MASTER OF PHARMACY



ORDINANCE FOR MASTER OF PHARMACY(M.Pharm)

Ist Year(Semester I and II) and IInd year

.

1.1 The duration of course for the degree of Master of Pharmacy shall be of two years . The first year shall comprise

of two semesters i.e. semester I and II . The second year shall be devoted to research project

.1.2 Master of Pharmacy shall be awarded in the following specializations

Group A M.Pharm ( PHARMACOLOGY )

Group B M.Pharm ( PHARMACEUTICS )

Group C M.Pharm ( PHARMACEUTICAL CHEMISTRY)

Group D M.Pharm(PHARMACY PRACTICE)

2.1 The examinations of M.Pharm shall consist of two semesters (First year) and second year. M.Pharm Semester-I examination shall be held at the end of academic term of six months involving theory and laboratory courses. Semester II examination shall be held at the end of the second academic term of six months including theory and laboratory courses. The second year examination shall include submission of thesis on a research project allocated in the beginning of second year and presentation of work in a seminar.

2.2 The examinations of M.Pharm Semester I and Semester II (First Year) shall be held in the month of December/ January and April/May respectively or on such dates as may be fixed by the University.

2.3 Candidates after the completion of Second year shall submit three printed, type written or reprographed copies of his/her thesis. Thesis shall be submitted within 30 days after the date fixed by the Head of the Department, some time in the month of April/May.

3.1 Candidates appearing for first year(Semester-I/Semester II) and second year examination shall submit their admission forms to the controller of examination after getting them duly countersigned by Head of the Department.

3.2 The last dates by which examination admission forms and fees without or with late fee for first year(Semester-I/Semester II) and second year should be deposited according to university rules.

3.3. Incomplete form or forms of candidates who have not cleared his/her all dues will not be accepted.

4.1 The examination in M.Pharm Semester I shall consist of two theory papers and one laboratory or practical as specified for each specialisation in the syllabus.

4.2 The examination in M.Pharm Semester-II shall consist of three theory papers and one laboratory or practical. One theory paper on Molecular Biology and Biotechnology and its laboratory/practical and other theory paper on Regulatory Affairs and Documentation shall be compulsory for each specialisation as specified in the syllabus.

4.3 The examination of M.Pharm II Year shall consist of thesis and its presentation in the form of a seminar on the date fixed by the Head of the Department. The external examiner, members of the teaching staff and research students of the department shall participate in the seminar presented by the candidate.

5.1 A person who has passed B.Pharm examination from recognized Board/University and qualified GPAT/GATE or Equivalent examination shall be eligible to join the first semester of M.Pharm course.

5.2 A person who has appeared in the first semester examination of M.Pharm shall be eligible to join the second semester class.

5.3 A person who has passed 50% papers of first and second semester examination of M.Pharm shall be eligible to join the second year of M.Pharm class.

6.1 A student who possesses qualifications laid down in 5.1/5.2 /5.3/5.4 stated above and has been on the rolls of the University Department of Pharmaceutical Sciences and Drug Research for the relevant examination and submits the following certificates signed by the Head of the Department shall be eligible to appear in the First/Second semester/second year examinations as the case may be

(a) of good character

(b) of having attended not less than 75% of the full course of the lectures and practicals in each of the course/paper.

6.2 A deficiency in the required number of lectures and practicals may be condoned as per university rules.

6.3 A candidate who is short of the required attendance in lectures and practicals for the examination of M.Pharm Semester I/Semester II, may after making up the deficiency, appear in the next examination held for the relevant semester.

6.4 A candidate who has attended the prescribed number of lectures and practicals fails or does not appear in the examination held for relevant semester shall be allowed to appear in the next examination held for that semester

6.5 A candidate who does not appear or fails in one or more than one theory papers or practicals in M.Pharm Semester I/Semester II examination may be allowed to appear in such paper/papers in the relevant examination of the semester . The candidate will only get two chances to appear/pass the papers in which he/she got reappear.

6.6 A candidate who does not appear or fails in the examination held for M.Pharm Semester I/Semester II in three consecutive examinations held for the relevant semester shall be debarred from continuing his studies for the degree of Master of Pharmacy.

6.7 Re-evaluation of scripts shall be admissible in M.Pharm examination except practical examinations and dissertation/thesis. The re-evaluation shall be allowed in theory papers as per university rules relating to "Re-evaluation of Scripts".

7.1 A student who possesses qualifications laid down in 5.4 stated above and has been on the rolls of the University Departments of Pharmaceutical Sciences and Drug Research for M.Pharm second year and submit certificates(i) of good character by the Head of the Department (ii) from his/her supervisor or supervisor and co-supervisor as the case may be, that thesis embodies the results of the candidates own research or observations and shall submit thesis within 30-days of the date fixed by the Head of the Department.

7.2 In case candidate submits the thesis after the expiry of the period allowed under regulation 7.1 the Dean of Academic Affairs may condone delay, upto three months The Vice-Chancellor may on the individual merits of each case and on the recommendation of the Head of the Department ,condone the delay to the extent he may deem necessary.

7.3 The title of the thesis shall be recommended by the supervisor or supervisor in consultation with co-supervisor and Head of the department, if needed.

7.4 The evaluation of thesis for second year examination shall be done by a board consisting of an external examiner, research supervisor, co-supervisor of the candidate and senior most professor of the Department on the basis of the contents of the thesis, its presentation and discussion thereon. In case of any controversy, the awards given by the external examiner shall be final.

7.5 A candidate whose thesis for second year examination has been rejected may be allowed to resubmit a revised thesis after a period of three months from the date of declaration of result but not later than one year of the declaration of result.

8.1 The medium of instruction and examination shall be English.

8.2 The examination shall be held in accordance with the syllabus prescribed by the University.

8.3 Each paper shall have 20% marks for internal assessment and 80% marks for external examination.

8.4 To pass in each paper the candidate must secure 50% marks in the external examination and 50% marks in

aggregate ( Internal and external)

8.5 The grace marks shall be allowed according to the general ordinances of the university as applicable from time to

time relating to "Award of Grace Marks".

8.6 In case a candidate does not secure 50% marks in a paper (theory or practical) despite availing the grace marks, he/she shall be given opportunity to reappear in the concerned paper according to the rules of university. He/she shall be allowed to reappear only in the external examination and not in the internal examination. The marks obtained by the candidate in the internal examination in the first attempt shall be added to the marks obtained in the external examination in the subsequent attempt(s) for calculating the percentage of marks.

9.1 A successful candidate who obtains 80 percent of the marks in any paper shall be declared to have passed with’ distinction’ in that paper/those papers.

9.2 Successful candidates who obtain 60 percent or more of the aggregate marks in M.Pharm semester I, semester II and second year examinations taken together shall be placed in first division. Those who obtain in 50 percent or more but less than 60 percent shall be placed in second division.

9.3 The controller of examination shall declare the result after three weeks of termination of examination or as soon as thereafter.

9.4 A successful candidate of the first and second semester examination shall be granted a certificate.

9.5 A successful candidate of the second year examination of M.Pharm shall be granted a degree.

MASTER OF PHARMACY

M.PHARM SEMESTER I (Group A)

PHARMACOLOGY

Paper I: Clinical Pharmacology And Drug Therapy

Max. Marks : 80 4 Hrs./Week

Internal Assessment 20 Max Time 3 Hrs

Total Marks 100

1. Basic Principles of Clinical Pharmacology : Clinical pharmacokinetics, monitoring of drug therapy and adverse drug reactions, patient compliance, racial and ethnic differences in response to drugs, principles of paediatric and geriatric clinical pharmacology, drug therapy in pregnant and lactating mothers. (3 lectures)

2. Drugs affecting autonomic nervous system. (4 lectures)

3. Drug Therapy of Cardiovascular Disorders : Pathophysiology and drug therapy of congestive cardiac failure, Hypertension, cardiac arrhythmias, ischaemic heart disease, thromboembolic disease, hyperlipidaemia and atherosclerosis. (5 lectures)

4. Drug Therapy of Neurological Disorders : Pathophysiology and drug therapy of seizure disorders, Parkinsonism and myasthenia gravis, pharmacology of analgesics and drug therapy of headache and pain. (4 lectures)

5. Drug Therapy of Psychiatric Disorders : Biochemical basis and drug therapy of anxiety, mood and sleep disorders and schizophrenia. (3 lectures)

6. Drug Therapy of Endocrine Disorders : Pharmacology of corticosteroids, drug therapy of diabetes mellitus, thyroid and parathyroid disorders. Contraception and drug therapy of infertility, drugs affecting uterine motility. (3 lectures)

