`University of MumbaiBB M.Pharm.Sci.

ORDINANCES, REGULATIONS AND SYLLABI relating to the THREE Semester Master of Pharmaceutical Sciences(Faculty of Technology) M. Pharm. Sc. Degree Examination. This is effective from the academic year 2002-2003 and onwards. (Registration as Post-Graduate student shall be a condition precedent to the commencement of studies for the degree of M.Pharm.Sci.) Eligibility: O. 5103. A candidate who has passed the examination of the degree of B.Pharm.Sci. of this University or an examination of another University recognized equivalent there to with at least First Class or higher Second class, be admitted to M.Pharm.Sci. course (Partly by Papers and Partly by thesis) in one of the branches of Pharmaceutical Sciences mentioned below in which the candidate registers as a Post-Graduate student. O. 5104. The examination for the degree of M.Pharm.Sci. shall consist of the following branches of Pharmaceutical Sciences and will be held in two parts: I) a theory examination and II) a thesis to be submitted in the respective branches: The branches are: 1. Medicinal Chemistry 2. Pharmacology 3. Pharmaceutics 4. Pharmacognosy & Phytochemistry 5. Pharmaceutical Analysis 6. Clinical Pharmacy 7. Medicinal Natural Products 8. Biopharmaceutics & Pharmacokinetics 9. Quality Assurance R. 4498. Every candidate registered for the degree in any branch of Pharmaceutical Sciences mentioned in Oabove shall be required to pass a theory examination which will be held in two parts. Part I to be hereinafter as Semester I examination and Part II to be hereinafter referred to as Semester II examination. Semester III will be submission of research work in the form of thesis.

Examination Scheme
SEMESTER-I --------------------------------------------------------------------------------------------------------------------Branch Subjects Teaching Examination Marks Hours/Week Hours --------------------------------------------------------------------------------------------------------------------All Braches Core Subject-I 2 2 50 Core Subject-II 2 2 50 Core Subject-III 2 2 50 Elective-I 2 2 50 Elective-II 2 2 50 --------------------------------------------------------------------------------------------------------------------Total 250 ---------------------------------------------------------------------------------------------------------------------

SEMESTER-II --------------------------------------------------------------------------------------------------------------------Branch Subjects Teaching Examination Marks Hours/Week Hours --------------------------------------------------------------------------------------------------------------------All Braches Core Subject-IV 2 2 50 Core Subject-V 2 2 50 Elective-III 2 2 50 Elective-IV 2 2 50 Seminar 2 2 50 --------------------------------------------------------------------------------------------------------------------Total 250 ---------------------------------------------------------------------------------------------------------------------

Branch wise core subjects to be offered --------------------------------------------------------------------------------------------------------------------Branch Core Subjects No. Name --------------------------------------------------------------------------------------------------------------------1. Pharmaceutics I Pharmaceutics II Pharmacology, Toxicology and Therapeutics III Medicinal Chemistry IV Advanced Pharmaceutics V Biopharmaceutics & Pharmacokinetics 2. Medicinal Chemistry I II III IV V Medicinal Chemistry Pharmacology, Toxicology and Therapeutics Pharmaceutics Advanced Medicinal Chemistry Advanced Pharmacognosy and Phytochemistry Pharmacology, Toxicology and Therapeutics Biopharmaceutics and Pharmacokinetics Advanced Receptor Pharmacology Advanced Pharmacognosy and Phytochemistry Clinical Pharmacy Pharmacognosy and Phytochemistry Medicinal Chemistry Pharmaceutical Analysis Advanced Pharmacognosy and Phytochemistry Pharmaceutics

3. Pharmacology, Toxicology and Therapeutics

I II III IV V

4. Pharmacognosy and Phytochemistry

I II III IV V

5. Pharmaceutical Analysis

I II

Pharmaceutical Analysis Biopharmaceutics and

III IV

Pharmacokinetics Quality Assurance Advanced Analytical Chemistry & Instrumentation Pharmacognosy and Phytochemistry Clinical Pharmacy Pharmaceutics Pharmacology, Toxicology and Therapeutics Biopharmaceutics and Pharmacokinetics Advanced Receptor Pharmacology Medicinal Chemistry Pharmacology, Toxicology and Therapeutics Pharmaceutics Advanced Medicinal Chemistry Advanced Pharmacognosy & Phytochemistry Biopharmaceutics & Pharmacokinetics Pharmacology, Toxicology & Therapeutics Pharmaceutical Analysis Pharmaceutics Clinical Pharmacy Quality Assurance Biopharmaceutics & Pharmacokinetics Pharmaceutical Analysis Advanced Pharmaceutical Analysis Pharmaceutics

6. Clinical Pharmacy

I II III IV V

7. Medicinal Natural Products

I II III IV V

8. Biopharmaceutics & Pharmacokinetics

I II III IV V

9. Quality Assurance

I II III IV V

List of Electives:
1. Pharmaceutical Research Methodology 2. Therapeutic Drug Monitoring 3. Plant Tissue Culture 4. Technology of Cosmetics 5. Herbal Drug Development & Standardization 6. Pharmaceutical Biotechnology 7. Biological Standardization & Pharmacological Screening Methods 8. Topics in Toxicology 9. Topics in Pharmacology 10. Polymers in Pharmaceuticals 11. Packaging Technology 12. Rational Drug Design 13. Structural Elucidation by Physical Methods 14. Intellectual Property Rights & Patent Filing 15. Bluk Drug Technology & Process Chemistry

Semester I Every student admitted to M.Pharm.Sci. course shall be offered Five papers as follows: 1. Three papers covering Core subject of candidates specialization (core subjects I-III) and 2. Two electives amongst the elective offered by the admitting institutions, which may be either from remaining Core subjects or from the list of electives. There will be 2 sessions of 1.0 hour each for each subject per week. The student will be assigned research project in this semester and they will complete the literature survey related to research work. Semester II In this semester, every student shall be offered two core subjects (Core subject IV & V) of that branch along with two electives offered by the admitting institution. The electives shall be from the list of Core subjects or from the list of electives. There will be one seminar by each student in this semester. There will be 2 sessions of 1.0 hour each for each subject and each elective per week. The students will start with the research work in the laboratory in this semester under the supervision of a recognized research guide. Semester III Every student will continue with his/her research project in this semester. Each student will give an exit seminar (Research colloquium) on the topic or his/her research project before submitting the thesis. The candidates must submit their research synopsis at the end of the 16 months from the date of registration.

Examination Scheme Each paper in Semester I and Semester II will be of 50 marks. The duration of the paper will be 2 hours. The seminar in semester II shall carry 50 marks to be assigned as follows: --------------------------------------------------------------------------------------------------------------------Scientific content Presentation, Discussion Report Communication, Slides etc. 10 10 10 20 --------------------------------------------------------------------------------------------------------------------Successful candidate shall be awarded classes, as under, jointly on the basis of the Semester I and Semester II examination and the thesis submitted by them: 1. Those obtaining 65% marks or more of the grand total at both the Semester I and Semester II examination taken together and grade A in the thesis First class with distinction 2. Those obtaining 65% marks or more of the grand total at both the Semester I and Semester II examination taken together and grade B in the thesis First class 3. Those obtaining 55% marks or more of the grand total at both the Semester I and Semester II examination taken together and grade A in the thesis First class All other cases - Second class Pass the Semester I and II examinations, a candidate must obtain atleast 50% of rks in each subject, each elective and seminar. Failure to pass in any subject held in Semester I and Semester II shall not debar the candidate from appearing at any of the examination at higher semester. However, result of such a candidate after completion of the Semester III will not be declared until he/she has cleared the examination at the preceding semesters. Exemption: 1. At the Semester I and Semester II of M.Pharm.Sci. a candidate who has failed in that semester, may at his option, be exempted from appearing at that subject at a subsequent examination of the semester in pass class. 2. Failure to pass the Semester I, Semester II and Semester III examination will not disqualify the candidate from presenting himself on a subsequent occasion on a fresh application being forwarded and fresh fee being paid.

Detailed Syllabus for the Core Subjects

*Pharmaceutics
1. General Aspects 2. Pharmaceutical Pre-formulation 3. Product design development, Manufacture & Evaluation. a) Physical Pharmaceutics & allied aspects of the product including micromeritics, compression, compaction, Dissolution technology, Intrinsic dissolution, dissolution at different pH, testing devices viz. forced convention non sink & sink devices, continuous flow through methods. Validation of Dissolution rate test for solid dosage forms, suspension, topical & transdermal products. In vivo - In vitro correlations. Complexation using cyclodextrins. b) Pharmaceutical experimental design & interpretation. c) Project design & application of Pharmaceutical production facilities. d) Evaluation of the product. e) Optimization & validation of the processes & qualification of equipment. f) Drug stability In vivo & In vitro. g) Documentation. 4. Study of Excipients I: Introduction to Excipients & their importance in Pharmaceutical & Cosmetic industry with special reference to USP, specialize type of excipients used in tablets such as super disintegrants, surfactants in dispense systems, Taste masking excipients, colors, flavours, sweetening above their characteristic & gel forming agents, solubilizers their evaluation method & controls material safety data sheet. 5. Delayed release & pulsatile delivery systems Oral control release Introduction: a) Solid oral tablets & multiparticulate systems b) Liquid sustained release. Advantages & disadvantages Mechanism of release their mathematical treatments, Biopharmaceutical consideration in design with the development, manufacturing technologies. Microencapsulation technique for sustained released with the evaluation In vitro & In vivo (by including determination of site of disintegration wherever applicable) In vitro In vivo correlation. Colloidal & disperse systems: Specialized pharmaceutical emulsion like multiple emulsion, microemulsion, vesicles, indictable emulsions with the suspensions, gels and liposomes, Quality assurance of dispered system. Reconstituted oral suspensions, aerosol with the ophthalmic.

