Syllabus - B. Pharm - 4th Year - CBCS 2019-2020
Syllabus - B. Pharm - 4th Year - CBCS 2019-2020
Syllabus - B. Pharm - 4th Year - CBCS 2019-2020
S. No. Subject Subject Name L--T--P T/P Marks Sessional Total Credit
Code (ESE)
Theory
1. RPH-733/ Pharmaceutical Chemistry-VIII 3---0---0 70 30 100 3
(Medicinal Chemistry-III)/
RPH-741 Pharmaceutics-XI
Pharmaceutical Marketing &
Management
2. RPH-734/ Pharmaceutics-IX 3---0---0 70 30 100 3
(Biopharmaceutics &
Pharmacokinetics)/
RPH-740 Pharmaceutics-X
Pharmaceutical Biotechnology
3. RPH-735 Pharmacology-III 3---0---0 70 30 100 3
(Pharmacology &
Pharmacovigilance)
4. RPH-736 Pharmacognosy-IV 3---0---0 70 30 100 3
Practical/ Project
S. No. Subject Subject Name L--T--P T/P Marks Sessional Total Credit
Code (ESE)
Theory
1. RPH-839 Pharmaceutical Chemistry-IX 3---0---0 70 30 100 3
(Chemistry of Natural Products)
2. RPH-840/ Pharmaceutics-X 3---0---0 70 30 100 3
Pharmaceutical Biotechnology/
RPH-834 Pharmaceutics-IX
(Biopharmaceutics &
Pharmacokinetics)
3. RPH-841/ Pharmaceutics-XI 3---0---0 70 30 100 3
Pharmaceutical Marketing &
Management/
RPH-833 Pharmaceutical Chemistry-VIII
(Medicinal Chemistry-III)
4. RPH-842 Pharmaceutics-XII 3---0---0 70 30 100 3
(Food & Nutraceuticals)
5. RPH-843 Elective 3---0---0 70 30 100 3
(A) (Computational Methods in Drug
Design
(B) Good Manufacturing Practices
(C) Clinical Pharmacy
(D) Standardization of Herbal Drugs
(E) Research Methodology)
Practical/ Project
6. RPH-839P Pharmaceutical Chemistry-IX 0---0---4 50 50 100 2
(Chemistry of Natural Products)
Practical
7. RPH-840P/ Pharmaceutics-X 0---0---4 50 50 100 2
Pharmaceutical Biotechnology
RPH-834P Practical/
Pharmaceutics-IX
(Biopharmaceutics &
Pharmacokinetics) Practical
8. RPH-842P Pharmaceutics-XII 0---0---4 50 50 100 2
(Food & Neutraceuticals) Practical
9. RPH-843P Elective 0---0---4 50 50 100 2
(A) Computational Methods in Drug
Design Project
(B) Good Manufacturing Practices Project
(C) Clinical Pharmacy Project
(D) Standardization of Herbal Drugs
(E) roject
Research Methodology Project
10. RPH-844P Report on Industrial/ Research 50 50 100 2
Laboratory Visit
TOTAL 1000 24
SEVENTH SEMESTER
RPH-733/RPH-833
PHARMACEUTICAL CHEMISTRY-VIII (MEDICINAL CHEMISTRY-III)
Classification, mode of action, uses, recent advances and structure activity relationship of
the following classes of drugs (Synthetic procedures of individually mentioned drugs only).
Unit I
Steroidal drugs: Introduction, classification, nomenclature, and stereochemistry of-
Androgens and anabolic steroids: Testosterone, Stanazolol. Estrogens and progestogens:
Progesterone, Estradiol. Adrenocorticoids: Prednisolone, Dexamethasone.
Unit II
Chemotherapy of microbial infections:
Antibiotics: Penicillin, Semi-synthetic Penicillins (Ampicillin), Cephalosporins
(Cefepime), Chloramphenicol, Tetracyclines (Doxycycline), Aminoglycosides, Macrolides.
Antifungals: Ketoconazole and Clotrimazole.
Antiseptics & disinfectants: Chlorhexidine.
Unit III
Chemotherapy of microbial infections:
Synthetic antibacterials: Sulphonamides (Sulphamethoxazole, Sulphadiazine,
Sulphacetamide), Quinolones/Fluoroquinolones (Nalidixic acid, Ofloxacin).
Antimycobacterial agents: PAS, Ethambutol, Isoniazid, Dapsone.
Unit IV
Chemotherapy of parasitic infections:
Antimalarials: Chloroquine, Primaquine, Pyrimethamine.
Antiamoebics: Ornidazole, Diloxanide.
Anthelmintics: Albendazole.
Unit V
Cancer chemotherapy: Alkylating agents (Chlorambucil, Carmustine),
Antimetabolites
(Methotrexate, 5-Fluorouracil), Anticancer antibiotics (Doxorubicin).
Antiviral/Anti-HIV agents: Amantadine, Acyclovir, Zidovudine, Saquinavir, Raltegravir.
BOOKS RECOMMENDED
1. Abraham D.J., Burger’s Medicinal Chemistry and Drug Discovery, John Wiley and Sons Inc.,
New York.
2. Block J.H. and Beale J.M., Wilson and Gisvold’s Textbook of Organic Medicinal and
Pharmaceutical Chemistry, Lippincott Williams and Wilkins, Philadelphia.
3. Lemke T.L., Williams D.A., Roche V.F. and Zito S.W., Foyes Principles of
Medicinal Chemistry, Lippincott Williams and Wilkins, Philadelphia.
4. Vardanyan R.S. and Hruby V.J., Synthesis of Essential Drugs, Elsevier, Philadelphia.
5. Singh H. and Kapoor V.K., Medicinal and Pharmaceutical Chemistry, Vallabh Prakashan,
Delhi.
6. Nogrady T., Medicinal Chemistry: A Biochemical Approach, Oxford University Press,
New York.
7. Patrick G.L., An Introduction to Medicinal Chemistry, Oxford University Press, New York.
8. Hansch C., Comprehensive Medicinal Chemistry, Pergamon Press, U.K.
9. Dharuman J., Chemistry of Synthetic Drugs, AITBS Publishers, New Delhi.
10. Mann F.G. and Saunders B.C., Practical Organic Chemistry, Orient Longman Limited,
New York.
