M. Pharmacy (Pharmacology) Syllabus by RGUHS, Bangalore

Modern Pharmaceutical Analysis

1.      UV-VISUAL SPECTROSCOPY

a.       Brief review of electromagnetic spectrum, UV-visual range, energy, wavelength and color relationships

b.      Interaction of electromagnetic radiation (UV-Visible) with matter and its effects.

c.       Chromophores and their interactions with EMR absorption spectra of organic compounds and complexes illustrating the phenomenon and its utilization in qualitative and quantitative studies of drugs.

d.      Shifts and their interpretation (including solvent effects)

e.       Empirical correlation of structure with absorption phenomena (woodward’s rules etc.,)

f.       Quantitative estimations, modern instrumentation.

2.      INFRARED SPECTROSCOPY

a.       Nature of infra-red radiation.

b.      Interaction of IR radiation with organic molecules and effects on bonds.

c.       Molecular infrared spectra.

d.      Brief outline of classical I.R. instrumentation and particle details of obtaining spectra, including sample preparation for spectroscopy,

e.       Qualitative interpretation of I.R. spectroscopy including FT-IR,

f.       ATR.

3.      OPTICAL ROTATORY DISPERSION

a.       Fundamental principles of ORD

b.      Cotton effect curves, their characteristics and interpretation

c.       Octant rule and its application with examples.

d.      Circular dichroism and its relation to ORD.

4.      NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY

a.       Fundamental principles of NMR (magnetic properties of nuclei; applied field and precession; absorption and transition; frequency)

b.      Chemical shifts concept: Isotopic nuclei,

c.       Reference standards: Proton Magnetic spectra, their characteristics, presentation terms used in describing spectra and their interpretation (signal No., position, intensity)

d.      Brief outline of instrumental arrangements and some practical details.

e.       Signal multiplicity phenomenon in high resolution PMR

f.       Spin-spin coupling  

g.      Application of signal split and coupling constant data to interpretation of spectra.

h.      De-coupling and shift reagent methods,

i.        Brief outline of principles of FT-NMR with respect to 13C NMR: spin-spin and spin-lattice relaxation phenomenon

j.        Free induction decay (FID) proton noise de-coupling signal

k.      Average time domain and frequency domain signals nuclear overhauser enhancement 13C NMR spectra, their presentation, characterizes, interpretation, examples and applications.

l.        Brief indication of application of magnetic resonance spectral data of other nuclei by modern NMR instruments.

m.    Introduction to 2-D NMR techniques.

5.      MASS SPECTROSCOPY

a.       Basic principles and brief outline of instrumentation

b.      Ion formation and types: Molecular ion, Meta-stable ions, fragmentation processes.

c.       Fragmentation patterns and fragmentation characteristics in relation to parent structure and functional groups.

d.      Relative abundances of isotopes and their contribution to characteristic peaks.

e.       Mass spectrum, its characteristics, presentation and interpretation

f.       Chemical ionization mass spectrometry

g.      GC-MS, other recent advances in MS.

h.      Fast atom bombardment mass spectrometry.

6.      CHROMATOGRAPHIC TECHNIQUES

a.       Classification of chromatographic methods based on mechanism of separation.

b.      Paper chromatography, techniques and application

c.       Thin layer chromatography, comparison to paper chromatography and HPLC, adsorbents for TLC.

d.      Preparation techniques, mobile phase selection, reversed phase TLC

e.       High performance TLC detection methods

f.       Quantitative methods in TLC

g.      Programmed multiple development techniques.

7.      GAS CHROMATOGRAPHY

a.       Instrumentation, packed and open tubular column,

b.      Column efficiency parameters, vandeemeter equation, resolution, liquid stationary phases,

c.       Derivatization methods of GC including acylation, perfluoroacylation, alkylation and esterification.

d.      Detectors: FID, ECD, TCD, NPDA critical comparison of sensitivity, selectivity and field of application of these detectors.

e.       Examples of GC applications in pharmaceutical analysis.

