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Saturday, March 17, 2012

JNTU M. Pharm. (Pharmaceutical Chemistry) SYLLABUS


M. Pharm. (Pharmaceutical Chemistry)
COURSE STRUCTURE AND SYLLABUS

I YEAR  I SEMESTER
Code
Group
Subject
L
P
Credits


Modern Pharmaceutical Analytical Techniques
3
0
3


Advanced biostatistics and research methods
3
0
3


Advanced Pharmaceutical Organic Chemistry – 1
3
0
3


Advanced Medicinal Chemistry – I
3
0
3


Advanced Medicinal Chemistry-II
3
0
3

Lab
Advanced Pharmaceutical Organic Chemistry Practical Lab– 1
0
3
2

Lab
Advanced Medicinal Chemistry Practical Lab– I
0
3
2


Seminar
-
-
2


          Total Credits 


21


MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES
(Common to all Branches)

Unit-I
A detailed study of separations and determination involved in the following chromatographic techniques.
  1. Column chromatography : Theory, preparation, procedures, methods of detection.
  2. This layer chromatography : Theory, preparation, procedures, detection of compounds
  3. Paper  Chromatography : Theory, different techniques employed, filter papers used, quantitative and quantitative detections.
  4. Counter, current extraction , soild phase extraction techniques.

Unit-II
  1. Gas chromatography: fundamentals, Instrumentation, columns preparation and operations, detection, derivitasation, LC-MS, GC-MS.
  2. HPLC : Principles and Instrumentations.

Unit-III
  1. UV-Visible Spectroscopy : Principle, Beer Lambert’s law, study and working principle of instrumentation, applications in pharmaceutical analysis and derivatives spectroscopy.
  2. IR Spectroscopy: Theory, different types of molecular vibrations, sampling techniques, instrumentation and applications in pharmaceutical analysis, FTIR
  3.  Flurorimetry :  Theory, fluorescence and chemical structure, factors affecting the fluorescence, study of working principles of the instrument and applications in pharmaceutical analysis.

Unit-IV
  1. NMR : theory, Chemical-shift, spin-spin coupling, shielding, working principle of instrumentations and applications in pharmaceutical analysis, HNMR, and cosy 13CNMR.
  2. Mass: principle, different methods of  production of ions metastable ions, working principle of mass spectrometer and applications in pharmaceutical analysis.

Unit-V
  1. Differential thermal analysis, partial thermal analysis.
  2. Radiometric techniques, Radio immunoassay, Elisha test.
  3. X-ray diffraction, polarimetry.

ADVANCED BIOSTATISTICS & RESEARCH METHODS

Unit-I :
Developing a research question, Resources for research question,
Literature Review: Traditional Qualitative Review
                                    Meta-Analysis—A Quantitative Review
Preparation of Research Proposal

Variables—Definition of Variable, Types of variables—Dependent and Independent variables, Confounded variables, Measurement of variables, Types of measurement scales and their comparison. Reliability and Validity of Measurements.

Unit-II :
Validity, Types of validity—Internal validity, Construct validity, External validity, Threats to validity. 

Control: Subject as own control (Within Subject control), Statistical control.

Unit-III:
Non-experimental Research:
Part 1—Observational, Archival and Case-Study Research: The Hermeneutic Approach. 
Observational Research: Naturalistic Observation, Participant-Observer Research.
Archival Research: Archival Data Collection and Compilation.
Case Studies:  Characteristic of Case Studies.  
Non-experimental Research: Survey Research—Designing of Questionnaire, Methods of Administration, Response Rates.  Types of Samples—Haphazard Samples, Purposive Samples, Convenience Samples and Probability Samples.  

Unit-IV :
True Experiments: Single-Factor Designs, Factors, Levels, Conditions, and Treatments.  Within-Subject Designs. 
True Experiments Part-2—Factorial Designs—Main Effects, Interactions, A Mixed Factorial Design. 

Unit V :
Single-Subject Experiments: Advantages and Disadvantages. 
Quasi Experiments: The differences between Quasi and True Experiments.
Design without Control Groups—Interrupted Time Series Designs and Repeated Treatment Designs. 