11. Furniss B.S., Hannaford A.J., Smith P.W.G. and Tatchell A. R., Vogel’s Textbook
of Practical Organic Chemistry, Dorling Kindersley (India) Pvt. Ltd. (Pearson Education
Ltd.), New Delhi.
RPH-734/RPH834
Unit I
Introduction to biopharmaceutics and pharmacokinetics and their role in formulation development.
Mechanism of absorption, physicochemical and pharmaceutical factors influencing absorption,
drug distribution, volume of distribution and distribution coefficient. Plasma protein binding
and its significance.
Unit II
Significance of plasma drug concentration measurement.
Compartment models and non-compartment models: Definition and scope.
Pharmacokinetics of drug absorption: Zero order and first order absorption rate
constant. Determination of absorption rate constant using Wagner-Nelson and Loo-Reigelman
method.
Unit III
Compartment kinetics: One compartment and preliminary information of multicompartment
models. Determination of pharmacokinetic parameters from plasma and urine data after drug
administration by intra venous (I.V.) bolus and I.V. infusion.
Unit IV
Dosage adjustment in patients with renal and hepatic disease. Clinical Pharmacokinetics:
Definition and scope.
Unit V
Brief introduction to bioavailability and bioequivalence: Definition and significance.
Measurement of bioavailability.
Introduction to in-vivo in-vitro correlation (IVIVC) and its significance. Review of regulatory
requirements for conduction of bioequivalence studies.
RPH-734P/RPH834P
Suggested Practicals
1. In-vitro drug release study of the any powder, uncoated tablet, capsule, film-coated
tablet, sustained release tablet and fast release (M.D, Dispersible etc.) tablet using
various dissolution media.
2. To determine the % protein binding of some drugs.
3. To determine the effect of protein binding on drug bioavailability.
4. To calculate various Pharmacokinetic parameters from zero order drug release data, first
order drug release data, blood data of I.V. bolus injection (one compartment model) and
urinary excretion data of I.V. bolus. Injection using both methods (Rate of elimination &
sigma minus method one compartment model).
5. To study in-vitro drug- drug interactions.
6. To study the passive diffusion of a drug using cellophane membrane.
7. To study the passive diffusion of a drug using egg membrane.
8. To determine the various Pharmacokinetic parameters from the given blood data of oral
administration of dosage form.
9. Determination of bioavailability by urinary method.
10. Determination of bioequivalence by dissolution method.
BOOKS RECOMMENDED
1. Notari, R.E, Biopharmaceutics and Pharmacokinetics-An introduction, Marcel Dekker Inc.
New York.
2. Rowland M, and Tozer T.N. Clinical Pharmacokinetics, Lea and Febriger, New York.
3. Wagner J.G. Fundamentals of Clinical Pharmacokinetics, Drugs Intelligence Publishers,
Hamilton.
4. Wagner J.G. Pharmacokinetics for the Pharmaceutical Scientist, Technomic Publishing A.G.
Basel, Switzerland.
5. Gibaldi, M., Biopharmaceutics & Clinical Pharmacokinetics, Pharma Book Syndicate,
Hyderabad.
6. Robert, Rodriguezdiaz, Analytical Techniques for Biopharmaceuticals Development.
7. Curry, S. H., Drug Disposition & Pharmacokinetics, Pharma Book Syndicate, Hyderabad.
RPH-735
PHARMACOLOGY-III (PHARMACOLOGY & PHARMACOVIGILANCE)
Unit I
Pharmacology of endocrine system: Hypothalamic and pituitary hormones, thyroid
hormones and thyroid drugs. Parathormone, Calcitonin and Vitamin D, Insulin, oral
hypoglycemic agents and Glucagon. Corticosteroids, androgens and anabolic steroids, Estrogens,
Progesterone and oral contraceptives, drugs acting on the uterus.
Unit II
Chemotherapy: General principles of chemotherapy. Sulfonamides, Quinolones, Beta-lactam
antibiotics, Chloramphenicol, Tetracyclines, Macrolides and Aminoglycosides.
Chemotherapy of parasitic infections: Tuberculosis, leprosy, malaria, fungal infections, viral
diseases.
Unit III
Naturopathy: History, definitions, mechanism and its effect on various systems, hydrotherapy,
mud therapy, chromotherapy, acupressure, aromatherapy and therapeutic massage.
Unit IV
Pharmacovigilance: Scope, definition and aims of pharmacovigilance and
pharmacoepidemiology, therapeutic index- LD50 and ED50, drug interactions.
Adverse drug reactions: Classification, mechanism, predisposing factors and causality assessment.
Role of clinical pharmacist in reporting, evaluation, monitoring, prevention and management of
ADR, drug induced diseases affecting different organ systems.
Fixed dose drug combinations (FDDCs): Rational and irrational combinations, FDDCs in Indian
scenario.
Unit V
Epidemiological methods: Case control study: Selection of cases, selection of controls,
matching, measurements of exposure, analysis, odds ratio, bias in case control study, advantages,
disadvantages.
Cohort study: Concept, framework, combination of prospective and retrospective cohort study,
relative risk, attributable risk, advantages, disadvantages.
RPH-735P
PHARMACOLOGY-III (PHARMACOLOGY & PHARMACOVIGILANCE) PRACTICAL
Suggested Practicals
1. To calculate the pA2 value of Atropine and Chlorpheniramine.
2. Bioassay of Ach, Histamine and Oxytocin on suitable isolated preparations using
matching assay, bracketing assay, interpolation, three point assay and four point assay.
3. Bioassay of histamine and acetylcholine using matching and interpolation method on rat and
guinea pig.
The experiments should be conducted using software, wherever possible.
BOOKS RECOMMENDED:
1. Rang M.P., Dale MM, Riter JM, Pharmacology Churchill Livingstone, China.
2. Tripathi, K.D. Essentials of Medical Pharmacology, Jay Pee Publishers, New Delhi.
3. Satoskar & Bhandarkar: Pharmacology & Pharmacotheropeutics, Popular Prakashan Pvt. Ltd.,
Bombay.
