IV B. PHARM SEMESTER VIII (relevant year sem course structure) 1.8.

.1 BIOPHARMACEUTICS & PHARMACOKINETICS I (THEORY) TOTAL HOURS: 36 Sr TOPIC . No 1. Introduction Biopharmaceutics definition and subject relevance, Definition of absorption, distribution, metabolism, excretion, elimination, disposition, first pass effect, enterohepatic cycling, bioavailability, pharmacokinetics and Pharmacodynamics 2 Absorption of drugs - factors affecting drug absorption and bioavailability, methods for studying drug uptake, drug absorption barriers 3 Mechanism of Drug Transport Different mechanism of drug transport, passive transport and pH partition theory, facilitated diffusion, Active Transport etc.; Blood and its binding constituents as carriers of drug in the body, Perfusion limitation and permeability limitation in drug transport. 2. Concepts of Compartment Models Pharmacokinetics of one compartment model drug, mathematical treatment to pharmacokinetics upon I.V. bolus dosing, I.V. Infusion and first order extravascular input, Multicomparment model behaviour (excluding the derivation or mathematical treatment), Central and Peripheral Compartments, distribution phase and pseudo distribution equilibrium phase. Definition of pharmacokinetic parameters including volumes of distribution, clearance, biological half life, renal clearance, non renal clearance absolute clearance, bioequivalence and miscellaneous parameters. Methods of estimation of pharmacokinetic parameters and NUMBER OF HOURS 2

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parameters for bioavailability /bioequivalence, including methods for residuals, rate method and sigma minus method of estimation of renal clearance, area under the curve, area under moment curve, mean residual time. Plasma Concentration and therapeutic Response An introduction to pharmacodynamics Non Linear Pharmacokinetics Non Linearities in absorption and elimination. Examples of drug showing non-linear absorption or elimination, individualization of dosage regimens and non linear Pharmacokinetics. Dosage Regimens Factors affecting dosage regimens, utility curve and therapeutic window, multiple dose pharmacokinetics, fluctuation, accumulation index, steady state concept, time to reach steady state, loading dose, maintenance dose, calculations for determination, problem solving, drugs requiring individualization of dosage regimes-a discussion

4.

5.

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 (PRACTICALS) 3 hrs/Week 1. Calibration & standardization of Dissolution Apparatus.
2. Determination of dissolution rate from two marketed capsules/tablets of a

poorly water soluble drug ( Rotating Basket) a) Medium without surfactant b) Medium with surfactant
3. Determination of Dissolution rate of drugs from two marketed immediate

and sustained released tablets.( Rotating Paddle Method)