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Hemchandracharya North Gujarat University

 

FACULTY OF PHARMACY

 

SYLLABUS OF M.PHARM

 

Subject Code : interpretation


1.   First Digit Indicates Semester Number  e.g. 

        1 for 1st Semester, 2 for 2nd Semester, 3 for 3rd Semester, 4 for 4th Semester

2.  Second Digit Indicates Paper Number e.g. 1,2 and 3

3.  Alphabets A, B, C, D Indicates Subject 

       A.    Quality Assurance (QA)

       B.    Pharmacognosy (CG).

       C.   Clinical Pharmacy (CP)

       D.    Pharmaceutical Chemistry (PC)

       E.    Dosage formdesign and BioPharmaceutics (DB)

       F.    Pharmaceutics & Pharmaceutical Technology (PT)

       G.    Pharmacology (CL)

 

Semester - I

 

Subject Code Disciplines Subject Name Distribution of Marks Grand Total
Theory Practical
11 (All) QA,CG,CP,PC,DB,PT,CL Modern Analytical Techniques 100 100 200
12 (All) QA,CG,CP,PC,DB,PT,CL Advance in Pharmaceutical Sciences 100 - 100
13A QA Pharmaceutical Quality Assurance 100 100 200
13B CG Chemistry of Medical Natural Product 100 100 200
13C CP Pathophysiology and Pharmacotherapeutics - I 100 100 200
13D PC Organic Chemistry 100 100 200
13E DB Pharmaceutical Formulation Design and Development 100 100 200
13F PT Pharmacokinetic and Formulation Design 100 100 200
13G CL Cellular and Molecular Pharmacology 100 100 200
Total Marks for each Discipline 300 200 500

 

Semester - II

Subject Code Disciplines Subject Name Distribution of Marks Grand Total
Theory Practical
21A QA, Standardization and Stabilization Method of Drugs 100 100 200
21B CG, Standardization and Stabilization Method of Herbal Formulation 100 100 200
21C/21E CP, DB Biopharmaceutics and Pharmacokinetics 100 100 200
21D PC Organic Chemistry - II 100 100 200
21F PT Advance in Pharmaceutical Technology 100 100 200
21G CL Advance Systemic Pharmacology 100 100 200
22A QA Special Techniques in Drug Analysis 100 100 200
22B CG Evaluation of Herbal Drugs and Formulations 100 100 200
22C CP Pathophysiology and Pharmacotherapeutics - II  100 100 200
22D PC Pharmaceutical Chemistry - I 100 100 200
22E/22F DB, PT Design & Development of Novel Drug Delivery System 100 100 200
22G CL Pharmacometrics and Evaluation of Drugs 100 100 200
23A/23E/23F QA, DB, PT Validation & c-GMP  100 - 100
23B CG Biotechnology and Cultivation of Medicinal Plants 100 - 100
23C CP Clinical Research and Approval of New Drugs 100 - 100
23D PC Pharmaceutics Chemistry - II 100 - 100
23G CL Clinical Pharmacotherapeutics and Toxicology  100 - 100
Total Marks for each Discipline 300 200 500

 

Semester - III

Subject Code Disciplines Subject Name Distribution of Marks Grand Total
Theory Practical
31 QA,CG,CP,PC,DB,PT,CL Seminar of Recent Subject in Pharmaceutical Sciences.  - 100 100
32 QA,CG,CP,PC,DB,PT,CL Seminar on Dissertation (Introduction) - 100 100
Total Marks for each Discipline - 200 200

 

Semester - IV

Subject Code Disciplines Subject Name Distribution of Marks Grand Total
Theory Practical
41 QA,CG,CP,PC,DB,PT,CL Thesis and Viva - 200 200
Total Marks for each Discipline - 200 200
 

11(All) : Modern Analytical Technique

Theory  

  1. Theory of UV, IR, derivative spectroscopy, FT-IR, NIR, ATR and their applications to structural elucidation.  

  2. Theory, instrumentation and application of flourimetry.

  3. Theory, instrumentation and application of atomic absorption and atomic emission spectroscopy. 

  4. Nuclear Magnetic Resonance Spectroscopy: Fundamental principles of NMR (Magnetic properties of nuclei: applied field & precession: absorption & transition frequency), chemical shift concept, factors affecting chemical shift, isotopic nuclei, reference standards; proton magnetic spectra, their characteristics, presentation, terms used in describing spectra & their interpretation (signal no, position, intensity), brief outline of instrumental arrangements & some practical details, signal multiplicity phenomena in high resolution PMR; Spin spin coupling application of signal splitting & coupling constant data to interpretation of spectra, proton exchange reaction, decoupling & shift reagent methods.

  1. Mass Spectrometry: Basic principles & brief outline of instrumentation, ion formation & types; molecular ions, meta stable ions, fragmentation processes, fragmentation patterns & fragment characteristic in relation to parent structure & functional groups, relative abundances of isotopes & their contribution to characteristic peaks mass spectrum; its characteristic, presentation & interpretation chemical ionization, Fast atom bombardment mass spectroscopy.

  2. Basic principle, applications and recent trends in chromatography.  

            o       HPLC, LCMS

            o       GC, GCMS

            o       HPTLC

            o       Ion exchange chromatography

            o       Ion pair chromatography

            o       Size exclusion chromatography

            o       Affinity chromatography

            o       Electro kinetic chromatography

            o       Supercritical Fluid Chromatography

 

Practical
The practical syllabus comprises of the exercises formulated based on the topics mentioned in the Theory syllabus.

 

Books Recommended:

1.      Munson Janues W. “Pharmaceutical Analysis” Marcel Dekker.

2.      Willard “Instrumental Method of Analysis” 7th edition CBS publication.

3.      SkoogPrinciples of Instrumental Analysis” 5th edition Thomson.

4.      Kenneth A. Conor “A textbook of Pharmaceutical Analysis, 3rd edition, John Wiley & sons.

5.      Robert M. Silverstein, “Spectrometric identification of organic compound”.

6.      B. K. Sharma Instrumental methods of chemical analysis, Goel Publication, 23rd edition.


12(All) : Advances in Pharmaceutical Sciences

Theory

Biostatistics 

The application of the following topics in Pharmacy shall be covered:

Mean, Median and Mode, Standard Deviation and Coefficient of variation, Students t-test, One way NOVA, Chi-square test, Probability, Frequency distribution, Regression analysis, Bioavailability – Cross-over study, Wilcoxon signed rank test, Introduction to control charts.

Pharmainformatics

Introduction to information resources available on Internet for the various subjects in Pharmacy (Pharmaceutical Technology, Pharmaceutical Chemistry, Quality Assurance, Pharmacology and Pharmacognosy). 

Experimental Designs 

Introduction to Full and Fractional Factorial Designs, central composite designs, Evolution of full and reduced mathematical models in experimental designs, Applications of the experimental designs for the subjects mentioned under Pharmainformatics, Introduction to contour plots.

Patents

Definition, Need for patenting, Types of Patents, Conditions to be satisfied by an invention to be patentable, Introduction to patent search.

The essential elements of patent; Guidelines for preparation of laboratory note book, Non-obviousness in Patent, Drafting of Patent claims, Important Patent related web-sites.
Brief introduction to Trademark protection and WO Patents.

Introduction to “The Patents Act 1970” and “The Patents Rules 2003”’ with special emphasis on the forms to be submitted along with a patent application.

Biotechnology in Drug Discovery

Cloning of DNA, Expression of cloned DNA, Manipulation of DNA sequence information, New Biological Targets for Drug Development. Novel Drug Screening Strategies, Novel Biological Agents, Antibodies, Antisense oligonucleotide Therapy, Gene Therapy 

Quality assurance and regulatory affairs

    1.      Basic Concept of quality assurance & requirement of cGMP (WHO, USFDA, MHRA).

    2.      ISO & ICH requirements of quality.

    3.      GLP Guidelines.

Registration of new drugs for importing and manufacturing in India.

Introduction to IND, NDA, ANDA for registration in USA.


Books Recommended:

1.      Web Resources in Pharmacy, InPharma Publication, Bangalore

2.       Basic Statistics and Pharmaceutical Statistical Applications by James E. De Muth, Marcel Dekker Inc.

3.      Method in Biostatistics by B.K.Mahajan, JayPee Brothers, New Delhi.

4.      Statistical Methods in Biological & Health Sciences by J.Susan Milton, Tata Mc GrawHill Int. Edition.

5.      Pharmaceutical Statistics by Standards Bolton, Marcel Dekker Inc.

6.      Pharmaceutical Experimental Design by G.A.Lewis, D.Mathiea, Roger Phan-Tan-Luu, Marcel Dekker Inc.

7.      Pharmaceutical Experimental Design and Interpretation by N.A.Armstrong L.K.C. James, Taylor & Francis.

8.      Current Patent Acts of Various countries.

9.      Sanford Bolton, “Pharmaceutical Statistics” 3rd edition, Drug & Pharmaceutical Sciences series Vol: 80, Marcel Dekker Inc.