6. Large volume parentrals 1) necessity to separate them from small volume, advances in Sterilization, validation of sterilization, particulate matter with the quality assurances 2) Performulation 3) Importance of osmolarity physiological with the pharmaceutical Including design, manufacturing of water for injection. Particulate mater & methods with the Equipments of measuring particulate matter, CL test for pyrogen. Packaging with the equipments used for LVPs.

Reference Books: 1. Pharm. Preformulation by J.T. Carstensen 2. Solid Pharmaceutics by Cartensen 3. Pharm. Technology Drug Stability by Rubinstein 4. Advances in Pharm. Sciences Bean Beckett & Carless 5. Pharmaceutical Principle of Solid Dosage Form Cartensen 6. Pharmaceutics of Solids & Solid Dosage Form - Cartensen 7. Pharmaceutical Experimental Design & Interpretation by Armstrong 8. Design & Application of Pharmaceutical Facilities Vol. I & II by Graham Cole 9. Parentrals by Lachman Vol. II & III 10. Controlled Release System Past, Present & Future by Hsieh Vol. I & II 11. Controlled Drug Delivery Challengen & Strategies by Park 12. Controlled Release Technology, Methods & Application by Kydonieus Vol. II 13. Principles of Polymer System by Fredinand Rodriguez 14. Drug Delivery Systems Juliano 15. Fundamental Principles of Polymeric Materials by Rosen 16. Dispersed System by Lachman, Lieberman Vol. I, II & III 17. Product Design & Testing of Polymeric Material by Nicholas P. Chezerisionoff 18. Polymers in Controlled Drug Delivery ed. by Lisbeth Illerm, Stanley Davis 19. Theory of Pharmaceutical Systems Vol. I & II Cartensen 20. Process Validation Loftus & Nash 21. Aseptic Process Validation Carleton & Agallaco 22. Oral Mucosal Delivery Rathbone 23. Quality Control Cooper Vol. I & II 24. Transdermal Controlled Systematic Medication Y.W. Chien 25. Good Manufacturing Practices for Pharmaceutical by S.H. Willig & J.R. Stroker (Vol. 78) Marcel Dekkar 26. Project Management & Plant Layout (Vol. 86) Marcel Dekkar

*Medicinal Chemistry
1. Receptor a) Basic ligand concept agonist, antagonist, partial agonist, inverse agonist, efficacy & potency b) Receptor Thories:- Occupancy theory, Rate theory & Activation theory c) Receptor Classification:- based on ligand & molecular biology d) 3D:- Structure of adrenergic, DHFR, Cyt-P450 & HIV-I Protease receptors e) Receptor Binding assays, determination of Bmax & Kd by transforming data with the Hill plot & Scatchard plot. 2. Design & Application of Prodrugs a) Definition of the prodrug concept b) Prodrugs of various functional groups, carboxyl & hydroxyl group, amides, imides & amines c) Application of the prodrug approach to i) Increase bioavailability ii) Prevent first pass metabolism iii) Reduction of side effects iv) Prolong duration of action v) Site specific delivery 3. Drug Discovery a) Historical perspective b) Sources for new drugs & current approaches in drug discovery c) Computer-aided drug design software & hardware, Demonstration of simple software programs & problem solving d) QSAR: Methods, Parametrization & Determination of Physicochemical properties, Requirements, Basic Equations of various methods, Limitations & Exceptions Quantitative models of QSAR: a) Hansch approach b) Free-Wilson analysis c) Topological Methods d) Principle Component Analysis 3D QSAR Models: CoMFA, CoMSIA, GFA & others. Molecular Modeling Methods: Structure-Based & Analog-Based Drug Design Lead Molecular search & Lead Optimization by above techniques. Introduction to i) High throughput screening ii) Combinatorial Chemistry & Compound Library Design iii) Genomics & Proteomics in Drug Design iv) Bioinformatics in Drug Discovery v) Quantitative Structure-Pharmacokinetic Relationships(QSPR)

Books Recommended: 1. Burgers Medicinal Chemistry 2. Organic synthesis the Disconnection approach by Stuart Warren 3. QSAR: Hansch Analysis & Related Approaches by Hugo Kubingi(Vol.I) 4. A Textbook of Drug Design & Development 2nd Edition edited by Povl Krogasgaard 5. Computer Aided Drug Design edited by Thomas J. Perum, C.L. Propst 6. Structure Based Drug Design edited by Pandi Veerapandian 7. Structure Based Drug Design by Ladbury & Connelly 8. Practical Application of Computer Aided Drug Design edited by Poul S. Charifson 9. Advanced Computer Assisted Techniques in Drug Discovery by Has Vande Waterbeemd 10. A Guidebook on Molecular Modeling & Drug Design by Cohen 11. References from Journal of Medicinal Chemistry, Journal of Computer-Aided Molecular Design, Indian Drugs etc.

*Pharmacology, Toxicology & Therapeutics

1. Introduction to cytokines, including their definition in brief the synthesis of cytokine cytokines as Immunosuppressant & Interleukine - 10 2. Evaluation of Drug activities Pharmacometrics Primary screening for evaluating potencial drugs Different approaches factors affecting the programs, primary general tests & selected special test Design statistical analysis & Interpretation. Randomization, different experimental designs Distribution free statistical test including wilcoonsignal-rank test, fredmans test, speamen test, Kruskal & wallis test, strain & sex differences in response to drug. Limitation of animal test & transfer of data from animal to man Clinical trials-Drug registration 3. Study of Models for Testing a) Analgesics, Antipyretic & Anti inflammatory b) Local Anesthetic c) Tranquillizers & sedatives d) Antidepressants, Analeptics e) Ant psychotics f) Anticonvulsants g) Antiparkinsonian agents h) Antihypertensive i) Diuretics j) Ant emetics k) Antipyretic l) Antitussives m) Antiasthamatic & Bronchodilator n) Cardio Vascular agents o) Hypoglycemic agents p) Anti Fertility agents q) Cholesterol reducing agents r) Immunomodulators s) Anticancer t) Antimicrobials u) Topical agents for Skin, Eye, Ent, Buccal, Nasal. 4. Drug Dependence drug resistance, drug tolerance & Hypersensitivity of Drug Definition & Perspectives withdrawal phenomenon pharmacological approach to drug dependence & tolerance, Humoral transmitters & receptors & dependence. Drug of abuse, dependence for morphine, barbiturates & narcotic analgesis cannabis, alcohol, methacolon & LSD heroin & brown sugar amphitamines, role drug disposition & metabolism. Microbial resistance to drugs - Role of outer membrane of gm negative bacteria in Ant microbial resistance - Cytoplasmic membrane transport - Resistance of plasmodium falciparum to Antimalarials - Resistance of plasmodium falciparum to -lactamase & their role - Resistance of plasmodium falciparum to phloroquinolones, trimethoprim, sulphonamide - Clinical Laboratory testing for Ant microbial resistance - Microbes causing problems for microbial resistance Hypersensitivity to drugs Definition & scope - Antibodies produced by drugs & methods for their detection - Morphology of reaction caused by the Hypersensitivity of drugs - Drug induced skin reaction - Renal disease & hepatic injury Toxicity:a) Toxicity testing - Acute, sub acute & chronic toxicity testing Biochemical bases of toxicity - Design of toxicological studies - Quality assurance in toxicology studies - Toxicity by routes Parental, oral, percutaneous & inhalation - Target organ toxicity exemplified by hepatotoxicity & cutaneous (dermal) toxicity

- Special toxicology including carcinogenisity, mutagenicity & feratogenicity - Regulatory status Ethical, moral & professional issues. b) In vitro toxicity testing & its application to safety evaluation - General perspectives, in vitro technology trends & issues - Evaluation of in vitro models for evaluation nephrotoxicity as an example - Ocular & cutaneous irritation, validation of In vitro toxicity tests - Industrial applications & product safety assessment 5. Combination Drugs:- Fixed dose combination in prescription drugs - Fixed dose combination in pharmacokinetic combination - Rational & Irrational combination - Marketing of fixed combination drugs - Regulatory status

Books Recommended:1. Screening Methods in Pharmacology II by Turner & Hebborn 2. Mutagenicity Testing & Related Analytical Techniques by R.W. Frei & U.A. Th. Brinkman 3. Evaluation of Drug Activites: Pharmacometrics by Laurence & Bacharach Vol. I & II 4. Quantitative Methods in Pharmacology by H.De. Jonge 5. In vitro Toxicity Testing by John M. Fraizer 6. Microbial Resistance to Drugs by L.E. Bryan 7. Combination Drugs: Their Use & Regulation by Louis Lasanga 8. Receptor Based Drug Design by Paul Left 9. Drug Discovery: The evolution of Modern Medicines by Walter Sneader 10. Psychopharmacology: The Third Generation & Progress by Herbert Y. Meltzer 11. Psychoactive Drugs: Tolerance: Tolerance & Sensitization 12. Psychopharmacology 1: Part 2: Clinical Psychopharmacology by H. Hippins & G. Winokur 13. Psychopharmacology 2: Part 1: Preclinical Psychopharmacology by D.G. Grahame-Smith & P.J. Cowen 14. Psychopharmacology Series Vol. 2 Psychotherapeutics Drugs Part 1 Principles by Earl Usdin & Irene S. Forrest 15. Drug Receptors & Their Effectors Edited by Nigel J.M. Birdsall 16. Textbook of Receptor Pharmacology by John C. Foreman, Torben Johansen 17. Fe Receptors & The Action of Antibodies by Henry Metzger 18. Scientific Basis of Drug Dependence by Hannah Steingerg 19. Hypersensitivity to Drugs Vol. I by Max Samter & C.W. Parker 20. Receptor Binding in Drug Research by Robert A. OBrien 21. Drug Receptors by H.P. Raug 22. Discoveries in Pharmacology Vol. I & II by Parnham & J. Bruinvels 23. Discoveries in Pharmacology Vol. I Pharmacological Methods, Receptors & Chemotherapy by Parnham & J. Bruinvels 24. General & Applied Toxicology by Bryan Ballantyne, T. Marrs & P. Turner 25. Safety Evaluation of Drugs & Chemicals by W. Eugene Llyod