4. Ghosh M.N. Fundamentals of Experimental Pharmacology, Scientific Book Agency, Calcutta.
5. Katzung, B.G. Basic & Clinical Pharmacology, Prentice Hall International, New Delhi.
6. Ronald D. Mann & Elizabeth B. Andrews, Pharmacovigilance, John Wiley & Sons,
West Sussex, England.
7. Waller and Patrick, An Introduction to Pharmacovigilance, John Wiley & Sons, West
Sussex, England.
8. Mohanta G.P., Elementary Pharmacovigilance, PharmaMed Press, Hyderabad.
9. Mohanta G.P., Manna P.K., Textbook of Pharmacovigilance: Concept and
Practice, PharmaMed Press, Hyderabad.
10. Grover J.K., Experiments in Pharmacy & Pharmacology, CBS Publishers, New Delhi.
11. Kulkarni S.K., Hand Book of Experimental Pharmacology, Vallabh Prakashan, Delhi.
12. Barar F.S.K : Text Book of Pharmacology, Interprint, New Delhi.
13. Goodman & Gilman, The Pharmacological basis of Therapeutics, Eds: Hardman J.G.,
Limbird Le, Molinoss P.B., Ruddon R.W. & Gil A.G., Pergamon Press, U.K.
14. Laurene, D.R. & Bennet P.N.; Clinical Pharmacology, Churchill Livingstone,
Harlow, England.
15. Paul L., Principles of Pharmacology, Chapman and Hall, New York.
16. Ravi Shanker K., Kiranmayi G.V.N., Pharmacology: A Companion Handbook
with Illustrations, PharmaMed Press, Hyderabad.
17. Singh S. J., History and Philosophy of Naturopathy, Nature Cure Council of Medical Research,
Lucknow.
18. Bakhru H. K., Complete Handbook of Nature Cure, Jaico Publishing House, New Delhi.
19. Pizzorno J. E., Murray M. T., The Encyclopedia of Natural Medicine, Simon & Schuster,
New York, USA.
20. Sheffield Bioscience Programs, U.K. ISBN. 1-8747558-02-6.
RPH-736
PHARMACOGNOSY-III
Unit I
Systematic study of source, cultivation, collection, processing, commercial varieties, chemical
constituents, substitutes/adulterants, uses, diagnostic macroscopic and microscopic features and
specific chemical tests of following alkaloid containing drugs-
Pyridine-piperidine: Tobacco, Areca and Lobelia.
Tropane: Belladona, Hyoscyamus, Datura, Coca and Withania. Quinoline and isoquinoline:
Cinchona, Ipecac and Opium. Indole: Ergot, Rauwolfia, Catharanthus and Nux-vomica.
Unit II
Imidazole: Pilocarpus.
Steroidal: Veratrum and Kurchi.
Alkaloidal amine: Ephedra and Colchicum.
Glycoalkaloid: Solanum. Purines: Coffee and Tea Quinazoline: Vasaka.
Unit III
Production and utilization of phytoconstituents: Calcium sennosides, Diosgenin,
Solasodine, Podophyllotoxins, Tropane alkaloids, Isoquinoline alkaloids and Quinoline alkaloids.
Unit IV
Plant tissue culture: Historical development of plant tissue culture, type of culture,
nutritional requirements, growth and maintenance, factors affecting plant tissue culture.
Applications of plant tissue culture in pharmacy.
Unit V
Introduction to herbal fingerprinting using HPTLC technique. Introduction to herbal drug
interactions.
Introduction to bioactive compounds enhancing bioavailability such as- Piperine, Vitamin K.
RPH736-P
PHAMACOGNOSY-IV PRACTICAL
Suggested Practicals
1. To study the morphology and microscopy of Datura and Withania.
2. To study the morphology and microscopy of Ipecac and Rauwolfia.
3. To study the morphology and microscopy of Catharanthus and Nux-vomica.
4. To study the morphology and microscopy of Ephedra and Kurchi.
5. To study the morphology and microscopy of Solanum and Vasaka.
6. a) Morphology of Areca, Colchicum.
b) Transverse section of Catharanthus leaf and Kurchi bark.
7. To study the TLC profile of Catharanthus leaf.
8. To study the TLC profile of Withania root.
9. Chemical test of Tea, Tobacco, Datura and Withania.
10. Chemical test of Nux-vomica, Ephedra and Kurchi.
11. Preparation of different callus cultures using various parts of plants.
12. Study of micopropogation using callus culture.
13. Effect of various plant hormones on micropropogation.
BOOKS RECOMMENDED
1. Trease, G.E., and Evans, W.C., Pharmacognosy, Bailliere Tindall East Baorne, U.K.
2. Wallis. T.E. “Text Book of Pharmacognosy” J&A Churchill Ltd., London.
3. Kokate C.K., Gokhale A.S., Gokhale S.B., Cultivation of Medicinal Plants, Nirali Prakashan.
4. Tyler V.E., Lynnr B. and Robbers J.E., Pharmacognosy, 8th Edition, Lea &
Febiger, Philadelphia.
5. Harborne J.B., Phytochemical Methods, Chapman & Hall International Edition, London.
6. Medicinal Plants of India, Vol. I & II, Indian Council of Medical Research, New Delhi.
7. Nadkarni A.K., Indian Materia Medica, Vol- 1&2, Popular Prakashan (P) Ltd., Bombay.
8. Sukh Dev, A Selection of Prime Ayurvedic Plant Drugs, Anamaya Publisher New Delhi.
9. Indian Herbal Pharmacopoeia, Vol. I & II, ICMR & RRL, Jammu.
10. Indian Ayurvedic Pharmacopoeia, Govt. of India.
11. The Wealth of India, Raw Materials (All volumes), Council of Scientific &
Industrial Research, New Delhi.
12. Rastogi R. P. and Mehrotra B.N., Compendium of Indian Medicinal Plants I-IV,
Publications & Information Directorate/Central Drug Research Institute, New Delhi.