8.      LIQUID CHORMATOGRAPHY

a.       Comparison of GC and HPLC,

b.      Instrumentation in HPLC,

c.       Analytical, preparative and micro bore columns, normal and reversed-phase packing materials.

d.      Reversed phase HPLC, column selection, mobile phase selection, efficiency parameters, resolution, detectors in HPLC refractive index, photometric and electrochemical.

e.       Comparisons of sensitivity, selectivity  and field of applications of these detectors

f.       HPTLC-instrumentation and application

9.      ELECTROPHORESIS

a.       Moving boundary electrophoresis

b.      Zone electrophoreses,

c.       Isotachophoresis,

d.      Iso-electric focusing and immune electrophores,

e.       Continuous electrophoresis (preparative) application.

10.  X-RAY DIFRACTION METHODS

a.       Introduction,

b.      Generation of X-rays,

c.       Elementary crystallography,

d.      Miller Indices,

e.       X-ray diffraction,

f.       Brag’s law,

g.      X-ray powder diffraction, X-ray powder diffractometer,

h.      Obtaining and interpretation of X-ray powder diffraction data.

11.  STATISTICAL ANALYSIS

a.       Introduction

b.      Significance of statistical methods,

c.       Normal distribution, probability, degrees of freedom, measures of variation-standard deviation, variance, standard error,

d.      Tests for statistical significance-students ‘T’ test, Chi-square test.

12.  TEACHING SKILLS, RESEARCH METHODOLOGY AND LITERATURE SOURCES

a.       Fundamentals of teaching and learning, art and science of teaching.

b.      Thesis writing and presentation of the work

c.       Citation of references.

13.  ETHICS IN PHARMACY

TEXT BOOKS

1.      Spectrophotometric identification of organic compounds, Silverstein (7^th edition).

2.      Fundamentals of applied statistics. S.C.Gupta and C.K.Kapoor

REFERENCE BOOKS

1.      X-ray methods by Clive whoston published by John Wiley & Sons 1987

2.      Statistics by Gofeti Radhakrishna.

3.      Bio statistics by Sadkar

4.      Instrumental methods of analysis by Scoog and West.

5.      Instrumental method of Analysis- Modern methods part-b, bol-2 pages 11 to 154, Editor-James W. Munson, Drug and Pharm. Sciences Marcel Dekker.

Journals

1.      At least one international journals is to be subscribed.

2.      Journal of Chromatography,

3.      Analyst.

ADVANCED PHARMACOLOGY AND TOXICOLOGY

1.      a. Neurotransmitter receptor mechanisms, ion channel and G-protein linked receptors, second messenger systems

b. receptor expression and regulation with specific emphasis on adrenergic, dopaminergic, cholinergic, serotonergic, histaminergic, GABA/BZ and excitatory amino acid receptors, opioid receptors, purinoceptors and their subtypes with agonists and antagonists.

c. Isolation and characterization of receptors.

2.      a. Mediators of inflammation and allergy.

b. Autacoids (Histamine, Bradykinins, PAF, Eicosanoids: Prostaglandins, thromboxanes, Leukotrienes and related compounds), nitric oxide/EDRF and vascular substances, oxygen free radicals, their scavengers.

c. Cytokines and their actions Cox-1, Cox-2 inhibitors and their role in inflammatory process, anti-inflammatory process, anti-inflammatory agents, asthma and COPD.

3.      Immunomodulators, AIDS, and Rheumatoid arthritis.

4.      Drugs acting on

a.       CNS: General anesthetics, anxiolytics & hypnotics, antipsychotics, antidepressants, anti epileptics, analgesics, anti migraine agents and Parkinsonism agents.

b.      ANS: Sympathomimetics, sympatholytics, parasympathomimetics,  parasympatholytics and neuro muscular junction blockers

c.       CVS: antihypertensives, cardiotonics, anti arrhythmics, anti anginal, hypolipidemics and anti atherosclerotic agents.

d.      Hormones- Pituitary, thyroid, parathyroid, pancreatic, adrenal, male and female sex hormones.

e.       Diabetes mellitus,

f.       GIT-GERD and antiulcer agents, emetics and antiemetics

g.      KIDNEY-diuretics and antidiuretics

5.      Recent developments in chemotherapeutic agents, mechanism of multidrug resistance (MDR), antibacterial, antiviral, anti protozoal and anthelmintics, Cancer chemotherapy.