*Pharmacognosy & Phytochemistry

1. (i) Various aspects of cultivation, processing & propagation of medicinal plants of medicinal plants of commercial importance as exemplified by the following examples a) Dioscorea b) Digitalis c) Senna d) Vinca e) Taxus Bravifolia f) Ginseng g) Aloes 2. Newer techniques of plant propagation including plant tissue culture for production of secondary metabolites. - Introduction to Transgenic Plants 3. Introduction to alternate systems of Medicine viz- Chinese, Tibetan, Homeopathy, Ayurveda, Unani & Siddha & Aromatherapy 4. i) Techniques of extraction including supercritical fluid extraction & other Advanced technology ii) Large scale extraction of phytochemicals as exemplified by the following examples a) Diosgenin b) Pyrethrins c) Taxol d) Opium Alkaloids e) Curecuminoids 1. Study of the following Classes of Natural Products a) Natural Colors as exemplified by Saffron, Cochineal, Annato b) Natural Antimicrobials as exemplified by:i) Benzoic Acid from butter fat ii) Propinoic Acid from butter fat iii) Tannius such as Gallic Acid & Ellagic Acid iv) Anthocyanius from Grape & Strawberry v) Essential oils containing Terpenes, Carvacrol & Thymol Lemon Grass, Mint caraway Fennel, Anise, Cardamom c) Natural Pesticide Neem, Tobacco, Pyrethrum d) Phytoalexins as exemplified by i) Reserated from Grape ii) Allixin from Garlic iii) Brassinin from Cabbage e) Photo-toxic plants as exemplified by i) Hypericum perforatum ii) Fagopyrum esculantum iii) Psoralea corylifera f) Allelolo chemicals as exemplified by i) Tuglone from bark of Juglans nigra ii) Chlorogenic Acid, Isochlorogenic Acid found in Soyabean, Cotton 2. Aflatoxins:Introduction, Different Fungi producing Aflatoxin affecting production, structure of Aflatoxin & their biosynthesis, spoilage in crops & seeds due to aflatoxin & its prevention, neurotoxicity due to aflatoxin.

Books Recommended: 1. Pharmacognosy Phytochemistry Medicinal Plants Jean Brunetton, Lavoisier Publishing, Paris 2. Textbook of Pharmacognosy Trease & Evans 14th Edition. 3. Transgenic Plants R. Ranjan Published by Agro Botanica, New Delhi 4. Transgenic Plants A Production system for Industrial & Pharmaceutical Proteins ed. by Meran Owen, Jan Pen Published by John Wiley. 5. Encyclopedia of Tibetan Medicine Vol. I to V- Vaidya Bhagwan Dash Published by Sri Satguru Publisher. 6. Medicinal Plant Their Bioactivity, Screening & Evaluation Published by CSIR. 7. Textbook of Pharmacognosy Trease & Evans 14th edition 8. Principles of Ayurvedic Therapeutics Kumar A.V.- Sri Satguru Publications. 9. Materia Medica of Homeopathic Medicines by Phatak S.R. 10. Homeopathic Pharmacopoeia of India Published by Ministry of Health. 11. The Ayurvedic Formulary of India Part I & II Published by Ministry of Health. 12. Chinese Materia Medica by You PingZhu Harwood Academic Publishers. 13. India Materia Medica by Nadkarni A.K. Published by Bombay Popular Prakashan. 14. Phytochemical Methods by J.B. Harbone. 15. Cultivations & Processing of Medicinal Plants ed. by L. Hornok Published by John Wiley. 16. Introduction to Flavonoids by Bohrn Bruce A. Published by Harwood Academic Publishers. 17. Cultivation & Utilization of Aromatic Plants ed. by Atal C.K. & Kapur B.M. Published by CSIR. 18. Plant Tissue & Cell Culture ed. H.E. Street Published by Blackwell Scientific Publications. 19. Alfatoxin by Leo A. Gold Blatt Published by Academic Press, New York. 20. Food Additive by R.J. Taylor. 21. Microtoxin in Humna Health by I.F. Purchase 22. Pharmacology & Toxicology of Natural Occurring Toxin International Encyclopedia of Pharmacology & Therapeutic. 23. Microbial Toxins by Ciejler, Kadis & Ajl Published by Academic Press. 24. Antimicrobial in Food by Alfred Larry Branen, P. Michael Davidson Publishing Corporation.

*Pharmaceutical Analysis
1. Review of Fundamental Concepts & IP Procedures a) General Information - I.P. Appendix 1996, 112.1-12.5 (Also cover types of glass for glassware, depassivation of glassware) b) Apparatus for Tests & Assays, I.P. - I.P. Appendix 1996, 1.1-1.6 c) Significance & Experimental Techniques including - Determination of pka values - Partition coefficient d) Reference standards & their significance: - I.P. Appendix 14 (primary standard) 2. Organization Plan of a Pharmaceutical Analytical Lab & Implementation of GLP, QA & & QC Concepts I) Good Lab Design i) Premises ii) Technical Personnel: Qualification, Experience, Dress code & Behaviour iii) Division Chemical Division, Microbiological Division, Pharmacological Division iv) Instruments a) Maintenance & Calibration of Instruments & Apparatus b) Standard Operating Procedures & Calibration of Analytical balance. c) Calibration of UV-VIS Spectrophotometer d) Reference standards & working standards v) Safety into the Laboratory a) Designing safety into the Laboratory 1) Laboratory Accidents & First Aid for Chemical Burns & Accidents 2) Laboratory Ventilation Systems 3) Egress 4) Hazard Zoning 5) Emergency Facilities 6) Hazards slippery spills of hazardous substances & their handling b) Laboratory Design Safety aspects 1) Storage of Laboratory Chemicals Laboratory Design Safety aspects 2) Principles of Chemical Storage 3) Inventory Control 4) Segregation II) Good Laboratory Practices i) Technical competence ii) Validation of Analyst & the procedures for the same iii) Desirable qualities of analyst iv) Safety guidelines in drug control laboratories v) Systems & procedures in a Quality Control Lab

vi) Steps for successful analysis vii) Planning work in the Lab viii) Responsibilities of key personnel in Quality Control Lab III) General Requirements, Quality Assurance & Accreditation of Testing Laboratory i) Organization & Management ii) Quality System & Quality Manual iii) Audit, Review & Quality Control IV) Documentation Documentation system based on clauses of ISO 9000 series Documentation for sample storage & destruction, procedure for document destruction & record maintenance - Maintenance of Laboratory manual - Good documentation practices - Drug master file - Standard operating procedures - Laboratory audits & certifications V) Raw Material Analysis Sampling plan Objectives, Nature of matrix, Type of sample, Statistical considerations Sampling techniques, Procedure & Handling, Labeling & Preservation, Material safety data sheets VI) Statistical Quality Control Techniques Control charts, X-charts, Spiked Sample control chart, R-charts Blind samples Performance evaluation samples VII) Quality Control of Packaging Materials Classification into Primary & Secondary Materials - Primary containers toxicity testing leaching from the plastics tube lacquering etc. - secondary cartons, shippers Road worthiness transport orifice accuracy(determined by engineering devices) VIII) Microbiological & Biological Assays - Introductory Microbiology - Comparison of Microbiological Assays with Bioassays using Animals - Basic Approaches to Microbiological Assays - Plate & Tube Assays - Enzyme based Assay ELISA - Michalis Mantel Equation - LAL Test for Endotoxin IX) Instrumental Analysis in Q.C. (Theory, Instrumentation & Applications) Good Chromatographic Practices Current trends in HPLC, HPTLC, GC, IR, NMR, Mass, PSA Introduction to Supercritical Fluid Chromatography(SFC) Properties of Supercritical Fluid that are to be used as mobile phase in Chromatography, Diffusion in the Instruments for SFC as compared to GC & HPLC equipment, Importance of pressure in SFC

Books Recommended: 1. Chromatographic Science Series: Vol. 74 & 75 2. Advances in automated analysis/Industrial analysis 3. Thermal Analysis: Theory & Application by R.T. Sane, Jagdish K. Gadge 4. Official & Standardized Methods of Analysis, 3rd ed. by Colin Watson 5. Handbook of Quality Assurance for the Analytical Chemistry Laboratory by James P. Dux 6. Ultra trace analysis of Pharmaceuticals & other compounds of Interest by Satinder Ahuja 7. Calculations of Analytical Chemistry by Hamilon Simpson Ellis 8. Jenkins Quantitative Pharmaceutical Chemistry by Adelbert M. Khevel, Frank E. Diagangi 9. Education & Teaching in Analytical Chemistry, G.E. Ballescu, C. Patroexu, R.A. Chalmers 10. Scanning Electron Microscopy & X-ray Microanalysis Series Graham Laws 11. Pharmaceutical Analysis by Higuchi Takeru 12. Handbook of Analytical Derivation Reactions by Daniel R. Knapp 13. An Introduction to Thermogravimetry by Keattch/Dollimore 14. Analysis of Drugs of Abuse by Berman 15. Methods of Protein Analysis by Kerese 16. Chiral Separations by HPLC by A.M. Krstulovic 17. Chromatographic Science Series Vol. 31, 37 18. Polymorphism in Pharmaceutical Solids Vol. 95 by Harry G. Brittain 19. Analytical Chemistry by R. Kellner, J. M. 20. Impurities Evaluation of Pharmaceuticals by Santinder Ahuja 21. Quality Assurance of Drugs in Pharmaceutical by P.D. Sethi 22. Cosmetic Analysis Selective Methods & Techniques ed. by P. Bore 23. Clinical Safety & Efficiency Testing of Cosmetics ed. by William 24. Cosmetic Product Testing A Modern Psychological Approach by Harward R. Moskowitz 25. Cosmetic Safety A Primer for Cosmetic Scientists ed. by James H. Whittan 26. Method if Protein Analysis ed. by Istran Kerese 27. The Practical Evaluation, Analysis of Phytopharmaceuticals by K.R. Brain, T.D. Turner 28. Polypeptide & Protein Drugs Production, Characterization & Formulations by R.C. Hider, D. Barlow 29. Stability & Characterization of Proteins & Peptide Drugs Case Histories ed. by X. John Wang & Rodney Rearlman 30. Purification & Analysis of Recombinant Proteins ed. by Ramnath Seetaram, Satish K. Sharma 31. HPTLC High Performance Thin Layer Chromatography Quantitative Analysis of Pharmaceutical Formulations by P.D. Sethi 32. Quantitative Bioassay by David Hawcroft, Terry Nector & Fed Rowell 33. Latest edition of IP, BP, USP, Eu. Pharma. Homeopathic Pharmacoepia, Ayurvedic Pharma & Ayurvedic Formulary 34. Drug & Cosmetic Acts & Rules with Amendments