13. Wallis T.E., Analytical Microscopy, J&A Churchill Ltd., London.
14. Kokate C.K., Practical Pharmacognosy, Vallabh Prakashan, New Delhi.
15. Iyengar M.A., Pharmacognosy of Powdered Crude Drugs, PharmaMed Press, Hyderabad.
16. Iyengar, M.A. and Nayak S.C.K., Anatomy of Powdered Crude Drugs, PharmaMed
Press, Hyderabad.
RPH-737
PHARMACEUTICAL ANALYSIS-III
(PHARMACEUTICAL ANALYSIS & QUALITY ASSURANCE)
Unit I
Ultra violet and visible spectroscopy: Principle and origin of spectra, quantitative laws,
chromophores and auxochromes, factors affecting absorption, instrumentation- single and double
beam spectrophotometer, Woodward-Fieser rule, applications.
Infra-red spectroscopy: Principle, effect of hydrogen bonding and conjugation on absorption
band, instrumentation, interpretation of IR spectra of simple compounds (Ethanol, Benzaldehyde).
FTIR, applications of IR spectroscopy in pharmaceutical analysis.
Unit II
NMR spectroscopy: Principle of 1H-NMR, chemical shift and factors affecting it, shielding and
desheilding, spin-spin coupling and coupling constant, spin-spin splitting, instrumentation, NMR
active compounds and study of 1H-NMR spectra of- Ethanol, Benzaldehyde. Introduction to13C-
NMR.
Unit III
Mass spectrometry: Principle, fragmentation pattern in relation to molecular structure and
functional groups including McLafferty rearrangement, ionization techniques (CI, FAB, ESI,
MALDI), instrumentation, applications, mass spectra of some simple compounds (Ethanol,
Benzaldehyde).
Unit IV
Miscellaneous techniques: Principle, instrumentation and applications of atomic absorption
spectroscopy, fluorimetry and flame photometry.
Introduction to gel electrophoresis, scanning electron microscopy (SEM) and transmission electron
microscopy (TEM).
Unit V
Quality Assurance: Basic concept of quality, difference between QC and QA, quality audit, types
of quality audits, concept of TQM, ISO 9000 series. Elementary study of WHO guidelines.
Different documents prepared by QA department (batch manufacturing record, master formula
record, validation master plan). Basic concept of validation, types of validation, different
validation parameters, protocols for process validation.
RPH-737P
PHARMACEUTICAL ANALYSIS-III
(PHARMACEUTICAL ANALYSIS & QUALITY ASSURANCE) PRACTICAL
BOOKS RECOMMENDED
1. Pharmacopoeia of India, Ministry of Health, Govt. of India.
2. Becket A. H. and Stenlake J. B., Practical Pharmaceutical Chemistry Vol. I and II, The
Athlone Press of the University of London.
3. Chatten L. G., A text book of Pharmaceutical Chemistry, Vol. I & II, Marcel Dekker,
New York.
4. Willard H.H.,Merrit L.L., Dean J.A.,Settle P.A., Instrumental Methods of analysis,
Van Nostrand Renhold, New York.
5. Obonson J.W.R., Undergraduate Instrumental Analysis, Marcel Dekker Inc, New York, 1970.
6. Parikh V.H., Absorption Spectroscopy of Organic Molecules, Addison-Wesley Publishing
Co., London.
7. Silverstein R.M.,and Webster F.X., Spectrometric Identification of Organic Compounds,
John Wiley & Sons.
8. Skoog V., Principles of Instrumental Analysis, Holler-Neimen.
9. Kemp W., Organic spectroscopy, 3rdEdition, Palgrave, New York.
10. Kalsi P.S., Spectroscopy of Organic Compounds, New Age International Publishers,
New Delhi.
11. Pavia D.L.,Lampman G.M., and Kriz G.S., Introduction to spectroscopy, 3rd Edition,
Harcourt College Publishers, Philadelphia.
12. Florey K., Analytical Profile of Drug Substance (All volume), Academic Press, Elsevier.
13. WHO-Quality Assurance of Pharmaceuticals, Vol. I & II, AITBS Publisher &
Distributors, Delhi.
14. Berry I.R. and Harpaz, D., Validation of API, 2ndEdition, CRC Press.
RPH-738P
HOSPITAL TRAINIGNG-II
Training of students at a hospital establishment for a minimum duration of 45 days. The hospital
training shall include: First aid (wound dressing, artificial respiration etc.), different routes of
injection, study of patient observation charts, prescriptions and dispensing, simple diagnostic
reports etc.
May be performed at the end of the 6th semester.
EIGHTH SEMESTER
RPH-839
Unit I
General methods of isolation and separation of plant constituents, qualitative tests for the
detection of plant constituents. Application of spectral techniques in the structure determination of
natural products.
Biogenetic investigations and basic metabolic pathways (Alkaloids, Terpenes, Steroids). Brief
introduction to biogenesis of secondary metabolites of pharmaceutical importance (Atropine,
Quinine, Papaverine, Morphine and Reserpine).
Unit II
Extraction, isolation and structure elucidation of alkaloids: Tropanes (Atropine);
Phenanthrenes
(Morphine); Quinolines (Quinine); Isoquinolines (Papaverine); Indoles (Reserpine).
Unit III
Extraction, isolation and structure elucidation of-
Glycosides: Digoxin. Flavonoids: Quercetin. Lignans: Podophyllotoxin. Purines: Caffeine.
Unit IV
Extraction, isolation and structure elucidation of- Terpenoids: Camphor, Menthol, Citral.
Carotenoids: β- Carotene.
Vitamins: α -Tocopherol.
Quassinoids: Quassin.
Unit V
Natural allergens, photosensitizing agents and fungal toxins. Role of natural products in drug
discovery and development.
Recent developments of natural products used as anticancer agents, antidiabetics, antimalarials
and immunomodulators.
