IV B. PHARM SEMESTER VIII 1.8.1 BIOPHARMACEUTICS & PHARMACOKINETICS- II (THEORY) TOTAL HOURS: 36 Sr.

No 1 TOPIC IINTRODUCTION TO BIOPHARMACEUTICS PART I Specific aspects covering fate of drug in the body and biological processes associated with it. PROTEIN BINDING OF DRUGS Factors affecting protein binding, significance, determination of protein binding, plasma and tissue binding of drugs. DISTRIBUTION Rate of distribution, perfusion limitation, permeability limitation, extent of distribution, drugs with small intermediate and high volume of distributions and their relative plasma and tissue binding. BIOTRANSFORMATION OF DRUGS Need for drug biotransformation, drug metabolizing organs and enzymes, chemical pathways, phase I and Phase II reactions, methods to study biotransformation, factors affecting biotransformation, bioactivation and tissue toxicity, Biopharmaceutics drug disposition classification system. ELIMINATION Organ clearance concepts, Hepatic clearance, Hepatic extraction ratio, Blood flow limitation in hepatic clearance, first pass effect; Renal clearance and mechanisms of renal excretion, estimation of renal clearance, factors affecting renal elimination; Biliary Clearance, enterohepatic cycling and other miscellaneous modes of drug elimination. TOPIC NUMBER OF HOURS 2

Sr. No

NUMBER OF HOURS

CLINICAL APPLICATIONS Effect of enzyme induction, enzyme inhibition blood low and protein binding on hepatic clearance, dose adjustment in renal failure BIOAVAILABILITY AND BIOEQUIVALENCE Absolute bioavailability, relative bioavailability, bioavailability study design, measurement of biovailability, pharmacokinetic and pharmacodynamic methods Dissolution rate and the methods of enhancing dissolution rate. Official and unofficial methods of estimation of dissolution/ in vitro release of drugs from the dosage form. In-vitro, in-vivo correlation and it significances. Physiology of gastro intestinal tract (review) and oral bioavailability. Physiochemical and physiological factors affecting bioavailability of drugs from parenteral routes- examples of procaine, penicillin G suspension and insulin- Zn suspension.

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BOOKS RECOMMENDED:

1. Wagner, J.G. Biopharmaceutics and Relevant Pharmacokinetics, Drug Intelligence Pub. Hamilton 2. Swarbrick, J : Current concepts in Pharmaceutical Biopharmaceutics: Lea & Febiger,Philadelphia Sciences:

3. Wagner J.G. ,Fundamentals of Clinical Pharmacokinetics.Drug Intelligence Publications,Hamilton

4. Gibaldi, M : Biopharmaceutics and Clinical Pharmacokinetics. Lea &

Febiger, Philadelphia
5. Rowland, M and Tozer,T.N.Clinical Pharmacokinetics :Concepts and

applications. Lea & Febiger, Philadelphia 6. Notari R.E.,Bippharmaceutics,Marcel Dekker. 7. Leon Shrgel and Andrew B.C. Yu, applied Biopharmaceutics and Pharmacokinetics( Appleton Century- Crofts) 8. Sarfaraz Niazi- Text book of Biopharmaceutics and Clinical Pharmacokinetics ( Appleton Century Crofts, New York)

1.8.1 BIOPHARMACEUTICS & PHARMACOKINETICS - I

(PRACTICALS) 3 Hours/Week
1. Study of drug release by diffusion cell (using biological and synthetic

membranes) 2. A study of drug binding to albumin using dialysis method.

3. Workshop on compilation of pharmacokinetic parameters given plasma and

urine data following a single i.v. bolus dose for a one compartment model drug. Plotting the data on a semi log paper. Use of linear regression analysis. 4. Workshop on computation of bioavailability parameters given individual plasma data following oral dose of test product and a standard product. Computation of AUC, Cmax, Tmax with their associated standard deviation. Use of trapezoidal rule. 5. Workshop on computation of pharmacokinetic parameters of a drug from plasma data following a single i.v. bolus dose for a two compartment model drug. Use of linear regression analysis and the method of residuals.