*Clinical Pharmacy
1. Introduction to Clinical Pharmacy - Scope, Objectives & Goal in Health Care - Practice of Clinical Pharmacy in Hospitals & Community 2. Understanding the Patient - Pharmacist Patient Interview - Interview Techniques, Communication Skills - Medication History, Habits related to the use of OTC Medications, Foods, Allergies & Sensitivities - Case Presentation 3. Fundamentals of Diseases - Symptoms & Disease identification General Discussion - General & systemic effects of Disease & Injury - Cardiovascular & other systemic effects of Disease & Injury - Endocrine & metabolic responses to Disease & Trauma - Nervous system involvement in Disease - Ageing & geriatric Disease - Communicable Disease prevention 4. Therapeutic use of Medicine - Drug selection & administration. Problems associated with concomitant therapy. Patient Sensitivities, Allergies. Precautions during use Diet control - Reasons for non-compliance Poor standards of labeling, social isolation, complex Therapeutic regimes, Nature of medication, side effects, lack of doctor/pharmacist/patient Rapport, inadequate patient education - Strategies for improving compliance Supplementary labeling, Simplification of therapeutic Regimen, patient counseling, use of warning cards, patient education, patient package inserts - Use of Drugs in geriatric, paediatric patients & in pregnancy 5. Monitoring the patient in Health & Illness - Fluid & Electrolyte imbalance - Cardiopulmonary Dysfunction - Metabolic disorders - Patient follow-up-discharge interview for hospitalized patients Precautions & directions during use of medications - Pharmacological & Biochemical examinations their significance - Supervision of therapeutic success, side effects & adverse effects 6. Drug Information Introduction to information resources available. Development of drug information & drug information services. Drug literature utilization, selection, evaluation & communication Physician-Pharmacist-Interactions Pharmacist-Patient-Interactions 7. Investigational Drugs & Clinical Research Ethical & legal considerations in evaluation of New Therapy Investigational Drugs-research design Bioequivalence & Clinical trials of Drug substances-Brief review

Books Recommened: 1. Clinical Pharmacy Practice ed. by Charles W., Blissit Lea & Febiger Publications 2. Clinical Pharmacy & Hospital Drug Management ed. by Lawson & Richards 3. Clinical Pharmacy Kleijn Elsevier Press, Amsterdam 4. Applied Therapeutics for Clinical Pharmacists by Koda Kimble M.N. Applied Therapeutics Inc., San Francisco 5. Drug Information for the Health Care Provider Vol.I USP DI 6. Advice for the Patient Vol. II, USP DI 7. Handbook of Pharmacy Healthcare Diseases & Patient Advice ed. by R.J. Harman, Pharmaceutical Press, London 8. Patient Care in Community Practices by R.J. Harman, Pharmaceutical Press, London

*Biopharmaceutics & Pharmacokinetics

*Pharmacokinetics
1. Introduction to Pharmacokinetics:Definition & importance of Clinical Pharmacokinetics 2. Basic concepts:Definition & introduction to basic Pharmacokinetics parameters like Volume of distribution, Elimination half life, Elimination rate constant, Clearance, area under curve, Bioavailability, Protein binding & Tissue binding. Calculation of parameters from Plasma & Urine data. 3. Compartment Modeling:a) One compartment open model I.V. route of administration, Elimination half life, Volume of distribution, First order Elimination, Fraction of drug remaining, Renal clearance, Total clearance, Calculation of elimination rate constant from Urinary excretion data. b) Multicompartment modeling Two compartment & three compartment models, determination of compartment model. 4. Therapeutic response & Toxicity:Concentration & response, Therapeutic concentration range, Therapeutic index, Therapeutic Window, Factors affecting plasma concentration & toxicity. 5. Constant rate & Multiple dose regimens:Drug level time relationship, Platue value, Mean residence time, Time to reach platue, Bolus & infusion, Practical issues, Drug accumulation, Adverage amount & concentration at platue, Accumulation index, Maintenance dose, Loading dose, Maintenance of dose in Therapeutic range. 6. Concept & Kinetics of physiological parameters:Absorption, Distribution & Elimination 7. Integration with Kinetics:Interrelationship between Pharmacokinetics parameters & physiological variables, induction & inhibition of metabolism, decreased hepatocellular activity, Alteration of blood flow, tubular secretion & plasma protein binding. 8. Variability in Clinical response & Drug Pharmacokinetics with special reference to renal & Hepatic diseases:Genetic factors, Age & weight, Diseases altering/affecting the Pharmacokinetic parameters. 9. Adverse Drug reaction & Drug interaction:Classification, Altered absorption & distribution, Therapeutic implications, Causes of drug interaction, Alteration in drug metabolism. 10. Non Linear Pharmacokinetics:Saturable enzymatic elimination process, drug elimination by capacity limited Pharmacokinetics, mixed drug elimination, time dependent Pharmacokinetics, bioavailability of drugs that follows the non-linear Pharmacokinetics, non-linear Pharmacokinetics due to protein binding(e.g. Phenytoin) 11. Application of Pharmaceutics in clinical situation: Individualization of dosing regimen, therapeutic drug monitoring, conversion from I.V. dosing ti oral dosing. Determination of dose, frequency of drug administration & route of administration, dosing of drug in infants, elders & patients.

12. Clinical case reports & discussion. Books Recommended: 1. Clinical Pharmacokinetics: Concepts & Application by Malcom Rawland, Thomas Tozer, 3rd edition, A Lea-Febiger book, B.I. Baverly Books Pvt. Ltd., 1996 2. Applied Biopharmaceutics & Pharmacokinetics by Leon Shargel, Andrew B.C. Yu., 3rd Edition, Prentice Hall International Inc., 1992 3. Biopharmaceutics & Pharmacokinetics by Milo Gibaldi, Lea-Febiger Publications, Philadelphia 4. Biopharmaceutics & Pharmacokinetics: An Introduction by Robert E. Notari, Marcel Dekker Inc., New York, 1971 5. Biopharmaceutics, Swarbrik, Lea-Febiger Publications, Philadelphia, 1970 6. Pharmacokinetics by Mile Gibaldi, Donald Perrier, Vol.I, Marcel Dekker Inc., New York, 1975 7. Handbook of Clinical Pharmacokinetics by Gibaldi & Pencot, 1977 8. Remingtons Pharmaceutical Sciences ed. by Jennoro, Mack Publishing Corp., Eastern Pennsylvanila, 1990 9. Biopharmaceutics & Clinical Pharmacokinetics by Niazi S., Prentice Hall, London, 1979

*Biopharmacokinetics
1. Introduction to Pharmaceutics 2. Cell membrane Structure of Cellular membrane Movement of Molecular & Ions across cell membrane Medicated Transport System, Pinocytosis, Phagocytosis. 3. Drug Absorption Biological considerations Physiochemical considerations Roll of dosage forms 4. Drug Distribution 5. Drug Elimination 6. Drug Dissolution Studies 7. Non Oral Medication & Bioavailability 8. Prolonged Action Medication & Bioavailability 9. Experimental Methods for In Vitro Absorption Studies

Books Recommended: 1. Biopharmaceutics & Pharmacokinetics by Micro-Gibaldi Lea & Febgier, Philadelphia, 1997 2. Remingtons Pharmaceutical Sciences ed. by Gennoro A.R. , Mack Pub.Co., 1990 3. Pharmacokinetics by Milo Gibaldi & Donald Perrier 4. Handbook of Clinical Pharmacokinetics by Gibaldi & Pencol 5. Biopharmaceutics by Swarbrick Lea & Febiger, Philadelphia, 1970 6. Introduction to Biopharmaceutics by G.P. Sriwastav 7. Biopharmaceutics & Pharmacokinetics by Robert E. Notary, Marcel Dekker N.V. by Nirari S.,

1987 8. Biopharmaceutics & Clinical Pharmacokinetics ed. by Gibaldi, Prentice Hall, London, 1989

*Quality Assurance
Quality Assurance Techniques I 1. Product Development stage documentation 2. Manufacturing documents, cleaning methods retention samples, records 3. Quality Control documentation 4. Batch release documents 5. Retention of records 6. Validation of equipments 7. Validation of processes 8. Validation of products 9. Application of Computers in store management, production & control Quality Assurance Techniques II 1. An understanding of the concepts of Quality Assurance good manufacturing practice & Quality control as applied to the Pharmaceutical industry. 2. Rules Governing the manufacturer of medicine in India. 3. Good Laboratory Practices(GLP) 4. Inspections from regulatory authorities Drugs & Cosmetics Act ad Rules, Narcotic Drugs & Psychotropic substances Act & Rules, Drugs & Magic remedies Act, Environmental Protection. 5. The role of Quality Assurance in raw materials, Product development, Preproduction Manufacture, Sales personnel in Quality Assurance programme ISO 9000 to 9004 & their Applications to Pharmaceutical Industry.

