockton Press.
2. Sato skar R.S. Bhandarkar S.D. & Rege N. N. Pharmacology & Therapeutics, Pop ular Prakashan.
3. Ra ng & Dale P harmacology, Churchill Li vingstone.
4. Toxicological and Risk assessment Principles, Methods and applications by Anna Fan, Louis Chang, Marcel Dekker.
5. La urence D. R. & Be nnett Cli nical Pharmacology, Elsevier, NY.
6. Ku lkarni S. K. Ha ndbook of Experimental Phar macolog y, Vallabh Prakashan, N ew Del hi.
7. Katz ung B. G. -Basic a nd Clinical Ph armacology, Appleton and Lange publicati ons.
8. Ghosh M. N. Fundamentals of E xperimental Ph armacology Hilton & Company, Kolkata.
9. Curtis D. Klaassen, Casarett & Doull's Essentials of Toxicology, McGraw Hill.
10. Karen Stine, Thomas M. Brown. John B. Watkins, Principles of Toxicology, CRC Press
11. Harsh Mohan Text Book of Pathology, Jaypee publication.
12. Shayne C. Gad, Regulatory Toxicology, Taylor & Francis.
13. A. Wallace, Hayes Principles and Methods of Toxicology, CRC Press.
BPH_E_611_T – Cell and Tissue Culture - (2 Hr/Wk)
Course Prerequisites
Basic knowledge of Cell Biology, Microbiology and Animal Physiology.
Course Objectives
1. To examine and analyze practical and theoretical principles of cell culture.
2. To explain the conditions under which cells can be cultured outside the body.
3. To explain the advantages and limitations of cell culture in biomedical research and applications.
Course Outcomes:
The learner will be able to:
1. Understand the basic requirements of cell and tissue culture.
2. Plan experiments using cultured cells.
3. Carry out cell culture, and associated laboratory techniques.
4. Explore the concepts of cell and tissue culture in pr oduction of pharmaceutical products.
No. Details Hours
1 Introduction to Animal Cell culture:
1.1 Historical background. Advantages of Tissue Culture, Limitations, Major Types of
Tissue Culture - Primary and secondary cell culture.
1.2 Laboratory Design & Layout of Animal Tissue Culture (ATC) laboratory, Equipment
and Materials of a Tissue Culture Laboratory, Media Preparation and Sterilization
techniques.
1
1
2 Media and reagents:
2.1 Types of cell culture media, Ingredients of media, Physiochemical properties,
Antibiotics, growth supplements, Foetal bovine serum; Serum free media, Trypsin
solution, Conditioned media, Other cell culture reagents,
2.2 Selection of medium and serum.
2.3 Preparation and sterilization of cell culture media, serum and oth er reagents.
2
1
1
3 Cell culture Techniques:
3.1 Different types of cell cultures, Trypsinization, Cell separation, Continuous cell lines,
Suspension culture, Organ culture.
3.2 Cloning and selection of Animal cells, the Culture Environment, Cell Adhesion, Cell
Proliferation, Differentiation, Cell Signaling, Energy Metabolism, Maintenance of cell
lines, Cryopreservation.
3.3 Primary Culture: Initiation of a Primary Cell Culture, Isolation of the Tissue, Types
of Primary Culture, Subculture and Deve lopment of Cell Lines.
3.4 Common cell culture contaminants.
3.5 Scale -up & Automation.
2
3
1
1
1
4 Applications of Cell and Tissue Culture:
4.1 Stem cell Culture, Embryonic Stem Cell Culture: Current status and application in
medicine, Cell based therapies, Nanomedicine.
4.2 Application of animal cell culture for in vitro testing of drugs.
4.3 Application of cell culture technology in product ion of human and animal viral
vaccines and pharmaceutical proteins.
4.4 Production of recombinant hemoglobin, blood substituents, Artificial blood, General
account of in vitro regulation of blood cells production.
4.5 Antibody Engineering and Large -scale Production of Pharmaceutical Products.
2
2
2
2
2
TOTAL 24
Books:
1. Ed. John R.W. Masters, Animal Cell Culture - Practical Approach, 3rd Edition, Oxford University Press, 2000.
2. Ed. Martin Clynes, Animal Cell Culture Techniques., Springer, 1998.
3. B.Hafez, E.S.E Hafez, Reproduction in Farm Animals, 7th Edition, Wiley - Blackwell, 2000.
4. Louis -Marie Houdebine, Transgenic Animals: Generation and Use, 1st Edition, CRC Press, 1 997.
5. Culture of Animal Cells: A Manual of Basic Technique and Specialized Applications By R. Ian
Freshney; 5th Edition, Wiley -Liss, 2005
6. Animal Cell Culture (Introduction to Biotechniques): Sara j. Morgan, David C. Darling; Published by BIOS Scientif ic Publishers
Ltd., 1993
BPH_E_612_T – Pharmaceutical Process Chemistry and Technology - (2 Hr/Wk)
Course Objectives
On completion of the following theory topics, learner should be able to understand basic concepts from process chemistry, app reciate
importance of unit processes, regulations and safety aspects at manufacturing of Active Pharmaceutical Ingredients (APIs) and New
Chemical Entities (NCEs) at drug development stage
Course Outcomes
The learner will be able to:
1. Describe the basic concepts of process chemistry and process development
2. Describe chemical process, reaction systems and equipment used in API manufacturing
3. Outline the regulatory guidelines related to API manufacturing
4. Appreciate the importance of safety in pharmaceutical industry
No. Details Hours
1 Process chemistry 3
1.1 Overview of fine chemicals industry
1.2 Stages of scale up process: Bench, pilot and large -scale processes
1.3 Process control for large scale process:
Definitions: process, process control, Process variables and set point and
Importance of process control
2 Process development 5
2.1 Process development: Definition, steps involved with examples 1
2.2 Process equipment/ production plants
Dedicated plants, multipurpose and mixed plants
Typical equipment: reactors, filters, centrifuge, driers, extractors and evaporators 2
2.3 Chemical process kinetics:
Factors affecting chemical processes,
Reactor shape and effect of back mixing 2
3 Unit processes 12
3.1 Nitration:
Nitrating agents, Aromatic nitration,
Kinetics and mechanism of aromatic nitration,
Process equipment for technical nitration, mixed acid nitration
Examples to be covered: Nitrobenzene, p -nitroacetanilide 2
3.2 Amination by reductio n:
Reduction methods for amines
Iron/acid reduction: Mechanism, chemical, physical factors, equipment
Sulfide reduction with example of manufacture of m -Niroaniline by Na 2S: Zinnin
reduction 2
3.3 Halogenation:
Kinetics of halogenations, types of halogenations, catalytic halogenations.
Case study on industrial halogenation process: Chloral 2
3.4 Oxidation:
Introduction, types of oxidative reactions,
Liquid phase oxidation with oxidizing agents
Non-metallic Oxidizing agents: H 2O2, sodium hypochlorite, Oxygen gas 2
3.5 Esterification:
Esterification of Organic acids, inorganic acids, case study: glyceryl trinitrate, cellulose
nitrate 1
3.6 Hydrolysis: Definition and scope, Hydrolyzing agents, Materials susceptible to hydrolysis,
mechanism of hydrolysis,
Equipment for hydrolysis, Case study 2
4 API technology 2
Impurities in API: Types and sources including genotoxic impurities
Brief overview of guidelines in API manufacturing
Chirality and polymorphism in API
5 Industrial Safety and environment 2
Basic knowledge about Material Safety Data Sheet (MSDS) for safety and handling of
chemicals without health hazards.
Fire hazards, types of fire & fire extinguishers
Occupational Health & Safety Assessment Series 1800 (OHSAS -1800) and
ISO-14001(Environmental Management System), Effluents and its management
TOTAL 24
Books:
1. A. Cybulski, Fine Chemicals Manufacture - Technology and Engineering, Elsevier Publication, 2001
2. Pharmaceutical Process Validation: An International Third edition, Revised and expanded, Edited by Robert Nash and Alfred
Wachter, Marcel Dekker, 2003
3. ICH Guidelines, www.ich.org (FDA Guidance for industry, Q3A, Q7)
4. Organic Synthesis, Groggins P. H, ( Fifth edition ). P. H. Groggins , McGraw -Hill, 1958
5. Neal G. Andreson, “Practical Process Research and Development” academic Press, 2000
6. Pharmaceutical Process Chemistry for Synthesis: Rethinking the Routes to Scale -Up, Peter J. Harrington, John Wiley and Sons Inc.
Publication 2011
7. Process Chemistry in Pharmaceutical Industry, Kumar Gadamasetti, Vol I & II, CRC Press; First edition, 2007.
8. Performance of Pharmaceutical Companies in India: Contribution to economic s Authors: Mazumdar , M. Springer Verlag Berlin,
2013, Chapter 2, 17 -44
9. Principles of Process Research and Chemical Development in the Pharmaceutical Industry by O. Repic, John Wiley & Sons.Inc
Publication New York, NY, 1998.
BPH_E_613_T – Pharmaceutic al Excipients - (2 Hr/Wk)
Course Objectives
To provide the learner an understanding of types, functions, applications and regulatory aspects of excipients used in develo pment
Pharmaceutical dosage forms
Course Outcomes
Upon completion of the course, the learner shall be able to:
1. Define, classify and elaborate on regulatory aspects of Pharmaceutical excipients.
2. Understand the characterization and interactions of excipients with APIs and packaging materials
3. Elaborate on common and novel excipients in Pharmaceuticals
4. Explain the role of polymers as excipients
No. Details Hours
1.0
1.1
1.2
Excipients - Introduction, Definition, Functional classification of excipients.
Excipient Characterization, Active –excipient interactions -Physical, Chemical and
Physiological/biopharmaceutical; Excipients -packaging material interactions,
storage conditions for excipients
Regulatory guidelines for the pharmaceutical excipients, Pharma copoieal,
Harmonization of the Excipients, safety testing of excipients 1
4
3
2.0 Study of some common Conventional excipients with respect to source, chemical
nature, role/functions, manufacture/processing steps, interactions, safety:
Lactose, Starc h, Magnesium stearate, Talc, Bentonite, Glycerol, Paraffins, Sodium
Lauryl Sulphate, Sodium saccharin, Tweens and Spans, Arachis oil, Wool fat,
Glyceryl mono stearate
Self-study with follow up 4
3.0 Organoleptive additives - colours, flavours and sweeteners -sources,
mechanism/basic principles and examples
Self-study with follow up 2
4.0 Excipients for solubility/dissolution and permeation enhancement -Need, basic
principles and examples
Self-study with follow up 2
5.0 Excipients for stabilizing / preservation of dosage forms - Study of antioxidants,
chelating agents, buffering agents, antimicrobial preservatives with respect to need,
mechanisms and examples.
Self-study with follow up 2
6.0 Improved and Novel Excipients – Need, sources of new excipients -co-processing
and particle engineering, benefits of co -processed excipients, characterisation,
examples, regulatory aspects. 3
7.0 Polymers as excipients - Introduction to polymers, classification, important
properties for applications, use of polymers in conventional formulations, modified
/controlled release formulations,
Self-study with follow up -of following polymers -HPMC, Gelatin, Carbopol and
Eudragits 3
TOTAL 24
Books:
1. Rowe, R. C., Sheskey, P. J., & Owen, S. C. (Eds.) Handbook of pharmaceutical excipients (6th ed.). London: Pharmaceutical Press
and A.A.P.S., 2009
2. Robert, W. M., & Aloysius, O. A., Pharmaceutical Dosage Forms —Tablets Vol 3 (Revised and expanded). (H. A. Lieberman, L.
Lachman, & J. B. Schwartz, Eds.) Informa Health Care., 2008
3. Lachman, L., Lieberman, H. A., & Kanig, J. L.. The Theory and Practice of Industrial Pharmacy (3rd ed.). Mumbai: Varghese
Publishing House. ,1991.
4. Rawlins, E. A. Bentley’s text book of Pharmaceutics (8th ed.). London: Bailliere Tindal., 1995.
5. Rubinstein, M. H.,Tablets. In M. E. Aulton, Pharmaceutics: the science of dosage form design , London: ELBS Longman Group Ltd.,
1988.
6. Rudnic, E. M., & Schwartz, J. D. , Remington: The Science and Practice of Pharmacy , (A. R. Gennaro, Ed.) Philadelphia: Lippincott
Williams & Wilkins, 2006
7. Saha, S., & Shahiwala, A. F.,Multifunctional coprocessed excipients for improved tabletting performance . Expert Opinion on Drug
Delivery , 6 (2), 2009.
8. Kadtare A. and Mahesh Chaube, Excipient Development for Phar maceutical, Biotechnology and Drug Delivery Systems, Informa
Healthcare USA, Inc. 270 Madison Avenue, New York 10016, 2006.
SYLLABUS FOR Final. Y. B. Pharm.
SEMESTER -VII
BPH_C_701_T – Pharmaceutical Chemistry II - (4 Hr/Wk)
Course Objective
1. Learn structure including stereochemistry, chemical name, SAR, metabolism, mechanism of action and selected synthesis of
anticancer agents
2. Learn structure including stereochemistry, chemical name, SAR, metabolism, mechanism of action and selected synthesis of
antiviral agents
3. Learn structure including stereochemistry, chemical name, SAR, metabolism, mechanism of action and selected synthesis of
cardiovascular drugs like antianginal agents, antiarrhythmic agents, diuretics, drug affecting the RAS pathway, vasodila tors,
antihyperlipidemic agents drugs
4. Learn structure including stereochemistry, chemical name, SAR, metabolism, mechanism of action and selected synthesis of
antihistaminics
5. Learn structure including stereochemistry, chemical name, SAR, metabolism, mechan ism of action and selected synthesis of
hypoglycemic agents and insulin analogs
Course Outcome
Students will gain knowledge in the thurst areas chemotherapy for cancer, antiviral diseases, cardiovascular drugs like antia nginal
agents, antiarrhythmic agents , diuretics, drug affecting the RAS pathway, vasodilators, antihyperlipidemic agents. They will be apply
this knowledge in research areas.
No Details Hours
Discussion of the following classes of drugs including classification, chemical
nomenclature, structure including stereochemistry, generic names, SAR and
metabolism, molecular mechanism of action, synthesis(*) and rational
development if any
1 Anti -Cancer agents:
• Alkylating agents like mechlorethamine , chlorambucil* (self study),
melphalan*, cyclophosphamide*, busulfan, carmustine, lomustine,
streptozocin, dacarbazine and procarbazine, timozolomide
• Antimetabolites like azaserine, methotrexate*, pralatrexate, azacytidine, 5 -
fluorouracil, cytarabine (Ara –C), 6 -MP and 6 -TG.