10.  James E. Demath “ Basic Statistics and Pharmaceutical Statistical Application Marcel Dekker Inc. 

11. Mueen Ahmed K.K. “Web Resources in Pharmacy” Gareth A. Lewis, Didier Mathieu, Roger Phan – Tan-Luu, “Pharmaceutical Experimental Design”, Vol-92, Marcel Dekker Inc.


13A : Pharmaceutical Quality Assurance
 

Theory:

1.      A critical review of pharmacopoeia and other advanced methods used for qualitative and quantitative estimation of drugs and their formulations.

2.      An approach to the development of analytical methods for drugs in bulk and in their formulations, recovery studies.

3.      Methods of analysis of common excipients/ additives in formulations. Determination of active constituents in presence of these excipients.

4.      Analysis of drugs/metabolites in biological fluids like urine, blood and tissues, enzymatic analysis.

5.      Biochemical analysis of drugs, estimation of enzymes and other endogenous materials.

6.      Microbiological assay of antibiotics and vitamins. Immunological assays : - ELISA, immunoblotting , immunoflorescence, immunoaffility.

7.      Reference and working standard: source, preparation, characterization, usage, storage and records.

 

Practical

Laboratory examination including oral and practical examination in general course illustrative of theory section in the syllabus.

 

Books RECOMMENDED:

1.      IP, BP & USP

2.      Enzymes – Biochemistry, Biotechnology, Clinical Chemistry 

3.      Michael E. Swartz, Analytical method development & validation.

4.      S.Suzanne Nielsen, “Introduction to the Chemical analysis of foods”.

            D.C.Garratt “The quantitative analysis of drugs” 2nd edition.

13b : CHEMISTRY OF MEDICINAL NATURAL PRODUCTS (CG)

 

THEORY

1.      Classification of medicinally active constituents. General methods of Extraction procedures, Isolation, Purification and Identification of Natural Products such as Alkaloids, Glycosides, Tannins and other Phenolics, Volatile oils and Terpenoids, Fixed oils, Carbohydrates, Acetogenins and Marine products.

2.       Study of Biogenetic pathways of therapeutically important active constituents of plant origins. Techniques to investigate biogenetic pathways.

3.      Study of sources, isolation, purification, identification and analysis and structure illucidation of plant constituents of economical and medicinal importance such as Atropine, Ergometrine, Vincristine, Disosgenin, Sennosides, Glycyrrhetanic acid, Guggulipids, Boswellic acids, Rutin, Psoralen, Digoxin, Podophyllotoxin, Quinine, Reserpine, Echimic acid, Andrographolide, Withanolides and Withanoferins, Ginkolide, Silymarin, Picroside, Artimisin, Gymnemic acids, Curcuminoids, Embelin, Opium alkaloids, Menthol, Thymol, Citrrl, Taxol.

4.      Review of recent literatures appearing on Phytopharmaceuticals used as antiallergic, antimicribials, anti-inflammatory, anticancer, antidiabetic, antihepatotoxic and immunomodulators.

 

PRACTICAL
The practical syllabus comprises of the exercises formulated based on the topics mentioned in the Theory syllabus.

BOOKS RECOMMENDED:
    1. Manske- The Alkaloid- Chemistry and Physiology.
    2. Sim - Medicinal Plant Glycosides.
    3. Sim - Medicinal Plant Alkaloids.
    4. IUPAC - Chemistry of Natural Products - International symposium.
    5. Zechmeister - Progress in the Chemistry of Organic Natural Products.
    6. Reinhold - Liwschitz - Progress in Phytochemistry.
    7. Wagner - Wolf- New Natural Products and Plant Drugs with Pharmacological, Biological or Therapeutic Activity
    8. Finar- Organic Chemistry.
    9. Peach - Tracey - Modern Methods of Plant Analysis.
    10. Geissman - Modem Methods of Plant Analysis.
    11. Garatt - The Quantitative Analysis of Drugs.
    12. Backett - Stenlake - Practical Pharmaceutical Chemistry,
    13. Arthur-Symposium on Phytochemistry.
    14. Pridham - Swain - Biosynthetic Pathways in Higher Plants.
    15. Greenbury - Metabolic Pathways.
    16. Margaret - Brain - Secondary Plant Metabolism.
    17. Wagner - Horhammer - Pharmacognosy and Phytochemistry
    18. Harborne - Comparative Biochemistry of Flavonoids.
    19. Lehninger - Principles of Biochemistry,
    20. Bonner - Plant Biochemistry.
    21. Harborne - Phytochemical Methods.
    22. Rosenthaler - The Chemical Investigation of Plants.
    23. Cheronis - Organic Functional Group Analysis.
    24. Nakanishi -Natural Products Chemistry, Vol. 1 & Vol. 2


13C :  PATHOPHYSIOLOGY AND PHARMACOTHERAPEUTICS – I (CP)

THEORY

    1. Basic Concepts of  Pathophysiology and Pharmacotherapeutics

    2. Recording of medication history, self-medication, non-prescription drug usage, improving patient compliance and providing patient counselling,     

        communication skills – behavioral and interpersonal with patients and other professionals.

    3. Principles of pharmacovigilance and pharmacoeconomics.

    4. Drug interactions

        i. Prescription monitoring, documentation and other methods for minimizing clinically relevant drug interactions.

    5. Drugs induced diseases, adverse drug reactions and the role of clinical pharmacist in their monitoring and prevention.

    6. Interpretation of clinical laboratory tests

        i. Hematological, pathological and biochemical investigations as markers of major organ damage and their effect on drug therapy decisions.

    7. Concept of essential drugs and rational drug use.

    8. Concept of therapeutic drug monitoring.

    9. General principles of clinical toxicology

    10. Drug treatment during infancy and in the elderly (pediatric and geriatric considerations)

    11. Drug treatment during pregnancy and treatment of women including dysmenorrhoea, fertility control and hormone replacement therapy.

 

PRACTICAL

Practical exercises will be based on theory syllabus (i.e. pertaining to hospital based Haematological, Bio-chemical, Pathological and Diagnostic Tests).

Hospital visits, ward rounds, medication history and prescription analysis, etc.

 

BOOKS RECOMMENDED

    1. British National Formulary (Current Edition) – BMA/RPSGB

    2. Medicines, Ethics & Practice. The Pharmaceutical Press

    3. Oxford Text Book of Clinical Pharmacology and Drug Therapy, 3rd edition,

        Graham-Smith D. and Aronson J., Oxford University Press

    4. Hand Book of Pharmacy Health Care. The Pharmaceutical Press

    5. Drug Interactions. Stockley I.H. (1996). The Pharmaceutical Press

    6. Katzung. B.B., Basic and Clinical Pharmacology. Prentice Hall, International.

    7. Harrisons Principles of Internal Medicine. Medical Toxicology (Ellen Horns)

    8. Davidson’s Principle and Practice of Medicine, Eds. Christopher R. W., Edwards & Ian A.D. Boucher ELBS with Cdnorchill Living stone. Edinburgh.     

        Latest Edition.

    9. Oxford Text Book of Medicine, 4th edition, David A. Warrell, Timothy M. Cox, John D. Firth.

    10. CRC desk reference of Clinical Pharmacology, Manuchair Ebadi.

    11. Oxford Text Book of Pharmaceutical Medicine, 4th edition, John P. Griffin, John O’Grady.    

    12. Principles of Pharmacology, the Pathophysiological Basis of Drug Therapy, Lippincott, Williams & Wilkins.

    13. Drug Interaction Facts, 2003. David S. Tatro.

    14. Emergency Toxicology, 2nd edition. Peter Viccellio.

    15. Toxicology - The basic science of poisons, international edition, Curtis D.Klaassen, 6th edition.

    16. Toxicology – Principles and Applications, Raymond J.M.Niesink, John de.Vries, Mannfred A. Hollinger.

    17. Clinical Pharmacy and Therapeutics. Roger Walker and Clive Edwards, Churchill Livingstone Edinburg/ London.

    18. Pathology & Therapeutics for Pharmacists. Russel. J. Greene and Normal F.Harris. Chapman & Hall, London/ Glasgow/ Madras.

    19. Text Book of Therapeutics: Drug and Disease Management. 7th Edition. Editors: Eric T. Herfindal and Dick R. Gourley, Williams and Wilkins, 2000.]

    20. Davidson’s Principles and Practice of Medicine, Eds. Christopher R.W.Edwards and Lan A.D.Bouchier ELBS with Churchill Livingstone, Edinburgh. Latest

          Edition.

    21. Applied Therapeutics: The Clinical Use or Drugs Eds. Brian S.Katcher, Lioyd Yee Young, Marry Anne Koda-Kimble, Applied Therapeutics Inc.     

          Spokane. Latest Edition.

    22. Pathology & Therapeutics for Pharmacists. Greene, R.J & Harris, N.D. (1993). The Pharmaceutical Press.

    23. De Gruchi’s Clinical Haemotology in Medical Practice. Frank Firkin, Bryan Rush, David Penington, Colin Chesterman. Blactwell Scientific Publication. 5th 

          edition.

    24. Robbins Pathologic Basis of Disease. Cartran, Kumar, Collins, W.B.Saunders. 6th edition.

    25. Textbook of Medical laboratory Technology. Praful B. Godkar, Darshan P.Godkar, Bhalani Publication House, Mumbai. 2nd edition.