6.      Toxicology:

a.       Definition,

b.      scope and general principles of toxicology,

c.       Dose-response relationships

d.      Factors influencing toxicity,

e.       Evaluation of safety,

f.       Biotransformation and toxicokinetics,

g.      Target organ toxicity: Neuronal and behavioural toxicity, kidney, pulmonary, hepatic, cutaneous, ototoxicity, haemotoxicity, mutagenecity, carcinogenicity, reproductive toxicity, environmental and industrial toxicology

h.      Management of toxicity reactions in humans.

TEXT BOOKS

1.      Basic and Clinical pharmacology by Bertram. G. Katzung (international edition) Lange Medical Book/McGraw-Hill U.S.A. (8^th edition).

2.      Pharmacology by Rang HP, Dale MM and Ritter JM. Churchill Livingstone, London, 4^th edition

3.      Goodman and Gilman’s The pharmacological basis of therapeutics, McGraw-Hill New York (10^th edition).

REFERENCE BOOKS

1.      General and applied toxicology by B. Ballantyne, T. Marrs, P.T urner (Eds) the Macmillan Press Ltd. London

2.      Clinical Pharmacy by D.R. Laurence, P.N. Bennett & M.J. Brown, 8^th edition Churchill Livingstone 1997

3.      Harrison’s principles of Internal medicine (2 volumes 2001) by Braunwald, Fauci, Kasper, Hauser, Longo Jameson, McGraw-Hill, New York 15^th edition.

Journals

1.      Trends in Pharmacological sciences.

2.      Indian Journal of Pharmacology

3.      Indian journal of physiology and pharmacology

4.      Annual reviews of pharmacology and Toxicology

5.      Pharmacological reviews

PHARMACOLOGICAL SCREENIG METHODS AND CLINICAL EVALUATION

1.      i. Study of lab animals, regulations and ethics requirements

ii. Transgenic animals and other genetically prone animal models (viz. Nude Mice, SH rats)

iii. Bioassays: basic principles of bioassays, official bioassays, experimental models and statistical designs employed in biological standardization.

iv. Intra cerebro-ventricular and other newer techniques of drug administration.

2.      Preclinical models employed in the screening of new drugs belonging to following categories:

a.       Antipsychotic agents

b.      Anti anxiety agents

c.       Nootropic drugs,

d.      Antidepressant drugs

e.       Anti Parkinson agents

f.       Analgesics

g.       Anti epileptics-models for status epilepticus

h.      Anti inflammatory agents,

i.        Antiulcer agents

j.        Anti anginals

k.      Anti arrhythmic

l.        Anti atherosclerotic drugs

m.    Anti malarial

n.      Anthelmintics

o.      Anti diabetics

p.      Drugs for myocardial infarction

q.      Anti hypertensive’s

3.      a. Definition and scope of pharmacokinetics

b. Physiological concepts and kinetics

c. Movement of drugs through membranes

d. Absorption

e. Distribution

f. Metabolism

g. Elimination

h. Integration with kinetics

i. Individualization: variability, genetics, age and weight, disease, interacting drugs, and monitoring of the same.

j. Pharmacokinetic models: compartment models, non-compartmental models and physiologic model.

h. Nonlinear pharmacokinetics, multiple dosing and dosage regimen.