• Antibiotics like dactinomycin, daunorubicin, doxorubicin , bleomycin and
other natural products like vincristine, vinblastine, paclitaxel, docetaxel,
topotecan, irinotecan (only highlights of structure to be discussed for
bleomycin and natural products)
• Platinum compounds like cisplatin and oxaliplatin
• Histone Deacetylase Inhibitors: romidepsin, vorinostat
• Tyrosine Kinase Inhibitors: imatinib, dasatinib, lapatinib
• Combination therapy for breast cancer, leukemia (Self study) 7
1
2. Antivirals agents including anti-HIV agents:
Amantadine*, rimantadine, oseltamivir, zanamivir, acyclovir and its prodrugs,
ganciclovir, famciclovir, penciclovir, idoxuridine, vidarabine
Reverse transcriptase inhibitors: , azidothymidine*, stavudine, lamivudine,
zalcitabine, didanosin e, abacavir, Non -nucleosides reverse -transcriptase inhibitors:
delaviridine, nevirapine, efavirenz.
HIV-protease inhibitors: raltegravir, saquinavir, ritonavir, (only highlights of structure
of protease inhibitors).
Drugs like nelfinavir, lopinavir, ataza navir, amprenavir, telaprevir and Combination
anti-therapy (Self Study) 4
2
3. Cardiovascular Drugs
3.1 Antianginal Agents 3
Antianginal agents: Amyl nitrite, isosorbide dinitrate, pentaerythritol tetranitrate,
verapamil, bepridil, diltiazem, nifedipine, dipyridamole*
3.2 Antiarrythmic Agents
Antiarrhythmic agents: quinidine, procainamide*, disopyramide, lidocaine, mexilitine,
amiodarone, propafenone, verapamil, diltiazem, propranolol, sotalol* 4
3.3 Diuretics
• Site 1. Carbonic anyhydrase inhibitors: acetazolamide*, methazolamide,
brinzolamide, ethoxzolamide
• Site 2. High celing or loop diuretics: Sulphamoyl anthranilic acids like
furosemide*, azosemide and bumetanide and phenoxyacetic acids ethacrynic
acid*
• Site 3. Thiazide and Thiazide lik e diureties, chlorthiazide* (self study)
hydrochlorthiazide, benzthiazide, methyclothiazide, trichlormethiazide,
chlorthalidone, metolazone, quinethazone, indapamide
• Site 4. Potassium sparing diureties such as spironoloactone, eplerenone (self
study) triamterene and amiloride.
Osmotic diuretics - mannitol, isosorbide. 4
1
3.4 Agents affecting Renin -Angiotensin Pathway and Calcium Blockers
• ACE Inhibitors - captopril* Lisinopril, perindopril
• Angiotensin II receptor blockers - losartan, valsartan, , telmisartan,
olmesartan, azilsartan.
• Also valsartan + sacubitril combination
• Calcium channel blockers - verapamil , diltiazem, nifedipine, amlodipine,
nimodipine, , cilnidipine, benidipine, efonidipine
• Renin Inhibitors - aliskiren (self study)
• Aldosterone antagonists: spironolacone, eplerenone (self study) 4
1
1
3.5 Vasodilators/Sympatholytics
• Vasodilators - Hydralazine*
• Non-selective beta blockers - propranolol, nadolol
• Selective beta -1 blockers - acebutalol, atenolol, esmolol
• Selective alpha -2 blockers - prazosin* terazosin
• Mixed alpha -beta blockers - carvedilol, labetalol
• K-channel agonists - Minoxidil 4
3.6 Antihyperlipoproteinemics
Clofibrate*, gemfibrozil, gemfibrate, fenofibrate
• HMG -CoA reductase inhibitors: lovastatin, atorvastatin, simvastatin,
rosuvastatin, ezetimibe. 3
4 Antihistaminics
Antihistaminies:H 1 and H 2 receptors, general SAR of classical H1 antihistaminics,
Emphasis to be on the second generation H 1 antagonists such as fexofenidine, ,
loratidine, cetrizine, , andacrivas tine, ebastine and bepotastine; combination of H1
antihistaminics and monteleukast H 2 receptor antagonists like cimetidine ranitidine*,
famotidine, nizatidine, lafutidine; proton pump inhibitors like omeprazole,
rabeprazole, pantoprazole and lansoprazole. 4
1
5 Hypoglycemics and Insulin Analogues
Hypoglycemics (Insulin not to be discussed)
• Biguanides e.g. metformin
• Sulfonylureas: 1st Generation like tolbutamide, chloropropamide, tolazamide
and acetohexamide* (self study); 2nd Generation like glyburide* glypizide and
glimepride,glyclazide and meglitinides like repaglinide, nateglinide.
• Thiazolidinediones such as troglitazone, ciglitazone, rosiglitazone and
pioglitazone.
• GLP -1 agonists and DPP -IV inhibitors - exenatide and liragl utide (no
structures), saxagliptin, vildagliptin, sitagliptin, linagliptin
• β – Glucosidase inhibitors like voglibose, and miglitol.
Insulin analgoues:Lisproinsulin, glargineinsulin 4
Total 48
*Synthesis to be taught
Latest editions of the following books to be adopted.
12. An Introduction to Medicinal Chemistry, Graham L. Patrick, Oxford University Press.
13. Fundamentals of Medicinal Chemistry, Gareth Thomas, Wiley, New York.
14. The Organic Chemistry of Drug Design and Drug Action, Richard B.Silverma n, Academic Press.
15. Foye’s Principles of Medicinal Chemistry, Thomas L. Lemke, David A Williams, Lippincott Williams & Wilkins.
16. Wilson and Gisvold’s Textbook of Organic Medicinal and Pharmaceutical Chemistry, John M. Beale, John H. Block, Lippincott
William s & Wilkins.
17. Medicinal Chemistry, Ashutosh Kar, New Age International Publishers.
18. Introduction to Medicinal Chemistry, Alex Gringauz, Wiley.
19. The Organic Chemistry of Drug Synthesis, Daniel Lednicer, Lester A. Mitscher, John Wiley and Sons.
20. Pharmaceutical Chemistry, Volume 1, Organic Synthesis, H. J. Roth & A. Kleemann, Ellis Horwood Series in Pharmaceutical
Technology, Halsted Series.
21. Synthesis of Essential Drugs, Ruben Vardanyan and Victor Hruby, Elsevier.
Pharmaceutical Substances: Syntheses, Patents, Ap plications, Kleemann& Engel, Thieme Publications.
BPH_C_702_T – Pharmacognosy III - (4 Hr/Wk)
Course Objectives
1. To introduce the learner to the chemistry, sources, cultivation and collection of crude drugs containing phytoconstituents like
steroidal, triterpenoidal, anthraquinone, flavonoid glycosides and alkaloids.
2. To introduce the learner to the biosynthesi s of alkaloids obtained from different amino acids
3. To introduce the learner to glycoproteins with the representative examples and their utility in diagnosis or therapeutics.
4. To make the learner aware of regulatory requirements for manufacture and sal e of Ayurvedic, Siddha and Unani (ASU) Medicines
and Phytopharmaceuticals, monographs of herbal drugs
5. To make the learner understand formulation aspects and challenges of Herbal formulations, standardization and interactions of
drugs of natural origin
6. To apply the spectroscopic techniques in characterization of phytoconstituents of both aliphatic and aromatic nature
Course Outcomes
Upon completion of the course student will be able to :
1. Write the source, composition, general methods of extraction, evaluation, chemical tests, therapeutic uses of crude drugs containing
phytoconstituents like steroidal, triterpenoidal, anthraquinone, flavonoidal glycosides, alkaloids glycoproteins.
2. Write the biosynthesis of biosynthesis of alkaloids obtained from d ifferent amino acids
3. Understand regulatory requirements for manufacture and sale of Ayurvedic, Siddha and Unani (ASU) Medicines and
Phytopharmaceuticals, monographs of herbal drugs
4. Apply the knowledge of excipients from natural origin and pharmaceuti cal technology to herbal formulation and understand the
challenges in herbal formulation
5. Understand the concept of herbal drug standardization and its application to herbal formulation
6. Apply the knowledge of pharmacology to understand pharmacodynami c and pharmacokinetic interactions of herbal drugs with food
7. Apply spectroscopic techniques to characterize small molecules both from the categories of aromatic and aliphatic nature
No. Details Hours
1 Steriodal and Triterpenoidal glycosides
Detailed study of drugs with respect source, chemistry, and therapeutic application of the following drugs –
Liquorice, Asparagus, Dioscorea, Fenugreek, Brahmi, Ginseng
Introduction to cardiac glycosides with respect to their classification, chemistry & gen eral chemical tests.
Detailed study of drugs with respect source, chemistry cultivation and collection, preparation & biopotential
of the following drugs –
Digitalis lanata, Digitalis purpurea , Squill
Extraction, Identification and Analysis of Phytoconstituents –
Liquorice constituents
Commercial application of Diosgenin
Interactive Session
Potency, marketed preparation of all cardiac glycosides
Composition and indication of Fenugreek containing formulations
6
1
2 Alkaloids
Introduction to alkaloids - Classification, properties, general methods of extraction.
Study of following drugs containing alkaloids with respect to their sources, chemistry (structures), salient
features of extraction and specific tests for detection (if any) and therapeutic applications of:
a. Alkaloidal Amines – Ephedra, colchicum
b. Tropane - Datura, Coca, Ashwagandha
c. Indole - Rauwolfia, Vinca, Ergot 8
d. Steroidal –Kurchi
e. Quinazoline – Vasaka
f. Benzyl isoquinoline – Opium
g. Isoquinoline - Ipecac, Berberis aristata
h. Quinoline - cinchona
i. Pyridine -Piperidine –Pepper, Tobacco
j. Purine - Tea, Coffee, Cocoa
k. Imidazole – Pilocarpus
l. Glycoalkaloids - Solanum
Isolation, Identification and Analysis of Phytoconst ituents
Piperine, Caffeine
Interactive Session
Market products and their therapeutic uses of Atropine, Pilocarpine, Vasaka, Kurchi, Ephedra, Pepper
1
1
3 Biosynthesis of lysergic acid, tropane alkaloids, emetine, quinine, 2
4 Glycoproteins – Castor, Pea and Oats 2
5 Glycosides
a) Anthracene derivative – Study of aloes, senna, rhubarb, with respect to Occurrence, chemistry, salient
features of cultivation, collection, preparation, chemical test and uses.
b) Source, chemistry an d uses of Rubia, St. John`s wort
Occurrence, Chemistry, Test and Uses of
a) Isothiocyanate – Brassica, cabbage
b) Cyanogenetic - bitter almond, wild cherry bark, Biosynthesis of amygdaline
Isolation, Identification and Analysis of Phytoconstituents – Anthraquinone - Aloe emodin 3
2
6 Detailed study of Flavonoids and Coumarins:
a. Introduction, classification, chemical tests occurrence & their biopotential as exemplified by
Orange Peel, Soyabean, Buckwheat, Psoralea.
b. Monomeric, dimeric and rela ted phenylpropanoid derivatives e.g.,
lignans - Podophyllum
Isolation, Identification and Analysis of Phytoconstituents - Rutin
3
7 Interactions with DONO :
Concept of pharmacokinetic interaction and pharmacodynamic interactions
herb- drug interactions – 3 examples each of synergistic and antagonistic interactions
herb- food interactions – 3 examples each of synergistic and antagonistic interactions
eg . Hypercium, Liquorice, Coffee, Ginseng, Ginkgo biloba, Digitalis, Garlic, Pepper & Ephedr a.
3
8 Use of spectroscopy techniques in characterization of phytoconstituents .
a. Citral b. Rutin c. Gallic acid
2
9 Standardization of herbal drugs using various type of markers with examples.
Application of various chromatographic techniques in standardization of herbal products with two examples.
Stability testing of herbal medicines with respect to marker analysis.
Interactive session
Standardization of polyherbal formulation with respect to respective marker constituents emphas izing on
simultaneous estimation.
3
1
10 Monograph of herbal drugs & excipients in Indian Pharmacopoeia (Two examples each)
Interactive session
Comparative study of herbal monographs in IP, USP, Ayurvedic Pharmacopoeia, American herbal
Pharmacopoeia, British herbal Pharmacopoeia. 2
2
11 Regulatory Issues - ASU formulations, patent and proprietary medicine and Phytopharmaceuticals
Schedule T & Y of Drugs & Cosmetics Act for ASU drugs and phytopharmaceuticals 2
12
Study of herbal formulations & Ayurvedic formulations
a. Ayurvedic Formulations –Introduction to Ayurvedic formulations like aristas, asava, gutika,taila, churna,
avaleha, bhasma, ghrita.
b. Introduction to the concept of detoxification in Ayurveda (2eg).
c. c. Herbal formulations: Challenges in the preparation and evaluation of Herbal tablets, capsules, liquid oral,
semisolid dosage forms 3
d. NDDS of Herbal medicine: Limitation of conventional formulations, challenges in development of NDDS of
Herbal medicine, Phytosomes with one example each
Interactive session
Phytopharmaceuticals in the market: Study of any two formulations under each category with respect to their
ingredients used and activities / claims of each ingredient used in them
1
TOTAL 48
Books:
Latest editions of the following books to be adopted.
1. Trease D. & Evans W.C.: Text Book of Pharmacognosy: W.B. Saunders.
2. Tyler V. E. Brady L. R. & Robbers J. E.: Pharmacognosy; Lea Feibger, USA.
3. Wallis T. E.; Text Book of Pharmacognosy; CBS Publishers, Delhi.
4. Kokate C. K., Purohit A. P. & Gokhale S. B.: Pharmacognosy; Nirali Publications, Pune.
5. Harbone J. B.: Phytochemical Methods: A guide to modern techniques Analysis: Chapman & Hall, London.
6. Bruneton J.: Pharmacognosy, Phytochemistry, Medicinal Plants: Interce pt Limited.
7. Vasudevan T. N. & Laddha K. S.: A Textbook of Pharmacognosy, Vrinda Publication House, Jalgaon.
8. The Indian Pharmacopeia: The Controller of Publication; Delhi.
9. R. S. Guad, S. J. Surana, G. S. Talele, S. G. Talele, Mr. S. B. Gokhale . Natural Excipients, Pragati Books Pvt. Ltd., 2006
10. Biren Shah , Avinash S eth, Textbook of Pharmacognosy and Phytochemistry , Elsevier Health Sciences,
11. Ashutosh Kar , Pharmacognosy And Pharmacobiotechnology, New Age International, 2003
12. Quality Control Methods for Medicinal Plant Materials, World Health Organization World Health Organization, 1998 - Botanical
drug industry
13. WHO Monographs on Selected Medicinal Plants, World Health Organization World Health Organization, 199 9
14. ESCOP Monographs : The Scientific Foundation for Herbal Medicinal Products, ESCOP , European Scientific Cooperative on
Phytotherapy , Thieme, 2003 -
15. Herbal Drugs and Phytopharmaceuti cals: A Handbook for Practice on a Scientific Basis, Max Wichtl CRC Press, 2004 - Health &
Fitness
16. Pulok K. Mukherjee Evidenc e-Based Validation of Herbal Medicine, Elsevier, 17-Feb-2015
17. Adverse Effects of Herbal Drugs 2, Springer Science & Business Media, 06-Dec-2012
18. Quality Control of Herbal Drugs : An Approach to Evaluation of Botanicals, Pulok K. Mukherjee Business Horizons, 2002
19. Brain K. R. & Turner T. D.: The Practical Evaluation of Phytopharmaceuticals: Wright, Scientica, Bristol.
20. Iy engar M. A. & Nayak S. G.: Anatomy of Crude Drugs: Manipal Power Press, Manipal
21. Iyengar M. A.: Pharmacognosy of Powdered Drugs; Manipal Power Press, Manipal
BPH_C_703_T – Pharmaceutical Analysis III - (4 Hr/Wk)
Course Objectives
On completion of this course, the learner should be able to apply the principles of spectroscopy for multicomponent analysis and describe
working principle, instrumentation and applications of chromatographic and characterization techniques.