*Advanced Pharmaceutics
1. Study of excipients II Polymers: Types of polymers (Biodegradable bioerodible & Introduction to methods of nonbiodegradable) Introduction to methods of polymerization of homo & hetero polymers. Mol.wt. of Polymers, flow characteristics of polymers. Crystallinity & phase transitions, polymers degradation & stabilization, polymer testing. Analysis & identification of polymers, fundamental principles of polymeric material polymer solubility. Polymers of control release delivery like hydrogels, microcapusles, bioadhesive polymers, transport of small molecules in polymers, Biodegradation of polymers, enzymatically degradable bonds in synthesis polymers. Acute & chronic evaluation of implanted polymeric materials. Evaluation of blood compatibility of polymeric implants. Applications of polymers. 2. New Drug Delivery Systems a) Changing needs in drug delivery in next millennim protein & peptide drug delivery physical, Biochemistry with the protein drugs (structure, properties & stability), Analysis of protein & peptide drugs, barriers to protein & peptide drugs, pharmacokinetics of protein & peptide drugs. Different routes of delivery for P & P drugs, practical considerations of P & P drugs Preformulation & formulation considerations, toxicity & immunno genecity. Stability & regulatory perspective. b) Drug Delivery Systems Note: For every delivery system study of equipment selection, operating techniques, scale up techniques, quality assurance & validation to be included. i) Oral drug delivery systems Osmotic pressure controlled membrane permeation controlled, pH controlled, Ion-Exchange controlled, gel diffusion controlled, hydro-dynamically balanced system, modulation of G.I. transit time, recent advances in tablet technology like double compress ion direct compression, direct compression, Iubrication & binding agents, extrusion, merumerization, sustained release special tablets like lozenges, soluble tablets, effervescent tabs, Hypodermic tabs. ii) Mucosol drug delivery Mechanism, models, buccal, nasal, pulmonary, ractal & vaginal rug delivery, delivery of peptide based pharmaceuticals iii) Ocular delivery Ocular delivery mechanism & development of ocular controlled release iv) Transdermal drug delivery Permeation through skin, permeation enhancers, gel, technologies for developimg transdermal drug delivery system & evaluation thereof v) Parental drug delivery systems Injectable controlled release formulations, long acting contraceptive formulation. Implantable drug delivery, Preformulation research of parental medication, particulate matter & quality assurance, freeze drying environmental control in parentral manufacturing vi) Intrauterine drug delivery Medicated IUDS, copper IVD, hormone releasing IVD vii) Site specific drug delivery Active & passive targeting, monoclonal antibodies for drug targeting particulate carrier systems, microspheres, liposomes & nanoparticles. Specific drug delivery to targeted organs like Brain, Colon etc. viii) Drug approval & preparation of documents. 3. Advances in Microencapsulation Technology & different process Books Recommended: Same as mentioned under Core Subject Pharmaceutics

*Advanced Pharmaceutical Analysis

1. Review of Advances in Chromatographic Techniques & Troubleshooting. - Hyphenated Gas/Liquid Chromatographic Systems in the study of impurity profiles, metabolite & drug analysis in the biological matrix. 2. Introduction to advanced techniques & their instrumentation. I) Current trends in Dissolution testing of solid dosage forms II) Chiral chromatography in the analysis of pharmaceuticals III) Ion Chromatography in the analysis of pharmaceuticals IV) Sample preparation technique: solid phase extraction 3. Development of Analytical method & validation of the method - Choice of method: a) for routine quality control b) for sensitive assays c) for complex matrix - Availability of sample - Instrumental aspect - Validation of analytical methods as per USP 4. Applications of analytical principles & procedures to - Stability studies construction of walking chambers for accelerated temperature studies - Selection of analytical method using stability indicating procedures - Forced degradation - Synthesis of degradation products - FDA guidelines - Global Harmonization, ICH guidelines - Solid state stability - Drug Excipient & Drug-Drug Interaction in solid dosage forms 5. Quality Control of Herbal Products & Products on the alternate systems of medicine. 6. Characterization & Anlysis of Proteins & Peptides. - Introduction: - Purification & Characterization of Recombinant Proteins - Purification & Production of Therapeutic grade proteins 7. Advances of Quantitative Bioassays - General aspects of Bioassays: Quantitative Bioassay - Basic principles unit employed (Reference to Eu. Ph.) - The use of animals & animal tissues - Biological Activity & standard materials - Types of effects - Experimental Design - Evaluation of Assays - Assays of biotechnological derived products - The nature & production of binding agents of biological origin - Haptens - Limitations of antibodies as analytical reagents - Polyclonal antibody production - Monoclonal antibodies

- Other binding agents of biological origin - Vaccines & others - Recombinant DNA products 8. Significance of impurities - Determination of impurities in Bulk drugs - Isolation & Characterization - Analytical methodology - Formulation related impurities - Isolation & Characterization - Analytical methodology 9. Role of Pharmaceutical Analysis in Bio-equivalence/Bio-availability.

Books Recommended: Same as mentioned under Core Subject Pharmaceutical Analysis

*Advanced Pharmacognosy & Phytochemistry

1. Systematic approach to Crude Drug Evaluation & Standardization:i) Literature survey ii) Collection & processing of drug iii) Establishing authenticity of the drug iv) Identifying the part having pharmacological activity of Therapeutic significance v) Suitable processes of extraction & selection of the same vi) Isolation, purification & structure elucidation of the active constituent vii) Isolation of marker compounds & confirming their identify & pharmacological activity viii) Development of Analytical method of standardization 2. Herbal Drug formulation, standardization & evaluation for safety & efficiency 3. i) General Biosynthetic pathways in the formation of secondary metabolites ii) Techniques employed in investigation of Biogentic studies viz.:- Tracer techniques & studies with respect to isolated tissues, organs & cells iii) Biosynthesis of phenyl propanoids 4. Isolation, identification, classification, structure determination & important Pharmacological activities of flavanoids. 5. Miscellaneouse Isoprenoids: i) Gentian ii) Artemisia iii) Santonica flowers iv) Colius Forscohli v) Ginkgobiloba vi) Carotenoids from different plants as exemplified by capsanthin from capsicum, beta carotene from different sources

Books Recommended: Same as mentioned under Core Subject Pharmacognosy & Phytochemistry

*Advanced Receptor Pharmacology

1. Development of receptor theory, criteria for characterization of receptor, Receptor operation, Receptor structure, Receptor transduction integrated approach to receptor classification. Basis of receptor classification. 2. Study of different classes of Receptors viz.:i) Ion channel ii) G-protein iii) Tyrosine-Kinase linked receptors iv) Opium receptors v) Neurotransmitters receptors vi) Harmone receptors vii) Nicofinic receptors viii) Presynaptic receptors for catecholamines & 5-HT - Muscarinic receptors, GABA receptor, Dopaminergic receptor, B-adrenergic receptors. ix) Second messenger receptor systems Phospholipases & phosphokinases, cyclic, Nucleotides, protein kinase c, signal Transduction through protein tyrosine kinase, diacyl glycerol. 3. Fc-Receptor:Introduction, Structure & Function of Antibodies, conformation of Antibodies FC8R family: Proteins, tanscripts & genes , Gene, structure & Action of high affinity Fc receptor for Immunoglobulin E. Fc Receptor mediated killing Fc Receptor on T an B Iymphocyte Immunoglobulin Binding factors 4. Analysis & Interpretation of Receptor screening data:Receptor screening in drug research & drug discovery as applied to specific therapeutic areas: Viz.: 1. Benzodiazapenes & non-benzodiazapene 2. Psychomotor stimulants 3. Opiod receptor binding 4. Leukotriene receptor 5. Receptor applications to peptides, growth Factors & endogenous ligands, Interferon Receptor, platelet derived growth factor Receptor, receptor screening assays for Insulin & other growth factors, cholecsytokinin Receptor binding 5. In vivo & In vitro receptor methodologies for use in drug discovery & characterization.

Books Recommended: Same as mentioned under Core Subject Pharmacology, Toxicology & Therapeutics

*Advanced Medicinal Chemistry

1. Enzyme & Enzyme Inhibitors i) Enzyme structure primary, secondary, tertiary & quaternary ii) Enzyme Kinetics (Revision) iii) Enzyme inhibitors a) Reversible enzyme inhibitors b) Irreversible enzyme inhibitors c) Kcat inhibitors (Mechanism based) d) Transition state analogs iv) Enzyme inhibitors as drugs a) ACE inhibitors b) Cytochrone P450 inhibitors c) HIV reverse-transcriptase, protease & integrase inhibitors d) Leukotrienes & lipooxygenase inhibitors e) Aromatase inhibitors 2. Molecular Modeling & Drug Design i) Molecular Mechanics force field (Potential energy function) ii) Energy minimization methods steepest descent, conjugate gradients & Newton methods iii) Conformational Analysis a) Systematic Search b) Monte Carlo simulations c) Molecular Dynamics simulations iv) Structure-based & Ligand-based drug design approaches v) 3D Pharmacophore modeling & database searching vi) Demonstration of Drug Docking & Design of New Chemical Entities by use of suitable computer hardware & software 3. Combinatorial Chemistry i) Introduction ii) Combinatorial approaches to chemical diversity iii) Chemical Compound Libraries iv) Combinatorial organic synthesis 4. QSAR i) Parameters: Lipophilicity Partition co-effiency, Electronics, Steric, Polarizability others ii) Quantitative Models: a) Hansch analysis b) Fress Wilson analysis c) Mixed approach iii) Other QSAR Approches : 3D QSAR, CoMFA, CoMSIA, GFA. iv) Applications of Hensch analysis, Free Wilson analysis 5. Introduction to High-throughput Screening, Genomics _& Proteomics in Drug Design 6. Synthon approach in Drug Synthesis:i) Definition of terms-disconnection, synthon, functional group, interconverion (FGI), functional group conversion (FAC) ii) Basic rules in disconnection iii) Use of Synthon approach/Retrosynthesis for the synthesis of the following compounds a) Sulfisoxazole

b) Ibuproden c) Atenolol d) Haloperidol e) Indinavir f) Losartan g) Ranitidine h) Piroxicam i) Glipizide j) Ciprofloxacin k) Captopril l) Diltiazem m) Nefazodone n) Linezolid o) Paclitaxel