7. Drug Therapy of Inflammatory Disorders : Biology of inflammation, pharmacology of non-narcotic analgesics and non-steroidal antiinflammatory agents. Drug therapy of rheumatic disorders and gout. ( 3lectures)

8. Drug Therapy of Renal Diseases: Pathophysiology and drug therapy of oedema and diabetes insipidus. Pharmacology of diuretics. (3 lectures)

9. Drug Therapy of Respiratory Diseases : Pathophysiology and drug therapy of asthma. (3 lectures)

10. Drug Therapy of Gastrointestinal Diseases : Pathophysiology and drug therapy of peptic ulcerand emesis. (3 lectures)

11. Drug Therapy of Diseases of the Blood : Drug therapy of anaemias . (2 lectures)

12. Drug Therapy of Infectious Diseases : Chemotherapeutic agents, antibiotics, antiviral agents and drug therapy of mycobacterial infections, urinary tract infection, sexually transmitted diseases, mycotic and parasitic infections. (4 lectures)

13. Drug Therapy of Neoplastic Disorders : Pharmacology of anticancer agents. (3 lectures)

14. Pharmacology of arachidonic acid metabolites and PAF and its antagonists. (3 lectures)

15. Immunopharmacology : Elements of Immune system, immunosupressive agents, immunomodulators and their clinical implications. (2 lectures)

BOOKS RECOMMENDED

1. D.G.Grahame-Smith and J.K.Aronson, Oxford Text Book of Clinical Pharmacology and Drug Therapy, Oxford University Press, New York,U.S.A., 1984.

2. E.T.Herfindal and D.R.Gourley, Text Book of Therapeutics, 6 th edition, Williams and Wilkins, London, U.K., 1996.

3. T.M.Speight(ed)Avery’s Drug Treatment Principals and Practice of Clinical Pharmacology and Therapeutics, 3rd edition, ADIS Press, Sydney, Australia.

4. L.L.Brunton, J.S.Lazo, K. L.Parker(eds) Goodman and Gillman's The Pharmacological Basis of Therapeutics, 11th edition, McGraw-Hill Companies, Inc.2006.

5. J.T.Dipiro, R.L.Talbert, P.E.Hayers, G.C.Yee and L.M.Possy (eds), Pharmacotherapy A Pathophysiologic Approach,5th edition Appleton Lange, U.S.A., 2002.

MASTER OF PHARMACY

M.PHARM SEMESTER I (Group A)

PHARMACOLOGY

Paper II : Drug Evaluation And Advanced Pharmacological Techniques

Max. Marks : 80 4 Hrs./Week

Internal Assessment 20 Max Time 3 Hrs

Total Marks 100

1. Principles of experimental pharmacology: Common laboratory animals in pharmacological research, anesthetics used in laboratory animals, some standard techniques used in laboratory animals, euthanesia of experimental animals, limitations of animal tests, statistical design and analysis. Regulations for the care and use of laboratory animals (9 lectures)

2. Drug Discovery : Strategies and approaches employed in drug discovery. Preclinical, safety and clinical evaluation of new chemical entity. Basic concept of combinatorial chemistry and high through put screening. Transgenic animal models in the development of new drugs. (9 lectures)

3. Receptor–ligand binding assays: General principle and techniques. Specific assay design for adrenoceptors, dopamine receptors, histamine receptors, GABA and Benzodiazepine receptors (14 lectures)

4. Pharmacological techniques to evaluate the following class of drugs : (16 lectures)

4.1 Antihypertensive agents

4.2 Antianginal agents

4.3 Antiarrhythmic agents and agents used in sudden cardiac death

4.4 Drugs used in cardiac failure and cardiomyopathies

4.5 Drugs used in hyperlipoproteinemias and aetherosclerosis

4.6 Anti-infarct agents

4.7 Antiplatelet and thrombolytic agents

4.8 Antianxiety agents and Drugs used in mood and sleep disorders

4.9 Antipsychotics

4.10 Antiepileptics

4.11 Antiparkinsonion agents

4.12 Drugs Affecting Memory.

4.13 Analgesics

4.14 Anti-inflammatory agents

4.15 Antifertility agents

4.16 Antidiabetic agents

4.17 Antimalarial agents

4.18 Antiviral agents

4.19 Anti-ulcer agents.

4.20 Antiasthmatic agents

BOOKS RECOMMENDED

1. M.N.Ghosh, Fundamentals of Experimental Pharmacology, 3rd edition, Hilton & Company, Kolkata, India,2005.

2. D.R.Laurence and A.L.Bacharach(eds),Evaluation of Drug Activities: Pharmacometerics Vol.1 and 2,Academic Press London, U.K,1964

3. P.Mantegazza and F.Piccinini(eds), Methods in Drug Evaluation, North Holland Publishing Company,Amsterdem, The Netherlands,1966

4. A.A.Rubin(ed) New Drugs Discovery and Development,Marcel Dekker Inc, New York, U.S.A,1978

5. David R.Gross, Animal Models in Cardiovascular Research, 2nd edition, Kluwer Academic Publishers, London, U.K.,1994

6. H.G.Vogel and W.H.Vogel (eds), Drug Discovery and Evaluation-Pharmacological Assays, 2nd edition Springer Verlag, Berlin, Germany, 2002.

7. Journal of Pharmacological and Toxicological Methods,Elsevier Science Inc., NewYork,U.S.A.

M.PHARM SEMESTER I

GROUP A PHARMACOLOGY

PAPER III PHARMACOLOGY LABORATORY

Max. Marks : 80 16 Hrs./Week

Internal Assessment 20 Max Time 16 Hrs

Total Marks 100

1. Experiments to study pharmacology of receptors using various isolated tissue

preparations.

2. Experiments in intact animals to study cardiovascular drugs, drugs affecting central nervous system, muscle relaxants and local anesthetics.

3. Identification of unknown cardioactive drugs using anaesthetized dog/rat blood

pressure.

4. Surgical techniques such as ovariectomy, adrenalectomy and Goldblatt’s technique.

5. Experiments to study acute toxicity.

6. Experiments related to bioassays.

M.PHARM SEMESTER I

PHARMACEUTICS GROUP B

PAPER I BIOPHARMACEUTICS AND ADVANCED PHARMACOKINETICS

Max. Marks : 80 4 Hrs./Week

Internal Assessment 20 Max Time 3 Hrs

Total Marks 100

1 Basic concepts of One Compartment and Multiple compartment, calculations of pharmacokinetic parameters and their relevance. (5 lectures)

1.1 Single and Multiple oral dosing regimens, calculations of dose and dosing frequency.

1.2 Calculations of dose for sustained release oral dosage forms.

2. Biopharmaceutics and Pharmaceutical Bioequivalence: (6 lectures)

1. Bioequivalence and its determination: Bioequivalence and therapeutic equi-valence, study design for the assessment of bioavailability and bioequivalence, factors influencing bioavailability and bioequivalence, intestinal metabolism and bioavailability, bioavailability of transdermal and topical dosage forms, invitro and in Vivo correlations to determine bioavailability, statistical concepts used in estimation of bioavailability and evaluation of bioequivalence.

2. Pharmacodynamic models in bioequivalence.

3. Regulatory agencies and bioequivalence testing.

3. Concept of chronopharmacokinetics and its evaluation. (7 lectures)

4. Toxicokinetics : (7 lectures)

1. Role of toxicokinetics in drug safety evaluations.

2. Importance of toxicokinetics in preclinical evaluation of drug safety.

3. Interspecies scaling in toxicokinetics and risk assessment.

4. Pharmacodynamic aspects of toxicokinetics.

5. Gastrointestinal toxicity

6. Renal toxicity

5. Non linear Pharmacokinetics: Recognition of non-linearity, and the tests employed. One compartment and two compartment open model with Michaels-Menton kinetics . (4 lectures)

6. Pharmacokinetics of Drugs and Pharmacological Response: (5 lectures)

1. Introduction, of relationships, between pharmacodynamics and pharmacokinetics.

2. Relationships between duration of response on dose, elimination half life and drug distribution.

3. Pharmacodynamic models used in the study of relationship between kinetics and response of drugs, analysis of clinical relevance of kinetic studies.

7. Computer use in Pharmacokinetics (8 lectures)

Introduction

Strategy for the building of pharmacokinetics models

Digital computers

ADME

Critical evaluation of computer fits

Study of some computer software such as AUTOAN1, AUTOAN2, CSTRIP, NONLIN, MACDOPE etc.