Course Outcomes
The learner should be able to:
1. Explain various methods used for multicomponent analysis of drugs by UV spectroscopy.
2. Summarize chromatographic and hyphenated techniques used for the separation, identification and quantification of analytes.
3. Describe the working of proton 1H NMR spectroscopy and mass spectrometry.
4. Interpret spectral data to predict structure of a given compound.
5. Summarize the parameters of ICH guidelines for analytical method validation.
No. Details Hours
1.0 Multicomponent analysis by UV Spectroscopy 4
1.1 Assay as a single component sample
Corrected interference
Assay after solvent extraction
Simultaneous Equation method 4
Absorbance Ratio method
Difference Spectroscopy method
Derivative Spectroscopy
2.0 Concepts of Chromatography 7
2.1 Terminologies: stationary phase, mobile phase, retention time, gradient and isocratic
elution, normal and reverse phase chromatography, planar chromatography, retention
factor, chromatogram, internal standard, reference standard, working standard, tailing
factor (symmet ry factor), asymmetry factor, resolution, signal to noise ratio, column
chromatography, preparative chromatography, adsorption chromatography and
partition chromatography. 3
2.2 Classification of chromatographic methods (Self study -0.5 hr)
Quantitative an alysis (Peak height, peak areas, calibration curve, internal standard,
and area normalization)
Optimization of column performance (Column efficiency and band broadening,
shape of peak -Gaussian, Plate height, Number of theoretical plates, van Deemter
equat ion, Capacity factor, Selectivity factor, Tailing factor, peak width, and
Resolution) 3
2.3 Numericals and justification based problems related to column performance 1
3.0 High Performance Liquid chromatography (HPLC) 4
3.1 Instrumentation:
Mobile phase reservoir
Pumps (reciprocating, displacement, pneumatic) (Self study -0.5 hr)
Sample injection systems (Rheodyne injector and autosampler)
Column types (analytical, guard and preparative columns) and column packing (
porous, pellicular and m onolithic),
Detectors (Concept of solute and bulk property detector -Refractive index ,UV -Vis,
Phototodiode array, fluorescence, , Electrochemical, Evaporative Light Scattering
),
Difference between UPLC and HPLC (Self study -0.5 hr)
Applications, Advantages and Limitations of HPLC (Self study -0.5 hr)
4
4.0 Gas chromatography (GC) 3
4.1 Introduction
Instrumentation
Carrier gas supply
Sample injection system including Head space analysis
Columns (Packed, Open tubular columns, Capillary columns) and column ovens
(Self study -0.5 hr)
Detectors (Thermal conductivity, Electron capture, Flame ionization)
Applications, Advantages and Limitations of GC (Self study -0.5 hr) 3
5.0 Planar chromatography 3
5.1 Paper chromatography -Principle, Developmental techniques (Ascending,
Descending, Radial and Two -dimensional), Spray reagents and Pharmaceutical
applications (Self study -0.5 hr)
TLC -Principle, types of adsorbents, Developmental techniques (Self study -0.5
hr), Visualisation techniques, factors affecting resolution, Pharmaceutical
applications of TLC and Preparative TLC.
HPTLC: Instrumentation - Applicator, photodensitometry, photodocum entation,
Advantages of HPTLC over TLC and HPLC (Self study -0.5 hr)
3
6.0 Ion exchange chromatography, Ion Pair and Size Exclusion chromatography 3
6.1 Principle, Stationary phases, Mobile phases and Applications (Self study -0.5 hr) 3
7.0 Nuclear Magnetic Resonance Spectroscopy (1H-NMR) 8
7.1 1H-NMR phenomenon - spinning nucleus, precessional motion, precessional
frequency, gyromagnetic ratio, energy transitions and relaxation processes, NMR
Spectra, Chemical shift, shielding and deshielding, Vande rwaal’s deshielding,
Deuterium exchange, Chemical and magnetic equivalence , anisotropic effect (eg.
Alkanes, alkenes, alkynes, carbonyl, aromatic and cyclohexane), Solvents, Reference
compounds and internal standards. 2
7.2 Measurement of chemical shift:
Scales used.
Factors affecting chemical shift (Electronegativity -Shielding and Deshielding,
Vanderwaal’s deshielding, anisotropic effect)
Instrumentation of NMR Spectrometer (including schematic representation) (Self
study -0.5 hr)
Principle of FT NMR (including representation of conversion of time domain
spectra to frequency domain spectra) 3
7.3 Spin -spin coupling -Spin -Spin splitting:
N+1 rule (Pascal’s triangle), theory of spin -spin splitting, formation of doublet,
triplet and quartet due to possible spin orientations, inverted tree diagram,
Coupling constants & values for alkyl, alkenyl , aromatic ).
Information obtained from proton NMR -Chemical shift, splitting, coupling constant,
integration. (Self study -0.5 hr) 3
8.0 Mass Spectrometry 4
8.1 Principle & basic theory - Mass spectrum, relative abundance, mass to charge ratio,
molecular ion, fragment ion (daughter ion), metastable ion, base peak, isotope peak,
mass to charge ratio. 1
8.2 Instrumentation:
Basic components of mass spectrometer (including block diagram).
Ionisation methods: Electron Ionisation, Chemical Ionisation, Desorption
Ionisation (MALDI), Fast Atomic Bombardment, Atmospheric Pressure Ionisation
(Electrospray, APCI, APPI).
Analysers: Quadrupole, Ion Trap and Ti me of Flight. 2
8.3 Examples of different mass fragmentation pathways 1
9.0 Hyphenated techniques 2
Significance, interfaces and applications of
LC-MS
GC-MS (Self study -1 hr)
10.0 Structure Elucidation by spectral techniques using UV, IR, 1H -NMR and Mass
spectrometry 8
10.1 UV-Woodward Fieser rules for predicting λ max (acyclic & cyclic dienes, and α, β
unsaturated ketones (acyclic and 6 membered ring).
(Note -only alkyl substituents to be studied). (Practice problems -Self study -0.5 hr) 2
10.2 Elucidation of structure of a compound using IR and 1H NMR data - Problems for
simple organic compounds with molecular formula given (Practice problems -Self
study -0.5 hr) 3
10.3 Mass spectrometry : 3
Fragmentation: Representation of fragmentation process, Bas ic types of
fragmentation:
Fissions (homolytic and heterolytic, α and β fission).
Rearrangement (Mclafferty, Retro Diel -Alders, 4 membered cyclic
rearrangement),
Nitrogen rule and Even electron rule. (Practice problems -Self study -0.5 hr)
11 Analytical method Validation. (Self study - 0.5 hr) 2
11.1 Analytical method Validation as per ICH guidelines.
Total 48
Books:
1. D. A. Skoog, F. J. Holler and S. R. Crouch, Principles of Instrumental Analysis, Saunders College Publishing, USA.
2. K. A. Connors, A Te xtbook of Pharmaceutical Analysis, John Wiley and Sons, Canada.
3. A. H. Beckett and J. B. Stenlake, Practical Pharmaceutical Chemistry, ,Vol. 6, Part I and II, CBS Publishers and Distributors ,
India.
4. D. A. Skoog, D. M. West, F. J. Holler and S. R. Crouch, Fu ndamentals of Analytical Chemistry, Saunders College Publishing,
USA.
5. G. D. Christian, Analytical Chemistry, John Wiley & Sons, Singapore, reprint by Wiley India Pvt. Ltd.
6. H.H. Willard, L. L. Merrit and J. A. Dean, Instrumental Method of Analysis, CBS Publishers & Distributors, New Delhi.
7. Ashutosh. Kar, Pharmaceutical Drug Analysis, New Age International (P) Ltd. Publishers, India.
8. S. S. Mahajan, Instrumental Methods of Analysis, Popular Prakashan Pvt Ltd., India.
9. G. R. Chatwal and S. K. Anand, Instrume ntal methods of chemical analysis, Himalaya Publishing House Pvt. Ltd.
10. Indian Pharmacopoeia, The Indian Pharmacopoeia Commission, Ghaziabad, Government of India.
11. United States Pharmacopeia
12. J. Mendham, R. C. Denney, J. D. Barnes, M. J. K. Thomas, Vogel’s Te xtbook of Quantitative Chemical Analysis, Pearson
Education Ltd.
13. D. G. Watson, Pharmaceutical Analysis –A textbook for pharmacy students and pharmaceutical chemists. Churchill
Livingstone Elsevier.
14. J. W. Robinson, E. M. S. Frame and G. M. Frame II, Undergr aduate Instrumental Analysis, Marcel Dekker, New York, USA.
15. R. Kellnar, J. M. Mermet, M. Otto, M. Valcarceland, H. M. Widmer, Analytical Chemistry: A modern approach to analytical
science, Wiley -VCH, USA.
16. J. W. Munson, Pharmaceutical Analysis: Modern metho ds (in two parts), Marcel Dekker Inc., USA.
17. W. Kemp, Organic Spectroscopy, Palgrave Publishers Ltd., New York, USA.
18. R. M. Silverstein, F. X. Webster and D. J. Kiemle, Spectrometric identification of organic compounds, John Wiley & Sons,
Inc. (Indian edition), New Delhi.
19. D. B. Troy and P. Beringer, Remington -The Science and Practice of Pharmacy, Vol -I & II, Wolters Kluwer/ Lippincott
Williams & Wilkins (Indian edition), New Delhi.
20. 20 J. W. Robinson, E. M. S. Frame and G. M. Frame II, Undergraduate Inst rumental Analysis, Marcel Dekker, New York,
USA.
21. J. R. Dyer, Applications Of Absorption Spectroscopy Of Organic Compounds, Prentice - Hall of India Pvt Ltd, New Delhi,
India.
22. D. L. Pavia, G. M. Lampman, G. S. Kriz and J. R. Vyvyan, Introduction to Spectrosc opy, Brooks/Cole Cengage Learning,
Australia.
23. Y. R. Sharma, Elementary organic spectroscopy -Principles and Chemical Applications, S. Chand & Company Ltd, New Delhi,
India.
24. L. R. Snyder, J. J. Kirkland, J. L. Glajch, Practical HPLC Method Development, Wiley -Interscience publication, John Wiley
& Sons, Inc., Canada.
25. S. Ahuja and M. W. Dong, Handbook of Pharmaceutical Analysis by HPLC, Volume 6 of Separation Science and Technology,
Elsevier Academic Press, Indian edition.
BPH_C_704_T – Pharmacology III - (4 Hr /Wk)
Course prerequisites
Knowledge of anatomy, physiology and pathophysiology of diseases/disorders of central nervous system and gastrointestinal sys tem
Concept of Inflammation
Information on endogenous receptors in the human body
Course objectives
1. To educate on different drugs acting on central nervous system and its associated diseases.
2. To educate on pharmacology of anti -inflammatory drugs.
3. Impart knowledge on pharmacology of drugs used in inflammatory disorders like asthma and gout.
4. Educate on au tacoids and drugs impacting autacoids’ actions.
5. To provide understanding about drugs used in GIT associated disorders.
6. To convey principles of toxicity with briefing on common toxicants.
Course outcomes
1. Explain pharmacology of drugs acting on central nervous system and associated diseases.
2. Classify and explain pharmacology of anti -inflammatory drugs, make use of knowledge of these drugs to justify their use in asthma
and gout.
3. Discuss the pharmacology of drugs used in gastrointestinal disorders.
4. Know t he toxic effects of heavy metals, drugs and environmental toxicants.
Books:
Latest editions of following books to be adopted No Details
Hours
1 Drugs acting on Central Nervous System 24
1.1
Aliphatic alcohols
2
1.2 General and Local anaesthetics 4
1.3 Sedatives, Hypnotic and anxiolytic agents 3
1.4 Antiepileptic drugs 2
1.5 Drugs Used in Parkinson’s disease 2
1.6 Drugs used in Alzheimer’s disease 2
1.7 Antipsychotic, antidepressant, anti-mania drugs 4
1.8 Opioid analgesics 3
1.9 CNS stimulants 2
2 Autacoids; Drug therapy of inflammation 13
2.1 Histamine, bradykinin and their antagonists 2
2.2 Serotonin, agonists and antagonists 2
2.3 Lipid derived autacoids, Eicosanoids and platelet activating factor 2
2.4 NSAIDs 3
2.5 Pharmacotherapy of Asthma 2
2.6
Pharmacotherapy of Gout 2
3 Drugs acting on gastrointestinal tract 8
3.1 Antacids and Drugs for peptic ulcers 3
3.2 Emetics, anti-emetics and Prokinetics 2
3.3 Drugs for constipation and diarrhoea 2
3.4 Drugs for Inflammatory Bowel Diseases 1
4 Principles of Toxicology 3
4.1 Heavy metals (Lead, Mercury, Arsenic) Poisoning, 2
4.2 Pesticide and Opioid Poisoning and treatment 1
TOTAL 48
1. Goodman & Gilman’s Pharmacological Basis of Therapeutics, McGraw Hill Companies Inc.
2. Satoskar R.S. Bhandarkar S.D. & Rege N.N. Pharmacology & Therapeutics, Popular Prakashan.
3. Rang & Dale Pharmacology, Churchill Livingstone.
4. Lippincott’s Illustrated Reviews: Pharmacology- Lippincott-Raven Howland & Nyeets Publishers NY.
5. Laurence D.R. & Bennett Clinical Pharmacology, Elsevier NY.
6. Kulkarni S.K. Handbook of Experimental Pharmacology, Vallabh Prakashan, New Delhi.
7. B.G.Katzung-Basic and Clinical Pharmacology, Appleton and Lange publications.
8. Ghosh M.N. Fundamental of Experimental Pharmacology. Hilton and company, Kolkata
BPH_C_705_T – Pharmaceutical Jurisprudence - (3 Hr/Wk)
Course Objectives
To impart knowledge on important legislations related to the profession of Pharmacy
Course Outcomes
Upon completion of the c ourse, the learner shall be able to:
1. Interpret Pharmaceutical Legislation
2. Understand pricing of drugs & pharmaceuticals
3. Summarize offences & penalties concerned with laws for drugs and pharmaceuticals
4. Gain an insight into Drug Regulatory Affairs
No. Details Hours
1 Pharmaceutical Legislation – A brief review of Historical perspectives, Study of Drugs
Enquiry Committee (Chopra Committee), Hathi Committee, Dr Mashelkar Committee 1
2 PHARMACY ACT 1948
2.1 Definitions 0.5
2.2 Pharmacy Council of India and State Councils: Composition and Functions
2.3
Registration of Pharmacists: Preparation of registers and qualifications for entry into
registers 2
2.4 Educational Regulations and Approval of Courses and Institutions
2.5 Offences and Penalties
2.6 Pharmacy Practice Regulations, 2015 1
3
DRUGS AND COSMETICS ACT 1940 AND RULES 1945
3.1 Definitions 0.5
3.2 Advisory Bodies: DTAB and DCC: Composition and Function
2
3.3 Analytical Bodies: Drug control Laboratories and Government Analyst
3.4 Executive Bodies: Licensing Authorities, Controlling Authorities, Drug Inspectors and
Customs Collectors
3.5 Provisions regarding Import of Drugs 3
3.6 Provisions regarding Manufacture of Drugs
3.7 Provisions regarding Sale of Drugs
3.8 Labeling and Packing of Drugs 1
3.9 Provisions applicable to Manufacture, Sale, labeling and Packing of Ayurvedic Drugs 1
3.10 Provisions applicable to Import, Manufacture, Sale, labeling and Packing of Homeopathic
Drugs 1
3.11 Provisions applicable to Import, Manufacture, Sale, labeling and Packing of Cosmetics 1
3.12 Offences and penalties 1
3.13 Schedules to the Drugs and Cosmetics Act & Rules (in brief), Schedule M and Schedule Y in
moderate details 1
3.14 Self-study: Case Studies
4.0 DRUGS AND MAGIC REMEDIES (OBJECTIONABLE ADVERTISEMENTS) ACT
1954 & RULES 1955 2
4.1 Definitions
4.2 Prohibited Advertisements, Savings
4.3 Self-study: Case Studies
5 NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES ACT & RULES 1985 2
5.1 Definitions
5.2 Narcotics Commissioner and other Officers
5.3 Illicit Traffic and measures to prevent illicit traffic of opium
5.4 Essential Narcotic Drugs, Recognized Medical Institutions
5.4 Offences and penalties
6 DRUGS PRICES CONTROL ORDER 2013 2
6.1 Definitions
6.2 Calculation, fixation, revision of ceiling / retail price for a scheduled formulation and its
monitoring
6.3 Display of prices of non -scheduled formulations and price list thereof and Sale of splitSS
quantities of formulations
6.4 Manufacturer, distributor or dealer not to refuse sale of drug
6.5 National List of Essential Medicines and Schedule I
6.6 Draft Pharmaceutical Policy – 2017
7 MEDICINAL AND TOILET PREPARATIONS (EXCISE DUTIES ACT) 1955 2
7.1 Definitions, restricted and unrestricted preparations
7.2 Manufacturing in bond and outside bond
8 FOOD SAFETY AND STANDARDS ACT 2006 AND RULES 2011 3
8.1 Definitions: Food, Adulterant and Food additive
8.2 Authorities and bodies: Food Safety and Standards Authority of India, Central Advisory
Committee, Food safety Officer, Commissioner of Food Safety in the State, Analytical
Laboratories and Food Analysts
8.3 Different Food Safety and Standards Regulations
8.4 Food Safety and Standards (Packaging and Labeling) Regulation, 2011
9 INDIAN PATENTS ACT 2005 4
9.1 Intellectual Property and its types, PCT, Different Laws related to Intellectual Property in
India
9.2 Definitions, features of a patent
9.3 Criteria for patentability and inventions not patentable in India
9.4 Process of patenting in India
9.5 Working of Patents, Compulsory Licences
9.5 Self-study: Case Studies
10 BOMBAY SHOPS AND ESTABLISHMENTS ACT
10.1 Definitions of Shops and Commercial Establishments and Provisions under the Act in Brief 1
11 FACTORIES ACT 1954
11.1 Definitions 1
11.2 Provisions under the Act in Brief
12 INDIAN PENAL CODE AND CODE OF CRIMINAL PROCEDURES
12.1 Provisions pertaining to different courts, jurisdiction and power 1
12.2 Provisions governing entry, search, arrest, bailable and non -bailable offences, cognizable and
non-cognizable offences
13 INTRODUCTION TO DRUG REGULATORY AFFAIRS 2
13.1 Brief overview of Drug Regulatory Agencies of US, Australia, Europe, UK, Japan
13.2 Introduction to USFDA, European, ICH and WHO guidelines
TOTAL 38
Books:
Latest editions of the following
1. Kuchekar B. S., Khadtare A. M., Itkar S. C., Pharmaceutical Jurisprudence, Nirali Prakashan.
2. N.K. Jain, Pharmaceutical Jurisprudence, Vallabh Prakashan.
3. Mittal B. M., Forensic Pharmacy, Vallabh Prakashan
4. Deshpande S. W. & Nilesh Gandhi, Drugs & Cosmetics Act; 9th Edition;2018
5. Government of India Publications of above Acts and Rules
6. www.fda.gov
7. www.tga.gov.au
8. www.ema.europa.eu
9. www.mhra.gov.uk
10. www.ich.org
11. www.who.int
BPH_C_706_L – Pharmacognosy Lab II - (4 Hr/Wk)
Course Objectives
1. To study crude drugs representative to major parts of plants for their morphological features and microscopic characters i ncluding
histology, powder characteristics.
2. To apply the knowledge of microscopic characters of the crude drugs in ascertaining genuinely of powdered formulations.
3. To extract and perform qualitative chemical tests belonging to various classes of phytoconstituents viz. Anthraq uinone Glycosides,
Cardiac Glycosides, Flavonoids, Cyanogenetic Glycosides, Alkaloids, Triterpenoid and Steroidal Glycosides, Saponins, Tannins.
4. To apply knowledge of analytical procedures in quantitative determination of total Aldehyde content / Phenol content / total alkaloids
from crude drugs
5. To understand principles involved and carry out extraction of active constituents
6. To identify crude drugs based on the morphological characters and quote some formulations available in market with their t herapeutic
utility
Course outcomes
At the end of the course the learner will be able to
1. Identify crude drugs based on morphological characters, microscopic characters and give biological source with the chemica l
constituents and therapeutic uses
2. Apply the knowledge of microscopic characters in ascertaining the genuinely of powdered formulations.
3. Extract and perform qualitative chemical rests on the crude drugs containing Anthraquinone Glycosides, Cardiac Glycosides,
Flavonoids, Cyanogenetic Glycosides, Alkaloids, Triterpenoid and Steroidal Glycosides, Saponins, Tannins
4. Apply analytical procedures and principles for quantitative determination of total Aldehyde content / Phenol content / total alkaloids
from crude drugs
5. Understand princi ples involved apply these for carrying out extraction of active constituents
6. Identify crude drugs based on the morphological characters and quote some formulations available in market with their ther apeutic
utility
No. Details Hours
1 Study of morphology, histology, powder characteristics, Extraction Chemical test, and TLC. (TLC of any 5
drugs)
Clove, Fennel, Senna, Cinnamom bark, Ephedra, Kurchi, Liquorice 20
2 To ascertain the authenticity of the powder formulation using microscopy containing drugs listed in topic 1.
Qualitative Phytochemical Tests of all phytoconstituents – Anthraquinone Glycosides, Cardiac Glycosides,
Flavonoids, Cyanogenetic Glycosides, Alkaloids, Triterpenoid and Steroidal Glycosides, Saponins, Tannins, 8
3 Monograph anal ysis of 1 herbal drug or 1 herbal excepient from IP 4
4 Estimation of Aldehyde content / Phenol content / total alkaloids from crude drug (Beckett) 4
5 Exercise involving isolation & detection of active principles of any two – Piperine / Caffeine/ eugenol /
embelin / rutin) 8
6 To study morphological characters and one marketed formulation of Arjuna, Vasaka, Brahmi, Fenugreek,
Garlic, Guggul, Asafoetida, Pepper, Ergot, Mint, Jatamansi, Lemon grass, Digitalis, Vinca, Aloe vera, Vidang,
Myrobalans, D ill, Cumin, Lemon grass. 4
TOTAL 48
Books:
1. Trease D. & Evans W. C.: Textbook of Pharmacognosy: W. B. Saunders.
2. Tyler V.E., Brady L.R. & Robbers J. E.: Pharmacognosy; Lea Febiger, USA.
3. Wallis T. E.; Textbook of Pharmacognosy; CBS Publishers, Delhi.
4. Kokate C.K., Purohit A. P. &Gokhale S. B.: Pharmacognosy; Nirali Publications, Pune.
5. Harborne J. B.: Phytochemical Methods: A guide to modern techniques Analysis: Chapman& Hall, Lon don.
6. Bruneton J.: Pharmacognosy, Phytochemistry, Medicinal Plants: Intercept Limited.
7. Vasudevan T.N. & Laddha K.S.: A Textbook of Pharmacognosy, Vrinda Publication House, Jalgaon.
8. The Indian Pharmacopeia: The Controller of Publication; Delhi.
9. Brain K.R. & Turner T. D.: The Practical Evaluation of Phytopharmaceuticals: Wright, Scientica, Bristol.
BPH_C_707_L – Pharmaceutical Analysis Lab III - (4 Hr/Wk)
Course Objectives
On performing the following experiments, the learner should be able to o perate the instruments, understand their functioning, prepare
solutions accurately, conduct analysis using appropriate instrument, calculate, report and interpret the results of analysis.
Course Outcomes
The learner should be able to:
1. Record, calculate and interpret data obtained by UV spectrophotometric analysis for pK a determination and concentration
determination by multicomponent analysis techniques.
2. Apply ICH guidelines to validate an analytical method by UV spectroscopy and interpret results obtained.
3. Develop and optimize mobile phase composition for qualitative analysis by TLC and interpret qualitative analysis data by TLC
and paper chromatography.
4. Outline working and application of column chromatography, HPLC and GC.
No. Details
1. UV spectrophotometric estimation of two components formulation by simultaneous equation method, Eg -
Caffeine and Sodium benzoate injection.
2. UV spectrophotometric estimation of two components formulation by absorbance ratio method, Eg -
Caffeine and Sodium be nzoate injection.
3. UV spectrophotometric estimation of formulation by Difference spectroscopy: Eg: Phenylephrine HCl
ophthalmic solution.
4. Assay of Trimethoprim in cotrimoxazole tablets
5. Determination of concentration of sample by UV spectroscopy (Construction of calibration curve using
linear regression analysis). Eg -Ibuprofen.
6. Determination of validation parameters by UV spectroscopy: Eg -Ibuprofen, Paracetamol.
Linearity
Precision
Accuracy
7. Separation and identification of compounds by TLC
8. Determination of pKa by UV spectroscopy eg. Phenylephrine HCl
9. Demonstration experiments:
Separation and identification of amino acids by paper chromatography.
Development of mobile phase for TLC
Working of HPLC, GC and HPTLC.
Separation of compounds by column chromatography
Note: Examples of drugs are provided for reference purpose only. Any other suitable drug can also be used.
Books:
1. A.H. Beckett and J.B. Stenlake, Practical Pharmaceutical Chemistry , 4th Edn., Part I and II, CBS Publishers and Distributors,
India.
2. G. D. Christian, Analytical Chemistry , 6th Edn., John Wiley & Sons, Singapore, reprint by Wiley India Pvt. Ltd.
3. Indian Pharmacopoeia, The Indian Pharmacopeia Commission, Ghaziabad, Government of India.
4. United States Pharmacopeia.
5. J. Mendham, R. C. Denney, J. D. Barnes, M.J. K. Thomas, Vogel’s Textbook of Quantitative Chemical Analysis, Pearson
Education Ltd.
6. D.G. Watson, Pharmaceutical Analysis –A textbook for pharmacy students and pharmaceutical chemists . 3rd Edn., Churchill
Livingstone Elsevier.
7. L. R. Snyder, J. J. Kirkland, J. L. Glajch, Practical HPLC Method Development , 2nd Edn., Wiley -Interscience publication, John
Wiley & Sons, Inc., Canada.
8. S. Ahuja and M. W. Dong, Handbook of Pharmaceutical Analysis by HPLC, Volume of Separation Science and Technology,
Elsevier Academic Press, Indian edition.
BPH_C_708_L – Pharmacology Lab II - (4 Hr/Wk)
Course prerequisites:
Ability to perform in vitro “dose response” experiments using cock ile um.
Course objectives:
1. Practical training on performing Bioassay of acetylcholine and atropine using cock ileum.
2. Demonstration of oxytocin bioassay and behavioural experiments using interactive CDs.
3. Information on Regulatory and toxicity guidelines.
Course outcomes:
1. Define Bioassay, list the types, methods and applications of bioassay and perform in vitro bioassay using cock ileum and record,
calculate and interpret unknown concentration of agonist/antagonist/drug.
2. Observe preclinical models which provide evidences on drug/lead pharmacological activity.
3. Relate to and apply the ethical, regulatory and toxicity guidelines/rules (ICH, OECD, CPCSEA, Schedule Y) in drug/lead testin g
using preclinical animals.
No. Details
1. Experiments:
1. Bioassay of Acetylcholine using suitable isolated tissue preparation e.g. Cock ileum
2. Bioassay of Atropine using suitable isolated tissue preparation e.g. Cock ileum
2. Demonstrations: (with kymograph recordings or audio -visual aids)
1. Bioassay of oxytocin
2. Behavioral Pharmacology Demonstrations/ Simulated experiments (CDs).
To study effect of drugs on locomotor activity in rodents using actophotometer.
To study the muscle relaxant property of drug using Rota -rod.
To study analgesic activity of drug using an analgesiometer.
To study anticonvulsant activity of drugs using maximal electroshock/ chemically induced
seizures.
To study phenothiazines induced catalepsy using suitable animal model.
3. Toxicity studies
• Introduction to CPCSEA, OECD guidelines
• Introduction to acute, sub -acute and chronic toxicity studies
Books:
Latest editions of the following books to be adopted:
1. Kulkarni S. K. Handbook of Experimental Pharmacology, Vallabh Prakashan, New Delhi.
2. Ghosh M.N. Fundamentals of Experimental Pharmacology Hilton & Company, Kolkata.
3. S. B. Kasture. A handbook of Experiments in Pre -Clinical Pharmacology, Career Publications.
4. W. L. M. Perry, Pharmacological Experiments on isolated preparations, E & S Living stone, Edinburg & London.
5. Patil C. R. X -cology (Software), Pragati Book Co. Pvt. Ltd, Pune.
ANY ONE SUBJECT FROM THE FOLLOWING 2 CREDIT SUBJECTS TO BE CHOSEN AS
ELECTIVE FOR A TOTAL OF 2 CREDITS
BPH_E_709_T – Intellectual Property Rights - (2 Hr/Wk)
Course Objectives
The course is framed to impart knowledge to the learners so that they get conversant with the Fundamentals of Intellectual
property Rights (IPR), their types and governing laws.