    26. Manual of basis techniques for a health laboratory, 2nd edition, World Health Organization, Geneva.


13D : ORGANIC CHEMISTRY-I (PC)
 

THEORY  

    1.   Chemical Bonding and Structure

          Chemical bonding, Bond energies, Orbital theory, Orbital Hybridization Reson    Electronegativity, Polarity, Hyperconjugation.

    2.   Chemical Reactivity and Molecular Structure

          Kinetics, Resonance, Stearic, Inductive and electrostatic effect on reactivity, Acids and Bases

    3.   Various Reaction mechanisms

            a)    Substitution Reaction: Nucleophilic substitution reaction in aliphatic systems- SN1, SN2, Hydride transfer reaction, Cram’s rule, Participation of 

                   neighboring group in nucleophilic substitution-reactions and rearrangements.Aromaticity, electrophonic and nucleophilic substitution in aromatic 

                   systems Reactivate orientation in electrophilic substitution.

            b)   Elimination Reaction: Beta elimination reactions, E1, E2 & E1cb mechanisms Hoffman Saytzeff’s elimination.

            c)   Addition Reactions: Nucleophilic additions, Markonikov’s rule

            d)   Rearrangement reactions:  Transannular rearrangement, Pinacol and related rearranger Beckman rearrangement, Hofmann rearrangement.

            e)   Free radical reactions: Formation – Detection – Reactions, Homolysis and free displacements – additions and rearrangements of free radicals.

    4.    Reactions of carboxylic acids and esters

           BAC2, AAC2, BAL2, BAL1, AAL1. Claisen condensation, decarboxylation, cabanions enolis keto-enol equilibria

    5.    Stereochemistry

            Molecular asymmetry, compounds with one, two or more unequal asymmetric carbon racemic modifications, Configurations – absolute, relative, synthesis 

            of optically active compounds cyclohexane, six membered heterocyclic rings – stereoisomerism of compounds with asymmetric plane – allenes and related 

            compounds – stereoselective synthesis.

 

PRACTICAL

The practical syllabus comprises of the exercises based on the topics mentioned in the Theory syllabus.

 

BOOKS RECOMMENDED

  1. J. March , Advanced Organic Chemistry, Reaction Mechanisms and Structure, (John Wiley and Sons, N.Y).

  2. E.S.Gould, Hold Rinchart and Winston,, Mechanisms and structure in Organic Chemistry, New York.

  3. Thomas N. Serrell, Organic Chemistry, 1st edition, (Viva Books Pvt. Ltd.)

  4. A. Carey, Organic Chemistry, 5th edition, (Tata Mcgraw -  Hill Pub. Comp. Ltd.)

  5. R.A. Sheldon, Chirotechnology, (Marcell Dekker Inc., New York, 1993).

  6. R.A. Aitken and S.M. Kilengi, Asymmetric Synthesis, , Ed., (Blackie Academic and Professional, London, 1992).

  7. Finar Vol-1 & 2, Organic Chemistry.


13e : PHARMACEUTICAL FORMULATION DESIGN AND DEVELOPMENT (DB)

 THEORY  

     1.     Preformulation studies - Perspective and concepts: Detailed study of parameters like solubility, paratition coefficient, dissolution, 

           crystal morphology, crystal optics, polymorphism and purity studies: drug excipient compatibility study.

    2.    Dissolution Study:

            - Importance, objectives, equipments

            - Biological classification system (BCS); its significance on dissolution study and application in dosage form development.

            - Selection of dissolution medium and conditions.

            - Comparison of dissolution profile by model independent (similarity and dissimilarity factor) and    dependent method.

    3.    Stability studies: 

            - Basic concept and objectives of stability study.

            - Order of reaction and their applications in predicting shelf life and half-life of Pharmaceutical formulations.

            - Importance of accelerated stability study.

            - Effect of various environmental / processing on stability of the formulation and techniques for stabilization of products against the same.

            - Regulatory requirements related to stability testing with emphasis on matrixing/bracketing techniques, climatic zone, impurities in stability study 

               photostability testing etc.

            - Application of microcolorimetry in stability study.

    4.    Polymers - Classification. General methods of synthesis, properties, characterization and evaluation: Biodegradable polymers - Classification - Mechanism 

           of  biodegradation in the body: Polymer processing with respect to novel formulation design: Applications of polymers in novel drug delivery systems, 

           Medical prosthetics and packaging.

    5.    In-vitro In-vivo Correlation (IVIVC)

           Methods of establishing IVIVC

           Factors effecting IVIVC

    6.    A Brief study on formulation and evaluation of specialized pharmaceutical dosage form Dry syrup, Topical gel,, Microemulsion, dry powder, Parenteral 

           emulsion  and suspension, occuserts, Clear shampoo, hair cream, Face wash, Sunscreen Lotion, Antiwrinkle cream, Face wash

 

PRACTICAL

The practical syllabus comprises of the exercises formulated based on the topics mentioned in the Theory syllabus.

 

BOOKS RECOMMENDED

    1.      Milo Gibaldi and Donald Perrier, "Pharmacokinetics", Drugs and Pharm. Sci. Series, VoL 15., Marcel Dekker Inc., N.Y.

    2.   J.C. Wagner, "Fundamentals of Clinical Pharmacokinetics", Drug Intelligence Publications, Hamilton, 1975.

    3.   Bert N. LaDu, "Fundamentals of Drug Metabolism & Disposition", Waverley Press Inc., Baltimore, 1972.

    4.   T.Z.Laaky, "Intestinal Absorption & Malabsorption", Raven Press, N.Y., 1975.    

    5.   J.T.Carstensen, "Theory of Pharm. Systems", Vols. 1-3, Academic Press, N.Y.

    6.   U.S. Beans, A.K.Beckett and J.E.Caraless,  “Advances in Pharm.Sci.”, Vol. 1 to 4.

    7.   J.T.Carstensen, "Drug Stability: Principles and Practices", Drugs and Pharm. Sci. Series, Vol. 43, Marcel Dekker Inc., N.Y.

    8.   Lisbeth lliun & Stanley S. Davis: "Polymers in Controlled Drug Delivery", Wright, Bristol (1987).

    9.   Pharmaceutics “The Science of Dosage form design” by Aulton.

    10.  Encyclopedia of Pharmaceutical technology Volumes: 1 to 19.

    11.  Remingtons Pharmaceutical Sciences 19th edition.

    12.  Pharmaceutical dissolution testing by Banaker.    

    13.  Pharmacokinetics by Welling and Tse.

    14.  Modern Pharmaceutics by G.S.Banker

    15.  Clinical Pharmacokinetics, Concepts and applications, by Rowland and Tozer.

    16.  Biopharmaceutics and Pharmacokinetics – An introduction by Notari.

           Techniques of Solubilization of Drugs by Yalkowsky


13 f : PHARMACOKINETICS AND FORMULATION DESIGN (PT)
 
THEORY  

1.      Nonlinear  Pharmacokinetics: Michaelis-Menten Kinetics, Estimation of Km and Vm Clearance, half life and volume of distribution, steady state, Bioavailability etc., Urinary excretion process and other nonlinear elimination process, some problems in quantifying nonlinear pharmacokinetics.  

2.   Physiological Pharmacokinetic Models: Compartment models, Blood flow rate - limited models - blood clearance, lung clearance, apparent volume of distribution, nonlinear dispositions, Membrane limited models.

3.      Noncompartment Analysis : based on statistical moment theory : statistical moments, Bioavailibility, clearance, Half life, Absorption kinetics, apparent volume of distribution etc., Steady state.

4.   In-vitro In-vivo Correlation (IVIVC) 

Methods of establishing IVIVC

Factors effecting IVIVC

5.      Computer modeling of dissolution & pharmacokinetic data.

6.      Preformulation studies - Perspective and concepts: Detailed study of parameaters like solubility, partition coefficient, dissolution, crystal morphology, crystal optics, polymorphism and purity studies: drug excipient compatibility study.

7.      Stability studies: 

    - Basic concept and objectives of stability study.

    - Order of reaction and their applications in predicting shelf life and half-life of pharmaceutical formulations.

    - Importance of accelerated stability study.

    - Effect of various environmental / processing on stability of the formulation and techniques for stabilization of products against the same.

    - Regulatory requirements related to stability testing with emphasis on matrixing/bracketing techniques, climatic zone, impurities in stability study 

       photostability   testing etc.

    - Application of microcolorimetry in stability study.

      8.      Polymers - Classification. General methods of synthesis, properties, characterization and evaluation: Biodegradable polymers - Classification - Mechanism 

            of biodegradation in the body: Polymer processing with respect to novel formulation design: Applications of polymers in novel drug delivery systems, 

            Medical prosthetics and packaging.

9.      Dissolution Study:

    - Importance, objectives, equipments

    - Biological classification system (BCS); its significance on dissolution study and application in dosage form development

    - Selection of dissolution medium and conditions.

    -   Comparison of dissolution profile by model independent (similarity and dissimilarity factor) and dependent method.

 

PRACTICAL

The practical syllabus comprises of the exercises formulated based on the topics mentioned in the Theory syllabus.

