PB4002 Applied Biopharmaceutics and Pharmacokinetics Syllabus:
PB4002 Applied Biopharmaceutics and Pharmacokinetics Syllabus – Anna University PG Syllabus Regulation 2021
COURSE OBJECTIVES:
To learn the principle parameters involved in drug absorption and disposition
To understand the concepts of bioavailability and bioequivalence of drug products and their significance
To understand the pharmacokinetic parameters and its application as clinical pharmacokinetics
UNIT I BIOPHARMACEUTICS IN DRUG ABSORPTION AND DISTRIBUTION
Mechanisms of drug absorption through GIT, factors influencing drug absorption though GIT, absorption of drug from Non-per oral extra-vascular routes, Distribution of drugs, Tissue permeability of drugs, binding of drugs, apparent volume of drug distribution, plasma and tissue protein binding of drugs, factors affecting protein-drug binding. Kinetics of protein binding, Clinical significance of protein binding of drugs.
UNIT II BIOPHARMACEUTICS IN ELIMINATION
Drug metabolism, metabolic pathways, factors affecting metabolism, renal excretion of drugs, factors affecting renal excretion of drugs, renal clearance, Non- renal routes of drug excretion of drugs
UNIT III BIOAVAILABILITY AND BIOEQUIVALENCE
Definition and Objectives of bioavailability, absolute and relative bioavailability, measurement of bioavailability, in-vitro drug dissolution models, in-vitro-in-vivo correlations, bioequivalence studies, methods to enhance the dissolution rates and bioavailability of poorly soluble drugs.
UNIT IV PHARMACOKINETICS
Introduction to Pharmacokinetics, Pharmacokinetic models, One compartment open model Intravenous Bolus Injection – Intravenous infusion – Extra vascular administrations. Determination of pharmacokinetics parameters and their significance – Absorption Rate Constant (ka), Elimination Rate Constant (K) & Elimination Hal- life (t½), AUC, Cmax, and tmax. Apparent Volume of Distribution (Vd) & Renal Clearance (Q).
UNIT V CLINICAL PHARMACOKINETICS AND NONLINEAR PHARMACOKINETICS
Altered kinetics in pregnancy, child birth, infants and geriatrics. kinetics in GI disease, malabsorption syndrome, liver, cardiac, renal and pulmonary disease states. Concept, Accumulation, Persistent and elimination factors. Calculation of dosage regimen following repetitive IV and oral administration. Nonlinear Pharmacokinetics – Introduction, factors causing Non-linearity, Michaelis-menton method of estimating pharmacokinetic parameters.
TOTAL: 45 PERIODS
COURSE OUTCOMES:
The student will be able to
Explain the various factors influencing the drug disposition, various pharmacokinetic parameters
Design and interpret the bioavailability and bioequivalence of dosage forms.
Identify the factors affecting the rate of drug absorption.
Know about clinical pharmacokinetics
Recognize the application of pharmacokinetics
Be familiar with applications of Biopharmaceutics
REFERENCES:
1. Shargel,L and Andrew, B.C. Yu. “Applied Biopharmaceutics & Pharmacokinetics”,7th Edition, The McGraw-Hill Companies, Inc, 2016.
2. Brahmankar, D.M. and Jaiswal, S.B. “Biopharmaceutics and Pharmacokinetics: a Treatise” ,3rd Edition, Vallabh Prakashan, 2015.
3. Chatwal, G.R. “Biopharmaceutics and Pharmacokinetics”, 2nd Edition, Himalaya Publishing House, 2014.
4. Rosenbaum, S. E. “Basic Pharmacokinetics and Pharmacodynamics: An Integrated Textbook and Computer Simulations”, 2 nd Edition, John Wiley & Sons, 2016.
5. Gibaldi, M. “Biopharmaceutics & Clinical Pharmacokinetics”, 4th Edition, Pharma Book Syndicate, 2016.
6. Jambhekar, S.S. and Philip, J. B. “Basic Pharmacokinetics” 2nd Edition, Pharmaceutical Press,2012