Text Books   
 1. Donald H. McBurney -Theresa L. White   “Research Methods” ( Cengage learning India Pvt. Ltd)
2. Statistics for business and economics 3rd edition by-Hooda-R.P- MC. Millan Business books
3. Biostatistics & Computer applications by GN Rao and NK Tiwari
Reference Books
1. Remingtons pharmaceutical Sciences
2.. Theory & Practice of  Industrial  Pharmacy by Lachman


ADVANCED PHARMACEUTICAL ORGANIC CHEMISTRY – I


Unit I.  Stereochemistry: a. Elements of symmetry,  simple axis of symmetry . Notation, relative configuration and absolute configuration .Compounds with a chiral carbon atom, compounds with other quadrivalent chiral atoms. Optical isomerism in compounds containing no chiral atom, biphenyl, allenes, compounds with exocylic double bonds and spirans.
b Chirality due to helical shape.. Cis / Trans, E – Z isomerism resulting from double bonds, monocyclic compounds, fused ring system. Racemic modifications and methods for resolution of racemic mixtures. Asymmetric synthesis and stereo – selective synthesis.

Unit-II.   a.  Reactive Intermediates:
                     Definitions, generation, stability, structure and reactivity of free   
                      radicals carbocations, carbanions, carbenes, Nitrenes/Nitrenium ions.
                b. . Concepts of aromaticity and anti aromaticity, non benzenoid aromatic compounds.

Unit-III. Mechanisms of organic reactions: Free radical, Electrophilic, Nucleophilic reactions of  aliphatic and aromatic compounds

Unit-IV. Elimination Reactions: E1, E2, E1CB and E2CB mechanisms, Mechanisms and orientation in Pyrolytic eliminations, effect of substrate structure, Attacking base, leaving group and reaction  bond, medium and reactivity addition to carbon – carbon multiple bond reactions.  Mechanisms, Orientation and reactivity.

Unit-V. Electrocyclic, pericyclic and sigmotropic reactions: introduction, terminology and mechanism   with suitable examples.

Recommended Books

  1. Francis A. Carey & Richard J. Sunberg, Advanced Org. Chemistry , III rd Edition , Par B; Reactions and synthesis , Plenum Press, new York , London , Latest Edition.
  2. Eliel I. Ernest and Samuel h, Stereochemistry of Org. Compounds, John Wiley and sons, New York, 2003 Edition.
  3. Roland E. Lehr & Alan P Marchard, Orbital Symmetry: A Problem solving approach, Academic Press, New York Latest Edition.
  4. J. March , Advanced Org. Chemistry , Reactions Mechanisms and Structure , 4th Edition, John Wiley  & Sons , New York Latest Edition
  5. I. L. Finar , Organic Chemistry , ELBS
  6. Herbert O. Modern Synthesis Reactions IInd Edition W.A. Beenamis Inc. Menco Park California
  7. W. Carruthers, Some Modern Methods of Org. Synthesis, III rd Edition, Cambridge University Press, Cambridge.



ADVANCED MEDICINAL  CHEMISTRY – I


Unit-I Theoretical  Aspects of Drug Action
            Types of drug action, Physiochemical parameters and pharmacological     activity,              Non empirical Electronic parameters, steric parameters and Stereo Chemical aspects of Drugs. Drug Receptors, Receptor types and isolation, Drug Receptor Interaction, theories of drug action, mechanism of drug action.

Unit-II  Targets for the development of following chemotherapeutic agents:
Anti-tubercular, Anti malarial , Anti – fungal, Immuno- modulators, Anti- amoebic drugs.

Unit-III Targets for the development of following pharmacodynamic agents –
 Antiulcer, Analgesic – Anti Inflammatory, Anti atherosclerotic, Anti- Angiogenesis, anti – hypertensives.

Unit-IV Biotransformation of drugs- Prodrug approach, Soft Drug approach, enzymes responsible for biotransformation, microsomal and non microsomal mechanisms. Factors influencing enzyme induction and inhibition.

Unit-V   Design of Local anesthetics, diuretics, Anti- HIV, anticancer,
Introduction, general considerations on the development of new drugs, classical    and rational procedures for the development of local anesthetics

Recommended Books


1.     Richard B. Silvermann, Org. Chemistry of Drug Design and drug Action.
2.     Berger’s Medicinal Chemistry and Drug Design. 6th Edition.
3.     Korolkovas Essentials of Medicinal Chemistry
4.     Purcell Strategies of Drug Design
5.     Alfred Berger Biochemical Basis of Drug Design
6.     Corwin , Hansen Comprehensive Medicinal Chemistry
7.     William O Foye Medicinal Chemistry
8.     Testa B and Jenner P. Drug Metabolism Chemical & Biochemical Aspects, Marcel Dekker
9.     Gyorgy Keri & Istdan Toth Molecular Pathomechanism and New Trends in Drug Research, Taylor & Francis Pub.
10.  Ariens. Drug design medicinal chemistry a series of monograph-volume 11- III, academic press, an imprint of Elsevier pub.