 

BOOKS RECOMMENDED

    1.   Milo Gibaldi and Donald Perrier, "Pharmacokinetics", Drugs and Pharm. Sci. Series, VoL 15., Marcel Dekker Inc., N.Y.

    2.   J.C. Wagner, "Fundamentals of Clinical Pharmacokinetics", Drug Intelligence Publications, Hamilton, 1975.

    3.   Bert N. LaDu, "Fundamentals of Drug Metabolism & Disposition", Waverley Press Inc., Baltimore, 1972.

    4.   T.Z.Laaky, "Intestinal Absorption & Malabsorption", Raven Press, N.Y., 1975.

    5.   J.T.Carstensen, "Theory of Pharm. Systems", Vols. 1-3, Academic Press, N.Y.

    6.  U.S. Beans, A.K.Beckett and J.E.Caraless,  “Advances in Pharm.Sci.”, Vol. 1 to 4.

    7.   J.T.Carstensen, "Drug Stability : Principles and Practices", Drugs and Pharm. Sci. Series, Vol. 43, Marcel Dekker Inc., N.Y.

    8.   Lisbeth lliun & Stanley S. Davis : "Polymers in Controlled Drug Delivery", Wright, Bristol (1987).

    9.   Pharmaceutics “The Science of Dosage form design” by Aulton.

    10.  Encyclopedia of Pharmaceutical technology Volumes: 1 to 19.

    11.  Remingtons Pharmaceutical Sciences 19th edition.

    12.  Pharmaceutical dissolution testing by Banaker.

    13.  Pharmacokinetics by Welling and Tse.

    14.  Modern Pharmaceutics by G.S.Banker

    15.  Clinical Pharmacokinetics, Concepts and applications, by Rowland and Tozer.

    16.  Biopharmaceutics and Pharmacokinetics – An introduction by Notari.    

    17.  Techniques of Solubilization of Drugs by Yalkowsky.

    18.  Applied biopharmaceutics & Pharmacokinetics, Leon shargel

 


13g : cellular and molecular pharmacology (cl)
 

THEORY

  1. Molecular structure of biological membrane and transport mechanism across cell membrane.

  2. Factors influencing drug absorption.

  3. Drug distribution -  protein binding, tissue binding - blood brain, barrier, placental barrier, Volume of Distribution.

  4. Biotransformation of drugs - microsomal, non-microsomal metabolism, factors influencing, enzyme induction and inhibition, pharmacogenetics.

  5. Drug excretion - renal and non renal, factors influencing renal clearance, biological half life.

  6. Pharmacokinetics - single and multiple dose therapy, single and multiply compartment models, bioavailability

  7. Physicochemical basis of drug action including quantitative structure activity relationship.

  8. Theories of drug receptors and drug receptor interactions.

  9. Drug antagonism

  10. Cellular and molecular basis of drug action.

  11. Neurotransmitters and neuropeptides in CNS disorders.

  12. Electrophysiotogy of heart - pathophysiology of cardiac disorders

  13. Molecular structure and functions of ion channels.

  14. Physiology of renal functions - electrolyte metabolism, acid - base  equilibrium, renin angiotensin system.

  15. Vitamins.

  16. Hematinics.

  17. Gene expression and regulation

  18. Gene cloning with respect to action of drugs.

  19. Pharmacogenomics.

  20. Autacoids.

  21. Immunopharmacology

PRACTICALS

  1. Calculation of PA2, PD2 values using isolated tissue preparations - Rat fundus strip, rat uterus, guineapig tracheal chain, rabbit aortic strip, I leal preparation, mammalian heart - etc.

  2. Simple Bioavailability studies

  3. Exercise in Molecular Pharmacology.


21A: Standardization and Stabilization Methods (QA) 

Theory

  1.      General methods

                                 i.            WHO guide lines of the standardization of Herbal raw materials and finished products.

                               ii.            Morphological, microscopical, cytomorphological and chemical examinations of raw materials and finished products.

                              iii.            Determination of Physical and chemical constants such as extractive values, moisture content, alcohol content, volatile oil content, ash values, bitterness values, foreign matters, and physical constants applicable to the lipid containing drugs.

                             iv.            Microbial counts, bioburden and Pharmacopoeial microbial assays.  

2.      Standardization

                                 i.            Standardization of food products. Concepts of nutritional requirements at different age, sex, and in different conditions like normal, pregnancy and diseases like diabetes, hypertension and atherosclerosis, jaundice etc. Different types of additives used and analysis of these ingredients in ethical and non ethical foods.

                               ii.            Standardization of cosmetics. Information on ingredients used in various cosmetics such as creams, powders, lotions, hair products nail polishes, lipstick, depilatories, toiletries etc. and their analysis.

                              iii.            Standardization of Herbal products. Physicochemical characterization in whole form, separation and identification of active principles, excipients and their estimation by different techniques.  

3.      Stability

                                 i.            Factors affecting stability of a formulation, ICH guidelines, Methods of stabilizations and Methods of stability testing. Concept of development of stability indicating analytical methods.

Practical
    The practical syllabus comprises of the exercises based on the topics mentioned in the Theory syllabus.

Books recommended
    1. Food additive- R. J. Taylor
    2. Antimicrobial in food- Alfred larry branen. P Michael division publishing
corporation
    3. Method of protein analysis by istran kerese.
    4. Cosmetic analysis- selective methods and techniques by P. Borc
    5. Henry,s cosmeticology- Martin M. Rieger.
    6. Cosmaceuticals Drug vs Cosmetics
    7. Herbal cosmetics. Beuty through Herbs- Dr. Urjita jain.
    8. Morris B. Jacobs. The chemical analysis of foods and food products.
    9. S. Suzanne Neilson. “ Introduction to chemical analysis of foods.’
    10. Jemns T Cartenson. Drug stability- Principles and Practices. 2nd edition,
Marsel deckker.  
    11. Applied Microbiology. Vinitakale Kishor Bhusari.
    12. Michael J. Pelezar/ Chan/ Kricg. “ Microbiology. 5th edition,
    13. Tortora, Funke, Case.” Microbiology”- An introduction. 8th edition.
    14. P.P.Sharma.- Cosmetics Formulation, Manufacturing and Quality control.
    15. WHO Guide line for the quality control of herbal plant material.
    16. The practical evaluation of phytopharmaceutical by brain & turner
    17. Indian herbal pharmacopoea- Vol-I & II


21C/21E : BIOPHARMACEUTICS AND PHARMACOKINETICS (CP, DB)

 

 THEORY

    1.  Drug Absorption

         Relevant anatomy & Physiology of organs involved in drug absorptions; factors affecting drug absorption following oral, parenteral, topical, Buccal, rectal,     

         vaginal, urethral and nasal administration of drugs; methods of studying drug absorption following different routes of administration; kinetics of drug     

         absorption.

    2.  Drug Distribution

         Distribution in the blood, beyond the blood compartment tissue localization; volumes of distribution.

    3.  Drug Biotransformation 

         Sties of drug biotransformation; kinetics of drug biotransformation, Phase-l and Phase-II biotransformation reactions; mechanisms of microsomal     

         oxidation; mechanisms of glucuronide formation; factors affecting biotransformation; methods of studying biotransformation of drugs; usefulness of     

          biotransformation study in drug design and dosage forms.

    4.  Drug Excretion 

         Excretion in urine, biliary excretion, excretion in expired air, excretion in the stomach; excretion in the intestine, saliva, breast-milk, genital  secretions, sweat.

    5.  Bioavailability and Bioequivalence Testing

    6.  Pharmacokinetic Models

         Instantaneous distribution models; delay distribution equilibrium models; nonlinear pharmacokinetic models; pharmacological pharmacokinetic models.

    7.  Clinical Applications of Pharmacokinetic Parameters

         Blood level curves; continuous blood and tissue levels in therapy; dosage regimensaccumulation during repetitive dosing; adjustment of dosage regimen in     

         renal failure; distribution dependent dosage adjustment; pharmacokinetic drug interactions. Applications in TDM and patient care specific drugs and disease 

        states, effects of age and concomitant drug administration.

    8.  Pharmacokinetic Basis of Controlled Drug Delivery

    9.  Statistical treatment of data, test for significance, t-test, analysis of variance repression analysis, standard deviation, standard error, fiducial limits, hypothesis 

         testing,randomization etc.

    10 Application of computer in clinical research.

 

PRACTICAL

Practical exercises will be based on theory syllabus

 

BOOKS RECOMMENDED

    1. Modern Pharmaceutics by Banker & Rhodes.

    2. Pharmacokinetics, Milo Gibaldi and Donald Perrier

    3. Pharmacokinetics and Drug Metabolism by Testa – Jhenner

    4. Rowland M. and Tozer T.N. Clinical Pharmacokinetics, Lea & d Febiger, NY.

    5. Winter M.E., Basic Clinical Pharmacokinetics, Applied Therapeutics, Inc. San Fransisco

    6. Welling Peter G. and Tse Francis L.S., Pharmacokinetics, Marcel Dekker Inc. N.Y.

    7. Wirth N. Systematic Programming – An Introduction Prentice Hall Englewood Cliff’s New Jersey.

    8. S. Bolton – Pharmaceutical Statistics

    9. Lectures on Biostatistics by D.Colquhoun


21d: ORGANIC CHEMISTRY-II (PC)

 

Theory

    1.      Study of individual reactions

    Allylic rearrangement – Arndt Eister synthesis – Baeyer  Villiger reaction Baker-Venkatraman reaction - Benzidine rearrangement - Benzilic acid         

    rearrangement-Carrol reaction-Curtius rearrangement- Dimorth rearrangement - Favorskii rearrangement - Lossen-Schmidt rearrangement - Pinner reaction 

    - Reformatsky reaction - Robinson Annelation reaction - Witting reaction - Diels-Alder reaction, Birch reduction, Mannich reaction.