8. Statistical modeling. (8 lectures)

9. Physiological pharmacokinetic models. (8 lectures)

BOOKS RECOMENDED

1. J.G.Wagner,Fundamentals of clinical pharmacokinetics,Drug Intelligence

Publications,Hamilton.

2. P.G.Welling,F.L.S.Tse and S.V.Dighe(eds) Pharmaceutical Bioequiralence,Marcel

Dekker Inc.New York.

3. M .Gibaldi and d.Perrier,Pharmacokinetics second edition, Marcel Dekker Inc.

New York.1982

4. Shargel,L.and Andrew, B.C.Applied Biopharmaceutics and Pharmacokinetics, 3rd ed, Appleton-Century-Crofts,1992.

5. Notari, R.E.Biopharmaceutics and Clinical Pharmacokinetics, Marcel Dekker Inc.Indian Reprint,2005.

6. P.Veng-Pedersen, An Algorithm and Computer programe for Deconvolution in linear Pharmacokinetics, J. Pharamco.Biopharm.,8(5),463-481(1980)

7. P.Veng-Pedersen,Stochastic Interpretation of Linear Pharmacokinetics: A Linear

System Analysis Approach,J.Pharm.Sci.,80,621-631(1991).

8. W.R.Gillespie,Non-Compartmental Versus Compartmental Modelling in Clinical

Pharmacokinetics,Clin.Pharmaco.,23,223-262(1991).

9. D.Z.D'Argenio(ed) Advanced Methods of Pharmacokinetic and Pharmacodynamic System Analysis, Plenum Press, New York 2004.

10. A.Yacobi,J.P.Skelly and V.K.Batra(ed) Toxicokinetics and New Drug Development ,Pergamon Press, New York U.S.A.

11 R.D.Schoenward(ed) Pharmacokinetics in Drug Discovery and Development, CRC Press, New York, 2002.

MASTER OF PHARMACY

M.PHARM SEMESTER I (GROUP B) PHARMACEUTICS

Paper II: Advanced Physical Pharmaceutics and Modified Drug Delivery

Max. Marks: 80 4 Hrs/Week

Internal Assessment 20 Max Time 3 Hrs

Total Marks 100

1. Preformulation : (8 lectures)

• Introduction: Consideration of factors influencing formulation performance. Polymorphism, methods to determine polymorphic state including thermal methods. Drug-excipient interaction and compatibility tests. Improvement of drug stability, powder flow properties.

• Solubility and Solubilization: Micellar solubilization, solubilization by cosolvents, complexation, solid state manipulations.

• Partition coefficient: Pharmaceutical significance of partition coefficient, choice of solvent system, correlation with in-vivo performance, techniques to estimate partition coefficient, distribution coefficient

2. Protein binding: Theory of plasma protein binding and its implications, mathematical techniques, experimental methods to estimate binding parameters, factors influencing protein binding, effect of protein binding on pharmacokinetics. (4 lectures)

3. Polymers : (15 lectures)

3.1: Polymer classification, synthetic and natural polymers, evaluation of physicochemical and mechanical properties approaches for crosslinking/ modification of polymers for dosage form design.

3.2: Use of polymers in controlled release (Diffusion controlled, solvent controlled and chemically controlled devices).

3.2: Evaluation of biocompatibility, blood compatibility of polymers.

4. Modified drug delivery systems: (10 lectures)

a. Fundamentals of controlled drug delivery systems, pharmacokinetic/pharmacodynamic basis of controlled drug delivery systems.

b. Design and evaluation of the following modified drug delivery systems

• Oral (Dissolution controlled, Diffusion controlled, Dissolution and diffusion controlled release, ion exchange resins, pH independent formulations, osmotically controlled release, altered density formulations)

• II Parenteral (Major routes of parenteral administration, Biopharmaceutics of sustained/ controlled release parenteral drug products, sustained/ controlled release parenteral dosage forms.

• III. Implantable (Diffusion controlled, Activation controlled)

• IV. Transdermal (Membrane moderated systems, Adhesive diffusion controlled, Matrix dispersion type, microreservoir systems)

• Liposomes and their modifications (Physical dispersion, Solvent dispersion, Detergent solubilization

• VI. Nanoparticles (Crosslinking, polymerization, polymer precipitation)

1. Targeted drug delivery: (10 lectures)

5.1. Basic principles of drug targeting. Selection of drug candidate

5.2. Introduction to approaches for drug delivery targeted to

I. Brain.

II. Bone marrow

III. Tumor

BOOKS RECOMMENDED

1. J.R. Robinson and V.H. Lee (Eds.) Controlled Drug Delivery: Fundaments and Application, 2nd edition, Marcel Dekker Inc., New York, U.S.A. 1987.

2. S.D. Bruck, Controlled Drug Delivery, Vol I and II, CRC Press Florida, U.S.A., 1983.

3. J.I. Wells. Pharmaceutical Preformulation: The physiological properties of Drug Substances, Ellis Horwood, Chicheater, U.K. 1987.

4. Y.W. Chien (Eds.), Transdermal Controlled Systemic Medications, Marcel Dekker Inc., New York, U.S.A.

5. S.H. Yalkowshy (Eds.), Techniques of solubilization of Drugs, Marcel Dekker Inc., New York, U.S.A.

6. A. Martin, Physical Pharmacy, 3rd edition. B.I. Waverly Pvt. Ltd., New Delhi, India, 1995.

7. A. Yacobi, J.P. Skelly, V.K. Batra (Eds.) Toxicokinetics and New Drug Development, Pergamon Press, New York, U.S.A.

8. Dr. N.K. Jain (Eds.) Controlled and Novel Drug Delivery, CBS Publishers and Distributors, New Delhi, 1997.

9. S.P.Vyas and R.K.Khar,(EDs.) Targeted and Controlled Drug Delivery CBS Publishers and Distributors, New Delhi,2007.

10. N.K.Jain, Progress in Controlled and Novel Drug Delivery Systems CBS, Publishers and Distributors, New Delhi

M.PHARM SEMESTER I (GROUP B )PHARMACEUTICS

PAPER III PHARMACEUTICS LABORATORY

Max. Marks : 80 16 Hrs./Week

Internal Assessment 20 Max Time 16 Hrs

Total Marks 100

1. Experiments based on flow of granules, kinetics of degradation, polymorphism and solid-solid mixtures.

2. Preparation and study of colloid dispresions and complexation.

3. Experiments for the determination of pharmacokinetic and bioavailability based on salivary secretion, urinary excretion and blood levels in man and animals. Effect of surfactants and diet on absorption.

4. Computer application in pharmacokinetics studies.

5. Evalution of OTC antacids.

6. Preparation and evaluation of solid dispersions

7. Experiments involving bioavailability and bioequivalence testing.

MASTER OF PHARMACY

M.PHARM SEMESTER I (GROUP C) PHARMACEUTICAL CHEMISTRY

PAPER I : ADVANCED ORGANIC CHEMISTRY

Max. Marks : 80 4 Hrs./Week

Internal Assessment 20 Max Time 3 Hrs

Total Marks 100

1. Investigation of Reaction Mechanism : Identification of products, determination of the presence of intermediates, study of catalysis, crossover experiments, stereochemical evidences. Kinetic Evidences isotopic labeling and isotope effect. (5 lectures)

2. Reaction Intermediates : Formation, structure, stability and reactions of carbocations, carbanions, free radicals, carbenes, nitrenes and benzynes (4 lectures)

3. Molecular Rearrangements : Mechanism, migratory aptitude and stereochemistry of Wagner-Meerwein, pinacol-pinacolone, benzil-benzilic acid, acid catalysed rearrangements of aldehydes and ketones, Demyanov, Favorskii and Wolff's rearrangements. Expansion and contraction of rings. Hofmann, Curtius, Beckmann, Fries, Schmidt, Lossen and benzidine rearrangements. (5 lectures)

4. Name Reactions : Perkin reaction, Mannich reaction,Michael condensation, Darzens glycidic ester condensation, Kolbe-Schmitt reaction, Hofmann- Loffler- freytag reaction. Barton reaction, Wittig's reaction, Reformatsky reaction and Knoevenagel reaction. (3 lectures)

5. Pericyclic Reactions : Symmetry properties of molecular orbitals, FMO approach, Correlation diagram and Woodward-Hoffmann rules for 4 π and 6 π electrocyclic reactions, 2 π + 2 π and 4 π + 2 π cycloaddition reaction and 1,3 and 1,5 and 3,3 sigmatropic rearrangements respectively. (5 lectures)

6. Organic Photochemistry : Light absorption, electronic transitions, Jablonski diagram, intersystem crossing, photosensitization. Excited states of ketones, α-cleavage, γ-hydrogen abstraction, Paterno-Buchi reaction and photoreduction. Photochemistry of conjugated dienes and enones. (6 lectures)

7. Combinatorial Chemistry : Introduction, creating molecular libraries, split synthesis and parallel synthesis. Combinatiorial synthesis of carbohydrates and benzodiazepine derivatives on solid support.Introduction to solution phase and liquid phase combinatorial organic synthesis. Introduction to HTS. (6 lectures)

8. Optical and Geometrical Isomerism : (5 lectures)

8.1 Molecular dissymmetry : Kind of molecules displaying optical activity. Configuration, assignment of configuration, Fischer projection, absolute and relative configuration, determination of configuration by chemical interconversion not affecting bond to the asymmetric atoms and by chemical transformation involving the asymmetric center in a predictable way. Meso compounds & diastereomers. Formation of racemic modifications by synthesis and their resolution by formation of diastereomers and kinetic method.