Course Outcomes
1. Correlate the knowledge of IPR with respect to pharmaceutical products.
2. Apply knowled ge of IPR in designing strategy for pharmaceutical p roduct development.
No. Details Hours
1 Intellectual Property Rights (IPR) – Introduction, definition, need history 2
2 Patents – Introduction, Indian Patent Act (1970), Patent and claim drafting, Process of filing and prosecution,
Rights achieved, Patentability with respect to Regional/ country’s
Requirement, Opposition of Patent
Self-Study - Case Study Presentations 8
1
3 Industrial Design – Introduction, filing and prosecution 2
4 Geographical Indication - Introduction, filing and prosecution 1
5 Natural biodiversity Act and Depository Bodies – Introduction and filing procedure 1
6 Patent Filing under PCT (Paris Convention Treaty/Patent Convention Treaty) - Introduction, filing and
prosecution, territorial specificity 3
7 Trademark – Introduction, filing and prosecution, opposition to trademark 3
8 Copyright – Introduction, filing and prosecution 1
9 Role of IP R in pharmaceutical product launch 1
10 IPR infringement and remedies 1
TOTAL 24
Books:
1. Intellectual Property Law, P. Narayanan, , Eastern Law House, Revised Edition, 2017.
2. www .wipo.int (World Intellectual Property Organization)
3. Indian Patent Act (www.ipindia.nic.in)
BPH_E_710_T – Green Chemistry and Catalysis - (2 Hr/Wk)
Course Objective
1. To introduce the learner with principles of green chemistry.
2. To study the source, disposal and prevention of chemical waste.
3. To learn basic level environmental management system.
4. To learn and select various kinds of catalysis with respect to industrial case studies.
Course Outcomes
The learner should be able to :
1. Know the terms involved i n green chemistry.
2. Understand the concept and techniques of waste management.
3. Know various guidelines of environmental management system.
4. Outline type of catalysis and their uses.
5. Learn greener process designing.
No. Details Hours
1 Principles and Concepts of Green Chemistry 2
1.1 Introduction and Twelve principles
1.2 Sustainable development and green chemistry
1.3 Atom economy, Atom economic reactions like rearrangement and addition reactions, Atom
uneconomic reactions like substitution, elimination
1.4 Reducing and measuring toxicity, E -Factor
2 Waste: Production, problems and prevention 3
2.1 Introduction, Problems caused by waste
2.2 Sources of waste from chemical industry, cost of waste
2.3 Waste minimization techniques: Approach, Process design, minimizing waste from existing
resources
2.4 Treatment of waste: Physical, Chemical, Biotreatment
2.5 Design for degradation: Degradation and surfactants, DDT, Polymer
2.6 Polymer recycling: Separation and sorting, Incineration, Mechanical and chemical recycling of
monomers
3 Environmental Management Systems (EMS)
ISO 4000, The European Eco -Management and Audit Scheme (EMAS) 2
3.1 Introduction to Life Cycle assessment system (LCA): Four stages, carbon foot printing
3.2 Eco labels, Integration Pollution Prevention and Control (IPPC), REACH
4 Catalysis and Green Chemistry 4
4.1 Introduction to catalysis, comparison of catalyst types
4.2 Heterogeneous catalysts: Basics, Zeolites and bulk chemical industry, heterogeneous catalyst
in Fine chemicals and pharmaceutical Industry, Catalytic converters
4.3 Homogeneous catalysts: Basics, Transition metal catalysts, Greener lewis catalyst, asymmetric
catalyst
4.4 Phase transfer catalysis: Basics, hazard reduction, C -C bond formation, oxidation using H 2O2
4.5 Biocatalysis, Photocatalysis
5 Use of solvents 4
5.1 Organic solvents and volatile organic compounds, solvent free system, Supercritical fluids,
scCO 2,scH 2O
5.2 Water as reaction solvent
5.3 Ionic liquids as solvent and catalyst, Fluorous biophase solvents,
5.4 Greenness of solvent a comparison
6 Renewable resources 2
6.1 Biomass as renewable resource, Energy: from biomass, solar power, fuel cells
6.2 Chemicals from renewable feedstock: from fatty acids, polymers, natural resources
7 Emerging Greener technology 3
7.1 Photochemical reactions: Advantages and challenges, examples
7.2 Microwave assisted chemistry: Microwave heating and examples
7.3 Sonochemistry, Electrochemistry with examples
8 Designing green process 2
8.1 Conventional reactors: Batch reactors, continuous reactors
8.2 Inherently safer design using concept of minimization, simplification, substitution, moderation,
limitation
8.3 Process intensification: PI equipment with examples of intensified processes
8.4 In-process monitoring, Process safety
9 Industrial case studies:
Methyl Methcrylate, acetic acid manufacturing, Vitamin C, Dyes, Naproxen, Ibuoprofen 2
TOTAL 24
Books:
1. Green Chemistry: An Introductory Text, Mike Lancaster, 2nd edition, RSC publishing.
2. Green Chemistry: Theory and Practice, Anastas P T and Warner J C, Oxford University Press.
3. Introduction to Green Chemistry, Ryan M. A., Tinnesand M., American Chemical Society (W ashington).
4. Handbook of Green Chemistry and Technology, Clarke J and Macquarrie D, Blackwell.
BPH_E_711_T – Preformulation Studies - (2 Hr/Wk)
Course Objectives
On completion of the course the learner will be able to understand the importance of physicochemical properties of a drug candidate in
design and development of an effective, stable, acceptable and safe formulation
Course Outcomes
At the end of the course the learners will be able to:
1. Explain physicochemical principles relevant to pharmaceutical dosage forms.
2. Comprehend the importance of solubility, stability and compatibility of drug substances with different excipients
3. Understand the role of preformulation studies in drug discovery, drug and product development
No Details Hours
1 Drug Discovery and Development Process in the Pharmaceutical Industry - Need,
Hurdles faced, Scheme of Steps in New Drug Development Process.
The concept of preformulation -Goals and scope of preformulation, Basic information
for designing preform ulation studies.
Principal areas of Preformulation research 3
2 Bulk Characterization 10
2.1 Organoleptic properties: Appearance, odour and taste, Hygroscopicity 1
2.2 Crystallinity & Polymorphism: Crystal morphology & Crystal habit,
Pseudopolymorphism (solvates), True polymorphism. Methods to characterize
polymorphs -Melting point determination, Hot-stage microscopy, Differential scanning
calorimetry and thermal analysis, PXRD (basic principles of the methods only) 3
2.3 Fine particle characterization - Particle size distribution measurements, Microscopy, sieve
analysis. Laser diffraction method (basic principle)
Particle Size Reduction, effect of milling and micronization, 3
2.4 Powder flow and Compression properti es: Bulk density, void volume, Carr’s
compressibility, Hausner’s ratio, Angle of repose.
Deformation behaviour of particles under the influence of applied forces -Elastic & Plastic
deformation, Fragmentation, Punch filming (sticking). 3
3 Solubility 7
3.1 Aqueous solubility: Intrinsic solubility (K 0), pK a determination, pH solubility profile and
Common ion effect, effect of temperature,
Techniques of solubilization -Co solvents, Chelating agents, Surfactants Complexation. 4
3.2 Dissolution: Intrinsic dissolution rate, Measurement of intrinsic dissolution rate
Partition coefficient (K o/w): Significance in preformulation studies as predictor of in vivo
absorption, methods to determine partition coefficient 3
4 Stability
Temperatu re, Order of reaction, Hydrolysis, Oxidation, photolysis (Self -study with
follow up)
Solid -state stability: bulk stability, effect of high humidity
Compatibility in presence of excipients
Solution phase stability: pH stability profile 3
5 Preformulation a spects for development of Tablets and Monophasic liquid dosage forms 1
TOTAL 24
Books:
1. M.E. Aulton. Pharmaceutics: The Design and manufacture of medicines. Third edition. 2007. Churchill Livingstone Elsivier.
2. David B. Troy, Paul Beringer. Remington’s - The Science and Practice of Pharmacy. Twenty first Edition. 2006. Lippincot Williams
& Wilkins.
3. Mark Gibson. Pharmaceutical Preformulation and Formulation: A Practical Guide from candidate selection to commercial dosage
form. Second editio n. Informa Healthcare.
4. Leon Lachman , Herbert A. Lieberman . Theory and Practice of Industrial Pharmacy. Special Indian edition. 2009; CBS Publishers.
5. Herbert Lieberman, Leon Lachman, Joseph B. Schwartz. Pharmaceutical Dosage Forms: Tablets, Volume 1. 1989. Second Edition.
Marcel Dekker Inc. NY
SEMESTER -VIII
BPH_C_801_T – Pharmaceutical Chemistry III - (4 Hr/Wk)
Course Objectives
1. Learn structure including stereochemistry, chemical name, SAR, metabolism, mechanism of action and selected
synthesis of CNS active drugs like sedatives/hypnotics, anticonvulsants, antidepressants, anxiolytics and antipsychotics
2. Learn structure including stereochemistry, chemical name, SAR, metabolism, mechanism of action and selected
synthesis of ANS active drugs like adrenergic and cholinergic agents
3. Learn structure including stereochemistry, chemical name, SAR, metabolism, mechanism of action and selected
synthesis of t estosterons and adrenocorticoids
Course Outcome
Students will gain knowledge in the thurst areas of CNS, ANS active drugs, analgesic agents and male female hormones. They wi ll be
apply this knowledge in research areas.
No. Details Hours
Discussion of the following classes of drugs including classification, chemical
nomenclature, structure including stereochemistry, generic names, SAR and
metabolism, molecular mechanism of action, synthesis(*) and rational development
if any
1 CNS Drugs
1.1 Sedatives – Hypnotics
Benzodiadepines: chlordiazepoxide, diazepam, nitrazepam*, temazepam, alprazolam,
estazolam; zolpidem, eszopiclone, ramelteon (last 3 for self study – 1 hr). 3
1.2 Anticonvulsants
Types of seizures (Self study - 1 hr)
phenytoin, mephenytoin, ethotoin, trimethadione, diazepam, clonazepam,
carbamazepine*, valproic acid, vigabatrine, progabide, lamotrigine, tiagabine 3
1
1.3 Antidepressants
imipramine*, chlorimipramine, amitriptyline, nortriptyline, doxepine*
fluoxetin e*, paroxetine, sertraline, escitalopram, amoxapine 3
1.4 Anxiolytics
Oxazepam, buspirone 1
1.5 Antipsychotics
chlorpromazine*, triflupromazine, thioridazine, fluphenazine, trifluperazine,
chlorprothixen(self study), droperidol , pimozide, risperidone, loxapine, clozapine,
sulpiride 4
1.6 Antiparkinson’s
carbidopa, levodopa, selegiline, amantadine, benztropine, procyclidine, orphenadrine
(last 3 for self study - 1 hr) 1
2 ANS Drugs
2.1 Adrenergic Drugs
Alpha adrenergic agonists: phenylephrine*, naphazoline, xylometazoline,
oxymetazoline, methyldopa, clonidine, guanabenz, guanafacine
Beta agonists : Isoproterenol, colterol, metaproterenol, terbutaline*, albuterol,
isoxsuprine, ritodrine
Alpha antagonist : tolazoline, phentolamine, phenoxybenzamine, prazosin, doxazosin
Beta Antagonists : pronethalol, propranolol*, sotalol, timolol, atenolol, metoprolol,
esmolol, acebutolol, carvedilol, labetalol* (last two for self study, including synthesis of
labetalol)
Other adrenergic agents (Sel f study -2 hrs) : pseudoephedrine, ephedrine, guanethidine,
propylhexedrine, reserpine 7
2.2 Cholinergic Drugs
Muscarinic agonists : methacholine, carbachol, bethanechol, pilocarpine
Acetylcholineesteraseinhibitors : physostigmine, neostigmine*, pyridostig mine,
edrophonium, echothiophate, malathion, parathion, pralidoxime
AntiAlzheimer’s :Tacrine*, donepezil, rivastigmine 7
Cholinergic antagonists : Atropine, scopolamine, homatropine, ipratropium
cyclopentolate*, dicyclomine*, benztropine, procyclidine, isopropamide, tropicamide
Neuromuscular blockers :(Self study) tubocurarine, gallamine, succinylcholine,
decamethonium
3. Analgesic Drugs
3.1 Opioid peptides(Self study)
Different types of opioid receptors, Potuguese and Becket Casy model, agonists, p artial
agonists and antagonists of these receptors
Morphine, codeine, levorphanol, buprenorphine, phenazocine, pentazocine,
meperidine*, alpha and beta prodine, pheniridine, anileridine, fentanyl, methadone,
dextropropoxyphene*, tramadol, nalorphine, nalox one, naltrexone, flupirtine
Antidiarrhoeals (Self study -1 hr) : loperamide, diphenoxylate 6
3.2 NSAIDS
paracetamol, aspirin, indomethacin, sulindac, mefenamic acid, ibuprofen, naproxen*,
nabumetone, diclofenac*, piroxicam*, nimesulide, celecoxib, valdecoxib. Cytokine
inhibitors :(Self study -1 hr) infliximab, rituximab, anakinra, abatacept
Drugs in Gout : c olchicine, probenecid, sulfinpyrazone, allopurinol, febuxostat 5
4 Drugs affecting Male and Female Health (Steroids)
4.1 Testosterone, 17 -alphamethyltestosterone, oxymesterone, fluoxymesterone, stanazolol,
danazol (Self study)
estradiol, ethinyl estradi ol, mestranol, medroxyprogesterone acetate, megestrol acetate,
norethindrone, norgestrel, diethylstilbestrol*(Synthesis for self study), clomiphene (Self
study), tamoxifen, anastrozole, letrozole, exemestane (Self study -1 hr)
medroxy progesterone acetate, megesterol acetate, norethindrone and norgestrel 3
4.2 Adrenocorticosteroids
cortisone, hydrocortisone, prednisone, prednisolone, dexamethasone and betamethasone,
flurometholone, fluocinolone, triamcinolone, aldosterone, fludrocortisone 2
TOTAL 48
Books:
Same as prescribed for Pharm. Chem. – III
BPH_C_802_T – Pharmaceutics IV - (4 Hr/Wk)
Course Objectives
To provide detailed insights into formulation and technology of sterile products including parenterals and ophthalmic dosage form, to
orient students about oral sustained and controlled release systems, to introduce important pharmacokinetics models and parameters
and to familiarize students with the concept of Pilot plant, Validation, cGMP etc. as important quality management systems in the
pharmaceutical industry.