    2.      Use of diazonium salt-diazomethane and peracids in synthesis

    3.      Y-lides of phosphorous-sulphur-nitrogen

    4.      Photochemistry

    Theory-energy transfer-characteristics of photoreactions – typical photo reaction

    5.  Concerted pericyclic reactions

                Electrocyclic reaction – sigmatropic rearrangem cycloaddition reactions.

          6.   Heterocyclic chemistry

          Introduction-nomenclature-properties-synthesis and reactions involved in five membered and six membered heterocycles. Heterocycles with one, two or 

          more hetero atoms . Biological importance of heterocycles.

 

PRACTICAL

The practical syllabus comprises of the exercises based on the topics mentioned in the Theory syllabus.

 

BOOKS RECOMMENDED

  1. J. March , Advanced Organic Chemistry, Reaction Mechanisms and Structure, (John Wiley and Sons, N.Y).
  2. E.S.Gould, Hold Rinchart and Winston,, Mechanisms and structure in Organic Chemistry, New York.
  3. Bernard Miller , Advanced Organic Chemistry, Reaction Mechanisms, 2nd edition, (Pearson education Ptc. Ltd. Singapore).
  4. Thomas Lane & Andreas Plagens, Named Organic Reactions, 2nd edition, (John Wiley and Sons, N.Y).  
  5. Maya Shankar singh, Advanced Organic Chemistry, Reaction Mechanisms 1st edition, (Pearson education Ptc. Ltd. Singapore).
  6. Finar Vol-1 & 2, Organic Chemistry.

21F : ADVANCE IN PHARMACEUTICAL TECHNOLOGY (PT) 

 

Theory

    I.       Production Management, Production Planning, Fundamentals of production, organization, economic policy, manufacturing economics, production     

          capacities,production lines, and job balancing.

    II.   Consideration for design of large scale manufacturing unit including intricate design criteria for units to manufacture of sterile and nonsterile products with     

           special reference to tablets, capsules and injections. As per Schedule M.

    III.  Design and development of packaging units including recent advances in packaging techniques for various types of sterile and non sterile dosage 

           forms.Stability aspects of packaging, regulatory aspects of packaging.

    IV.  Process automation in Pharmaceutical manufacturing.

    V.   Pilot plant, scale up technique, introduction to SUPAC guidelines.

    VI.  A Brief study on formulation and evaluation of specialized pharmaceutical dosage form Dry syrup, Topical gel,, Microemulsion, dry powder, Parenteral 

           emulsion and suspension, occuserts, Clear shampoo, hair cream, Face wash, Sunscreen Lotion, Antiwrinkle cream, Face wash etc

 

PRACTICAL

The practical syllabus comprises of the exercises formulated bases on the topics mentioned in the Theory syllabus

 

BOOKS RECOMMENDED

    1.      H.A. Libermen & L. Lachman, Pharmaceutical Dosage Forms: Tablets, Vol. I to III, Marcel Dekker Inc., N.Y.

    2.   K.E.Avis, Pharmaceutical Dosage Forms: Parental Medication, Vol. I Marcel Dekker Inc., N.Y.

    3.   S. Turco and R.E. King, Sterile Dosage Forms, 2nd edition.

    4.   Pharmaceutics “The Science of Dosage form design” by Aulton.

    5.   Encyclopedia of Pharmaceutical technology Volumes: 1 to 19.

    6.   Remingtons Pharmaceutical Sciences 19th edition


21G : ADVANCED SYSTEMIC PHARMACOLOGY (CL)

THEORY

  1. Parasympathomimetics.                                                                                                         

  2. Parasympathetic blocking agents

  3. Sympathomimetics.

  4. Sympathetic blocking agents                                                                                

  5. Ganglion stimulants and blockers                                                                

  6. Neuromuscular stimulants and blockers                       

  7. General and local anaesthetics                                                                                        

  8. Sedatives and Hypnotics.                                                                                                       

  9. Antiepileptics.                                                                                           

  10. Psychopharmacological agents                                                                   

  11. Analgesics                                                                                           

  12. Anti-inflammatory agents                                                                             

  13. Drugs used in Alzeimer's disease                                                                  

  14. Drugs used in Migraine                                                                                                          

  15. Anti-Parkinson's drugs                                                                                                               

  16. CNS Stimulants                                                                                                                    

  17. Cardiotonics                                                                                                                           

  18. Anti-Hypertensive drugs                                                                                                   

  19. Anti-Arrhythmic drugs                                                                                                   

  20. Drugs used in Ischaemic Heart Disease                                                                          

  21. Drugs used in Atherosclerosis                                                                                                

  22. Diuretics                                                                                                                                  

  23. Drugs used in Gastro-intestinal disorders                                                                                 

  24. Drugs used in Respiratory disorders                                                                                             

  25. Drugs used in Urino-genital disorders                                                                                 

  26. Drugs used in Diabetes                                                                                                          

  27. Drugs used in Endocrine disorders

 

PRACTICAL

Practicals related to above mentioned syllabus for Paper-II

 

BOOKS RECOMMENDED 

    Latest editions of

    1.      Goodmann & Gilmann’s The Pharmacological basis of therapeutics – J.G.Hardman & L.E.Limbird

    2.      Pharmacology by H.P.Rang & M.M.Dale

    3.      Pharmacology & Pharmacotherapeutics by R.S.Satoskar & S.D.Bhandarkar

    4.      Essential of Medical Pharmacology, By K D Tripathi

    5.      Textbook of Pharmacology, By S. D. Seth

    6.      Principle of Internal Medicine Vol I & II by Braunwald, Harrison et al.

    7.      Essential of Pharmacotherapeutics By F. S. K. Barar

    8.      Textbook of Therapeutics, Drug and Disease Management, By Fric T. Herfindal, Dick R. Gourley

    9.      Principles of Pharmacology A Tropical Approach, By D T Okpako, M Thomas, M A Oriowo

    10.  Medical Pharmacology Principles and Concepts, By Andres Goth and Elliot S Vessell

    11.  Pharmacology By Mary J Mycek et al.

    12.  Principles of Pharmacology Basic Concepts and Clinical Applications By Paul L. Munson et al.

     13. Essential of Pharmacology for Health Occupations by Ruth Woodrow


22A: Special Techniques in Drug Analysis (QA)

 

Theory

  1. Ion Selective Electrodes: Classification, instrumentation and applications in drug analysis.

  2. Voltametry : Theory and Principles, AC pulse polarography and Square wave polarography.

  3. Chemiluminescence; Principle, instrumentation and applications.

  4. Electron spin Resonance - Principle, Instrumentation, interpretation of spectra, applications.

  5. Emission Methods - Spark emission and Plasma emission, instrumentation and application.

  6. Flow injection Analysis.

  7. Radiochemical Analysis - Instruments used - analytical and screening instruments, Isotopic dilution, neutron activation, and Positron Emission  Topography (PET).

  8. Photoacoustic spectroscopy; Principle, instrumentation and applications.

  9. Laser: Basic principles, Classification, instrumentation and applications.

  10. Raman Spectroscopy; Principle, Instrumentation & applications, Interpretation of Raman Spectra.

  11. Electrophoresis. Moving boundary electrophoresis, zone electrophoresis isotachphoresis isoelectric focousing continuous electrophoresis (preparative)

  12. Principals and procedure involved in using the following reagents in pharmaceuticals analysis: - 2, 6 – dichloro qunone chlorimide, 1, 2- nappthaquinone –4- sulfate, 2,3,5-triphenyltetrazolium salt, 3- methyl-1, 2-benzothiazoline hydrazone hydrochloride (MBTH), Folium ciocalteu reagent, p- dimethylamino benzaldehyde/ cinnamaldehyde (PDAB), (PDMAC), ninhydrine reagent.

  13. X-ray diffraction methods: - Introduction, generation of X- ray, elementary crystallography, milier indices, X-ray, diffraction Bragg’s low X-ray power diffraction, X-ray power diffractometer, obtaining and interpretation of X-ray power diffraction data.

  14. Thermal method of analysis: - Introduction TCA, DTA, and DSC theory, instrumentation of thermographs and application.

Practical
The practical syllabus comprises of the exercises based on the topics mentioned in the Theory syllabus.