8.2 Geometrical isomerism : E and Z, Syn and Anti, Endo and Exo concepts.

9. Conformational Analysis : Steric strain in acyclic and cyclic molecules, study of carbocyclic rings with 3,5 and 6 carbon atoms and decalins. Introduction to steric strain in heterocyclic compounds such as glucosides, 5-substituted-1,3-dioxanes, piperidines and morpholines. (4 lectures)

10. Asymmetric Synthesis : Crams rule, Prelog’s generalisation and study of various models for asymmetric synthesis. Asymmetric synthesis of amino acid, asymmetric hydrogenation of diketopiperizines, hydrogenation of 2-benzoylaminocinnamates, pyridoxal dependent trans amination and asymmetric Strecker amino acid synthesis. (5 lectures)

11. Chemistry of Steroids: Nomenclature, Stereochemistry, important reactions & medicinally important steroids. (5 lectures)

BOOKS RECOMMENDED

1. Jerry March, Advanced Organic Chemistry, Reactions, Mechanisms andStructure, 6th edition, John Wiley and sons, New York,U.S.A., 1986.

2. Edwin S. Gould, Mechanism and Structure in Organic Chemistry, Holt Rinehart and Winston, New York, U.S.A., 1965.

3. Peter Sykes, A Guidebook to Mechanism in Organic Chemistry 5th edition, Orient Longman, New Delhi, India, 1987.

4. Ernest L. Eliel & Samuel H. Wilen, Stereochemistry of Organic Compounds, reprint 2005, McGraw Hill Book Company Inc. New York, U.S.A.1995.

5. James.D. Morrison and Harry S. Mosher, Asymmetric Organic Reactions, Prentice Hall Inc. Englewood Cliffs, New Jersey, U.S.A., 1971 .

6. Charles H. DePuy and Orville L.Chapman, Molecular Reactions and Photochemistry, Prentice-Hall of India Private Limited, New Delhi, India, 1972

7. S.P. Singh and S.M. Mukherji, Reaction Mechanism in Organic Chemistry The Macmillan Company of India Limited, New Delhi, India, 1990.

8. R.O.C. Norman and J.M.Coxon, Principles of Organic Synthesis, 3rd edition ELBS,Chapman and Hall, London, U.K., 1993.

9. W. Carruthers, Some Modern Methods of Organic Synthesis, 4th edition, Cambridge University Press, U.K., 2004.

10 Manfred E.Wolff, (ed),Burger’s Medicinal Chemistry and Drug Discovery, Principles and Practice, 6th Ed., John Wiley and Sons,2003.

MASTER OF PHARMACY

M.PHARM SEMESTER I (GROUP C) PHARMACEUTICAL CHEMISTRY

Paper II : Organic Molecular Spectroscopy

Max. Marks : 80 4 Hrs./Week

Internal Assessment 20 Max Time 3 Hrs

Total Marks 100

1. Ultraviolet And Visible Spectroscopy : Colour and light absorption, the chromophore concept. Theory of electronic spectroscopy, orbitals involved and electronic transitions. Effect of solvent and conjugation on ⋋ max. Woodward–Fieser, Fieser-kuhn and Nelson's rules. Spectral correlation with structure; conjugated dienes and polyenes; α, β-unsaturated carbonyl compounds; benzene, substituted benzenes and polynuclear aromatic hydrocarbons. Stereochemical factors in electronic spectroscopy: biphenyls and binaphthyls, cis and trans isomers, angular distortion and cross conjugation, steric inhibition of resonance. (8 lectures)

2. Infrared spectroscopy : Molecular vibrations and modes of vibrations. Factors influencing vibrational frequencies: vibrational coupling, hydrogen bonding, conjugation, inductive, mesomeric (resonance), and field effects.Bond angles. Application to identify functional groups. (6 lectures)

3. Nuclear Magnetic Resonance Spectroscopy : (8 lectures)

3.1 1H-NMR spectroscopy : Nuclear spin and resonance. Chemical shift and its measurement. Relaxation processes. Factors influencing chemical shifts:shielding, deshielding and anisotropic effects;effect of restricted rotation, concentration, temprature and hydrogen bonding. Spin-spin coupling (simple and complex), mechanism of coupling. Coupling constants, geminal coupling, vicinal coupling, virtual and long range coupling. Chemical shift equivlance and magnetic equivalance. Factors influencing geminal and vicinal coupling. Non first order spectra. Simplification of complex PMR spectra: Increased field strength, spin decoupling or double resonance and the use of chemical shift reagents. Variable temprature NMR spectroscopy: introductione and applications.

3.2 13C-NMR spectroscopy : Natural abundance of 13C, resolution and multipilicity.The FT mode and rf pulse. Use of proton coupled, proton decoupled and off resonance decoupling techniques; deuterium substitution and chemical shift equivalence in peak assignment. Chemical shift: effect of substituents on chemical shift position of alkanes, alkenes, alkynes and bezene. Spin coupling and 13C - 1H coupling constants.

3.3 New dimensions in NMR spectroscopy : Nuclear Overhauser Effect and NOE difference spectra. Introduction to correlated spectroscopy (COSY). HOMCOR (1H - 1H) and HETCOR (1H - 13C) of menthol and geraniol. APT and DEPT techniques (menthol and geraniol). A brief introduction to Nuclear Overhauser Effect Spectroscopy ( NOESY) with a suitable example.

4. Electron Spin Resonance Spectroscopy : Principle and correlation with proton magnetic resonance. Derivative curves, g-values, hyperfine splitting. Applications. (6 lectures)

5. Mass Spectrometery : Introduction, mass spectrum and metastable ion peak. Determination of molecular formula. Recognition of molecular ion peak and the nitrogen rule. Molecular formula and index of hydrogen deficiency. General rules of fragmentation and the McLafferty rearrangement. Use of APCI,ESI, APPI, FAB, MALDI, DART and MSn in structure elucidation . Application of mass fragmentation in structure elucidation. (6 lectures)

6. Optical Rotatory Dispersion/Circular Dichorism : Introduction, cotton effect, axial haloketone rule, octant rule, interpretation with examples. (6 lectures)

7. Separation Techniques : (7 lectures)

7.1 Chromatography : General principles, classification of chromatographic techniques, normal and reversed phase, bonded phase, separation mechanisms.

7.2 Column Chromatography :Introduction & applications of Short column chromatography: flash chromatography, vacuum liquid chromatography (VLC); Medium pressure liquid chromatography and Centrifugal chromatography.

7.3 Counter current chromatography, droplet counter current chromatography, ion exchange affinity, size exclusion and ion pair chromatography.

7.4 High Performance Liquid Chromatography : Principles & Applications of HPLC, method development, instrumentation, selection of columns and detectors , column problems and remedies, HPLC of non-ionic and ionic samples. Semi-preparative and preparative HPLC systems.

7.5 TLC and HPTLC : Selection of TLC and HPTC plates, sorbents and mobile phase. Normal and reverse phase TLC. Factors influencing TLC and HPTLC separation, detection/visualization, instrumentation and densitometric scanners . Application of HPTLC.