Books Recommended: Same as mentioned under Core Subject Medicinal Chemistry

For Synthon Approach 1. Dissection of Organic Compounds by Warner 2. Synthon Approach by Prabhu & Iyer 3. Retrosynthesis by E.J. Corey

Detailed Syllabus for Elective Subjects

Elective I : Pharmaceutical Research Methodology
I. 1. Research Meaning of Research, Purpose of Research, Types of Research(Eductional, Clinical, Experimental, Historical, Descriptive, Basic applied and Patent Oriented Research)Objective of Research Literature survey Use of Library, Books & Journals Medline Internet, getting patents and reprints of articles as sources for Literature survey. Selecting a problem and preparing research proposal for different types of research Mentioned above. Methods and tools used in Research - Qualitative studies, Quantitative Studies - Simple data organization, Descriptive data analysis - Limitations and sources of Error - Inquiries in form of Questionnaire, Opinionnaire or by interview - Statistical analysis of data including variance, standard deviation, students t test and annova, correlation data and its interpretation, computer data analysis Documentation - How of Documentation - Techniques of Documentation - Importance of Documentation - Uses of computer packages in Documentation The Research Report/Paper writing/Thesis writing - Different parts of the Research paper 1. Title Title of project with authors name 2. Abstract Statement of the problem, Background list in brief and purpose and scope 3. Key-words4. Methodology-Subject, Apparatus/Instrumentation (if necessary) and procedure

2. 3. 4.

5.

6.

7. Results Tables, Graphs, Figures and Statistical presentation 8. Discussion Supports or non-support of hypothesis practical & theoretical implications, conclusions 9. Acknowledgements 10. References 11. Errata 12. Importance of spell check for Entire project 13. Use of footnotes II Presentation (Specially for oral) - Importance, types, different skills - Content of presentation, format of model, Introduction and ending - Posture, Genstures, Eye contact, facial expressions, stage fright - Volume pitch, speed, pause and language - Visual aids and seating - Questionnaire

III

Protection of patents and trade marks, Designs and copyrights - The patent systems in India Presents status Intellectual Property Rights (IPR), Future changes expected in Indian Patents - Advantages - The Science in Law, Turimetrics (Introduction) - What may be patented - Who may apply for patent - Preparation of patent proposal - Registration of patents in foreign countries and vice-versa Cost Analysis of the Project - Cost incurred on Raw Material - Cost incurred on Procedure - Cost incurred on Instrumentation - Cost incurred on Clinical trials Sources for procurement of Research Grants Industrial Institution Interaction - Industrial projects Their feasibility reports

IV

V VI

Books Recommended: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. Research in Education John V. Best, James V. Kahn Presentation skills Michael Halton-Indian Society for Institute Education A Practical Introduction to copy right Gavin Mcfarlane Thesis projects in Science and Engineering Richard M. Davis Scientists in legal systems Ann labor science Thesis and Assignment writing Jonathan Anderson Writing a technical paper Donald Menzel Effective Business Report writing Leland Brown Protection of Industrial property right Purushottam Das and Gokul Das Spelling for the million Edna furmess Preparing for publication King Edwards Hospital fund for London Information Technology The Hindu speaks Documentation Geneis and Development 3792 Manual for evaluation of Industrial projects United Nations Manual for the preparation of Industrial feasibility studies

Elective II: Therapeutic Drug Monitoring

I. Introduction to Therapeutic drug monitoringDefinition and introduction, Historical background, Indication for Therapeutic drug monitoring, Monitoring plasma drug levels, Clinical application of Therapeutics drug monitoring, Role of Clinical pharmacist in Therapeutic drug monitoring. Techniques used in Therapeutic drug monitoringOverview of Physicochemical methods used for Therapeutic drug monitoring. Techniques-

II

A)

1. Physical methods: Detailed study of different chromatographic techniques like High Performance Liquid Chromatography (HPLC), High Performance Thin Layer Chromatography (HPTLC), Gas Chromatography (GC), Counter Current Chromatography (CCC). 2. Immunoassays: Detailed study of following immunoassays: Radio Immunoassay (RIA), Enzyme Multiplied Immunoassay Technique (EMIT), Fluoroscence Polarisation Immunoassay (FPIA), Enzyme Linked Immunosorbent Assay (ELISA), RPIA, Apoenzyme Reactivation Immunoassay System (ARIS), Nephalometric Inhibition Immunoassay (NIIA), Substrate Labeled Fluoroscence Immunoassay (SLFIA), Prosthetic Group Labeled Immunoassay (PGLI). B) Criteria for selection of method for Therapeutic Drug Monitoring-

1. Physical properties for drug molecule such as chemical structure present, Molecular weight, Pka Values, Melting and Boiling point, Drug Solubility Concentration range of Compound. 2. Characteristic of method like Level of Precision and accuracy required, complexity of the sample, Number of samples to be analysed, Time required for analysis, Specificity and Sensitivity of the method, Cost of the method. III Importance of Therapeutics Drug Monitoring with reference to Adverse Drug Reactions and Drug Interaction. Variation of Clinical Laboratory Tests due to drugs: Tests Serum Creatinine, Blood Urea Nitrogen, Plasma Glucose, Creatine Kinase, Phosphatases, Amylase, Bilirubin, Serum Proteins, Globulin, Complete Blood Count and Differential Blood Count. Therapeutic Drug Monitoring of specific drugs: Clinical pharmacokinetics, General guidelines, Sample collection, Time of sample collection, Clinical comments, Clinical monitoring parameters, Usual dosing parameters, Common toxicities, Adverse drug reaction and drug interaction, Clinical interpretation,

IV

Techniques used for estimation and importance of Therapeutic Drug Monitoring of following drugs: 1. Digoxin 6. Valproic Acid 2. Gentamicm 7. Procainamide 3. Lidocaine 8. Phenytoin 4. Lithium 9. Phenobarbitone 5. Theophyllin 10. Quinidine

11. 12. 13. 14. 15.

Amikacin Aspirin Carbamazepine Rifampicin Imipramine

VI

Cytotoxic and Hepatotoxic drugs: Classification of Cytotoxic drugs, Mechanism of action, Pharmacokinetics, Adverse drug Reaction, Potential drug interactions, Importance and necessity of Therapeutic Drug Monitoring of cytotoxic and various hepatotoxic drugs.

VII Buioequivalance and Therapeutic Equivalance: Definition and concept, Terminology involved, Invivo bioequivalance criteria and issues, Study design for assessment of the bioavailability and bioequivalence, Statistical criterias, Regulatory requirements, Type of bioequivalence studies, Pharmacodynamic models for Bioequivalence, Fundamentals of integrated PH/PD in models and importance of Bioequivalance. VIII Clinical case Reports and Discussion.

Books Recommended: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Pharmacotherapy, Dipiro, Appleton and Lange, Norwalk, Connectiut, 2nd ed., 1992 Drug Level Monitoring, John Wiley, Sudee and Beeten, 1980 Clarks Isolation and Identification of Drugs, Pharmaceutical Press, London, 1986 Clinical Chemistry, Riehterich and Column, John Wiley, 1981 Therapeutic Drug Monitoring and Toxicology by Liquid Chromatography, Steven Hywong, Vol. 32, Marcel Dekker Inc., 1985 Therapeutic Drug Monitoring, B. Widdop(Edi), Churchill Livingstone, 3 1985 Therapeutic Drug Monitoring and Clinical Biochemistry, Mike Hallworth, Nigel, Capps, ACB Venture Publications, 1993 Simkin Handbook of Therapeutic Drug Monitoring, William J. Taylor, J. Daniel Robinson, Simkin Inc., Gainesville, 1981 Therapeutic Drug Monitoring Clinical Guide, 2nd ed., Abbot Laboratories Diagnostic Division, 1994 Pharmaceutical Bioequivalance, P.G. Welling, Francies L.S. Tse, Shrikant V.