ADVANCED MEDICINAL  CHEMISTRY – II (Drug Design)


Unit-I
Genesis of New Drugs: Serendipity, Random Screening, Extraction of active     principles from Natural Sources, Molecular Modification of Known Drugs, Selection or Synthesis of Soft Drugs, Drug Latentiation and rational drug design

Unit-II  
Rational Drug Design: QSAR: Parameters involved in QSAR, lipophilicity (Polarisabiltiy, electronic and steric parameters). Quantitative models. Hansch Analysis, Free Wilson Analysis and their relationships, linear relationships and applications of Hansch and Free Wilson Analysis.

Unit-III 
Molecular Modeling: Introduction, molecular methods, Known receptors, unknown receptors.

Unit-IV 
Natural Products as Leads for New Drugs
Introduction/History, approaches to discovery and development of natural
products as potential new drugs, selection and optimization of lead compounds for further developments from CNS, anticancer antibiotics and cardiovascular drugs.

Unit-V 
Structure based drug design :  Inhibitors of HIV-I Prokinase,  Structural studies of  HIV-I
               Reverse transcriptase and implications for drug design, Bradykinin receptor Antagonists, Design of purine nucleoside and Phosphorylase inhibitors, Aldose Reductase Inhibitors, Thrombin inhibitors. Rhinoviral-Capsid-biding Inhibitors.

Recommended Books :

1. Berger’s Medicinal Chemistry and Drug Design. 6th Edition.
2. Korolkovas Essentials of Medicinal Chemistry
3. Purcell Strategies of Drug Design
4. Corwin , Hansen Comprehensive Medicinal Chemistry
5. William O Foye Medicinal Chemistry
6. Structure based Drug Design by Pandi Veerapandion.


ADVANCED PHARMACEUTICAL ORGANIC CHEMISTRY PRACTICAL LAB-I

BASED ON THEORY AT LEAST 10 EXPERIMENTS



ADVANCED MEDICINAL CHEMISTRY PRACTICAL LAB– I


BASED ON THEORY AT LEAST 10 EXPERIMENTS


JNTU M. PHARM. (QUALITY ASSURANCE) SYLLABUS


M. PHARM. (QUALITY ASSURANCE)

COURSE STRUCTURE AND SYLLABUS

I YEAR  I SEMESTER
Code
Group
Subject
L
P
Credits


Modern Pharmaceutical Analytical Techniques
3
0
3


Advanced Biostatistics and Research Methods
3
0
3


Formulation Development and Quality Control
3
0
3


Good Manufacturing Practices and Audits
3
0
3


Evaluation of Pharmaceutical Dosage Forms
3
0
3

Lab
Modern Pharmaceutical Analytical Techniques Lab
0
3
2

Lab
Formulation Development and Quality Control Lab
0
3
2


Seminar
-
-
2


          Total Credits 


21

 



MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES 
(Common to All Branches)

Unit I

a.    Column Chromatography: Adsorption and partition, theory, preparation, procedure and methods of detection
b.    Thin Layer Chromatography: Theory, preparation, procedures, detection of compounds
c.   Paper Chromatography: theory, different techniques employed, filter papers used, qualitative and quantitative detection
  1. Counter – current extraction, solid phase extraction techniques, gel filtration

Unit II

a.   Gas chromatography: Introduction, fundamentals, instrumentation, columns: preparation and operation, detection, derivatisation.
b.   HPLC: Principles and instrumentation, solvents and columns used, detection and applications

Unit III

a.      UV-Visible spectroscopy: Introduction, electromagnetic spectrum, absorbance laws and limitations, instrumentation-design and working principle, chromophore concept, auxochromes, Wood-Fisher rules for calculating absorption maximum, applications of UV-Visible spectroscopy
b.     IR spectroscopy: Basic principles-Molecular vibrations, vibrational frequency, factors influencing vibrational frequencies, sampling techniques, instrumentation, interpretation of spectra, FT-IR, theory and applications