7.6 Gas chromatography : Principles, instrumentation, selection of carrier gas and detectors used in gas chromatography. Application of gas chromatography

7.7 Hyphenated Techniques : Principles and applications of GC-MS, LC-MS and LC- NMR techniques.

BOOKS RECOMMENDED

1. William Kemp, Organic Spectroscopy, 3rd edition, ELBS, Mac Millan, Hampshire, U.K., 1991.

2. D.H. Williams and I. Fleming, Spectroscopic Methods in Organic Chemistry, 4th edition, Tata Mc Graw-Hill Publishing Company Ltd. New Delhi, India, 1988.

3. R.M. Silverstein, G.C. Bassler and T.C. Morrill, Spectrometric Identification of Organic Compounds, 6th edition, John Wiley and Sons Inc., New York, U.S.A., 2003.

4. F.A. Bovey, Nuclear Magnetic Resonance Spectroscopy, 2nd edition , Academic Press Inc., New York, U.S.A.,1988.

5. K.W.Bentley, Elucidation of organic structures by Physical and chemical methods Part I and II Techniques of organic chemistry Vol. XI Interscience Publishers, New York,U.S.A.1963

6 D.L. Pavia, G.M.Lampman & G.S.Kriz, Introduction to Spectroscopy-A guide for students of organic chemistry, 3rd edition, Harcourt College Publishers,2001.

7. H.H.Willard, L.L.Merriet and J.A. Dean, Instrumental Methods of Analysis, 5 th edition,Van Nostrand Reinhold, New York , U.S.A., 1974.

8. D.A. Skoog, Principles Of Instrumental Analysis, 3rd edition, Holt Rinchard and Winston Inc., New York, U.S.A., 1985.

9. C.N.Banwell and E.M..Mccash, Fundamentals of Molecular Spectroscopy, 4th edition, Tata McGraw-Hill Pubcishing Company Ltd., New Delhi,1994.

M.PHARM SEMESTER

(GROUP C) PHARMACEUTICAL CHEMISTRY

PAPER:III PHARMACEUTICAL CHEMISTRY LABORATORY

Max. Marks : 80 16 Hrs./Week

Internal Assessment 20 Max Time 16 Hrs

Total Marks 100

1. Identification of organic compounds in a mixture through physical, chemical and spectral studies and their confirmation through the preparation of derivatives.

2. Chromatographic techniques for qualitative and quantitative estimation.

3. Preparation of organic compounds involving various synthetic reactions.

4. Spectral Workshop: Workshop involving interpretation of IR, NMR and Mass Spectra of simple organic compound to elucidate their chemical structures.

5. Stereomodel Workshop: Exercises involving preparation of stereomodels with a view to assess the importance of stereochemistry in drug action. Examples of pharmacopoeial substances of stereochemical importance should be taken for illustration.

BOOKS RECOMMENDED:

1. F.C.Mann and B.C.Saunders, Practical Organic Chemistry, Orient Longman, 4th edition, New-Delhi, India.1960.

2. A.I.Vogal, A Text Book of Practical Organic Chemistry, 5th edition, The English Language Book Society and Longman Group Limited,London, U.K.1991.

3. R.M. Silverstein, G.C. Bassler and T.C. Morrill, Spectrometric Identification of Organic Compounds, 5th edition, John Wiley and sons Inc., New York, U.S.A., 1991.

4. Ernest L. Eliel & Samuel H. Wilen, Stereochemistry of Organic Compounds, reprint 2005, McGraw Hill Book Company Inc. New York, U.S.A.1995.

MASTER OF PHARMACY

M.PHARM SEMESTER I (GROUP D) PHARMACY PRACTICE

Paper 1: Pharmacotherapeutics

Max. Marks : 80 4 Hrs./Week

Internal Assessment 20 Max Time 3 Hrs

Total Marks 100

1. Laboratory investigations and interpretation. (20 lectures)

2. Pathophysiology, clinical features, major laboratory investigations, pharmacotherapy (classification, mechanism of action, clinicaly significant drug interactions, major adverse reactions, dosage schedule and clinical status of drugs) and therapeutic management of the following clinical disorders. (30 lectures)

. Disorders of Cardiovascular System : Congestive heart failure, cardiac arrhythmias, ischaemic heart disease hypertension, atherosclerosis and shock.

Disorders of Blood : Anaemia and thromboembolism.

Psychiatric Disorders : Schizophremia, anxiety, mood and eating disorders.

. Neurological Disorders : Parkinsonism, seizure disorders, Alzheimers disease, headache, multiple sclerosis and myasthenia gravis.

. Respiratory Disorders : Asthma, chronic obstructive pulmonary disease (COPD) and acute respiratory distress syndrome (ARDS)

Gastromtestinal Disorders : Peptic ulcer, nausea and vomiting and inflammatory bowel disease.

Hepatic Disorders : Cirrhosis of liver and hepatitis.

Renal Diseases : Acute and chronic renal failure and oedema .

Endocrine and Metabolic Disorders : Diabetes mellitus, thyroid disorders, contraception and infertility and obesity.

Inflammatory Disorders : Arthritis, gout and osteoporosis

Disorders of Eye : Glaucoma.

Neoplastic Disorders : Leukaemia and lymphoma .

Infectious Diseases : Tuberculosis, leprosy, urinary tract infections, sexually transmitted diseases (STD) respiratory tract infections, meningitis, bacterial endocarditis, antimicrobial prophylaxis in surgery, fungal infections, malaria, amoebiasis and acquired immuno deficiency syndrome (AIDS)

BOOKS RECOMENDED

1. Eric T. Herfindal and Dick R. Gourley (eds), Text Book of Therapeutics: Drug and Disease Management, 6th edition, Williams and Wilkins, Baltimore, U. S.A.1996.

2. Roger Walker and Clive Edwards, (Eds) ,Clinical Pharmacy and Therapeutics, 3rd edition, Chrchil Livingstone, London.2003.

3. LLoyd Yeen Young, Mary Anne and Koda Kimble (eds), Applied Therapeutics : Clinical Use of Drugs, 6th edition.

4. J. I. Di Piro, R. L. Talbert, G.C. Yee, G.R. Matzke, B.G.Wells and L. M.Posey (Eds) Pharmacotherapy : A Pathophysiologic Approach, 5th edition, Mc. Graw Hill New York, 2002.

5. L.L.Brunton, J.S.Lazo, K.L.Parker(eds) Goodman and Gillman's The Pharmacological Basis of Therapeutics, 11th edition, McGraw-Hill Companies, Inc.2006.

MASTER OF PHARMACY

M.PHARM SEMESTER I (GROUP D) PHARMACY PRACTICE

Paper II : Pharmaceutical Medicine

Max. Marks : 80 4 Hrs./Week

Internal Assessment 20 Max Time 3 Hrs

Total Marks 100

1. Definition, development and scope of pharmaceutical medicine. (7 lectures)

2. New Drug Development Process: Concept of pharmagenology, strategies and various approaches for new drug development in industrial setting, concept of drug master file (DMF), pre-clinical evaluation. Safety evaluation including acute, sub-acute and chronic toxicity studies. Toxicokinetics in safety evaluation. Investigational new drug application (IND). Institutional review board. (8 lectures)

3. Clinical Trials Justification, purpose, clinical evaluation including phase I, II, III and IV studies, review of preclinical data and design decisions of clinical trial. Ethical and legal aspects of clinical trial. Methods of randomnisation, Protocol deviations and exceptional handlings related to patient and investigator. Size of clinical trial. Documentation, monitoring and managing of clinical trials. Clinical research in elderly, children and women. (8 lectures)

4. Assessment of Drug Activity in Humans Antianginal drugs, antiarrhythmic agents, antihypertensive drugs, drugs for heart failure, antiasthmatic drugs, antiepileptic drugs, anxiolytics and hypnotics, antidepressants, antipsychotic agents, antiparkinsonian agents, analgesics, drugs used in Alzheimer's disease, anti-ulcer drugs, diuretics, antidiabetics and antiviral drugs. (7 lectures)

5. Clinical Pharmacokinetics: Determination and clinical relevance of various pharmacokinetic parameters. Concept and measurement of bioavailability and bioequivalence. Concept of clearance. Measurement of renal and hepatic clearance. Calculation of loading and maintenance dose. Dose adjustment in renal impairment, paediatric and geriatric patients. Therapeutic drug monitoring (TDM). (8 lectures)

6. Clinical Research and Health Care: Good laboratory practice and Good Clinical practice. Contract research organizations (CRO). Relationship of marketing to clinical research. Product recall and withdrawal. Orphan drugs. Managed health care and pharmaceutical industry. (7 lectures)

BOOKS RECOMENDED

1. Stuart J.Pocock, Clinical Trial: Practical Approach.

2. Philip I.Good. A Manger's Guide to Design and Conduct of Clinical Trials. Wiley-Liss, Hobokem U.S.A. 2002.

3. John O'Grady and Picter H.Joubert (Eds) Handbook of phase I/II Clinical Drug Trials. CRC Press, New Yorks, U. S. A. 2000

4. P.L.Madan, Biopharmaceutics and Pharmacokinetics. Jay Pee. Brothers, New Delhi, India. 2000

5. Gary M.Matoren, The clinical Research Process in Pharmaceutical Industry. Marcelo Dekker, New York U. S. A., 1984

6. A.J.Fletcher, L.D. Edwards. A. W.Fox, P. Stonier, Principles and Practice of Pharmaceutical Medicine. Jhones Wiley & Sons Ltd. Westsussex, U.K. 2002.