 

Books RECOMMENDED 

    1.    H.M.Willard, L.L,Meritt, J. A. Dean and F. A. Settle, 'Instrumental methods of Analysis", CBS Publishers, Delhi.

    2.    D.A.Skoog & P.M.West, "Principles of Instrumental Analysis".

    3.    W. Kamp, "Organic Spectroscopy”.

    4.    G.H.W.Ewing, "Instrumental Methods of Chemical Analysis. 


22b: EVALUATION OF HERBAL DRUGS AND FORMULATIONS (CG)

 

THEORY

  1. Development of Ayurvedic and Herbal formulations and their evaluation by physical methods, chemical methods and microscopical techniques. 

  2. Application of various chromatographic methods in separation and identification of marker compounds in the formulations. Fingerprinting techniques and its importance.

  3. Development of analytical techniques for the estimation of markers present in the Herbal and classical formulations. 

  4. Evaluation of Herbal drugs and formulations by Biological methods. General animal models for screening of Herbal drugs and formulations. 

  5. Toxicological evaluations of herbal drugs and formulations. Methods and materials for Acute, sub acute and chronic toxicity studies. Teratogenicity, mutagenicity and carcinogenicity studies. WHO and other regulatory requirements for toxicological evaluations.

  6. WHO and Indian regulatory requirements of Clinical trials for herbal formulations. 

  7. Techniques in estimation of enzymes and endogenous substances in body fluids in physiological and pathological conditions.

  8. Schedule T requirements and other regulatory requirements for the manufacturing of Herbal and Ayurvedic products.

PRACTICAL
Laboratory examination including oral and Practical examination in general course illustrative of Theory section in the syllabus.

BOOKS RECOMMENDED
    1. Biological standardization by J.N.Barn, D.J.Finley and L.G. Good win
    2. Indiand pharmacopoea, Indian Herbal Pharmacopoea and other pharmacopoea.
    3. Ayurvedic Formulary of India.
    4. Screening methods of Pharmacology By Robert turner
    5. Evaluation of drug activities by Laurance and Bachrach.
    6. Methods in Pharmacology by Arnold Schwartz.
    7. Fundamentals of experimental pharmacology by. M. N. Ghosh
    8. Text book of invitro Practical pharmacology by Ian Kitchen.
    9. Peach - Tracey - Modern Methods of Plant Analysis
    10. WHO guide lines for the quality control of Herbal plant materials
    11. Wagner, Plant drug analysis.
    12. The Practical evaluation of Phytopharmaceuticals by Brain and Turner.
    13. Thin layer chromatography by Egon stahl. 
    14. Drug Discovery & Evaluation by H.Gerhard Vogel

    15. Quality Standards of Indian Medicinal Plants Vol-I, ICMR, New Delhi

22C: PATHOPHYSIOLOGY AND PHARMACOTHERAPEUTICS – II (CP)

 

THEORY

Pharmacotherapeutic management of selected acute and chronic diseases and disorders. Emphasis is on designing and monitoring of drug therapy to ensure optimum therapeutic outcomes for following diseases.

 

    1. Cardiovascular

        Hypertension, angina pectoris, congestive heart failure, myocardial infarction,cardiac arrhythmias, atherosclerosis.

    2. CNS

        Epilepsy, Parkinsonism, schizophrenia, depression, migraine, Alzheimerdisease.

    3. Renal

        Acute renal failure, chronic renal failure.

    4. Respiratory

        Chronic Pulmonary obstructive diseases including bronchial asthma.

    5. Gastrointestinal

        Peptic ulcer disease, ulcerative colitis, hepatitis, cirrhosis.

    6. Haemopoetic

        Anemias.

    7. Joint and Connective Tissue

        Rheumatoid arthritis, osteo arthritis, gout and hyperuricemia

    8. Endocrine

        Endocrinal disorders including Diabetes mellitus, thyroid and parathyroid diseases.

    9. Neoplastic

        Acute leukemias, Hodgkins disease and carcinoma of breast etc.

  10. Infections

        Various infectious diseases including Tuberculosis, urinary tract infections, enteric infections, upper respiratory tract infections, sexually transmitted

        diseases and AIDS.

  11. Concept of acute care medicine

        Managing ICUs, T.P.N. and Emergencies

  12. Diseases of skin and eye.

 

PRACTICAL

    1. Hospital based ward rounds and clinical case study.

    2. Interaction with patients in community and patient counselling.

 

BOOKS RECOMMENDED

  1 British National Formulary (Current Edition) – BMA/RPSGB

  2 Medicines, Ethics & Practice. The Pharmaceutical Press

  3 Oxford Text Book of Clinical Pharmacology and Drug Therapy, 3rd edition, Graham-Smith D. and Aronson J., Oxford University Press

  4 Hand Book of Pharmacy Health Care. The Pharmaceutical Press

  5 Drug Interactions. Stockley I.H. (1996). The Pharmaceutical Press

  6 Katzung. B.B., Basic and Clinical Pharmacology. Prentice Hall, International.

  7 Harrisons Principles of Internal Medicine. Medical Toxicology (Ellen Horns)

  8 Davidson’s Principle and Practice of Medicine, Eds. Christopher R. W., Edwards & Ian A.D. Boucher ELBS with Cdnorchill Living stone. Edinburgh. Latest 

     Edition.

  9 Oxford Text Book of Medicine, 4th edition, David A. Warrell, Timothy M. Cox, John D. Firth.

10 CRC desk reference of Clinical Pharmacology, Manuchair Ebadi.

11 Oxford Text Book of Pharmaceutical Medicine, 4th edition, John P. Griffin, John O’Grady.

12 Principles of Pharmacology, the Pathophysiologic Basis of Drug Therapy,Lippincott, Williams & Wilkins.

13 Drug Interaction Facts, 2003. David S. Tatro.

14 Emergency Toxicology, 2nd edition. Peter Viccellio.

15 Toxicology - The basic science of poisons, international edition, Curtis D.Klaassen, 6th edition.

16 Toxicology – Principles and Applications, Raymond J.M.Niesink, John de.Vries, Mannfred A. Hollinger.

17. Clinical Pharmacy and Therapeutics. Roger Walker and Clive Edwards, Churchill Livingstone Edinburg/ London.

18. Pathology & Therapeutics for Pharmacists. Russel. J. Greene and Normal F.Harris. Chapman & Hall, London/ Glasgow/ Madras.

19. Text Book of Therapeutics: Drug and Disease Management. 7th Edition. Editors: Eric T. Herfindal and Dick R. Gourley, Williams and Wilkins, 2000

20. Davidson’s Principles and Practice of Medicine, Eds. Christopher R.W.Edwards and Lan A.D.Bouchier ELBS with Churchill Livingstone, Edinburgh. Latest

      Edition.

21. Applied Therapeutics: The Clinical Use or Drugs Eds. Brian S.Katcher, Lioyd Yee Young, Marry Anne Koda-Kimble, Applied Therapeutics Inc. Spokane. 

      Latest Edition.

22. Pathology & Therapeutics for Pharmacists. Greene, R.J & Harris, N.D. (1993). The Pharmaceutical Press.

23. De Gruchi’s Clinical Haemotology in Medical Practice. Frank Firkin, Bryan Rush, David Penington, Colin Chesterman. Blactwell Scientific Publication. 5th 

       edition.

24. Robbins Pathologic Basis of Disease. Cartran, Kumar, Collins, W.B.Saunders. 6th edition.

25. Textbook of Medical laboratory Technology. Praful B. Godkar, Darshan P.Godkar, Bhalani Publication House, Mumbai. 2nd edition.

26. Manual of basis techniques for a health laboratory, 2nd edition, World Health Organization, Geneva


22D : PHARMACEUTICAL CHEMISTRY-I (PC)

 

Theory

1.      Molecular basis of drug action:

        a)  Receptor: Drug Receptor Interaction: Basic ligand concept, agonist, antagonist, partial agonist, inverse agonist, receptor Theories - Occupancy, Rate & 

             Activation Theories, receptor Binding Assays, determination of B-max and Kd by transforming data with Hill plot and Scatchered plot., above concepts 

             with special reference to Opioid,  Histaminergic, Adrenergic and GABA nergic receptors.

        b)  Enzyme Inhibition – Enzyme structure: primary, secondary, tertiary and quaternary, enzyme Kinetics, enzyme Inhibitors - reversible, irreversible, Kcat 

             inhibitors. Transition state analogs, enzyme Inhibitors as drugs - ACE, leukotrienes, Lipoxygenase, Cycloxygenase, Aromatase, Xanthine oxidase, DNA 

             PolymeraseInhibitors, HIV - Protease / Reverse Transcriptase, Integrase and Cytochrome P-450 Inhibitors.

        c)  Drug binding to nucleic acid -- Antimalarial, anti-cancer, antiviral.

2.      Synthon approach:

      Definition of terms - disconnection, synthon, functional group interconversion (FGI), Basic rules in Disconnection, Use of synthon approach in synthesis of following compounds: Trimethoprim, Terfenadine, lbuprofen, Propanolol, Fentanyl, Ciprofloxacin, Cimetidine Piroxicam, Rosiglitazone, Diclofenac, Captopryl, Nifedipine, Losartan.