Unit IV

Mass spectroscopy: Theory, ionization techniques: electron impact ionization, chemical     ionization, field ionization, fast atom bombardment, plasma desorption, fragmentation process: types of fission, resolution, GC/MS, interpretation of spectra and applications for identification and structure determination


Unit V

            NMR: Theory, instrumentation, chemical shift, shielding and deshielding effects, splitting of 
signals, spin-spin coupling, proton exchange reactions, coupling constant(J), nuclear overhauser effect(NOE), 13C­ NMR spectra and its applications, 2D-NMR, COSY and applications in pharmacy





REFERENCES

1.Instrumental Methods of Chemical Analysis by B.K Sharma
2. Organic spectroscopy by Y.R Sharma
3. A Text book of Pharmaceutical Analysis by Kerrenth   A. Connors
4.Vogel’s Text book of Quantitative  Chemical Analysis by A.I. Vogel
5.Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake
6.Organic Chemistry by I. L. Finar
7.Organic spectroscopy by William Kemp
8.Quantitative Analysis of Drugs by D. C. Garrett
9.Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi
10. Spectrophotometric identification of Organic Compounds by Silverstein
11. HPTLC by P.D. Seth
12. Indian Pharmacopoeia 2007



ADVANCED BIOSTATISTICS & RESEARCH METHODS

Unit-I :
Developing a research question, Resources for research question,
Literature Review: Traditional Qualitative Review
                                    Meta-Analysis—A Quantitative Review
Preparation of Research Proposal

Variables—Definition of Variable, Types of variables—Dependent and Independent variables, Confounded variables, Measurement of variables, Types of measurement scales and their comparison. Reliability and Validity of Measurements.

Unit-II :
Validity, Types of validity—Internal validity, Construct validity, External validity, Threats to validity. 

Control: Subject as own control (Within Subject control), Statistical control.

Unit-III:
Non-experimental Research:
Part 1—Observational, Archival and Case-Study Research: The Hermeneutic Approach. 
Observational Research: Naturalistic Observation, Participant-Observer Research.
Archival Research: Archival Data Collection and Compilation.
Case Studies:  Characteristic of Case Studies.  
 
Non-experimental Research: Survey Research—Designing of Questionnaire, Methods of Administration, Response Rates.  Types of Samples—Haphazard Samples, Purposive Samples, Convenience Samples and Probability Samples.  

Unit-IV :
True Experiments: Single-Factor Designs, Factors, Levels, Conditions, and Treatments.  Within-Subject Designs. 

True Experiments Part-2—Factorial Designs—Main Effects, Interactions, A Mixed Factorial Design. 

Unit V :
Single-Subject Experiments: Advantages and Disadvantages. 
Quasi Experiments: The differences between Quasi and True Experiments.
Design without Control Groups—Interrupted Time Series Designs and Repeated Treatment Designs. 



 
Prescribed Text     Donald H. McBurney
Theresa L. White   “Research Methods” ( Cengage learning India Pvt. Ltd)

FORMULATION DEVELOPMENT AND QUALITY CONTROL

Unit I

Manufacturing and Quality control of solid dosage forms: Tablets and Capsules. Liquid Dosage forms: oral and topical

Unit II
Parenterals: Formulation development and evaluation, Aerosol formulation Development and its quality control.

Unit III

Selection and evaluation of packaging material, containers and closures, special problems of containers and closures, special problems interactions. Pharmacoepial specifications, tests and standards for packaging material

Unit IV
Sterility testing of pharmaceutical products: -Physico chemical factors affecting stability of drugs, methods to find out degradation path ways.

Unit V
    1. Determination of shelf life by Accelerated stability testing
    2. Incompatibilities encountered in drug multi component formulation, rationale for drug combination case studies.


TEXT BOOKS
1.     Gennaro A.R.Remington the science and practice of pharmacy.20th edition, volume
1&2, Lippincott Williams and Willkins Pheledelphia, PA, 2000.
2.     Lachman and Libermann, the theory and practice of industrial pharmacy, third Edition, Vergis publishing House, Mumbai 1991.
3.     Banker GS and Rhodes CT, modern pharmaceutics, third edition, Marcel Dekker, Inc, New York 1995.
4.     Aulten ME.pharmaceutics-The science of dosage form design, 1st (international student) Edn.
     Churchill Livingstone, New York., 1996


REFERENCES
1.     Lachman L, et al, pharmaceutical dosage forms, tablets, second edition, volume 1,2, and 3, Marcel Dekkar, New York 1992.
2.     Lachman L. E t a I Phamraceutical dosage forms parenteral medication second edition Volume 1 and 2 Marcel Décor New York 1992.
3.     Turco Sand King RE, sterile dosage forms, third edition Lea and Febiger, Philadelphia1987.