Course Outcomes
Upon completion of the course, the learner shall be able to:
1. Apply the knowledge of sterile technology in designing safe and effective injectables and ophthalmic products
2. Study the rationale for oral SR/CR pro ducts, principles of design, development and evaluation of SR formulations
3. Understand the concepts of validation and pilot plant scale up for large scale manufacturing operations
4. Understand the concept of biopharmaceutics and significance of various pharmacokinetic parameters
No. Details Hours
1 Introduction to sterile dosage forms - Parenteral products 12
1.1 Various routes of parenteral administration, pyrogens, vehicle,
Water for Injection (WFI) - preparation, purity, storage and distribution, vehicles other than
WFI, additives in parenteral products. 3
1.2 Containers - glass and plastics - types and evaluation, rubber closures
– characteristics and testing. 2
1.3 Personnel, Manufacturing facilities - layout, environmental control,
cleanliness classes, air handling (HVAC systems), HEPA filters,
laminar flow 2
1.4 SVP: formulation considerations - solutions, suspensions, product procedures, freeze drying. 2
1.5 LVP – types, formulation aspects, packaging, FFS technology. 2
1.6 QA & QC - sterility test, pyrogen/ endotoxin test, particulate evaluation, leaker test. 1
2 Ophthalmic Products 5
2.1 Physiology of eye, lachrymal system, tears, precorneal tear film, cornea, ocular bioavailability 1
2.2 a) Formulations - additives and packaging of various ophthalmic products - solutions,
suspension, ophthalmic ointments and gels, preservatives and efficacy test
b) Contact lens solutions: types of lenses, cleaning solution,
disinfection solution, lubricants, multipurpose solutions and p ackages 3
2.3 QA and QC - sterility test, clarity, particle size for suspension,
tests on ointments and collapsible tubes 1
3 Oral sustained and controlled release systems 6
Need, definitions, Advantages of SR & CR systems, biopharmaceutical considerations;
Properties of drug with reference to the design of oral SR systems
Dose calculation of drug, calculation for dose - loading and maintenance 2
3.2 Matrix and reservoir type of systems, dissolution -controlled systems, diffusion -controlled
systems, ion exchange -controlled systems 3
3.3 Evaluation of sustained release systems 1
4 Microencapsulation 5
4.1 Definition, need/ reasons, concepts of core and coat 1
4.2 Methods of microencapsulation - phase separation coacervation (various techniques), Wurster
process, spray drying and related processes, interfacial polymerization, multiorifice centrifugal
process, pan coating, solvent evaporation; extrusion & spheronization
Evaluation of microcapsules 4
5 Introduction to Industrial Pharmacy 6
5.1 Pilot plant scale up techniques: Need, components, Factors considered while scaling up of
formulations: Mention the points for tablets, liquids (suspension, solutions, emulsions) and
semisolids 2
5.2 Validation: Definition, Types - Prospective, concurrent, Retrospective and revalidation.
Qualification of equipment -design, installation, operational, performance 2
5.3 Factory Layout: schedule M - general considerations/ steps,
Examples of Typical layout schemes for Tablets, capsule, liquids, sterile formulations
manufacturing areas (Individual layouts - Assignment with follow up) 2
6 Introduction to NDDS 8
6.1 Advantages of NDDS, concept of targeting -Active & Passive targeting 1
6.2 Concept, design and one suitable application of a typical system of
following NDDS:
a) Floating gastro -retentive systems,
b) Colon targeted drug delivery systems,
c) Mucoadhesive drug delivery systems,
d) Osmotic systems,
e) Transdermal DDS (membrane permeation systems),
f) Ocular inserts,
g) Colloidal DDS (liposomes, nanoparticles, microemulsions), 7
1 hour
for
each
system
8 Introduction to Pharmacokinetics 6
8.1 Definitions: Pharmacokinetics, ADME, bioavailability absolute and relative, bioequivalence.
Emphasis on the importance in drug discovery, development and clinical pharmacy 1
8.2 Pharmacokinetics: Introduction to compartmental and physiological models.
Introduction to the one compartmental open model and its assumptions 1
8.3 One compartment open model: IV bolus dosing: importance of volume of Distribution.
Clearance, elimination rate constant, half -life, area under the curve (trapezoidal rule) 2
8.4 One compartment open Model: Extra -vascular dosing.
Absorption rate constant, absorption half -life, bioavailability. Introduction of the Concept of
Cmax, T max, area under the curve, the trapezoidal rule and the method of Residuals. 2
TOTAL 48
Books:
Latest Editions
1. The theory and practice of Industrial Pharmacy, Ed. Leon Lachman, H. A. Liberman, J. L. Kanig; Varghese Publishing House.
2. Remington, The science and practice of Pharmacy, Vols. I and II, B. L. Publications Pvt. Ltd.
3. Cole Graham, Pharmaceutical Production Facilities, Design and Applications.
4. Pharmaceutical Process Validation, Nash Robert A., Berry Ir a R., Volume 57, Marcell Dekker INC, New York.
5. Pharmaceutical Dosage Forms: Parenteral medications. Vols. I, II, III, Ed Kenneth A. Avis, Leon Lachman and H. A. Liberman ,
Marcel Dekker INC.
6. Pharmacetuical Technology, Vols. I, II, R S R Murthy, Ashuto sh Kar, New Age Int. Ltd.
7. Pharmaceutical dosage forms: Parental medications, Vol. I, II, III, ed. by Kenneth A. Avis, Leon Lachman and H. A. Liberm an,
Marcel Dekker Inc., 1986.
8. Pharmaceutics. The Science of dosage form design ed. by M. E. Aulton, 2 nd ed., Churchill Livingstone, 2002.
9. Modern Pharmaceutics, 4 th ed. Revised and Expanded ed. by Gilbert S. Banker and Christopher T. Rhodes, Marcel Dekker INC. ,
2002.
10. The theory and practice of industrial pharmacy, ed. by Leon Lachman, H. A. Liberman, J. I. Kanig, 3 rd ed., Verghese Pu blishing
house, 1987.
11. Ophthalmic drug delivery, ed. by Ashim K. Mitra, 1993, Marcel Dekker INC.
12. Turco and Kings, Steril e Dosage forms, 3 rd Edn., Lea & Febiger, Philadelphia, 1985.
13. Michael J. Akers, Quality Control of Parenterals, Marcel Dekker
14. Controlled drug delivery – Fundamentals and Applications”, Robinson Joseph R., Lee Vincent H., Vol. 29, Marcel Dekker I nc
15. Leon Shargel, Susanna Wu – Pong, Andrew B.C, Applied Biopharmaceutics and Pharmacokinetics, Singapor
16. Brahmankar D.M and Jaiswal Sunil B, Biopharmaceutics and Pharmacokinetics – A Treatise, Vallabh Prakashan.
Note: References to latest amendment s of Schedule M and Schedule U of Drugs and Cosmetics Act 1940 to be made wherever
it is appropriate
BPH_C_803_L – Pharmaceutical Chemistry Lab II - 4 Hr/Wk)
Course Objectives
1) To introduce the learner to various hands -on experimental organic synthetic techniques including column chromatography
and thin layer chromatography.
2) To learn characterization of intermediates and final products by TLC and IR
3) To review important topics such as cyclization, reduction, rearrangement, condensation reactions .
4) To intr oduce the learner to the concepts of green chemistry.
5) To study the source, disposal and prevention of chemical waste.
Course Outcomes
The learner should be able to
1) Design and perform various unit operations of organic synthetic reactions
2) Characterize reaction intermediates and final products.
3) Know the theoretical concepts behind organic synthesis.
4) Understand the concept and techniques of waste management.
Synthesis of the following Drugs and Drug Intermediates
1. Synthesis of Benzilic Acid: Conventional Method and Green Modification as in Green Chemistry DST Monograph
2. Three Component Synthesis of Pyrimidone using Ethylacetoacetate, Benzaldehyde and Urea as per Green Chemistry DST
Monograph
3. Hofmann rearrangement: Anthranilic acid from Phthalimide.
4. Reducti on reaction: PABA from p-nitrobenzoic acid.
5. Pechmann condensation for coumarin synthesis using clay catalyst (Clay catalyzed solid state synthesis of 7 -hydroxy -4-
methylcoumarin) .
6. Synthesis of resacetophenone (Ref. Vogel page 983)
7. Synthesis of 4-methylcarbostyryl (old syllabus experiment)
8. Synthesis of Phenytoin
9. Synthesis of Hippuric Acid
(https://www.linfield.edu/assets/files/chem/Courses/CHEM%20322/3bAmide_synthesis_2015.pdf)
Or Synthesis of adipic acid (Ref. DST Monograph pg. 38)
Monitoring the progress of any two reactions by using TLC: Aim is to only monitor the completion of the reaction under
consideration. Student can comment on status of the reaction (completion/ incompletion) using TLC; they must develop the solv ent
system
Books:
1. Vogel’s A Text book of Practical Organic Chemistry by Vogel, Longman group limited, London.
2. Practical Organic Chemistry by Mann FC & Saunders BC, Longman Group Limited, London.
3. Laboratory Techniques in Organic Chemistry, Ahluwalia V.K. I.K. Publishers .
4. Green Chemistry, V. K. Ahluwalia.
5. New Trends in Green Chemistry, V K Ahluwalia and M Kidwai, KluwerAcademic Publishers
6. Monograph on Green laboratory Experiments, Grenn Chemistry Task Force Committee, DST.
7. Practical Organic Synthesis: A Studen t's Guide - Reinhart Keese, Martin Brändle, Trevor Toube.
8. Advanced practical Medicinal Chemistry by Ashutosh Kar, New Age International Publications.
BPH_C_804_L – Pharmaceutics Lab IV - (4 Hr/Wk)
Course Objectives
To train the learner with the practical aspects of formulation, manufacturing and quality control tests of parenteral and ophthalmic
products.
Course Outcomes
Upon completion of the course, the learner shall be able to:
1. Demonstrate the intricacies of formulation and development of p arenterals and ophthalmic products.
2. Understand and know about quality control and documentation of a manufacturing process.
3. Know about the pharmacopoeial tests for these products and their packaging materials.
4. Explain the concept of dissolution te sting as an important quality control tool and relate to its importance from regulatory point of
view.
5. Apply pharmacokinetic principles of oral routes of administration.
6. Demonstrate oral and written communication skills and ability to plan the experimentation with proper time management
EXPERIMENTS
No. Details
1 Preparation & Testing of WFI as per IP
2 Processing and monographic testing of Glass containers and rubber closures as per IP.
3 Preparation and documentation of the following injections:
a. Calcium Gluconate injection IP
b. Ascorbic acid injection IP.
c. Sodium chloride & Dextrose Injection IP
4 Preparation and documentation of following ophthalmic products:
a. Sulphacetamide eye drops, IP
b. Official antibiotic eye ointment (any one)
5 Preparation and in vitro release evaluation of sustained release oral tablets (matrix type)
6 Dissolution testing of marketed formulations of conventional tablets containing poorlywater soluble drug
(selection of medium)
7 Calculations of pharmacokinetic parameters -i.v. administration (plasma samples provided).
8 Microencapsulation of solid/liquid core using phase separation coacervation technique
9 Preparation and evaluation of mucoadhesive buccal formulation (tablet/film)
10 Validation of process - mixing/milling
11 Assignment on SOP’s of dissolution apparatus/tablet press/coating equipment
12 Assignment on excipient/API specifications. (One example of each)
Books:
All books listed in the theory syllabus as well as Current editions of IP, BP and USP.
BPH_E_805_D – Project - (12 Hr/Wk)
ANY TWO SUBJECTS FROM THE FOLLOWING 4 CREDIT SUBJECTS TO BE CHOSEN AS
ELECTIVES FOR A TOTAL OF 8 CREDITS
BPH_E_806_T – Phytopharmaceutical Technology - (4 Hr/Wk)
Course Objectives
1. To make learners aware of various terms used in Phytopharmaceuticals and understand the concept of standardization of natu ral
products utilized in cosmetics, medicine and as nutraceuticals.
2. To understand industrial preparation of s tandardized extracts and isolation of phytoconstitutents.
3. To give an insight towards various Conventional and Novel Drug Delivery Systems (NDDS) of Herbal medicines and the challen ges
faced along with the bioavailability aspects of Herbal formulations.
4. To introduce the concepts of QC and QA of Phytopharmaceuticals.
5. To learn role of herbs as Nutraceutical remedies for common disorders and in cosmeticeuticals.
6. To study the regulatory requirements for phytopharmaceuticals and Traditional Digital Kn owledge Library (TKDL)
Course Outcomes
Upon completion of the course learners will be able to –
1. Understand terms related to phytopharmaceuticals and standardization of Natural Products.
2. Explain industrial preparation of standardized extracts, isolat ion of phytoconstitutents and their applications.
3. Discuss the challenges faced in formulation of conventional and NDDS of herbal medicines.
4. Explain the applications of QC and QA of Phytopharmaceuticals.
5. To suggest the use of herbs as nutraceutical s in common disorders and cosmeticeuticals.
6. Describe the regulatory requirements for phytopharmaceuticals.
No Topics Hours
1 Introduction to the terms
Phytopharmaceutical Technology – Phytopharmaceuticals, Active ingredient, Botanical Drug Substance,
Ethnomedicine, Herbal Medicine, Phytomedicine, Phytopharmaceutical Science, Regulatory affairs,
Traditional medicine, Folklore medicine, Herbal medicine, Finished herbal product, Pharmaco -vigilance
of herbals, Phytopharmacoepidemology and Phytopharmacoeco nomics. 3
2 Herbal Extracts
Processing and authentication,
Introduction to Preparation and Types of extracts with suitable examples – liquid, solid, semisolid, dried
and powdered
Large scale industrial method for preparation of extracts,
Process and equ ipment: Names of equipment and their uses, merits and demerits in the unit operations of
size reduction, Extraction, Filtration, Evaporation/ Distillation, Drying of Extracts 8
3 Formulations and drug delivery system
A) Methods of preparations and evaluation of Herbal Tablets, Capsules, topical and liquid oral dosage
forms.
Study of any two examples of formulations under each dosage form with respect to their formulae
and activities / claims of each ingredient used in them.
B) NDDS of Herbal medicine: Limitation of Conventional, Challenges in Development of NDDS of
Herbal medicine, Phytosomes, Nanocarriers, Transdermal with one example each. Use of Bio -
enhancers in formulation development of herbal products.
Labeling of Phyto -pharmaceuticals. Preservation of Phy to-pharmaceuticals 8
4 Quality Assurance and Quality Control of Phytopharmaceuticals
A) For Herbal Extracts: Q.A by cultivation and Breeding,
Standardized extracts –Quantitative standardization using different types of Marker Compound. Stability
testing of Herbal extracts.