Elective III:

Plant Tissue Culture

History and Evaluation Laboratory Organisation for Plant Tissue Culture for 1. Washing up Facilities 2. Preparation of Culture Media 3. Sterilization 4. Aseptic Manipulation 5. Incubation of Cultures Classification of Plant Tissue Cultures a) Organ Culture b) Callus Cultures c) Suspension Cultures Tissue (Callus) Culture Techniques i) Protocol for initiation of callus cultures ii) Sterilization of plant material iii) Isolation and preparation of explants iv) Standard nutrient media Culture Techniques 1. Solid media 2. Stationary liquid media 3. Agitated liquid media Subculture and Preservation of Cultures a) Growth patterns and measurements of growth in callus cultures 1. Induction 2. Division 3. Differentiation Suspension Culture Techniques a) Auxophyton b) Platform Shaker and Orbital c) Spinnig Cultures d) Stirred Cultures e) Subculture of Suspension Cultures f) Growth Measurements Isolation of Protoplast a) Introduction b) Protoplast Isolation c) Role of Enzymes for Isolation of Protoplasts d) Isolation of Mesophyll Protoplasts e) Culture Media for Protoplast f) Protoplast Culture and Regeneration of Plants g) Protoplast Fusion and Somatic Hybridisation

Aspects of Organisation a) Morphogenesis b) Embryogenesis c) Organogenesis d) Mechanism of Differentiation Plant Tissue Culture Achievements and Prospects 1) Micropropagation 2) Disease Detection and Elimination 3) Production of Androgenic Haploids 4) Elimination of Breeding Barriers 5) Biosynthesis and Biotransformation of Secondary Emtabolites 6) Transgenic Plants Collection, Storage and Exchange of Germ Plasm ELECTIVE : IV Technology of Cosmetics

Elective IV:

Technology of Cosmetics

The scope of Cosmetics Historical development Classification of Cosmetics 1. Fundamentals of Cosmetic Product Development Regulatory Requirements for Cosmetic Products. Consumer Safety considerations associated with Microbiological Preservation of Cosmetics. Intelleutual Property Issues: Patents of Trade Secrets. Physiological Considerations Physiology of Skin and Appendages, Physiological and Pharmacological aspects of sweating. Surgactants, Perfumes, Colours, Humectants, Stabilizers and other Raw Materials used in Cosmetics a brief review. Study of more important Cosmetics (with respect to formulation and manufacture) Skin Care Products Skin Cleansing Products, Cold Creams, Vanishing Creams, All Purpose Creams, Emollient Creams, Sunscreen and Suntan Creams, Antiacne Face Packs and Face Scrubs. Hair Care Products Shampoos, Hair Conditioners, Hair Colourants, Hair Dressings, Depilatories. Colour Cosmetics Lipsticks, Nail Lacquers, Eye Make-up, Rouge. Herbal Cosmetics Antiacne, Antiwrinkle, Face Scrubs and Face Packs, Multipurpose Creams. Oral Hygiene Products Novel Cosmetics Delivery Systems Liposomes, Cyclodextrins in Cosmetics, Microcapsules and Multiple Emulsions, Gel Emulsions. Cosmeceuticals Photoaging, Hair Growth Enhancers, Moisturizers, Antioxidants defense systems in Skin and role of Antioxidants the the Photoprotection of Skin. Packaging of Cosmetics Liquids, Creams, Powder and Solid Products. Evaluation of Cosmetic Products Quality Control Tests. Microbiological environment of the manufacturing plant, preservative efficacy microbial content and disinfectant testing.

2. 3. 4. a)

b) c) d) e) 5. 6. 7. 8.

Books Recommended: 1. 2. 3. Harrys Cosmeticology Martin M. Rieger(Editor-in-chief), 8th ed. Surfactant in Cosmetics Edited by Martin M. Rieger Surfactant Science Series Marcel Dekker Inc., Vol. 16 Cosmeceuticals Drugs vs Cosmetics Edited by Peter Elsner, Haward I. Maibach, Marcel Dekker Inc. Cosmetic Science and Technology series Vol. 23 Novel Cosmetic Delivery Systems edited by Shlomo Magdarsi, Elka Tonitou Cosmetic Science and Technology series Vol. 19 Packaging of Cosmetics and Toiletries J.C. Mac Chesney Butterworth and co. (Publishers) Perfumes, Cosmetics and Soaps, Vol. I, II and III W.A. Pancher Published by B.I. Publications

4. 5. 6.

7. 8. 9.

Cosmetics Formulation, Manufacturing and Quality Control by P.P. Sharma Vandana Publications, Delhi Cosmetic Microbiology A Practical Handbook edited by Daniel K. Brannan CRC Press, Boca Raton, Newyork Herbal Cosmetics Beauty Through Herbs Dr. Urjita Jain

Elective V:
1.

Herbal Drug Development and Standardization

General Introduction Definition and Sources of Herbal raw materials, Methods for identification, Authentication and Quality evaluation of Herbal materials Collection and Processing Influence of seasonal variation and geographic sources on variation of phytoconstituents. Natural drying, Artificial drying Different methods of processing and packaging 2. Standardization of Raw Materials Importance of standardization Physical methods of standardization (including spectral evaluation and chromatography) Chemical methods of standardization Qualitative and quantitative estimation of phytoconstituents. 3. Methods of Preparation of Extracts Principle of extraction, Selection of extraction method and solvent selection, Cold extraction, Hot extraction methods their merits and demerits supercritical fluid extaction. 4. Standardization of Herbal Extracts Physical, Chemical, Spectral analysis with respect of different phytoconstituents like flavonoids, Glycosides, Alkaloids, Essential oils steroids tannins and Terpenoids, Methods for isolation and identification of active phytoconstituents (biomarkers), Quantification of biomarkers. Stability tests for extracts 5. Industrial methods of Preparation of Standardization Extracts Principle, Methods, Merits and demerits Preparation of standardization extracts of Turmeric, Green tea, Phyllanthus kalmesgh. 6. Herbal Dosage forms Use of excipients in preparation of free flowing extracts. Herbal liquid orals and solid Dosage forms. Evaluation of herbal dosage forms with respect to pharmacological, clinical, toxicological Evaluation and their quality control.

Elective VI:

Pharmaceutical Biotechnology

Production & Control of Biotech Derived Products 1. Recombinat DNA products (Insulin, Growth, Hormones, Erythropoetin Cutokines) 2. Vacccines : Attenuated virus,genetic alternations of lve virus as a vector of other pathogens (recombinant virus of recombinant vaccinia virus) 3. Dignostic Protins: Prottein A, Protein G, antibodies. 4. Quality control testing methods of Biotech products. Determining impurities / contamination ( viral,bacterial endotoxin (in-vitro) rabit pyrogen, sterility, protein identification,finger prints by electrophoresis, isoelectric focusing,immunogenicity,partial sequential analysis. Plant Biotech Products Substances produced by plant cell-culture Transgenic plants their application Biotransformation with plant cell culture. Biotech product through fermentation 1.Fernentation Batch,fed-batch & continuous fermentation 2.Role of bio engineering in fermentation (Geometry of fermentation, Designing of impellors, agitation system and environmental conditions of fermentation) 3.Fermentative production of important secondary metabolites.(e.g. Pencillins, amino glycosides,polyene macrolides,anthracyclines) 4.Principles of Downstream processing of fermentation products. Unit operations & techniques employed in down stream processing of fermentation products. Micarobial and strain selection & preservation methods Genotype and phenotype variation of characters of microbes. Biotranformaton 1.Biotransformation principles & Industrial application in the production of chemical And drugs. 2.Immobilisation of enzyme, protein & their applications ( Biosensors, enzyme electrode, immuno sensors, optical sensors ) Regulatory aspects of Biotech / DNA products 1. General requirements for the production of r-DNA products. 2. Containment measures,environmental and safety issues. 1. Biotechnology by H.J. Rechm. G. Reed Vol. 1-12 A.Puhler, P.Stadler , Weinhelm. New York.

2. A text book on Biotechnology 2nd edition -H.D. Kumar Affiliated East West Press Pvt. Ltd., 3. Genetic Engineering fundamentals- Karl Kammer Meyer Virgina C. Clark. 4. Genes V.- Benjamin Lewin Oxford University press. 5. Methods in plant Molecular Biology and Biotechnology Bernard R. Glick, John E. Thomson, CRC press. 6. Genetic and Biochemistry of Antibiotics production Leo C. Vining, Colin Stuttard Butter Worth Heinemann. 7. Biotechnology Applications and Research Paul N. chermisinoff, Robert p. OuelletTechnomic publishing co. Inc. 8. Transgenic Plants : A production systems for industrial and pharmaceutical proteins Meran R. L. Owen and Jan Pen John Wiley and Sons. 9. Biotechnology of antibiotics 2nd edition revised and expanded - willim R. Strohl- Marcel Dekker. 10. Molecular Biochemistry Therapeutic applications and Strategies Sunil Maulik and Salil D. Patel John Wiley and Sons. Inc. 11. Genetic Engineering Technology in Industrial Pharmacy Principles and applications John M. Tabor Marcel Dekker, Inc. 12. Advanced Molecular Biology A concise reference R. M. Twyman Viva Books Private Ltd.,

Elective VII : Biological Standardization & Pharmacolgical Screening Methods. 1. Principles of Biological Standardization : a) Statistical treatment of model problems in evaluation of drugs. b) Methods of biological assay, principles of Biological assays. c) Methods used in bioassay of Vitamins, Harmones, vaccines, cardiac drugs & other Pharmacopieial preparations. d) Bioassy methods of auto coids e) Development of new bioassay methods 2. Immunoassay : a) General Principles of Immunoassay:

Theoretical basis, optimization of Immunoassay, heterogeneous, Immunoassay systems. b) Immunoassay method evaluation : Protoco; outline, Objectives & preparation, evaluation of precision,standard tracer, sensitivity, evaluation of accuracy, anti body characteristics monitoring, reaction conditions, clinical evaluation. c) Application of immunoassays in Research Quality control, Pollution Enzyme electrode, immunosensors 3) Organisation of screening for the Pharmacological activity of new substances with emphasis on evaluation of : a) Anti-hypertensive agents b) Cardiac drugs c) Psychopharmacological drugs & others CNS depressant drugs d) Drugs action on Autonomic Nervous System e) Diuretic drugs f) Analgesis & anti inflammatory drugs g) Muscle relaxants h) Anti-ulcer agents i) Anti Cancer agents j) Antidiabetic drugs k) Anti-fertility agents 4 Maintanance and breeding of laboratory animals. 5.Hypothalmic & Pituitary hormones 6.Essential of Toxicology: a) Physicochemical, biochemical & genetic basis of toxicity principles of toxicokinetics, mutagenesis & carcinogenesis b) Behavioural, inhalation, celluar & sub-toxicity hypersensitivity & immune response, range finding tests. c) Environmental toxicology d) Pharmacology plant toxins, venoms e) New drug application requirements from regulatory agency. Books Recommended : 1.Biological standardization by J.N.Barn,D.J. Finney and L.G. Good win 2. Indian Pharmacopoeia and other pharmacopoeias 3. Screening methods in Pharmacology by Robert Turner A. 4. Evaluation of drugs activities by Laurance and Bachrach 5. Methods in Pharmacology by Arnold Schwartz 6. Selected topics on Experiemental Pharmacology by Usha G. Kamat, Dedkar N.K. and U.K. Seth 7. Fundamentals of experimental Pharmacology by M.N.Ghosh 8. Textbook of Invitro practical Pharmacology by Ian Kitchen 9. Pharmacological experiments on intact preparations by Churchill Livingstone.