GOOD MANUFACTURING PRACTICES AND AUDITS


Unit I
GMP general considerations and definitions, Aims & Objectives of GMPs, GMP requirements for activities of manufacturing/ packaging/ labeling, testing


Unit II
 Introduction  to GMPs-MHRA, GMPs-HPFBI, GMPs-MCC, GMPs-EDQM, etc.
ICH Q7A, GMPs for APIs


Unit III
Audits: GMP compliance audit, Definition Summary, Audit policy, Internal and External Audits, Second Party Audits, External third party audits


Unit IV
Preparation for Audit, Conducting audit, audit analysis, audit report, audit follow up,


Unit V
A typical internal Audit Report (First party), External (Second party) Audit Report Third party audit report


TEXT BOOKS :

1. How to practice GMP, 1st Edition, P.P. Sharma
2. Good Laboratory Practices, Selier, Jurg P
3. Good Pahrm. Manufacturing Practice Rational and Compliance, John Sharp



SUGGESTED REFERENCES:

1. The Gazette of India, Extra ordinary, New Delhi
2. A Text book of Forensic Pharmacy by Mithal
3. WHO Technical Report Seies, No..908,2003
4.  Quality Assurance of Pharmaceuticals

EVALUATION OF PHARMACEUTICAL DOSAGE FORMS


Unit I
Detailed study of the principles and procedures involved in various physicochemical methods of analysis of Pharmaceutical dosage forms belong to the following classes of drugs.

A. Sulphonamides                  B. Antibiotics             C. Anti- histamines           D. Vitamins

Unit II
A detailed study on the principles and procedures involved in the determination of the dosage forms of the following group of drugs

A. Adrenergics   B. Anti- malarials          C. Steroids              D. Analgesics and antipyretics

Unit III
Official methods of determination for the mentioned below pharmaceutical dosage forms of the following group of drugs

A. Local anesthetics               B. Barbiturates         C. Anti-diabetics            D. Diuretics

Unit IV
Various in process Quality Control tests carried on the following of Dosage Forms

A. Tablets                               B. Capsules               C. Injectables                 D. Liquid Orals

Unit V
A detailed study on the biological evaluation of the following dosage forms

A. Rabbis Vaccine                  B. Oxytocin                            C. Tetanus Antitoxin

Unit VI
Microbiological evaluation of the following dosage forms

A. Neomycin Sulphate          B. Cyanocobalamin                 C. Diphtheria Vaccine



Recommended Books:
a.      Remington’s Pharmaceutical Sciences by Alfonso and Gennaro
b.     Microbiological Assays by Barton J. Wright
c.      Pharmaceutical Chemistry by Becket and Stanlake
d.     Quantitative Analysis of Drugs in Pharmaceutical Formulations by P.D.Sethi
e.      Pharmaceutical Analysis by Higuchi, Bechmman and Hassan
f.      Theory and Practice of Industrial Pharmacy by Lieberman and Lachman
g.     Indian Pharmacopoeia 1996





MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES LAB
(Common to All Branches)

1. Use of spectrophotometer for analysis of Pharmacopoeial compounds and their formulations
2.Simultaneous determination of combination formulations (Minimum of 04 experiments)
3. Effect of pH and solvent on UV spectrum of certain drugs
4. Experiments of Chromatography
a.  Thin layer chromatography
   b.  Paper chromatography: Ascending, Descending, circular and two-dimensional techniques
     5. Experiments based on HPLC and GC
     6. IR, NMR and mass spectra: Interpretation for the structural elucidation of organic compounds
     7. Any other relevant experiments

FORMULATION DEVELOPMENT AND QUALITY CONTROL LAB


    1. In process quality control Tests for Tablets, Capsules, Liquid Dosage Forms
    2. Formulation development and Evaluation of parenterals
    3. Intraday and interday analysis for the dosage forms
    4. Determination of shelf life by accelerated stability studies
    5. Experiments on incompatibility