B) For Formulations: Stability of herbal formulation,
Bioavailability of Phytoconstituents from Herbal Formulations – Factors affecting bioavailability and
pharmacokinetics of some herbal drugs and phytoconstituents. 4
5 Herbs as Phytopharmaceutical Products
Occurrence, Structure, Pharmacology, Metabolism and Pharmacokinetics, Therapeutic uses,
Recommended doses and Marketed preparations, Toxicity and Regulatory status of the following –
Ephedra Alkaloids, Ginger, Garlic, Kava kav a, Ginkgo Biloba, Valerian, Chammomile, Echinacea, Panax
Ginseng, Cranberry, Acoruscalamus, Comfrey, Tomato, Liquorice, Senna, Cascara. 8
6 Non-Nutritive Sweeteners from Natural sources
Preparation, evaluation and salient features of Steveosides, Thaumatin, Glycyrrhizin. 2
7 Herbal Cosmeceuticals
Role of Herbs and phytoconstituents in the following categories of cosmetic preparations. Formulation
aspects of the following cosmetic preparations and their market potential
Skin cosmetics –
herbs us ed as
Fairness agents - Turmeric (Curcumin), Uvaursi (Arbutin)
Moisturizers – Aloe vera (mannans), Coriander seed oil (SELENOL) 8
Anti-ageing agents - Rose and rosehip (Rosa canina ), Chamomile (Matricariachamomilla )
Face packs -Apricot, Orange peel
Colour cos metics advantages of natural dyes and colourants – Onosmaechioides, Carthamine,
Bixin - their use in lipsticks, rouges, eye shadows
Cosmetic products for eyes – Butcher’s broom, Chammomile
Hair cosmetics –
Colouring of hair - Tea extracts, Amla, Henna
Herbs used in improving health of hair -shampoos, oils, conditioners.
(Any two examples)
Dental hygiene Products: Salvadorepersica , clove, neem
8 Industrial production and estimation of the following phytoconstituents
Preparation of their derivatives and products
Alkaloids -Berberine
Carotenoids - Capsanthin
Flavonoids - Naringenin, Hesperidin
Terpenoids - Citral, Forskolin, Gymnemic acid
Steroids -Diosgenin
Carbohydrates -Pectin 4
9 Regulatory issues in Phytomedicine
Indian and International requirements.
TKDL (Traditional Knowledge Digital Library), Certification of Phytodrug industry.
(DSHE) Dietary Supplement Health and Education.
Acts related to banned or restricted phytoingredients.
Standardization Regulation for labeling purpose. 3
TOT AL 48
References:
1. Evidence -Based Validation of Herbal Medicine edited by Pulok K. Mukherjee Business Horizons Publishers
2. Phytotherapies: Efficacy, Safety, and Regulation. Ed Iqbal Ramzan John Wiley and Sons
3. Contemporary Phytomedicines. Amritpal Singh Saroya, CRC press
4. Journal of Ethnopharmacology 140 (2012) 513 –518: www.elsevier.com/locate/jethpharm Pharmacovigilance of herbal
medicine Shaw Debbiea,, Ladds Graeme B, Duez Pierrec, Williamson Elizabeth D, Chan Kelvine,F
5. Textbook of Pharm acognosy by Trease & Evans.
6. Textbook of Pharmacognosy by Tyler, Brady & Robber.
7. Pharmacognosy by Kokate, Purohit and Gokhale
8. Essential of Pharmacognosy by Dr. S.H. Ansari
9. Pharmacognosy & Phytochemistry by V.D.Rangari
10. Pharmacopoeial standards for Ayurv edic Formulation (Council of Research in Indian Medicine & Homeopathy)
11. Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals. Business Horizons Publishers,
New Delhi, India, 2002
12. Toxicology and Clinical Pharmacology of H erbal Products,Steven B. Karch, Humana Press
13. Herbal Principles in Cosmetics Properties and Mechanisms of Action, Bruno Burlando, Luisella Verotta, Laura Cornara, and
Elisa Bottini -Massa, CRC Press.
BPH_E_807_T – Clinical Pharmacy - (4 Hr/Wk)
Course Prerequisites
Understanding of Pharmacology and its applications.
Course Objectives
1. Introduction to clinical pharmacy, Role of clinical pharmacist, patient case history, presentation of cases and counselling.
2. Educate on personalized drug therapy taking in to consideration general and special population.
3. Teach basics of ADRs and pharmacovigilance.
4. Introduce the concept of therapeutic drug monitoring and its importance in therapy areas like epilepsy, cardiovascular disord ers,
and others
5. Introduce the concepts of pharmacoepidemiology and pharmacoeconomics
Course Outcomes
1. Relate to the role of pharmacist in different setups like clinics, pharmacies and in the community and appraise the crucial r ole of
pharmacists in patient counselling and eventually in drug adh erence and compliance to therapy.
2. Discuss the types, risk factors, classification, methods of detection, monitoring and reporting of ADRs, drug interactions,
pharmacovigilance and TDM in normal as well as special populations.
3. Outline the process of drug di scovery and development, Ethical Guidelines/Schedules, Role of Ethics Committee, essential
documents in clinical trials/research, BA -BE studies and, apply and appreciate the role of GCP in conduct of clinical research.
4. Identify and analyze the trends in dr ug use to optimize health outcomes.
No. Details Hours
1 Introduction to Clinical Pharmacy: Concept of Clinical Pharmacy, Community
pharmacy and hospital pharmacy (Definition, scope and objectives) 4
2 Pharmacist -Patient Interaction 4
2.1 Patient Counselling: Role of Pharmacist in patient counselling 2
2.2 Patient Compliance, Methods of assessment of compliance, Reason for patient
noncompliance, Strategies to improve compliance, Precaution and directions for
medication, Administration instructions
2
3 Adverse Drug reactions:
Epidemiology, Classification, Risk factors, Monitoring, Detecting and reporting of
ADR 5
4 Drug interactions:
Types, General Considerations and Mechanisms 3
5 Drug use in special population 6
5.1 Drugs used in Geriatrics 2
5.2 Drugs used in Paediatrics 2
5.3 Drugs used in Pregnancy 2
6 Therapeutic Drug Monitoring: Definition, indications and strategies 2
7 Drug discovery & development 14
7.1 Preclinical development 2
7.2 Clinical development - 5
a. History, terminologies, types of clinical research, phases of clinical trials, role of
clinical trial in new drug developments. Ethical issues in clinical trials: Principle of
regulatory requirements, responsible conduct, supe rvision of ethics, (Informed
Consent, Independent Ethics Committee, Institutional Review Board)
7.3 Good Clinical Practice (GCP): Concept and importance 1
7.4 Definitions of essential documents; SOP, protocol, Investigator’s brochure, 2
7.5 Introduction to BA/BE studies 2
7.6 Pharmacovigilance: Definition, scope and aims of Pharmacovigilance 2
8 Pharmacoepidemiology:
Definition, types, methods, factors affecting drug utilization, applications of
pharmacoepidemiology 4
9 Pharmacoeconomics and outcomes Research:
Theories and methodologies of pharmacoeconomics and outcomes research,
applications to pharmacotherapy and managed health care 6
Total 48
Books:
Latest editions of the following books to be adopted
1. Clinical Pharmacy and Therapeutics, Roger Walker, Clive Edwards, Churchill Livingstone.
2. Clinical Pharmacy, H. P. Tipnis, A. Bajaj, Career Publications.
3. Clinical Pharmacology, P.N. Benett, M. J. Brown, Churchill Livingstone.
4. Text Book of Clinical Pharmac y Practice, G. Parthisarathi, Karin Nyfort Hansen, Milap C. Nahata, Orient Longman.
5. Strom BI, Limmel SE. Textbook of Pharmacoepidemiology. Chichester, West Sussex, England: John Wiley & Sons Ltd; 2006.
6. Rascati, Karen L. Essentials of Pharmacoeconomics. Philadelphia, Pa.: Lippincott Williams and Wilkins, 2009.
7. M. F. Drummond, M. J. Sculpher and G. W. Torrance, Methods for the economic evaluation of health care programmes. Oxford
University Press, USA, 2005.
8. Brenda Waning; Michael Montagne; William W McClo skey, Pharmacoepidemiology: Principles and practice, New York,
McGraw -Hill, 2001.
BPH_E_808_T – Pharmacovigilance - (4 Hr/Wk)
Course Prerequisites
Basic/core courses in Pharmacology.
Course Objectives
1. Provide an opportunity for the student to learn about development of pharmacovigilance.
2. Learn the basic terminologies used in pharmacovigilance, global scenario of Pharmacovigilance.
3. Train students on establishing pharmacovigilance programme in an organization.
4. Various methods that can be used to assess adverse drug reactions generate safety data and signal detection.
5. Regulatory aspects of pharmacovigilance.
Course Outcomes
1. Relate to the role of pharmacovigilance and its prevalence in different setups.
2. Discuss the different facets of ADRs in normal as well as special populations with their relation to pharmacovigilance methods.
3. Integrate knowledge of resources of drug information, safety data and drug utilization.
4. Outline the regulatory processes in pharmacovigilance.
5.
No. Details Hours
1 Introduction to Pharmacovigilance 6
1.1 History and development of Pharmacovigilance 0.5
1.2 Importance of safety monitoring of Medicine 0.5
1.3 WHO international drug monitoring programme 1
1.4 Pharmacovigilance Program of India (PvPI) 1
1.5 Vaccine safety surveillance 1
Vaccine Pharmacovigilance, Vaccination failure
1.6 Establishing pharmacovigilance programme 2
Establishing in a hospital
Establishment & operation of drug safety department in industry
Contract Research Organizations (CROs)
Establishing a national programme
2 Adverse drug reactions 9
2.1 Definitions and classification of ADRs 1
2.2 Detection and reporting 3
2.3 Methods in Causality assessment 2
2.4 Severity and seriousness assessment 1
2.5 Predictability and preventability assessment 1
2.6 Management of adverse drug reactions 1
3 Pharmacogenomics of adverse drug reactions: Drug safety evaluation in special
population 6
3.1 Pediatrics 2
3.2 Pregnancy and lactation 2
3.3 Geriatrics 2
4 Pharmacovigilance methods 10
4.1 Passive surveillance – Spontaneous reports and case series 7
Stimulated reporting
Active surveillance – Sentinel sites, drug event monitoring and registries
Comparative observational studies – Cross sectional study, case control study and cohort
study
Targeted clinical investigations
4.2 Communication in pharmacovigilance 3
Effective communication in Pharmacovigilance
Communication in Drug Safety Crisis management
Communicating with Regulatory Agencies, Business Partners, Healthcare facilities &
Media
5 Drug dictionaries and coding in pharmacovigilance 10
5.1 WHO adverse reaction terminologies 2
MedDRA and Standardized MedDRA queries
WHO drug dictionary
5.2 Information resources in pharmacovigilance 2
drug information resources
Specialized resources for ADRs
5.3 Basic terminologies used in pharmacovigilance 1
Terminologies of adverse medication related events
Regulatory terminologies
5.4 Drug utilization: 2
Need, types of drug utilization studies
Drug use evaluation
5.5 Medication safety data: Safety data generation 3
Pre-clinical phase
Clinical phase
Post approval phase
6 Regulatory Aspects of Pharmacovigilance 7
6.1 ICH Guidelines for Pharmacovigilance 4
Organization and objectives of ICH
Expedited reporting
Individual case safety reports
Periodic safety update reports
Post approval expedited reporting
Pharmacovigilance planning
Good clinical practice in pharmacovigilance studies
6.2 CIOMS 1
CIOMS Working Groups
CIOMS form
6.3 CDSCO (India) and Pharmacovigilance 2
D & C Act and Schedule Y
Differences in Indian and global pharmacovigilance requirements
TOTAL 48
Books:
Latest editions of the following books to be adopted
1. Textbook of Pharmacovigilance: S K Gupta, Jaypee Brothers, Medical Publishers.
2. Practical Drug Safety from A to Z, Barton Cobert, Pierre Biron, Jones and Bartlett Publishers.
3. Mann's Pharmacovigilance: Elizabeth B. Andrews, Nicholas, Wiley Publishers.
4. Stephens' Detection of New Adverse Drug Reactions: John Talbot, Patrick Walle, Wiley Publishers.
5. An Introduction to Pharmacovigilance: Patrick Waller, Wiley Publishers.
6. Cobert's Manual of Drug Safety and Pharmacovigilance: Barton Cobert, Jones & Bartlett Publishers.
7. Textbook of Pharmacoepidemiology, Eds Brian L. Strom, Stephen E Kimmel, Sean Hennessy, Wiley Publishers.
8. A Textbook of Clinical Pharmacy Practice -Essential Concepts and Skills: G. Parthasarathi, Karin Nyfort Hansen, Milap C.
Nahata
9. National Formulary of India
10. Text Book of Medicine by Yashpal Munjal
11. Text book of Pharmacovigilance: Concept and Practice by GP Mohanta and PK Manna, PharmaMed Press/BSP Books.
12. http://www.cioms.ch/
13. http://cdsco.nic.in/
14. http://www.who.int/vaccine_safety/en/
15. http://www.ipc.gov.in/PvPI/pv_home.html
16. http://apps.who.int/medicinedocs/pdf/s4876e/s4876e.pdf
BPH_E_809_T – Pharmaceutical Regulatory Affairs - (4 Hr/Wk)
Course Objectives
The course is framed to impart knowledge to the learners so that they get conversant with drug regulatory practices and procedures
followed at national and international level for registration and approval.
Course Outcomes
The learner should be able to:
1. Understand the basics of new drug and generic product development.
2. Apply knowledge of regulatory requirements for preparing the documents for registration of pharmaceutical product in India and
overseas.