Elective VIII : Topics In Toxicology

1.Acute, subacute and chronic toxicity testing Biochemical basis of toxicity. 2. Evaluation of dermal and ocular toxicity, Evaluation of mutagenesis and carcinogenesis, Evaluation of teratogenesis and reproduction, plat toxins and venoms. 3.Occupational and Environmental Toxicology, chelators and heavy metal toxication. ( live stocks, birds, insects, fishes ) 4. Target Organ toxicity, exemplified by hepatoxicity and dermal toxicity. 5. Invitro toxicity testing and its application to safety evaluation of drugs / chemicals. 6. General perspectives, invitro technology trends and issue. 7. Ocular and cutenous irritation.

Elective IX :

Topic in Pharmacology

Biochemical Pharmacology : Biochemical mechanism of drug action, drug metabolizing enzymes, biochemical pathway of drug metabolism, metabolic factors influencing drug metabolism and drug action, drug as activators and inhibitors of drug metabolism, the physiological and pathological impairment of drug metabolism, drug interactions with cellular particles and biochemical factors concerned with functional activity of nervous and other systems. Immunotherapy : Immuno Stimulants, Immuno depressants. The Eicosanoids : Prostaglandins,thromboxanes,Leukotrienes. Pharmacology of ca-antagonists,Encaphalins Drugs used in disorders of coagulation Agents used in Anemias,Hematopoietic growth factors. Books as recommended under Core Subjects

Elective X : Part I :

Polymers in Pharmaceuticals

Introduction to Polymer Chmistry Types of Polymer (Biodegradable / Bioerodable and Biodegradable / nonbioerodable ), hydrogel.

Polymer classification1.Linear branched and cross linked polymers Addition and condensation polymers 2.Chain polymerization and step growth polymerization. 3.Chain polymerization Anionic and Cationic polymerization and Ziegler Natta polylmerization.

Co-Polymerization Introduction to general methods of preparation and manufacture of Polymers like solution, bulk suspension,emulsion polymerization. MoI. Wt of polymers flow characterstics of polymers, crystallinity and phase transition. Solubility of polymers Implication of additives in polymers Microencpsules, bioadhesives polymers, Acrylic latex systems Transport of small molecules in polymers, Biodegradation of polymers of pharmaceutical importance, enzymatically degradable bonds in synthetic polymers. Acute and chronic blood compatibility of polymeric implants Part II Application of Polymers in new drug delivery systems including oral, mucosal (Buccal,Nasal, Rectal and Vaginal) ocular delivery, Transdermal delivery, locally acting parental, IUDS and other devices. Elective XI:

Packaging Technology

1.Its status and scope in Pharmaceutical Industry 2. Classification of packaging into primary and secondary packaging, functions of packaging. 3. Primary Packaging Materials : a. Glass containers (ampoules, vials and bottles) metals (tins for consmetic powders, tubes for skin and ophthalmic ointments, Aluminium containers and foils) 9 Fibers board and paperboard for bluk packaging in containers and drums. b. Containers and laminations of the metal containers Flims and Foils including AI, PVC, used in strip packaging of tablets, cellulosics and cellophone. c. Plastic polymers and copolymers, electrosetting and thermoforming (Medium and high density polystyrene PET) d. Equipment in primay packaging including strip packing, blister packing powder filling,liq filling, snap on closures. e. Designe and Specification for the containers including bottles, thread, their dimensions and others. 4. a. Secondary Packaging Materials : Folding cartons and set of boxes. Materials of constructions and test methods and quality control.

b . Cushioning materials, applications for impact, vibrations, temperature and humidity closures, applicatures fasteners and adhesive cap threads, cap liners, aluminimum bands, stoppers and plugs, tapes, adhesives. c. Shrink Warp Process 5. Specifications, quality control tests and methods and evaluation of packaging of materials. 6. Labels and labeling. a. Direct printing heat transfer, ordinary labels, adhesives b. Standard and Quality control test including dimensions printing and lists such as folding test, gluing, ageing, block vibration and shock for the box. c. Toxicity and safety of printing inks 7. Sterilization of containers : Different methods of sterilization for containers (primary) including autoclaving, dry heat, gas sterilization, ionizing and non-ionizing radiations. 8. Stability of packaging materials 9. Law and regulation governing packaging.

Elective XII:

Rational Drug Design

A. Design of enzyme Inhibitors : a. Forces involved in formation of enzyme substrate and enzyme inhibitor compleses. b. Design of Rapid reversible inhibitors, Slow / tight binding inhibitors, Transition state analogs, Mechanism based inhibitors, Application with recent examples from literature. B. Docking of flexible molecules in protein/enzyme active sie a. Energy calculations in binding energy estimation b. Docking by energy minimization, superimposition, molecular dynamic, Monte Carlo, distance geometry and build-up methods c. Applications with recent examples from literature C. De Novo Ligand Design a. Classes of De Novo Design methods like active site analysis, whole molecule methods, connection methods, random connection and disconnection methods. b. Advantages and Disadvantages of the above methods c. Discussion of software programs such as Sybyl, Insight II, Cerius 2.0, MOE, Catalyst, etc. d. Applications with recent examples from literature and demonstration of software programs on computer. e. X-ray crystal structure and Protein Data Bank.

D.3D-QSAR in Drug Design. a. Stereochemistry and Drug Action b. Active site interaction modes c. Comparative Molecular Field Analysis ( CoMFA) and other methods d. Application with recent examples E. Computer-Aided Development of Three-Dimensional pharmacophore Models a. direct and indirect ligand design b. The Pharmacophore concept, steps in 3D- pharmacophore identification, selection of pharamacophore elements, representation of pharmacophore elements as ligand points or site points. c. The receptor bound or active conformation, thermodynamics considerations, moleculer mechanics calculations and systematic conformational search. d. Molecular superimposition-least square superimposition (rms) and template forcing,property and field fit. e. Receptor exclude and receptor essential volumes f. Solvation effects g. Examples of 3D-pharamcophores and their use

Books Recommended : 1. 2. 3. 4. 5. 6. 7. Comprehensive Medicinal Chemistry vol. 4, Edited by C. Hansch Molecular Modeling and Drug Design by Cohen Computer-Aided Drug Design: Methods and applications. Edited by perun and propst Drug Design by Ariens, series of Monographs. Qtrantitative Structure-Activity Relationship by Topliss. Drug Design by M. Kulkarni Burgers Medicinal Chemistry.

References from Journal of Medicinal Chemistry , Journal of Computer-Aided Molecular Design, etc. may be refered.

Elective XIII: Part I

Structural Elucidation by Physical Methods

Theory, Instrumentation and applications in structural elucidation of the following techniques with suitable examples

1) Ultraviolet spectroscopy - Concepts of Chromophore, Woodward and fischer rules derivative spectroscopy, isobetic point. 2) Infrared spectroscopy Vibrational and rotational modes, harmonic and anharmonic oscillators, degree of freedom, fermis resonance, group frequencies, factors affecting group frequencies, sample preparation, Discussion of advanced techniques and interpretation of IR spectra. 3) Nuclaer magnetic resonance spectroscopy- Concept of chemical shift and splitting of NMR signal. Techniques of simplification of NMR spectra 13C NMR spectroscopy. Introduction of 2D-NMR spectroscopy, Interpretation of PMR and 13C-NMR spectra and prediction of 13C-NMR signals using structures. 4) Mass Spectroscopy Concept of molecular iron, metastable ion and base peak. Isotopic abundance and its significance in molecular formula determination. General rule for fragmentation pattern. Mc-Laffertys rearrangement, Fragmentation patterns of compounds of various chemical classes. Interpretation of mass spectra. 5) ORD and CD Concept of ORD and CD spectra. Cotton effect and its significance. Application of ORD and CD studies in the determination of in the determination of stereochemistry of organic compounds. 6) Introduction to hyphenated techniques including GC-MS, LC-MS and LC-NMR Part II Problems based on ultraviolet, infrared, 1H NMR, 13C NMR spectra and mass fragmentation pattern in elucidating the structure of compounds. Books : Spectroscopy by Silverstein Identification of organic compounds by spectroscopy by Dyer Organic Spectroscopy by W.Kemp

Elective XIV:

Intellectual Property Rights and Patent Filing

1.Pharmaceutical Research and development in India. 2.Patent laws: Process and Product patenting. General Agreement on Trade and Tariff (GATT), Role of world trade organization (WTO) and Intellectual property rights(IPR) 3. Challenges in post GATT/IPR era. Procedure of patent filing of basic drugs, Herbal medicines, biomolecules, agro-chemicals and bulk drugs in India, USA, and Europe. 4. Manuscript Preparation for Patent Filing, Patent Granting, Patent Maintenance, Patent Expiry, etc. Elective XV: Bulk Drug Technology and Process Chemistry

1.Importance of Development of Bulk Drug Technology 2.Import, Export of Bulk Drugs 3.Development of Process chemistry 4.Plant Layout, Plant Design, Utilities, Process Flowsheets, etc. 5.Raw Material Consumption and cost. 6.Safety, Pollution Control and Effluent Treatment 7.Good Laboratory and Manufacturing Practices

8.Quality Assurance and Regulatory Affairs Books Recommended : 1.Manufacturing Technology of Drugs by Sitting Sitting 2.Encyclopedia of Chemical Technology by Kirk-Othmer 3.Handling of Hazardous Chemicals and Pollution Control.