M. Pharm.

(Pharmaceutics)
COURSE STRUCTURE AND SYLLABUS I YEAR I SEMESTER Code Group Subject Modern Pharmaceutical Analytical Techniques Advanced biostatistics and research methods Biopharmaceutics and Pharmacokinetics Advanced Physical Pharmaceutics Advanced pharmaceutical technology-I Modern Pharmaceutical Analytical Techniques Lab Advanced Physical pharmaceutics Lab Seminar Total Credits L 3 3 3 3 3 0 0 P 0 0 0 0 0 3 3 Credits 3 3 3 3 3 2 2 2 21

Lab Lab

MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES (Common to all Branches) Unit-I A detailed study of separations and determination involved in the following chromatographic techniques. a. Column chromatography : Theory, preparation, procedures, methods of detection. b. This layer chromatography : Theory, preparation, procedures, detection of compounds c. Paper Chromatography : Theory, different techniques employed, filter papers used, quantitative and quantitative detections. d. Counter current extraction, soild phase extraction techniques. Unit-II a. Gas chromatography: fundamentals, Instrumentation, columns preparation and operations, detection, derivitasation, LC-MS, GC-MS. b. HPLC : Principles and Instrumentations. Unit-III a. UV-Visible Spectroscopy : Principle, Beer Lamberts law, study and working principle of instrumentation, applications in pharmaceutical analysis and derivatives spectroscopy. b. IR Spectroscopy: Theory, different types of molecular vibrations, sampling techniques, instrumentation and applications in pharmaceutical analysis, FTIR c. Flurorimetry: Theory, fluorescence and chemical structure, factors affecting the fluorescence, study of working principles of the instrument and applications in pharmaceutical analysis. Unit-IV a. NMR: theory, Chemical-shift, spin-spin coupling, shielding, working principle of instrumentations and applications in pharmaceutical analysis, HNMR, and cosy 13CNMR. b. Mass: principle, different methods of production of ions metastable ions, working principle of mass spectrometer and applications in pharmaceutical analysis. Unit-V a. Differential thermal analysis, partial thermal analysis. b. Radiometric techniques, Radio immunoassay, Elisha test. c. X-ray diffraction, polarimetry. Recommended Books: 1. Munson J.W. Pharmaceutical Analysis; Mercel Dekker. 2. Willard Dean Merrit Instrumental Methods of Analysis 3. David underwood, Text Book of Quantitative analysis. 4. Skogadwest, Instrumental methods of analysis.

ADVANCED BIOSTATISTICS AND RESEARCH METHODS Unit-I : Developing a research question, Resources for research question, Literature Review: Traditional Qualitative Review Meta-AnalysisA Quantitative Review Preparation of Research Proposal VariablesDefinition of Variable, Types of variablesDependent 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 validityInternal validity, Construct validity, External validity, Threats to validity. Control: Subject as own control (Within Subject control), Statistical control. Unit-III: Non-experimental Research: Part 1Observational, 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 ResearchDesigning of Questionnaire, Methods of Administration, Response Rates. Types of SamplesHaphazard Samples, Purposive Samples, Convenience Samples and Probability Samples. Unit-IV : True Experiments: Single-Factor Designs, Factors, Levels, Conditions, and Treatments. WithinSubject Designs. True Experiments Part-2Factorial DesignsMain 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 GroupsInterrupted 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 3

BIOPHARMACEUTICS AND PHARMACOKINETICS Unit-I 1. Bioavailability and bioequivalence studies: Designing of bioavailability and bioequivalence studies and interpretation of results. 2. Physicochemical properties affecting bioavailability, pH-partition theory, dissolution, surface area adsorption, complexation, polymorphism and techniques of enhancing dissolution rate. 3. Formulation factors affecting bioavailability of drugs in dosage forms of tablets, capsules, parenterals, liquid orals and topical dosage forms. Unit-II 4. Basic concepts of pharmacokinetics: compartment models: One, two and noncompartmental approaches to pharmacokinetics. Recent trends, merits and limitations of these approaches. Application of these models to determine the various pharmacokinetic parameters pertaining to a. Absorption: (wherever applicable) absorption rate constant, absorption half-life, lag time and extent of absorption, AUC. b. Distribution: Apparent volume of distribution and its determination. c. Metabolism: Metabolic rate constant d. Elimination: Over all apparent elimination rate constant, and half life. All the above under the following conditions: 1. Intravenous bolus injection 2. Intravenous infusion 3. Single dose oral administration 4. Multiple dose injections 5. Multiple dosage oral administration e. Noninvasive methods of estimating pharmacokinetics parameters with emphasis on salivary and urinary compartments f. Concept of clearance: organ, total clearance, hepatic clearance, lung clearance and renal clearance. Unit-III 5. Non-linear pharmacokinetics: Concepts of linear and non-liner pharmacokinetics, Michaelis-Menton Kinetics characteristics. Basic Kinetic parameters, possible causes of non-induction, non-linear binding, and non-linearity of pharmacological responses. 6. Clinical Pharmacokinetics: Altered kinetics in pregnancy, child birth, infants and geriatrics. Kinetics in GI disease, malabsorption syndrome, liver, cardiac, renal and pulmonary disease states. Unit-IV 7. Time dependent pharmacokinetics: Introduction, classification, physiologically induced time dependency: Chronopharmacokinetics, chemically induced dependency. 4

8. Drug metabolism: Site of metabolism, factors affecting drug metabolism (genetic, species and environmental). Unit-V 9. Drug Interactions: Kinetics of drug interaction, study of drug-drug interaction mediated through absorption, distribution, metabolism and elimination, mechanisms of interaction and consequence. Influence of alcohol, smoking, food and beverages on drug action.