 3.      Combinatorial Chemistry

      Introduction, combinatorial approaches, chemical Peptide and small molecule libraries, applications, methodology, combinatorial organic synthesis, assays and screening of combinatorial libraries, i6ntroduction to High Throughputs Screening (HTS)

            1.       Nanochemistry

2.      Synthesis of vitamins

3.      Microwave synthesis

 4.      Drugs acting on the Central Nervous System:

      Anesthetics agents, Sedative and Hypnotics, Opioid analgesics, NSAID,   

      Antiparkisonian and Psychopharmacological agents.

5.      Drugs acting on the Cardiovascular System:

      Antihypertensive agents, Antianginal and Vasodilators, Lipid lowering agents.

6.      Chemotherapeutic agents:

      Antibacterials, Antivirals, Antifungals, Antineoplastic, Antiprotozoles

7.      Insulin and oral hypoglycemic agents

8.      Drug Metabolism and concepts in prodrug

 

PRACTICAL

The practical syllabus comprises of the exercises based on the topics mentioned in the Theory syllabus.

 

BOOKS RECOMMENDED

  1. Burger: Medicinal Chemistry (John Wiley & Sons N.Y.)

  2. Foye: Principles of Medicinal Chemistry (Varghese & Co.)

  3. Ledinicer: Organic Drug synthesis Vol. 1,2,3,4 (John Wiley &. Sons N.Y.)

  4. Ariens : Medicinal Chemistry Series.

  5. Ellis and West : Progress in Medicinal Chemistry Series.

  6.  Butterworther: Progress in Medicinal Chemistry Series.
  7. Wilson and Gisvold: Text book of Medicinal Chemistry (J.B. Lippincoff cam).
  8. Stuart Warren : Organic Synthesis – The Disconnection Approach (John Wiley & Sons).
  9. Comprehensive Medicinal Chemistry - Series -I-VI (Academic Press).
  10. Nanochemistry: A chemical approach to nanomaterials, G Ozin, A. Arsenault, (RSCPublishing).
  11. Microwaves in organic and medicinal Chemistry, C.O. Kappe, A. Stadler, (Wiley-Vch) June 2005


22E/22F : DESIGN & DEVELOPMENT OF NOVEL DELIVERY SYSTEMS (DB, PT)

THEORY                    

  1. Theory of controlled release drug delivery systems : Zero order kinetics, theory of diffusion :  Release and diffusion of drug from polymers – mechanism and kinetics – General methods of design and evaluations of controlled release products.

  2. Microencapsulation – Methods of encapsulation, kinetics of drug release from microcapsules, technology and applications.

  3. Transdermal drug delivery systems – Theory, formulation, production and evaluation.

  4. Implants and Inserts – Types of implants, Osmotic pumps, design and evaluation methods. Types if Inserts, design and evaluation methods.

  5. Targetted drug delivery systems – concept of drug targeting, importance in therapeutics; Principals of molecular biology – Cell recognition and signaling – signal transduction – cell surface receptors – Methods in Drug Targetting.

  6. Liposomes – Structure and stability, composition of liposomes, methods of preparation, application in drug delivery and drug targeting. Commercial concepts in liposomes. Neosomes and pharmacosomes – Long circulating liposomes.

  7. Advanced concepts in the design, development and production of sustained release products.

  8. Recent innovations in conventional dosage form like tablets, capsules, sterile dosage forms, pellets, Mucoadhesive system, GRDDS etc.

  9. Introduction of formulation of protein and peptides, supercritical fluid technique, PEGylation, Biotechnology based pharmaceuticals, taste masking, particle coating.

PRACTICAL

The practical syllabus comprises of the exercises formulated based on the topics mentioned in the Theory syllabus.

 

BOOKS RECOMMENDED

    1.      Joseph R. Robinson, “Sustained and Controlled Release Drug Delivery Systems”, Drugs & Pharm. Sci. Series, Vol. 6 Marcel Inc.,N.Y.

    2.      Yie W. Chien, Novel Drug Delivery Systems, Drugs and Pharm. Sci. Series, Vol.14, Marcel Dekker Inc.N.Y.

    3.      J.N.Nixon, Microencapsulation, Drugs and Pharm. Sci. Series, Vol.3, Marcel Dekker Inc., N.Y.,

    4.      G. Jolles and R.H. Wooldridge, Drug Design – Fact of Fantasy? Academic Press, 1984

    5.      J.R.Robinson and Vincent H.L. Lee, Controlled Drug Delivery, Drugs and Pharm. Sci. Series, Vol. 29, Marcel Dekker Inc. N.y.

    6.      J.R.Juliano, Drug Delivery Systems Oxford University Press, Oxford, 1980.

    7.      M.I.Gutcho, Microcapsules and Microencapsulation Techniques, Noyes Data Corporation, 1976.

    8.      E.B.Roche, Design of Biopharmaceutical properties through prodrug and analogs, Am. Pharm. Assoc. Academy of Pharm. Sci. 1977.

    9.      Lisbeth, llum & Stanley S. Davis. Polymers in controlled drug delivery wright Bristol (1987)


22g : PHARMACOMETRICS AND EVALUATION OF DRUGS (cl)

 

THEORY

Screening and evaluation (including modern methods like molecular pharmacology) Techniques of the following:

  1. Parasympathomimetics                                                                                                          

  2. Parasympathetic blocking agents                                                                                      

  3. Sympathomimetics                                                                                                                  

  4. Sympathetic blocking agents                                                                                                  

  5. Ganglion stimulants and blockers                                                                                              

  6. Neuromuscular stimulants and blockers                                                                                  

  7. General and local anaesthetics                                                                                        

  8. Sedatives and Hypnotics                                                                                                        

  9. Antiepileptics                                                                                                                          

  10. Psychopharmacological agents                                                                                      

  11. Analgesics                                                                                                                               

  12. Anti-inflammatory agents                                                                                                  

  13. Drugs used in Alzeimer’s disease                                                                                    

  14. Drugs used in Migraine                                                                                                         

  15. Anti-Parkinson’s drugs                                                                                                   

  16. CNS Stimulants                                                                                                                   

  17. Cardiotonics                                                                                                                           

  18. Anti-Hypertensive drugs                                                                                                   

  19. Anti-Arrhythmic drugs                                                                                                   

  20. Drugs used in Ischaemic Heart Disease                                                                                   

  21. Drugs used in Atherosclerosis                                                                                    

  22. Diuretics                                                                                                                                  

  23. Drugs used in Gastro-intestinal disorders                                                                                

  24. Drugs used in Respiratory disorders                                                                                            

  25. Drugs used in Urino-genical disorders                                                                                

  26. Drugs used in Diabetes                                                                                                          

  27. Hormone and Endocrine disorders Concepts of high throughput screening, cell lines and stem cell research

PRACTICAL

Practical related to above-mentioned syllabus for Paper IV

 

BOOKS RECOMMENDED

    Latest editions of

    1)      Drug Discovery & Evaluation by H.Gerhard Vogel

    2)      Pharmacology & Pharmacotherapeutics by Satoskar & Bhandarkar

    3)      Goodmann & Gilman’s The Pharmacological Basis of Therapeutics – J.G.Hardman & L.E.Limbird

    4)      Fundamentals of Experimental Pharmacology by M.N.Ghosh

    5)      Handbook of Experimental Pharmacology – by S.K.Kulkarni.

 


23A/23E/23F : VALIDATION AND CGMP (QA, DB, PT)

 

THEORY

    1.      Detailed study of the equipments required in the manufacture of different dosage forms as per schedule M

    2.      Pharmaceutical factory location: selection, layout, planning, selection of utilities and process equipments.

    3.      Pilot plant and scale up technique.

    4.      Production planning and control.

    5.      Preparation of manufacturing documents like, MFR, BMR, BPR.

    6.      Preparation of standard operating procedures (SOPs) regarding production, engineering and quality systems.

    7.      GMP- Validation:

          Approaches to validation and scope of validation, relationship between validation & qualification, calibration & verification, validation master plan,         

          qualifications of utilities and process equipments (protocols & reports for DQ, IQ, OQ, PQ), validation of manufacturing process for sterile and 

          non-sterile products (protocols and reports), validation of HVAC systems, validation of water systems, cleaning validation and validation of 

          computerized systems.  

    8.      History and various phases of drug development and drug approval, Investigational New drug (IND), New Drug Application (NDA) (Phase I-IV):     

          content and format, Abbreviated new drug application (ANDA), Content, development flow sheet and format.

    9.      Present status & scope of Pharmaceutical industry in India.

    10.  Regulatory scenario in India:

          Regulatory aspects of pharmaceutical and bulk drug manufacture and drug analysis, loan license (contract manufacture) auditing, recent amendments to 

          drugs and cosmetics act, provisions of consumer protection act, environment protection act.

 

BOOKS RECOMMENDED

    1.      Lachman ‘The thory and practice of Industrial pharmacy edition.

    2.      Remington ‘ Pharmaceutical Science’

    3.      Bently’s Pharmaceutics

    4.      Pilot plants model and scale-up methos, by Johnstone and Thring.

    5.      GMP practices for pharmaceutical- James swarbrick.

    6.      How to practice GMPs by P.P. Sharma.

    7.      Chemical Engineering Plant Design by Vibrant.

    8.      Pharmaceutical Process Validation by Loftus and Nash.

    9.      Drug and Cosmetic Act 1940.

    10. WHO: Technical report series 937: 40th report on specifications for pharmaceutical preparations.


23b : BIOTECHNOLOGY & CULTIVATION OF MEDICINAL PLANTS (CG)

 

THEORY

    1.      Factors affecting plants and their constituents such as hybridization, polyploidy, mutation, gene selection, allelopathy, chemical races, plant growth     

           regulators, geographical sources, altitude, rainfall, Ontogenic variations, soil and soil fertility. 