7. Michael Winter Basic Clinical Pharmacokinetics. Lippincott Williams and Wilkins. Philadelphia. 2004

8. David Machin, Simon Day and Sylvan Green(eds.) Text Book of Clinical trials. John Wiley and Sons, West Sussex, England, 2004.

MASTER OF PHARMACY

M.PHARM SEMESTER I (GROUP D) PHARMACY PRACTICE

Paper III Clinical Pharmacy Practice Laboratory

Max. Marks : 80 16 Hrs./Week

Internal Assessment 20 Max Time 16 Hrs

Total Marks 100

1. Exercises to calculate various Pharmacokinetic parameters.

2. Exercises to calculate bioavailability and bioequivalence.

3. Determination of serum creatinine and blood urea nitrogen in order to assess the function of Kidney and calculation of dose adjustment on the basis of these functions.

4. Exercises based on therapeutic drug monitoring.

5. Analysis of patient focused case histories to develop pharmacotherapeutic skills.

Visits to hospital to record patient history, collect and preserve blood samples, understanding of laboratory investigations, choice and use of therapeutic agents.

M.PHARM SEMESTER II

COMPULSORY PAPER

PAPER I ADVANCED MOLECULAR BIOLOGY AND BIOTECHNOLOGY

Max. Marks : 80 4 Hrs./Week

Internal Assessment 20 Max Time 3 Hrs

Total Marks 100

1. Introduction and Historical Perspective (4 lectures)

Recombinant DNA Technology, emergence of molecular biotechnology, commer-cialisation of molecular biotechnology, biotechnology industry, products and markets.

2. Recombinant DNA Technology (6 lectures)

DNA structure and function, restriction endonucleases, plasmid cloning vectors, creating and screening gene library, vectors for cloning large pieces of DNA, genetic transformation and selection of prokaryotes. Choice of Expression system for production of protein pharmaceuticals with special reference to human insulin, human growth hormone, erythropoietin, tissue plasminogen activator

3. Molecular Diagnostics (5 lectures)

DNA diagnostic systems, hybridization probes, fluorescent in-situ hybridization procedure. Molecular diagnosis of genetic disease-PCR/OLA procedure, immunohistochemistry

4. Monoclonal Antibodies (6 lectures)

Scope and limitation of monoclonal antibodies, formation and selection of hybrid cells, identification of specific antibody-producing hybrid cell lines. Application of monoclonal antibodies in clinical diagnosis, treatment and biomedical research. Monoclonal antibodies as therapeutic agents-preventing rejection of transplanted organs, treatment of bacterial blood infections. Genetically engineered immunotherapeutic agents-Chemically linked monoclonal antibodies, human monoclonal antibodies, hybrid human-mouse monoclonal antibodies, HIV therapeutic agents.

5. Vaccines (3 lectures)

Subunit vaccines, peptide vaccines, genetic immunization, live recombibant vaccines, attenuated vaccines-Cholera, Salmonella species, Vector Vaccines- vaccines directed against viruses, vaccines directed against bacteria, anti-idiotype vaccines. Concept, applications and examples of edible vaccines.

6. Nucleic Acid Therapies (6 lectures)

Techniques and clinical applications of gene therapy, antisense and triplex therapy, aptamer and ribozyme therapy.

7. Transgenics (8 lectures)

7.1 Transgenic animals: Transgenic technologies and their application in drug development.

7.2 Transgenic plants: Application in production of biopharmaceuticals.

8. Fermentation Technology (8 lectures)

8.1 Microbial growth kinetics-batch fermentation, fed batch fermentation, continuous fermentation. Maximizing the efficiency of fermentation process. Bioreactors-instrumentation for monitoring and controlling bioreactors. Typical large scale fermentation systems-two stage fermentation in Tandem Airlift reactors, two stage fermentation in a single stirred tank reactor. Harvesting microbial cells, disrupting microbial cells, down stream processing.

8.2 Antibiotics as fermentation products. Cloning antibiotic biosynthesis genes by complementation and other methods, synthesis of novel antibiotics-actinorhodine, medermycin, granaticin, improving antibiotic production. Synthesis of adhesive biopolymer.

9. Immobilized Enzyme Technology (4 lectures)

Techniquesof immobilization, Matrices-types, advantages and limitations. Comparative account of immobilized enzymes and concept of co-immobilization. Kinetics of immobilized enzymes, stability.

11. Pharmacogenetics and Pharmacogenomics: Personalized Medicine, use of SNP's in Pharmacogenomics. (4 lectures)

BOOKS RECOMMENDED

1. Bernard R.Glick and J.J.Pasternak, Molecular Biotechnology: Principles and Applications of Recombinant DNA, 3rd Edition. ASM Press,Washington,U.S.A.,2003.

2. T.V.Ramabhadran, Pharmaceutical Design and Development : A Molecular Biology Approach, Ellis Horwood, New York,U.S.A.,1994.

3. H.W.Blanch and D.S.Clark, Biochemical Engineering,Marcel Deckker Inc.,U.S.A. 1996.

4. S.S.Purohit, H.N.Kakrani, A.K.Saluja, Pharmaceutical Biotechnology, Agrobios (India) 2007.

5. S.P.Vyas and V.K.Dixit Pharmaceutical Biotechnology, CBS Publishers, New Delhi.

6. P.K.Gupta, Biotechnology and Genomics. Rastogi Publications(India) 2004.

MASTER OF PHARMACY

M.PHARM SEMESTER II

COMPULSORY PAPER

Paper II : REGULATORY AFFAIRS AND DOCUMENTATION

Max. Marks : 80 4 Hrs./Week

Internal Assessment 20 Max Time 3 Hrs

Total Marks 100

1. Regulatory Aspect of New Drug Discovery: Concept and historical development of pharmaceutical product registration. New strategies and approaches employed in drug discovery. Brief concept of IPR. Introduction to Indian, US and International Patenting process. (5 lectures)

2. Harmonization of Regulatory Requirements : The ICH Guidelines for establishing quality, safety and efficacy of drug substances and products. Study of ICH common technical document. VICH process of harmonization of requirements for Veterinary pharmaceuticals. (4 lectures)

3. The WHO Guidelines : The who guidelines and their relevance in International registration. The WHO certification scheme on the quality of Pharmaceutical products moving in international commerce. (5 lectures)

4. Regulatory Considerations for Preclinical Testing: Preclinical requirements currently in use. Regulatory requirements of single dose and repeat dose toxicity studies, reproductive toxicology, mutagenicity, carcinogenicity, animal phamacokinetics and toxicokinetics. (4 lectures)

5. Regulatory Considerations for Clinical Evaluation: ICH Regulatory requirements of clinical evaluation. Requirements pertaining to immediate and controlled release dosage forms, paediatric and geriatric patients. ICH-GCP requirements. Design and interpretation of clinical safety data mangement, periodic safety update reports for marketed drugs, pharmacovigilance. Clinical study reports, ethnic factors. Pharmacogenomics. Schedule Y of India. (6 lectures)

6. Regulatory Consideration for Manufacturing: Regulatory guidelines for packaging materials, manufacturing information, excipient approval, control tests on the finished product, stability testing, analytical validation; bioavailability and bioequivalence . Auditing of manufacturing facilities by international regulatory agencies. The quality system standards, ICH-GMP requirements. (4 lectures)

7. Regulatory Consideration for Biological and Biotechnological Products Principle, toxicological, clinical and manufacturing regulatory requirements requirements of biological and biotechnological products. (6 lectures)

8. Registration Applications: Registration applications for marketing approval (IND, NDA, ANDA). Comparative study of United States, European Community, Japan and Indian requirements. Drug Master File. The establishment licence application and the product licence application of biotechnology derived products. (7 lectures)

BOOKS RECOMMENDED

1. International Pharmaceutical Product Registration. A.C. Cartwright and B.R. Matthews (eds.). Ellis Horwood, New York, 1994.