RPH-839P
PHARMACEUTICAL CHEMISTYRY-IX
(CHEMISTRY OF NATURAL PRODUCTS) PRACTICAL
Suggested Practicals
1. Isolation of Caffeine from tea leaves.
2. Isolation of Piperine from black pepper.
3. Isolation of Hesperidin from orange peel.
4. Isolation of Clove oil from clove.
5. Isolation of Caraway oil from caraway.
6. Isolation of Cumin oil from cumin.
7. To study the TLC profile of extracted oils.
8. To perform the column chromatography of any available herb.
9. To study the paper chromatographic profile of glycone portion separated from senna.
10. To isolate the active constituent of any available drug with the help of preparative TLC.
11. Quantitative determination of Ascorbic Acid present in amla.
BOOKS RECOMMENDED
1. Brain K.R. and Turner T.D., The Practical Evaluation of Phytopharmaceutical, Wright, Bristol.
2. Kokate C.K., “Practical Pharmacognosy” Vallabh Prakashan, New Delhi.
3. Stahl E., Thin Layer Chromatography: A Laboratory Hand Book, Springer International
Edition, New York.
4. Harborne J.B., Phytochemical Methods: A Guide to Modern Techniques of Plant
Analysis, Springer (India) Pvt. Ltd., New Delhi.
5. Dewick P.M., Medicinal Natural Products: A Biosynthetic Approach, John Wiley and Sons
Ltd., England.
6. Wagner H., Plant Drug Analysis, Springer, Berlin.
7. Cutler S.J. and Cutler H.G., Biologically Active Natural Products: Pharmaceuticals,
CRC Press, London.
8. Manitto P., Biosynthesis of Natural Products, BSP Books Pvt. Ltd., Hyderabad.
9. Finar I.L.,Organic chemistry, Volume II: Stereochemistry and the Chemistry of
Natural Products, Pearson Education, New Jersey.
10. Indian Herbal Pharmacopoeia, Indian Drug Manufacturers Association and Regional
Research Laboratory, Jammu.
11. Agarwal O.P., Organic Chemistry, Natural Products, Krishna Prakashan Media (P)
Ltd., Meerut.
12. Evans V.C., Trease and Evans Pharmacognosy, Harcourt Publishers Ltd., Sydney.
13. Wallis T. E., Textbook of Pharmacognosy, CBS Publishers and Distributors, New Delhi.
14. Kokate C.K., Practical Pharmacognosy, Vallabh Prakashan, Delhi.
15. Jarald E.E. and Jarald S.E., Textbook of Pharmacognosy and Phytochemistry, CBS
Publishers and Distributors Pvt. Ltd., New Delhi.
16. Tyler V.E., “Pharmacognosy” Lea & Febiger, Philadelphia.
17. Deore S.L., Khadabadi S.S., Baviskar B.A., Pharmacognosy and Phytochemistry: A
Comprehensive Approach, PharmaMed Press, Hyderabad.
18. Prasad M. R, Rao A.R., Advanced Medicinal Chemistry: A Laboratory Guide, PharmaMed
Press, Hyderabad.
RPH-840/ RPH-740
PHARMACEUTICS-X (PHARMACEUTICAL BIOTECHNOLOGY)
Unit I
Immunology and immunological preparations: Principles, antigen and haptens, immune
system, cellular and humoral immunity, immunological tolerance, antigen-antibody reactions and
their applications, standardization and storage of vaccine.
Unit II
Recombinant DNA technology: A brief introduction to genetic engineering and techniques,
production of r-DNA and their application, development of hybridoma for monoclonal antibodies
and their application, protoplast fusion and biotechnological production of products such
as Insulin and Somatotropin.
Unit III
Antibiotics: Screening of soil for organisms producing antibiotics. Fermentor: Basic design,
control of different parameters and application. Isolation of mutants and factors affecting
mutation.
Unit IV
Microbial transformation: Introduction, types of reactions mediated by microorganisms,
selection of organisms, methodology of biotransformation, process improvements with special
reference to steroids.
Unit V
Enzyme immobilization: Sources of enzymes, techniques of immobilization of enzymes and
cell, advantages and limitation of immobilization, application of immobilization in pharmacy.
Biotechnological production and pharmaceutical application of enzymes such as penicillinase, α-
galactosidase, amylases and proteases.
RPH-840P/ RPH-740P
PHARMACEUTICS-X (PHARMACEUTICAL BIOTECHNOLOGY) PRACTICAL
Suggested Practicals
1. Estimation of protein in given sample.
2. Production of protoplast fused cells by chemical method.
3. Production of protoplast fused cells by mechanical method.
4. Estimation of immunological reaction (blood group etc.).
5. Assay of antibiotics.
6. Screening of soil for antibiotic producing microorganisms.
7. Immobilization of drug.
8. Immobilization of enzyme.
9. Immobilization of cell.
10. Protein estimation by gel electrophoresis.
11. Isolation of enzymes from natural sources.
BOOKS RECOMMENDED
1. Prescott and Dunn’s Industrial Microbiology, CBS Publishers and Distributors, New Delhi.
2. Vyas S.P. and Dixit V.K., Pharmaceutical Biotechnology, CBS Publication, New Delhi.
3. Kieslich K. , Biotechnology, Verleg Chernie, Switzerland.
4. Standury P.F.,Whitaker A. & Hall S.J. ,Principles of Fermentation, Aditya Book
Private Limited, New Delhi.
5. Crueger W. & Crueger A, Biotechnology- A Textbook of Industrial Microbiology,
Panima Publishing Corporation, Delhi.
RPH-841/ RPH-741
PHARMACEUTICS-XI (PHARMACEUTICAL MARKETING & MANAGEMENT)
Unit I
Concepts of management: Definition, administrative management (planning, organizing,
staffing, directing and controlling). Entrepreneurship development, introduction to operative
management (personnel, materials, production, financial management).
Unit II
Principles of management: Coordination, communication, motivation, decision making,
leadership, innovation and creativity.
Production management: A brief study of the different aspects of production
management, methodology of activities: performance evaluation, review technique, maintenance
management.
Unit III
Pharmaceutical marketing: Introduction to pharmaceutical marketing. Functions, buying,
selling, transportation, storage and finance. Feedback information, channels of distribution,
wholesale, retail, department store. Introduction to e-commerce (online shopping, online banking,
pretail, marketing to prospective and established customers) and start up business.
Unit IV
Salesmanship: Principle of sales promotion, advertising, ethics of sales, merchandising,
literature, detailing, recruitment, training, performance appraisal of sales force.