    2.    Plant insecticides and Pesticides, Biofertilizers and Biopesticides.

    3.    Recent developments in cultivation of some important medicinal and aromatic plants such as Senna, Digitalis, Ergot, Isabgol, Glycyrrhiza, Dioscorea,     

           Mentha, Cardamom, Pinus, Ginger, Musli, Taxas baccata, Ginseng, Guggal, Artimisia, Cinchona, Hyocyamus, Dubosia, Opium poppy, Jatropa curcus.

    4.    Plant tissue culture techniques: including types, media, methodology, micropropagation, hairy root culture, protoplast culture, biotransformation, 

           immobilization, Role of elicitors, artificial seeds, transgenic plants and commercial applications.

 

BOOKS RECOMMENDED:

    1.     Ramstad - Modem Pharmacognosy.

    2.   Herskowitz - Principles of Genetics

    3.   Stricknerger - Genetics

    4.   Hess - Plant Physiology.

    5.   William - Genetical Principles and Plant Breeding

    6.   Kruse - Patterson - Tissue Culture - Methods and Applications.

    7.   Bartz - Reinhard - Zenk - Plant Tissue Culture and its

    8.   Biotechnical Applications.

    9.   John - Dodds - Lorin - Experiments in Plant Tissue Culture.

    10.  Handa S.S. & Kaul. K.L. Supplement to cultivation & utilization of medicinal plants.

    11.  Gamborg, O.L. an Wetter, L.R., Plant Tissue Culture Methods, National Research Council of Canada, Saskatchewan. 

    12.  HE Street Plant Tissue and Cell Culture, Blackwell Scientific Publication.

    13.  P.Prave, U.Fause, W. Sittig, and D.A. Sukatsch; Fundamentals of Biotechnology, VCH Publisher. 

    14.  Alan T Bull, Howard Dalton and Murray Mao-Young, Comprehensive Biotechnology. The principles, Application & Regulation of Biotechnology in     

           Industry, Agriculture & Medicine; Vol. 1 to 4

    15.  Medicinal plants: Alkaloids and Glycosides By Toronto

    16.  CSIR- Cultivation and Utilization of Medicinal Plants

    17.  CSIR - Wealth of India, Raw Materials


23c : CLINICAL RESEARCH AND APPROVAL OF NEW DRUGS (CP)

 

THEORY

    1. Clinical Research

        (A) Basic concepts and introduction to Clinical Drug Development.

        (B) Clinical Trials

              Introduction to the fundamentals of the design and analysis of clinical trials. Ethical considerations intention-to-treat versus efficacy trials, principles of     

              sampling and exclusion, methods of allocation and techniques of randomization, parallel versus cross over designs, monitoring treatment outcomes, 

              adverse effects, stopping rules, data interpretation and logistical issues in the management of clinical trials. Schedule – Y, DCGI  and  FDA guidelines for 

              clinical trials, reviews and approval of a clinical study. GCP, ICMR, ICH , and  WHO guidelines.

    2. Approval of New Drugs

        Principal of IND submission, format and content of IND, content of investigator brochure. General consideration of the NDA, specific requirements, content  

        and  format of NDA, manufacturing and control requirements of NDA.

 

BOOKS RECOMMENDED

    1. New Drug Approval Process, Third Edition by Richard A. Guarino, Volume 100, Marcel Decker Inc.

    2. IND and NDA Guidelines of Various Regulatory Authorities


23d : PHARMACEUTICAL CHEMISTRY-II (PC)

 

Theory

    1.      Drug Discovery

          Historical perspective, Drug Discovery Strategies in Direct Drug Design (Structure based) and Indirect drug design, Target selection and lead identification,     Natural product sources, Fermentation / Microbial sources, Synthetic, Introduction to Pharmacogenomics.

    2.      QSAR

           Parameters - Lipophilicity, electronic, Stearic factors, Quantitative Models – Hansch analysis, Free Wilson Analysis, Mixed approach, Other QSAR         

           Approaches, Applications of Hansch Analysis, Free Wilson Analysis.

    3.      Enzymes, Peptides in Drug Design

    4.      Molecular Modeling in Drug Design

          Introduction to Computer aided drug design and Molecular Modeling: Concepts and  Methods, Molecular Mechanics - force fields (Potential energy     

          function), Energy Minimization Methods - Steepest, descent. Conjugate gradients, Newton methods (Non mathematical), Conformational Analysis-     

          Systematic search, Monte Carlo simulations, Molecular dynamics simulations, Ligand design based on 3D structure of receptor /enzyme

 

BOOKS RECOMMENDED

  1. Hugo Kubingi - QSAR, Hansch Analysis and Related approaches Vol I.

  2. Poul Krogsgaand Larsen: A textbook of Drug Design and Development first Edition.

  3. Thomas J. Penim, C.L-Propst - Computer Aided Drug Design.

  4. Pandi Veerapandian - Structure Based Drug design.

  5. Paul S. Charifson - Practical Applications of Computer Aided Drug Design (Marcel & Dekkar Inc. New York).  

  6. Paul Leff-Receptor Based Drug Design.

  7. Bernard Testa, Walter Fuhrer – Perspectives in-Medicinal Chemistry.

  8. C. Hansch Comprehensive Medicinal Chemistry Vol.-IV


23G : CLINICAL PHARMACOTHERAPEUTICS AND TOXICOLOGY (CL)

Theory

  1. General principles of toxicology and various preclinical toxicity tests as per schedule Y  and ICH guidelines.                                                                      

  2. Clinical trials, GCP, ICH and WHO guidelines.                                                            

  3. General principles of chemotherapy.                                                                                    

  4. Sulphonamides – trimethoprim – nitrofurans.                                                                 

  5. Antibiotics.                                                                                                                              

  6. Chemotherapy of tuberculosis – leprosy – malaria- amoebiasis – helminthiasis – viral  diseases – fungal diseases – neoplastic diseases.                      

  7. Introduction to diseases – Patho- physiology, Symptoms and General principles of    

    treatments of the following:

    Cardiovascular system

    Central nervous system

    Respiratory system- excretory system

    Gastrointestinal system

    Endocrine system

    Infectious diseases

    Immunological disorders

  8. Clinical pharmacy practice. Clinical pharmacology and therapeutics of above mentioned diseases

  9. Clinical Pharmacokinetics.                                                                                                       

  10. Drug allergies – drug dependence – drug tolerance and drug interactions.                             

  11. Management in acute care medicine – role in intense care unit. Emergencies, total prenatal nutrition.                                                                            

  12. Heavy metals poisoining and chelating agents.                                                             

  13. Adverse drug reactions, Iatrogenic diseases and their importance in clinical pharmacy.       

  14. Radioactive isotopes – Handling of cytotoxic drugs and radiopharmaceuticals.        

  15. Drug and poison information Pharmacy administration                                     

  16. Social pharmacy, development of interpersonal skills, pharmacy practice and prescription analysis.

 BOOKS RECOMMENDED

    Latest editions of

      1)     Clinical Pharmacology by D.R.Lawrence, P.N.Bennatte and M. J. Brown

      2)    Clinical Pharmacology By James M Ritter et al.Clinical Pharmacology and Drug Therapy By D G Grahame Smith and J K Aronson

      3)     Modern Pharmacology with Clinical Application By Charles R. Craies and Robert E. Stitzal

      4)    Goodmann & Gilmanns The Pharmacological Basis of Therapeutics

      5)    Clinical Pharmacy & therapeutics by Roger Walker & Clive Edwards

      6)    Davidson’s Principle & Practice of Medicine by Christopher Haslett, E.R.Chilvers, J.A.A.Hunter, N.A.Boon.

      7)    Professional Guide to Pathophysiology – Lippincott Williams & Wilkins

      8)    Clinical Pharmacokinetics by Malcolm Rowland, T.N.Tozer

      9)     Principle of Internal medicine Vol I & II by Harrison.

    10)     Drug interactions.

    11)    Pharmacotherapy & Pathophysiology – Dipiro & Josep.

    12)     Toxicology – Principle & applications – RJM Niesink, J.Devries, M.A.Hollinger

    13)    Text book of Therapeutics – E.T.Herfindal, D.R.Gourley.

    14)    Clinical PsycoPharmacology By Jerrodd G. Bermstein

    15)    Clinical Methods By Michael and Swash

    16)    Handbook of Antibiotics By Rochard E. Reese, Robert F. Betts and Bera Gumustop

    17)    Toxicology Priciples and Applications By Raymond J H et al.

    18)    Basis of Toxicology Testing Edited by Douald J Ecobichon

    19)    CRC Handbook of Toxicology edited by Michael J Derelanko et al


      Ordinances for the Post-Graduate Course Leading of Master Degree in Pharmacy