Text Books 1. Biopharmaceutics and Clinical Pharmacokinetics by Milo Gibaldi. 2. Biopharmaceutics and Clinical pharmacy by Robert E. Notari. 3. Biopharmaceutics and Clinical Pharmacokinetics - An Introduction by Robert E. Notari.

Recommended Books 1. Bio-Pharmaceutics and Pharmacokinetics by D.M. Brahmankar and Sunil B. Jaiswal. 2. Bio-Pharmaceutics and Pharmacokinetics by V.Venkateshwarlu. 3. Text Book of Biopharmaceutics by R. H. Shobharani.

ADVANCED PHYSICAL PHARMACEUTICS Unit-I 1. Particle science and powder technology: Crystal structure, amorphous state polymorphism, particle size distribution, particle size analysis methods, solid dispersions/ solid solutions. 2. Physics of tablet compression: Compression and consolidation, strength of granules, compression and consolidation under high loads, effect of friction, distribution of forces in compaction, force volume relationships, Heckel plots, compaction profiles, energy involved in compaction, strength of tablet, crushing strength, friability, lamination, instrumentation of tablet machines. Unit-II 3. Kinetics and drug stability: Stability calculations, rate equation, complex order kinetics, kinetics of some decompositions, strategy of stability testing, method of stabilization, method of accelerated stability testing in dosage forms, Freeze Thaw methods, centrifugal methods, temperature and humidity control, physical stability testing of pharmaceutical products. Unit-III 4. Theories on stability of disperse systems: Adsorption, wetting, crystal growth mechanisms, physical stability of suspensions and emulsions, stability testing of emulsions and suspensions and release of drugs from suspension and emulsion formulations. Biopharmaceutical aspects of disperse systems. 5. Rheology: Theoretical consideration, instrumentation, rheological properties of disperse systems and semisolids. Unit-IV 6. Dissolution and solubility: Solubility and solubilization of nonelectrolytes, solubilization by the use of surfactants, cosolvents, complexation, drug derivatisation and solid state manipulation, dissolution rates of solids in liquids, measurement of dissolution rates. Unit-V 7. Polymer science: Properties of polymers, phase separation, polymers in solid state and application of polymers in pharmaceutical formulations.

Text Books 1. Physical Pharmacy by Alfred Martin. 2. Pharmaceutical Dosage forms by Howard. C. Ansel. Recommended Books: 1. Practical Physical Pharmacy (Vol-I and Vol-II) by Gaud and Gupta. 2. Cooper and Gunn`s Tutorial Pharmacy by S.J Carter. 3. Cooper and Gunn`s Dispensing for Pharmaceutical Students by S.J. Carter. 6

ADVANCED PHARMACEUTICAL TECHNOLOGY-I Unit-1 1. Preformulation studies Goals of preformulation, preformulation parameters, methodology, solid state properties, solubility and partition coefficient, drug-excipient compatibility. Unit-II Formulation development of solid and powder dosage forms Improved production techniques for tablets, new materials, processes, equipment improvements, high shear mixers, compression machines, coating machines, coating techniques in tablet technology for product development and computerization for in process quality control of tablets. Formulation development and manufacture of powder dosage form for internal and external use including inhalation dosage forms. Unit-III Formulation development of soft and hard gelatin capsules Introduction, production and methods of manufacture, filling equipment and filling operations, formulations, finishing, special techniques, the nature of the capsule shell and capsule, advances in capsule manufacture, processing and control including pharmaceutical aspects, physical stability and packaging. Unit-IV Formulation development of liquid dosage forms Recent advances in formulation aspects and manufacturing of monophasic dosage forms as well as suspensions. Unit-V Optimization techniques in pharmaceutical formulation and processing Introduction, optimization parameters, classical optimization, statistical design, applied optimization methods and their applications in pharmaceutical industry.

Text Books 1. Pharmaceutics - The Science of Dosage form design by ME Aulton. 2. Pharmaceutical Dosage forms - Tablets (Vol I, II and III) by Lieberman, Lachman and Schwartz. 3. Pharmaceutical Dosage forms - Capsules (Vol I, II and III) by Avis, Lieberman and Lachman. 4. Pharmaceutical Dosage forms Disperse systems (Vol I, II and III) by Avis, Lieberman and Lachman. 5. Modern Pharmaceutics by Gilbert S. Banker and Christopher T. Rhodes. Recommended Books: 1. The Theory and Practice of industrial Pharmacy by Leon Lachman, Herbert A. Lieberman. 2. Remingtons Science and Practice of Pharmacy by A. Gennaro. 3. Ansels Pharmaceutical Dosage form and Drug delivery system by Loyd V. Allen, Jr. Nicholas G. Popovich, Howard C. Ansel. 4. Generic Drug Product Development by Leon Shargel and Isadore Kanfer. 7

5. Dispensing for Pharmaceutical Students by SJ Carter. 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 ADVANCED PHYSICAL PHARMACEUTICS LAB Practical shall be based on theory.