4.      a. Drug development process,

b.      Clinical trials,

c.       Safety evaluation,

d.      Preparation of IND/NDAs

e.       Statistical designs in clinical trials,

f.       Data analysis techniques and presentation skills

g.      International guidelines (ICH recommendations) GLP including GCP

h.      ICMR guidelines

5.      a. Alternatives to animal screening procedures

b. cell-line,

c. Patch-clamp technique,

d. in-vitro models

e. Molecular biology techniques

TEXT BOOKS

1.      Drug discovery and Evaluation Pharmacological assays, 2^nd edition by H.Gerhard.vogel, springer-Verlag, Berlin Heidelberg.

2.      Fundamentals of Experimental pharmacology by M.N.Ghosh, Scientific book Agency, 2^nd edition, Calcutta.

3.      Clinical pharmacokinetics by Malcolm Rowland and Thomas M. Tozer 3^rd edition A. Lea and Febiger Book

4.      Bio-pharmaceutics and Pharmacokinetics by Leon Shargel, 3^rd edition, Williams and Wilkins

5.       Bio-pharmaceutics and Pharmacokinetics by Madan.

REFERENCE BOOKS

1.      Pharmacological experiments in intact preparations, Edinburgh university Pharmacology staff, Livingstone

2.      Pharmacological experiments on isolated preparations, Edinburgh University Pharmacology staff, Livingstone E & S Livingstone Edinburgh & London.

3.      Screening methods in Pharmacology, Academic press, New York and London.

4.      Biopharmaceutics and clinical Pharmacokinetics by Milo Gibaldi, Lea and Febiger Book, 3^rd edition.

Journals

1.      Indian Journal of pharmacology

2.      British Journal of pharmacology

MOLECULAR BIOLOGY

1.      Introduction

2.      The cell, cell cycle, Cellular aging and death, Animal cell culture.

3.      Structure and functions of plasma membrane

4.      Cell signaling: communication between cells and their environment, ion channels, organization of signal transduction pathways, third messengers, biosensors

5.      Role of genes within cells, DNA- the primary genetic material, elucidation of genetic code, Gene expression, Genetic elements that control gene expression.

6.      a. Recombinant DNA technology: Principles, process and applications

b. Gene cloning: isolation cloning vectors, enzymes used in molecular cloning, PCR (Polymerase chain Reaction), LCR (Ligation chain reaction) and their applications

c. The formation and uses of RFLP’s (Restriction Fragment Length Polymerism)

7.      Recombinant DNA and Human genetics:

a.       DNA sequencing,

b.      Mapping and cloning of human disease genes,

c.       DNA-Based diagnosis of genetic diseases

d.      Gene therapy and antisense technology

e.       Human genome project

8.      Biotechnology related techniques:

a.       Protein engineering,

b.      peptide chemistry

c.       peptidomimetics

d.      Nucleic acid technologies

e.       Catalytic antibodies

f.       Glyco biology

9.      Recombinant products in medicine with special reference to

A.    Insulin

B.     GH

C.     Vaccines

D.    Monoclonal antibodies

E.     FSH

F.      t-PA (tissue plasminogen activator)

G.    Biotechnology products in the pipeline

10.  Pharmacokinetics and pharmacodynamics of peptide and protein drugs: Elimination, distribution, pharmacodynamics and immunogenicity of protein therapeutics

11.  Bio Ethics

 

TEXT BOOKS

1.      Crommelin, DJA and sindelar, RD (Eds)-Pharmaceutical Biotechnology, Harward Academic publishers, Australia, UK

2.      Alberts, B et.a;-Molecular biology of the CELL, 3^rd edition, Garlound Publishing Inc. New York and London

3.      Goodman and Gilman’s The pharmacological basis of therapeutics, McGraw-Hill New York (10^th edition).

REFERENCE BOOKS

1.      Biopharmaceuticals: Biochemistry and Biotechnology by Gary Walsh 1998, John Wiley and sons

2.      Recombinant DNA, 2^nd edition by James D. Watson, Michael Gilman, Jan Witowski, Mark zoller, Scientific American books, New York 1996

Journals

1.      Gene therapy

2.      Cell

3.      Nature

4.      Molecular biology and medicine