Internet sites Fdagov. , ifmaorg., eudralexorg., eudralexorg.,Vich.., and .

MASTER OF PHARMACY

M.PHARM SEMESTER II (GROUP A) PHARMACOLOGY

Paper III : RECENT ADVANCES IN PHARMACOLOGY

Max. Marks : 80 4 Hrs./Week

Internal Assessment 20 Max Time 3 Hrs

Total Marks 100

1. Molecular Pharmacology (5 lectures)

1.1 Receptor Occupancy and cellular signaling systems: G-Proteins, Cyclic nucleotides, Calcium and Calcium binding proteins, protein kinases, phosphatidylinostol, phospholipases.

2. Pharmacology of Receptors : Classification, cellular signaling systems, pharmacology of agonists and antagonists of the following receptor types: (5 lectures)

2.1 Angiotensin receptors.

2.2 Excitatory Amino acid receptor(EAA)

2.3 Purinoreceptors

2.4 Serotonin receptors.

2.5 GABA and Benzodiazepine receptors.

2.6 Canabinoid receptors.

2.7 Neurosteroid Receptors.

2.8 Erb B-receptors

3. Ionic Channel and their Modulators : Classification and biology of ionic channels. Pharmacology of substances which modulate the following channels. (3 lectures)

3.1 Calcium Channels

3.2 Potassium Channels

3.3 Sodium Channels

4. Neuropeptides : Neuropeptide Y, Calcitonin gene related peptide (CGRP), Cholecystokinin(CCK), Endogenous opioids, Substance P, ATP binding cassette proteins family. (4 lectures)

5. Pathobiology and management of the following disorders :

5.1 Alzheimer’s disease

5.2 Anorexia nervosa and Anorexia Bulimia

5.3 Ischaemia-reperfusion injury

5.4 Cystic fibrosis

5.5 HIV, related opportunistic Infections, HIV-1 vaccines and HIV associated lipodystrophy.

5.6 Inflammatory Bowel Disease

5.7 Obesity

5.8 Erectile dysfunction.

6. Apoptosis : Pharmacological implications and therapeutic opportunities. (3 lectures)

7. Pharmacological and clinical implication of phosphodiesterase enzymes and protein kinase C. (4 lectures)

8. Biology of vascular endothelium : EDRF EDCF, EDHF. Pharmacology of endothelins and nitric oxide. clinical implications of Endothelial Dysfunction. (5 lectures)

9. Basic aspects of chronobiology and chiral pharmacology and their implications in drug therapy. (3 lectures)

10. Nucleic Acid Therapies : Basic concepts and clinical potentials of gene therapy, oligonucleotide therapy, aptamer therapy and ribozyme therapy. (4 lectures)

11. Cytokines And Chemokines : Pharmacological, pathological and clinical implications of various cytokines and chemokines. (3 lectures)

12 Cell Adhesion Molecules and Matrix Proteins : Biological role of cell adhesion molecules and matrix proteins in various diseases. Potential target sites to develop new drugs for various disorders. GP II b/IIIa receptor antagonists. Anti-integrin therapy. (4 lectures)

13 Growth Factor : Biology of various growth afctors and their theraputic potentials. Pharmacology of cardic and vascular remodelling. (4 lectures)

14. New Strategies in Management of Malaria : Pharmacology of artimisniiin and related compounds. Development of antimalarial vaccines. (3 lectures)

15. Genomics : Impact of human genome sequence on development of novel therapeutics. Basic concept and application of proteomics and bioinformatics in drug discovery. (3 lectures)

REFERENCE

1. Annual review of Pharmacology & Toxicology

2. Annual review of Medicine

3. Annual review of Physiology

4. Annual review of Biochemistry

5. Trends in Pharmacological Sciences

6. Trends in Biochemical Sciences

7. Trends in Biotechnology

8. New England Journal of Medicine

9. Advances in Pharmacology

10. Advances in Drug Therapy

11. Drug Discovery Today

M.PHARM SEMESTER II (GROUP B) PHARMACEUTICS

PAPER III QUALITY ASSURANCE AND PACKAGING TECHNOLOGY

Max. Marks : 80 4 Hrs./Week

Internal Assessment 20 Max Time 3 Hrs

Total Marks 100

1. Quality Variation Control: (4 lectures)

1.1 Quality control of processes and packaging.

1.2 Statistical quality control and its importance in monitoring quality variation.

1.3 Quality assurance of manufacturing practices: GMP and its regulations pertaining to organization, personnel, building, infrastructure, equipment, containers & closures, packaging & distribution.

2. Pharmaceutical Process Validation: (5 lectures)

2.1 Definition, scope, importance and various terms used in process validation.

2.2 Design and techniques of process validation.

3. Process Validation of Raw Materials: (6 lectures)

3.1 Standard operating procedures(SOP) with special reference to facilities,

safety, housekeeping, equipment, sterilization, maintenance, personnel, controls, manufacturing and instructions.

3.2 Evaluation of sources of variation.

3.3 Procedure of Raw material validation.

4. Prospective & Retrospective Process Validation: (6 lectures)

4.1 Organisation and documentation of process validation.

4.2 Process validation of product development.

4.3 Evaluation of processing data obtained for tablets, soft gelatin capsules, liquids and semi-solids.

5. Validation of Solide Dosage Forms: (4 lectures)

5.1 Validation of raw materials, analytical methods and process variables.

5.2 Guidelines for process validation of solid dosage forms.

6. Validation of Sterlization Processes and Sterile Products: (5 lectures)

6.1 Validation of steam, dry heat, gaseous and radiation sterlization processes.

6.2 Validation of sterlizing filters.

6.3 Validation of equipment, containers and closures, sterlization processes and environmental conditions employed in manufacture of sterile products.

7. Validation of Lyophilized Products: (4 lectures)

7.1 Installations and operational qualifications of equipment.

7.2 Validation of filling, aseptic operations, lyophilization processes.

7.3 Product evaluation.

8. Validation of Inhalation Aerosols. (4 lectures)

8.1 Validation of raw materials and packaging components, manufacturing propellent filling of inhalation aerosols.

8.2 Documentation and validation protocols.

9. Packaging Technology: (4 lectures)

9.1 Glass as a packaging material: Types, tests for assuring quality of glass.

9.2 Plastic containers: Types of plastics used , permeation, leaching, sorption, chemical reaction, biological tests and modification of plastics by the drug.

9.3 Different types of closures and closure liners.

9.4 Tamper resistant packaging: Film wraper, blister packs, bubble packs, shrink banding, foil/plastic pouches, bottle seals, tape seals, breakable seals and sealed tubes.

9.5 Quality control of packaging material and filling equipment.

BOOKS RECOMMENDED

1. S.H.Wiling, M.M.Tuckerman and W.S.Hitchings, Good Manufacturing Practice

for Pharmaceuticals, Marcel Dekker Inc., New York, U.S.A., 1982.

2. I.R.Berry and R.A. Nash, Pharmaceutical Process Validation, Marcel Dekker Inc.

New York, U.S.A., 1993.

3. K.Harburn, Quality Control of Packaging Materials in the Pharmaceutical Industry

Marcel Dekker Inc., New York, U.S.A., 1991.

4. N.K.Jain, Pharmaceutical Product Development, CBS Publishers and Distributors, New Delhi.2006.

M.PHARM SEMESTER II (GROUP C) PHARMACEUTICAL CHEMISTRY

PAPER-III DRUG DESIGN AND MEDICINAL CHEMISTRY

Max. Marks : 80 4 Hrs./Week

Internal Assessment 20 Max Time 3 Hrs

Total Marks 100

1. Three Dimensional Structure Aided Drug Design: (4 lectures)

1.1 Methods to obtain Three Dimensional Structures: Crystallography, Nuclear Magnetic resonance and Homologous Modelling.

1.2 Examples of Structure Aided Drug Design: Design of inhibitors for Angiotensin Converting Enzyme( ACE), Renin & HIV Protease.

2. Drug Receptors: (5 lectures)

2.1 Concept of Receptors and Receptor Theories.

2.2 Molecular Biology of receptors: Receptor cloning strategies, Sequence

analysis, Expression and structural analysis of cloned receptors, Important

structural features in G-Protein Coupled receptors and Ion channel linked

receptors.

2.3 Receptor Binding Assays: Membrane receptor assay, separation techniques and data analysis.

3. Drug Target Binding Forces: (5 lectures)

3.1 Energy components for intermolecular non convalent interactions in gas

phase.