Unit V
Market research: Definition, steps and limitations of market research. Market segmentation and
market targeting. Major concepts in demand measurement, estimating current demand. Geo-
demo- graphic analysis. Estimating industry sales.
BOOKS RECOMMENDED
1. Beri, Marketing Research .Tata Mc Graw Hill Publishing Company Limited, New Delhi.
2. Chary S.N, Production and Operations Management. Tata Mc Graw Hill Publishing
CompanyLimited, New Delhi.
3. Datta A.K., Materials Management. Prentice Hall of India Private Limited, New Delhi.
4. Massie L. Joseph, Essentials of Management. Prentice Hall of India Private Limited,
New Delhi.
5. Shreenivasan K.R., An Introduction to Industrial Management. Vikas Publishing House
Private Limited, New Delhi.
6. Daver Rustam S., Salesmanship and Publicity. Vikas Publishing House Private Limited,
New Delhi.
7. Mukopadhyay S., Pharmaceutical Selling, Sterling Publishers.
8. Koontz H, Weihrich H, Essentials of Management. Tata Mc Graw Hill Publishing
Company Limited, New Delhi.
9. G Vidya Sagar, Pharmaceutical Industrial Management, Pharma Med Press, Hyderabad.
10. Micky C Smith, Principles of Pharmaceutical Marketing.CBS Publishers and Distributors,
New Delhi.
11. Chaganti S.R., Pharmaceutical Marketing in India: Concept, strategy and cases. Pharma
Med Press, Hyderabad.
RPH-842
PHARMACEUTICS-XII (FOOD & NEUTRACEUTICALS)
Unit I
Introduction to food technology.
Food Processing: Freezing, changes in food during refrigerated storage, progressive freezing,
Ice crystal damage, effect of dehydration, microwave heating and drying methods on food
products.
Unit II
Food packaging and preservation: Properties of packaging material used for food packaging,
influence of packaging material on changes of food stuffs, brief description of packaging of
frozen, dried products and thermally processed foods.
Brief description of food preservation and its methods.
Unit III
Neutraceuticals: Introduction, classification, categories and rational of use of neutraceuticals.
Brief description to dietary supplements, fortified foods, functional foods
and phytoneutraceuticals.
Unit IV
Development and marketing of neutraceutical products: Supercritical fluid extraction
technology-basics and application for extraction of neutraceuticals from various sources,
Packaging, label claims. Regulatory aspects of neutraceutical products in India.
Unit V
Testing of neutraceuticals and food products: Testing of microbial load, nutritional value,
heavy metals, calorific value and neutraceutical label claim test.
Brief introduction to Agmark, Bureau of Indian Standards (BIS) and Food Safety and
Standards Authority of India (FSSAI).
RPH-842P
PHARMACEUTICS-XII (FOOD & NEUTRACEUTICALS) PRACTICALS
Suggested Practicals
1. Preparation of traditional health products e.g. Gulkand, Amla syrup
2. Formulation of health drinks.
3. Preparation and testing of some food products.
4. Testing of food packaging materials.
5. Preparation and testing of some neutraceuticals.
BOOKS RECOMMENDED
1. Potter, N. M., Food Science, CBS Publishers and Distributors, New Delhi.
2. Manay, S. and Shadaksharaswami, M., Foods: Facts and Principles, New Age
Publishers, New Delhi.
3. Frazier W.C. and Westhoff, D.C., Food Microbiology, TMH, New Delhi.
4. Krammer, A. and Twigg B.A., Quality control for food industry, Third edition, AVI,
West port.
5. Ranganna S., Handbook of Analysis and Quality control for Fruit and Vegetables
Products, Tata McGraw Hill, New Delhi.
6. Girdharilal, Preservation of Food and Vegetables, ICAR, New Delhi.
7. Fellows P., Food Processing Technology: Principles and Practice, Ellis Horwood
Ltd, Horwood.
8. Earle R. L., Unit Operations in Food Processing, Pergamon Press, New York.
9. Deore, S. L. Khadbadi S. S., and Baviskar B. A., Pharmacognosy and Phytochemistry:
A Comprehensive Approach, PharmaMed Press, Hyderabad.
10. Robert E.C., Wildman, R., Taylor C. Wallace., Handbook of Nutraceuticals and
Functional Foods, Second Edition. CRC Press, Boca Raton.
ELECTIVE
RPH-843(A)
COMPUTATIONAL METHODS IN DRUG DESIGN
Unit I
Introduction to drug design concept, rational approaches of drug design, role of computational
chemistry in drug design. The concept of drug likeness and druggability.
Chemometrics: Introduction to multivariate analysis, linear (PCA, MLR, PLS) and non-linear
methods, validation tools. Introduction to some statistical softwares (such as; SPSS, Graph Pad
Prism etc.).
Unit II
Molecular Modeling: Introduction to the principles of molecular mechanics, quantum
mechanics, molecular dynamics and their applications in drug design.
Unit III
Quantitative structure activity relationship (QSAR): Basic concepts of QSAR, molecular
descriptors (2D and 3D parameters), biological parameters, tools and techniques,
quantitative models, validation of models, introduction to 2D and 3D QSAR methodologies.
Unit IV
Virtual screening: Introduction to some molecule databases. Ligand based and structure based
virtual screening. Similarity searching, various methods of similarity searching and their
applications in virtual screening: QSAR modeling, pharmacophore modeling, shape based
screening, fingerprint based screening etc.
Unit V
Structure based drug design: Protein Data Bank, molecular graphics, design of
enzyme inhibitors, receptor based drug design, molecular docking and protein homology
modeling. Introduction to bioinformatics and some drug design softwares (free and commercially
available).
RPH-843(A)P
COMPUTATIONAL METHODS IN DRUG DESIGN PROJECT
BOOKS RECOMMENDED
1. Patrick G.L., An Introduction to Medicinal Chemistry, Oxford University Press.
2. Perun T.J. and Propst C.L., Computer-aided Drug Design Methods and Applications,
Saurabh Prakashan Pvt.Ltd., New Delhi.