3. Understand various harmonized practices and integrate the knowledge required for various certifications.
No. Details Hours
1 Drug Regulatory Affairs
1.1 Introduction to Drug Regulatory Affairs(DRA)
1.2 DRA in Pharmaceutical Industry
1.3 Regulatory bodies across the world and different markets and brief introduction of registration process in UK,
Australia, Brazil, Canada, Japan, ASEAN countries, Commonwealth of Independent States, -Russian
Commonwealth (CIS) 4
1
1
2
2 Indian Regulations
2.1 Indian Pharmacopoeia (IP) commission - Introduction, IP review process with men tioning
monograph and IP reference substances (RS)
2.2 Pharmacovigilance Programme of India (PVPI)
2.3 Central Drug Standard Control Organization (CDSCO), Drug Controller General of India (DCGI), Food and
Drugs Administration (FDA), Centre Drugs Laborator y(CDL) - Structure, role, function and strategies of these
organizations
2.4 Procedure for obtaining test license (Form 29 and form 11), Export NOC, Loan License/Contract
manufacturing 9
3
1
3
2
3 US Regulations
3.1 USFDA - Structure, role and function
3.2 Drug price competition and patent term restoration act (Hatch Waxman Act 1984) - scope and objective
3.3 Type of filings - Type of application and relevant forms - Investigational New Drug (IND), New Drug
Application (NDA), Supplemental new drug applicat ion (SNDA), Abbreviated NDA (ANDA), Biologic License
Application (BLA)
3.4 Orange book Therapeutic Equivalent (TE) codes, Patent term and exclusivity
3.5 21 CFR - Brief introduction and mention of 21 CFR Part 11
3.6 Post Approval changes and SUPAC guideline s - Brief introduction
3.7 Drug master file (DMF) and different types 11
1
3
2
2
1
1
1
4 European Regulations (EU)
4.1 EMEA - Structure role and function 10
2
4.2 Types of filing - Centralized, Decentralized, Mutual recognition procedure, National
4.3 Type of applications for marketing authorization - New drug, Hybrid drug, Generic, similar biologic, Fixed
combination
4.4 Active Substance master file (ASMF) – Brief introduction, Certificate of suitability (COS)
4.5 Post Approval changes and handling variations 3
2
2
1
5 International Council for Harmonization (ICH)
5.1 Introduction - Composition, Role and responsibilities
5.2 ICH guidelines - Quality (Q), Safety (S), Efficacy (E), Multidisciplinary (M)
5.3 ICH quality guidelines – Terminologies
5.4 Introduction of ICH , multidisciplinary M4 guidelines 4
1
1
1
1
6 GMP certification and ISO 3
7 Clinical Trials
7.1 Regulatory perspective of clinical trials and brief overview of schedule Y and amendments
7.2 ICMR guidelines, Institutional Ethics commit tee for biomedical research (IRB/IEC)
7.3 Bioavailability and bioequivalence study, Biowaiver - Regulatory requirement 4
1
1
2
8 Intellectual Property rights and type Patent Act 1970, TRIPS, WTO, GATT and PCT -
Definition and Goals 3
TOTAL 48
Books:
1. New Drug Approval: Accelerating Global Registrations by Richard A Guarino, MD, 5th Edition, Drugs and the Pharmaceutical
Sciences, Vol.190.
2. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and Isader Kaufer, Marcel Dekker series, Vol.143.
3. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert P. Martin, Drugs and the Pharmaceu tical
Sciences, Vol.185, Informa Health care Publishers.
4. Intellectual Property Law, P. Narayanan, , Eastern Law House, Revised Edition, 2017.
https://www.ich.org
https://www.fda.gov
https://www.ema.europa.eu
https://www.cdsco.nic.in
https://www.icmr.nic.in
https://www.gov.uk
BPH_E_810_T – Lead Optimization – Strategies and Methods - (4 Hr/Wk)
Course Objectives
1. To introduce the learner to the concepts of druggability and physicochemical/ADME/Toxicity property optimization in new d rug
discovery.
2. To study the fundamentals, structure modification strategies and methods of determination of various physicochemical and
pharmacokinetic properties of lead compounds.
Course Outcomes
The learner should be able to :
1. Understand the impor tance of druggability and physicochemical/ADME/Toxicity property optimization in new drug discovery.
2. Understand the fundamentals of various physicochemical and pharmacokinetic properties and their significance in lead
optimization.
3. Know various strat egies for structure modification for optimizing druggability of lead molecules.
4. Describe different methods of determination of various physicochemical and pharmacokinetic properties of lead compounds.
No. Details Hours
1 Drug -like Properties 4
1.1 Introduction, drug -likeness and Drug Discovery
1.2 Property profiling and optimization
1.3 Rules for rapid property profiling from structure
1.4 Lead -like compounds
1.5 Strategies for integrating drug -like properties into Drug Discovery
2 Lipophilicity and pKa 4
2.1 Fundamentals, effects and structure modification strategies
2.2 Lipophilicity determination Methods: in silico lipophilicity methods,
experimental lipophilicity methods, in -depth lipophilicity methods
2.3 pKa determination methods: in silico methods, experimental methods, in -depth
methods
3 Solubility 4
3.1 Fundamentals of solubility, dissolution rate, structural properties affecting solubility,
kinetic solubility and thermodynamic solubility
3.2 Effects of solubility, IV formulations, solubility classification, effects of physiology
on solubility and absorption
3.3 Structure modification strategies to improve solubility, strategies for improving
dissolution rate, salt forms
3.4 Methods for solubility determination: solubility calculation methods and commercial
software, kinetic solubility methods, thermodynamic solubility methods
4 Permeability 4
4.1 Permeability fundamentals: passive diffusion permeability, endocytosis permeability,
active uptake permeability, paracellular permeability, efflux permeability, combined
permeability
4.2 Permeability effects: effect of permeability on bioavailability, effect of permeability
on cell -based activity assays
4.3 Permeability structure modification strategies
4.4 Methods for permeability determination:
in silico permeability methods, in vitro permeability, in depth permeability methods
5 Transporters 4
5.1 Transporter fundamentals
5.2 Transporter effects, efflux transporters: p -glycoprotein (MDR1, ABCB1) , breast
cancer resistance protein (BCRP, ABCG2), multidrug resistance protein 2 (MRP2,
ABCC2) , efflux transporters in the BBB
5.3 Uptake transporters, structure modification strategies
5.4 Methods: in silico transporter methods, in vitro transporter methods, in vivo methods
for transporters
6 Blood Brain Barrier 4
6.1 BBB fundamentals: BBB permeation mechanisms, brain distribution mechanisms,
brain –CSF barrier, interpreting data for brain penetration
6.2 Effects of brain penetration
6.3 Structure –BBB penetration relationships, structure modification strategies to
improve brain penetration
6.4 Methods for determining BBB: in silico methods, in vitro methods, in vivo methods,
7 Metabolic Stability, Plasma Stability, Solution Stability 6
7.1 Metabolic stability fundamentals: Phase I metabolism, Phase II metabolism,
metabolic stability effects
7.2 Structure modification strategies for metabolic stability: Phase I, Phase II,
consequences of chirality on metabolic stability
7.3 Plasma Stability: fundamentals, effects, structure modification strategies to improve
plasma stability
7.4 Solution Stability: fundamentals, effects, structure modification strategies to improve
solution stability
7.5 Methods: In silico metabolic stability methods, in vitro metabolic stability methods,
plasma stability methods, solution stability methods
8 Plasma Protein Binding 3
8.1 Plasma Protein Binding Fundamentals: consequences of chirality on PPB
8.2 Plasma Protein Binding Effects: Impact of PPB on distribution, clearance and
pharmacology
8.3 Structure modification strategies for PPB
8.4 Methods for determining PPB: in silico methods, in vitro Methods
9 Cytochrome P450 inhibition 4
9.1 CYP inhibition fundamentals and effects
9.2 Structure modification strategies to reduce CYP inhibition
9.3 Reversible and irreversible CYP inhibition
9.4 Methods for determining CYP inhibition: in silico methods, in vitro methods
10 hERG Blocking 3
10.1 hERG Fundamentals, hERG blocking effects
10.2 hERG Blocking Structure –Activity Relationship, structure modification strategies
for hERG
10.3 hERG methods: In silico hERG methods, in vitro hERG methods, in vivo hERG
methods
11 Toxicity 4
11.1 Toxicity Fundamentals: toxicity terms and mechanisms
11.2 Structure modification strategies to improve safety
11.3 Methods: in silico toxicity methods, in vitro toxicity assays, in vivo toxicity
12 Pharmacokinetics 4
12.1 Pharmacokinetic parameters: volume of distribution, Area Under the Curve,
clearance, half -life, bioavailability
12.2 Effects of plasma protein binding on PK parameters, tissue uptake
12.3 Using PK data in drug discovery
12.4 Pharmacokinetic methods: PK dosing (single -compound dosing, cassette dosing), PK
sampling and sample preparation, instrumental analysis
Total Hours 48
Books:
1. Drug -like Properties: Concepts, Structure Design and Methods from ADME to Toxicity Optimization, Li Di, Edward Kerns,
Academic Press.
2. Lead Optimization for Medicinal Chemists: Pharmacokinetic Properties of Functional Groups and Organic Compounds, Florencio
Zaragoza Dörwald, Wiley -VCH.
3. Pharmacokinetics and Metabolism in Drug Design, Volume 31, Dennis A. Smith, Han van de Waterbeemd, Don K. Walker, Series
Editors - Raimund Mannhold, Hugo Kubinyi and Gerd Folkers, Wiley -VCH.
BPH_E_811_T – Novel Drug Delivery Systems - (4 Hr/Wk)
Course Objectives
To provide the learner with knowledge of basic principles and the different types of Novel Drug Delivery Systems
Course Outcomes
Upon completion of the course, the learner shall be able to:
1. Understand the basic concept of NDDS
2. Discuss the different NDDS for different routes -oral, transdermal, ocular, transmucosal and implantable
3. Explain the need and concepts of targeting and active & passive targeting
4. Elaborate on principles and targeting systems for brain, colon, lymphatics and tumors
5. Discuss the various multiparticulate systems for targeting
No. Details Hours
1.0 Fundamentals of Novel drug delivery systems: Basic Concepts, Advantages and
Disadvantages, Limitations of conventional dosage forms 1
2.0 Polymers: Introduction, classification, Role and applications in NDDS, Biodegradable and
biocompatible polymers. 3
3.0 Particulate NDDS:
Microspheres, liposomes, nanoparticles, aquasomes, niosomes, dendrimers -Classification,
components & design, methods of preparation, characterization and applications of each
system. 4
3.0 Oral Controlled Drug Delivery Systems:
a) Matrix and reservoir systems - Diffusion and dissolution -controlled systems
b) Multiparticulate drug delivery systems (Pellets) - need and significance of pelletization,
techniques - pan coating, extrusion and spheronization, equipments, evaluation
c) Osmotic Systems - Basic principles, classification - Implantable osmotic pumps, oral
osmotic pumps, applications & evaluation
d) Gastroretentive drug delivery systems (GRDDS) -
Regional variability in intestinal absorption and concept of absorption window, Design of
GRDDS technologies - low density (Floating systems), Swelling and expanding systems,
Mucoadhesive systems, high density systems. Evaluation of GRDDS. 8
4.0 Ocular drug delivery systems: 4
Limitations of conventional systems, in situ gelling systems , Ocular inserts: Non -erodible
and Erodible inserts, Particulate systems for ocular delivery -liposomes & nanoparticles,
ocular iontophoresis, evaluation.
One example of each system
5.0 Transdermal Drug Delivery Systems (TDDS):
Permeation through skin, factors affecting permeation, Advantages and disadvantages of
TDDS, basic components of TDDS, Different types of TDDS and release control
mechanism, pressure sensitive adhesives, Evaluatio n 4
6.0 Transmucosal drug delivery systems :
Concept of bioadhesion/ mucoadhesion, Advantages and disadvantages of transmucosal
drug delivery, Bioadhesive polymers, Theories of mucoadhesion, Factors affecting
mucoadhesion, transmucosal permeability, Formu lation considerations: emphasis on
buccal drug delivery, Evaluation of mucoadhesive strength 4
7.0
Parenteral Controlled drug delivery systems - Need and Various approaches, Details of
Implantable Systems – Characteristics desired, routes employed, diff usion -controlled
systems, activation -controlled systems and feedback -regulated systems. One example of
each.
Biocompatibility issues of implantable systems 5
8.0 Nasal and Pulmonary Drug Delivery Systems -Advantages and limitations;
Nasal drug delivery -absorption pathways of intranasally administered drugs, permeation
enhancers, intranasal formulations, nose -to-brain delivery
Pulmonary delivery - Weibel model of Lungs (Pulmonary tree), aerosol deposition
mechanisms and pattern in lungs, concepts of mass median aerodynamic diameter
(MMAD) and Fine particle fraction (FPF); Delivery systems (nebulised, systems, pMDIs
and DPIs), Active and Passive devices, Evaluation methods. 7
9.0 . Targeted drug delivery systems:
a) Introduction to targeting, concepts of active and passive targeting.
b) Particulate systems for targeting - microspheres, aquasomes, niosomes,
dendrimers, and solid lipid nanoparticles, liposomes
c) Targeting to colon: Difficulties in colonic targeting, Approaches of colon
targeting, Eval uation
d) Targeting to Brain: Blood brain barrier (BBB), transport through BBB, factors
affecting drug permeation through BBB, strategies for brain drug delivery
e) Lymphatic targeting -need and approaches -
f) Targeting to tumor – EPR effect, ligand -based active ta rgeting with two
examples 8
TOTAL 48
Books:
Latest editions
1. Advances in controlled and novel drug delivery, ed. by N. K. Jain, CBS publishers and distributors, 2001.
2. Modern Pharmaceutics, 4th ed. Revised and Expanded, ed. by Gilbert S. Banker and Christopher T. Rhodes, Marcel Dekker INC.,
2002
3. Targetted and controlled drug delivery, Novel carrier systems, S. P. Vyas and R. K. Khar, CBS publishers and distributors, 2002.
4. Controlled and novel drug delivery, ed. by N. K. Jain, CBS publishers and distributors, 1997.
5. Controlled drug delivery, concepts and advances, S. P. Vyas and R. K. Khar, Vallabh Publishers, 2002.
6. The theory and practice of industrial pharmacy, ed. b y Leon Lachman, H. A. Liberman, J. L. Kanig, 3rd ed., Verghese Publishing
house, 1987.
7. The science and practice of pharmacy, 21st ed., Remington, Vol I and II, B. L. Publications Pvt. Ltd., 2005.
8. Bioadhesive Drug Delivery Systems – Fundamentals, Nove l Approaches, and Development, Mathiowitz Edith, Chickering III, Donald
E., Lehr Claus -Michael, Volume 98, Marcel Dekker Inc., New York, 1995.
9. Nanoparticulate Drug Delivery Systems, Thassu Deepak, Dellers Michael, Pathak Yashwant, Volume 166, Marcel Dek ker Inc., New
York, 2007.
10. Microencapsulation – Methods and Industrial Applications”, Benita Simon, 2nd Edition, Marcel Dekker Inc., New York, 2006.
11. Controlled and Novel Drug Delivery, Jain N. K., 1st Edition, CBS Publishers and Distributors, New Delhi, 2004.
12. Targeted and Controlled Drug Delivery - Novel Carrier Systems”, Vyas S. P., Khar R. K., 1st Edition, CBS Publishers and
Distributors, New Delhi, 2002.
13. Ophthalmic Drug Delivery Systems, Mitr a, Ashim K., Volume 58, Marcel Dekker Inc., New York, 1993.
14. Encyclopedia of Pharmaceutical Technology, Swabrick, Boylan, Volumes 1,6,8,9,10,12,13,14,15,16,17,18,19,20, Marcel Dekker
Inc., New York.