3.2 Thermodynamics of association in gas phase and solvation effects

3.3 Examples of drug receptor interactions: Biotin-avidin, dihydrofolate

reductase-trimethoprim, DNA-intercalators.

4. Molecular Modelling in Drug Design: (6 lectures)

4.1 Basics of molecular mechanics

4.2 Applications of quantum mechanics to molecular mechanics

4.3 Design of Ligands for Known Receptors: Characterization of site, design of ligands and calculation of affinity.

4.4 Design of Ligands for Unknown Receptors: Pharmacophore versus binding site models, searching for similarity, molecular comparisons and finding common patterns.

5. Quantitative Structure Activity Relationships: (5 lectures)

5.1 Parameters to describe intermolecular forces of drug receptor interactions

5.2 Quantitative Models: Hansch analysis, Free Wilson analysis, other QSAR approaches and their applications.

5.3 Statistical Methods: Regression analysis, Partial Least Squares (PLS) analysis.

5.4 3D-QSAR Approaches: Comparative Molecular Field Analysis(CoMFA).

6. Recombinant DNA Technique in Medicinal Chemistry: (6 lectures)

6.1 Protein engineering and site directed mutagenesis.

6.2 Genetically Engineered Drug Discovery Tools: Reagents for screening and biological studies, enzymes and receptors as drug targets, cellular adhesion proteins.

7. Rational Design of Enzyme Inhibitors: (4 lectures)

7.1 Enzyme inhibitors in medicine and basic research.

7.2 Rational Design of Non Covalently Binding Enzyme Inhibitors: Forces in formation of enzyme-inhibitor complexes, rapid reversible inhibitors, slow, tight and slow-tight binding inhibitors, transition state analogs, multisubstrate inhibitors.

7.3 Rational Design of Covalently Binding Enzyme Inhibitors: Mechanism based inhibitors, affinity labels, pseudo- irreversible inhibitors.

8. Analog Design: (4 lectures)

8.1 Strategies of Analog Design: Bioisosteric replacement, rigid analogs,

homologation of alkyl chains, alteration in chain branching, ring size and

ring position isomers, alteration in stereochemistry, fragments of lead

molecules, variation in interatomic distances.

9. Peptidomimetics in Drug Design: (6 lectures)

9.1 Cyclization of peptides,

9.2 Constrained amino acids: α (-Methylated amino acids, α,-αdialkylglycine and aminocycloalkane carboxylic acids, Nα-Cα cyclized amino acids, N-methylated amino acids, and aminocycloalkane carboxylic acids, unsaturated amino acids, dimethyl and β-methyl amino acids, substituted 2,3-methano amino acids.

9.3 Amide bond isosteres: Retro-inverso modifications, reduced amide bonds, methylene thioether and methylene sulfoxide, methylene ether, ethylene thioamide, trans-olefin, ketomethylene,1,5-disubstituted tetrazole ring.

9.4 Non peptide ligands for peptidergic receptors.

10. Oligonucleotide Therapeutics: (3 lectures)

10.1 Mechanisms of oligonucleotide interactions with nucleic acids, oligo- nucleotide stability

10.2 Medicinal Chemistry of Oligonucleotides: Heterocycle modifications, enhanced cellular uptake, cleavage reagents, sugar and backbone modifications.

11. Carbohydrate based therapeutics: (3 lectures)

11.1 Carbohydrate Related Pharmaceuticals: Antibiotics, nucleosides, cardiac glycosides, synthetic carbohydrate drugs.

11.2 Pharmacokinetic considerations and binding affinites.

11.3 Structural determination and synthesis of carbohydrate based agents

11.4 Glycoconjugates: Glycolipids, proteoglycans, glycoproteins

11.5 Inhibitors of carbohydrate enzymes, immunomodulators

BOOKS RECOMMENDED:

1) Manfred E.Wolff, (ed),Burger’s Medicinal Chemistry and Drug Discovery, Vol-I Principles and Practice, 6th Ed., John Wiley and Sons,1995.

2) J.G.Vinter and Mark Gardner,(eds) Molecular Modelling and Drug Design, The Macmillan Press Ltd, London, U.K., 1994.

3) C. Hansch, A. Leo and D. Hoekman, Exploring QSAR : Applications in Chemistry and Biology , ACS Professional Reference Book, American Chemical Society, Washington, U.S.A.,1995.

4) QSAR: Hansch Analysis and Related Approaches, Hugo Kubinys, R. Mannhold, P.Krogsgaard Larsen, Eds., VCH, 1993.

MASTER OF PHARMACY

M.PHARM SEMESTER II (GROUP D) PHARMACY PRACTICE

PAPER III : CLINICAL PHARMACY PRACTICE

Max. Marks : 80 Max Time 3 Hrs

Internal Assessment 20 4 Hrs./Week

Total Marks 100

1. Definition, scope, historical development of Clinical Pharmacy. (3 lectures)

2. Basic Principles of Clinical Pharmacy Practice (5 lectures)

Communication skills, drug therapy review and patient councelling.

Monitoring of Drug Therapy : Therapeutic, pharmacokinetic and pharmacodynamic monitoring of drug therapy.

Patient Compliance : Factors which affect compliance. Methods of measuring and improving drug compliance.

Adverse Reactions to Drugs : Incidence, classification and methods of surveillance of adverse reactions to drugs.

Pharmacogenetics : Pharmacokinetic and pharmacodynamic aspects pharmacogentic.

Drug Interactions : Pharmacokinetic and pharmacodynamic drug interactions of clinical importance. Clinical incidence and management of drug interactions.

3. Pharmacy practice in paediatric, geriatric, lactating and pregnant patients. (6 lectures)

4. Rational Drug use and Essential Drug Concept : Concept of rational use of drugs and essential drugs. WHO guidelines of essential drugs. Rational use of fixed dose combinations, OTC drugs, injectables and antimicrobial agents. (5 lectures)

5. Evidence Based Medicine: Sources of evidence, measurement of effectiveness and critical appraised of literature related to drug therapy. (4 lectures)

6. Medication Errors: Clinical incidence, classification, source and management of medication errors. (3 lectures)

7. Pharmacoepidemiology: Types, methods and factors affecting drug utilization. Application of pharmacoepidemiology in health care and drug use. (4lectures)

8. Pharmacoeconomics: Principles, methods and application of pharmacoeconomics to pharmacotherapy. (5lectures)

9. Health Outcome and Quality of Life : Types of health outcome, measurement of quality of life and quality adjusted life years (QALY) (5 lectures)

10. Drug and Poison Information Services: Documentation and organization of drug and poison information centers. (5 lectures)

11. Nutraceuticals: Concept and clinical use of various neutraceuticals. Parenteral nutrition and nutritional considerations in major organ failure. (5 lectures)

BOOKS RECOMENDED

1. G.Parthasarthi, Karin Nyfort Hansen and Milip C. Nahata (Eds), A Text Book of Clinical Pharmacy Practice, Orient Longman, Chennai, India, 2004.

2. Joseph D. Diparo, Robert L. Talbert, Garg C.Yee, Garg R.Matzke Barbara G.Wells and L Michael Posey (Eds), Pharmacotherapy: A Pathophysiologic Approach, 5th edition, Appleton Lange, Stanford U. S. A. 2002.

3. D.G.Grahme Smith and J.K Aronson. Oxford Text Book of Clinical Pharmacology and Drug Therapy, 2nd edition, Oxford University Press, New York, 1995

4. Brian L.Strom. Pharmacoepidemiology. 4th Edition. John Wiley and Sons Ltd., West Sussex, England, 2005.

M.PHARM SEMESTER II

COMPULSORY PAPER

PAPER IV ADVANCED MOLECULAR BIOLOGY AND BIOTECHNOLOGY LABORATORY

Max. Marks : 80 16 Hrs./Week

Internal Assessment 20 Max Time 16 Hrs

Total Marks 100

1. Exercises based on use of elctgrophoresis

2. Excercises based on enzyme kinetics

3. Exercises based on DNA recombinant technology using E.Coli

4. Mathematical probelms related to kinetics of immobilized enzymes.

5. Workshop to estimate heat and mass transfer in bioreactors.

BOOKS RECOMMENDED

1. S.J.Karcher,Molecular Biology: A Project Approach,Academic Press,U.S.A.,1995.

2. H.W.Blanch and D.S.Clark, Biochemical Engineering, Marcel Deckker Inc.,U.S.A.1996.

................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download