3. Veerapandian P., Structure-based Drug Design, Sirohi Brothers Pvt. Ltd., Noida.
4. Burger A., A Guide to the Chemical Basis of Drug Design, A Wiley Interscience
Publication (John Wiley & Sons), New York.
5. Wermuth C.G., The Practice of Medicinal Chemistry, Elsevier.
6. Purcell W.P., Bass G.E., Clayton J.M., Strategy of Drug Design: A Guide to
Biological Activity, Pharmamed Press, Hyderabad.
7. Nogrady T., Medicinal Chemistry: A Biochemical Approach, Oxford University
Press, NewYork.
8. Abraham D.J., Burger’s Medicinal Chemistry and Drug Discovery, John Wiley and Sons
Inc., New York.
9. Ananda Kumar T.D., Elementary Pharmacoinformatics, PharmaMed Press, Hyderabad.
RPH-843(B)
GOOD MANUFACTURING PRACTICES
Unit I
Introduction to good manufacturing practices (GMP), good clinical practices (GCP) and good
laboratory practices (GLP). Schedule M.
Standard operating procedure (SOP): Introduction, preparation, validation and revision.
Unit II
Documentation: Protocols, forms and maintenance of records in pharmaceutical industry,
preparation of document for investigational new drug (IND), new drug application (NDA),
abbreviated new drug application (ANDA) and export registration.
Unit III
Introduction to 21-Code of federal regulations. Current good manufacturing practices (c-GMP)
guidelines according to United States Food and Drug Administration (USFDA), difference
between GMP and c-GMP.
Unit IV
Pharmaceutical product recall: Recall classification, strategy for effective recall, FDA
requested recall, firm initiated recall, recall status reports, termination of recall.
Introduction to finished product reprocessing and salvaging.
Unit V
Sampling: Introduction, WHO guidelines, sampling plans and techniques,
operating characteristics curves, maintenance of sampling records of finished product and
packaging material.
RPH-843(B)P
GOOD MANUFACTURING PRACTICES PROJECT
BOOKS RECOMMENDED
1. Willing, Tuckerman and Hitchings, Good Manufacturing Practices for
Pharmaceuticals, Marcel Dekker, New York.
2. Garfield, Quality Assurance Principles for Analytical Laboratories, Published by
Oxford University Press, USA.
3. Potdar M. A., Current Good Manufacturing Practices for Pharmaceuticals. PharmaMed
Press, Hyderabad.
4. Loftus and Nash, Pharmaceutical Process Validation, Taylor & Francis, New York.
5. Florey, Analytical Profile of Drugs (All volumes), Academic Press, United States.
6. Indian Pharmacopoeia.
7. United States Pharmacopoeia.
8. British Pharmacopoeia.
RPH-843(C)
CLINICAL PHARMACY
Unit I
Introduction to clinical pharmacy: Definition, development and scope of clinical pharmacy.
Variability in human response to drugs and influence of disease processes: Drug handling and
prescribing in the elderly, infants and children. Drug usage in pregnancy and in breast-feeding
women. Prescribing for patients with renal or hepatic disease. Pharmacogenetics: implications for
altered or unusual drug handling. Pharmacoepidemiology.
Unit II
Data analysis and compiling: The patient’s case history, communication skills including patient
medication history interview, patient counseling. Pharmacoeconomics.
Medical writing: Regulatory and educational medical writing.
Literature review and meta-analysis: Process, methods and application, research, report and
paper/ thesis writing.
Pharmacovigilance programme of India (PvPI) and Geneva (UPSALA).
Unit III
Daily activities of clinical pharmacists: Drug therapy monitoring (medication chart view,
clinical review), therapeutic drug monitoring, ward round participation, drug utilization
evaluation/ review (DUE)/ (DUR). Quality assurance of clinical pharmacy services.
Unit IV
Research design and conduct of clinical trials: Research support including planning and
execution of clinical trials. Schedule Y, GLP, GCP and ICH Guidelines, trial master file
and ethical requirements. Various phases of clinical trials. Categories of Phase IV studies.
Bioavailability (BA) and bioequivalence (BE) studies and the estimation with the help of plasma-
concentration profile curve. Statistical analysis plan (SAP) and its importance in clinical research.
Unit V
Data collection and biostatistical analysis: Statistical principles underlying clinical trials, data
handling and role of biostatistician.
Sample size calculation, types of variables, Type I error and type II errors, application of
parametric and non-parametric tests, confidence intervals, outliers. Data analysis with the help of
bio-statistical software.
RPH-843(C)P
CLINICAL PHARMACY PROJECT
BOOKS RECOMMENDED
1. Scott L.T., Basic skills in interpreting laboratory data, American Society of Health System
Pharmacists Inc., USA.
2. Rowland and Tozer, Clinical Pharmacokinetics, Williams and Wilkins
Publication, Philadelphia, USA.
3. Shargel L., Biopharmaceutics and Applied Pharmacokinetics, Prentice Hall publication,
New Delhi.
4. Parthasarthi G., Nyfort-Hansen K. and Nahata M.C., A Text book of Clinical Pharmacy
Practice-Essential Concepts and Skills, Orient Longman, Chennai.
5. Colledge N.R., Walker B. R. and Stuart H., Ralston Davisson’s Principles and Practice of
Medicine, ELBS/Churchill Livingstone, Edinburgh, U.K.
6. Herfindal E.T. and Hirashman J.L., Clinical Pharmacy and Therapeutics Williams and
Wilkins, Philadelphia, USA.
7. Wagner J.G., Pharmacokinetics for the Pharmaceutical Scientist, Technomic Publishing A G
Basel, Switzerland.
8. Katzung B., Masters S. and Trevor A., Basic and Clinical Pharmacology, McGraw Hill
Professional, U.K.
9. Spilker B. and Schoenfelder J., Data Collection Forms in Clinical Trials, Raven Press,
New York.
10. Roger and Walker; Clinical Pharmacy and Therapeutics, Churchill, Livingston, London.
11. Stockley I.H., Drug interactions, Pharmaceutical Press, London.
12.Ravishankar K., Kiranmayi G.V.N., Clinical Pharmacy and Pharmacotherapeutics,
PharmaMed Press, Hyderabad.
RPH-843(D)
STANDARDIZATION OF HERBAL DRUGS
Unit I
Commerce and quality control of natural medicinal plants products, organoleptic,
microscopical, physical and chemical evaluation of crude drugs.
Unit II
Standardization of plant material as per WHO guidelines.
Unit III
Methods of extraction and modern techniques for the isolation, purification, separation
estimation and characterization of active plant constituents.
Unit IV
Analysis of official formulations derived from crude drugs, including some ayurvedic
preparations.
Unit V
General methods of screening of natural products for following biological activity:
a) Anti-inflammatory
b) Hypoglycaemic
c) Antifertility
e) Psychopharmacological.
RPH-843(D)P
STANDARDIZATION OF HERBAL DRUGS PROJECT
BOOK RECOMMENDED
1. Trease, G.E., and Evans, W.C., Pharmacognosy, Bailliere Tindall East Baorne, U.K.
2. Tyler V.E., Lynnr B. and Robbers J.E., Pharmacognosy, 8 th Edition, Lea &
Febiger, Philadelphia.
3. Harborne J.B., Phytochemical Methods, Chapman & Hall International Edition, London.
4. Pharmacoepial Standards for Ayurvedic Formulations, CCRAS, Delhi.
5. Dhavan B.N. and Srimal R.C., The Use of Pharmacological Techniques for Evaluation of
Natural Products. CDRI, Lucknow.
6. Brain K.R. and Turner T.D, The Practical Evaluation of Phytopharmaceuticals, Wright,
Bristol.
7. Peach K. and Tracey MV, Modern Methods of Plant Analysis, Springer, Berlin.
17. Indian Herbal Pharmacopoeia, Vol. I & II, ICMR & RRL, Jammu.
8. Chaudhary. R.D., Herbal Drug Industry, Eastern Publisher, New Delhi.
9. Deore S.L., Khadabadi S.S., Baviskar B.A., Pharmacognosy and Phytochemistry: A
Comprehensive Approach, PharmaMed Press, Hyderabad.
10. Nadkarni A.K., Indian Materia Medica, Vol- 1&2, Popular Prakashan (P) Ltd., Bombay.
11. Sukh Dev, A Selection of Prime Ayurvedic Plant Drugs, Anamaya Publisher New Delhi.
12. Indian Ayurvedic Pharmacopoeia, Govt. of India.
13. The Wealth of India, Raw Materials (All volumes), Council of Scientific & Industrial
Research, New Delhi.
14. Mukherjee P.K., Quality Control of Herbal Drugs, Business Horizones Pharmaceutical
Publisher, New Delhi.
RPH-843(E)
RESEARCH METHODOLOGY
Unit I
Fundamentals of research: Meaning and objective of research, types of research (basic, applied
and patent oriented), defining research problem, research design including various methods,
research process and steps involved.
Literature survey and documentation: Methods of literature survey, use of library, books,
journals, e-journals, thesis, chemical abstracts and patent database, importance of documentation,
documentation techniques, use of computer programs/packages (online resources such as-
scientific search engines and online servers) in literature survey and documentation.
Unit II
Data collection and data analysis: Execution of the research, observation and collection of data,
types of data (primary and secondary), methods of data collection, sample size, sampling
procedure and methods. Data processing and analysis strategies. Research hypothesis
(experimental and non-experimental), hypothesis testing (parametric and non-parametric tests),
types of errors and their control, generalization and interpretation of results. Use of statistical
softwares/ packages in data analysis (SPSS, Graph Pad Prism).
Unit III
Technical writing and reporting of research: Types of research report: Dissertation and thesis,
research paper, review article, short communication, conference presentation, meeting report etc.
Structure and organization of research reports: Title, abstract, key words, introduction,
methodology, results, discussion, conclusion, acknowledgement, references, footnotes, tables and
illustrations. Use of reference managing softwares (such as- MENDELEY, ENDNOTE). Impact
factor, rating, indexing and citation of journals.
Detailed study of ‘Instruction to Authors’ of any ACS or ScienceDirect journal, a
thorough understanding of steps involved in submitting articles electronically to any ACS or
ScienceDirect journal (registration, new article submission, tracking process, submitting revised
articles).
Unit IV
Research ethics, ethical consideration during animal experimentation including CPCSEA
guidelines, impact of research on environment and society, commercialization of research,
intellectual ownership, plagiarism and use of plagiarism detection softwares such as
TURNITIN, VIPER etc., responsibility and accountability of the researchers. Academia-Industry
interface and research.
Project cost management: Cost analysis of the project, cost incurred on raw materials,
procedure, instrumentation and biological testing.
Unit V
Funding agencies and research grants: Introduction to various research funding agencies
such as-DST, DBT, AICTE, UGC, CSIR, ICMR, AAYUSH, and DRDO along with their
functions in India. Writing a research project and procurement of research grant.
RPH-843(E)P
RESEARCH METHODOLOGY PROJECT
BOOKS RECOMMENDED
1. Kothari C.R., Research Methodology Methods and Techniques, 2nd Edition,
Wishwa Prakashan, New Delhi.
2. Lokesh K., Methodology of Educational research, 3rd revised Edition,Vikash
Publishing House Pvt. Ltd., New Delhi.
3. Kumar R., Research Methodology, 2nd Edition, Dorling Kindersley (India) Pvt. Ltd.,
New Delhi.
4. Rao G.N., Research Methodology and Qualitative Methods, B.S. Publications, Hyderabad.
5. Saunders M., Lewis P.and Thornhill A., Research Methods for Business
Students,3 rdEdition, Dorling Kindersley (India) Pvt. Ltd., New Delhi.
6. Bolton S. and Bon C., Pharmaceutical Statistics: Practical and Clinical Applications,
4th edition, Marcel Dekker, New York.
7. Matad V., Anusuya D., Medicomarketing Writing, PharmaMed Press, Hyderabad.
8. Garg, B.L., Karadia, R., Agarwal, F. and Agarwal, U.K., 2002. An introduction to Research
Methodology, RBSA Publishers.
RPH-844P
REPORT ON INDUSTRIAL/ RESEARCH LABORATORY VISIT