BIOPHARMACEUTICS AND PHARMACOKINETICS



Biopharmaceutics 
Introduction & their role in formulation development & clinical settings, fate of drugs after administration. 
Drug absorption: drug absorption mechanisms, factors affecting drug absorption (physiochemical, biological, metabolic, formulations and dosage form considerations). 

Drug distribution & protein binding of drugs 
Distribution of drug through organ /tissue - factors affecting distribution 
(Physicochemical properties of drugs, organ/tissue size, blood flow to the organ, physiological barriers  to the distribution of drugs, drug binding blood / tissue / macromolecules). 
Protein /tissue binding of drugs- factors affecting protein binding of drugs, significance and kinetics, tissue binding of drugs. 

Drug metabolism & excretion of drugs 
Biotransformation of drugs- drug metabolizing enzymes & organs, phase I & phase II reactions, factors affecting biotransformation, drug metabolism significance, extrahepatic metabolism, pharmacological activity of metabolite, deposition of metabolite. 
Excretion of drugs - renal excretion of drug, factors affecting renal excretion of drugs, nonrenal routes of excretion of drug & factors affecting them, enterohepatic circulation. 

Pharmacokinetics 
Introduction, basic concepts- rate processes in biological systems, pharmacokinetics parmneters- Cmax, tmax, AUC, biological half life, apparent volume of distribution, clearance (hepatic, renal, organ, metabolite). 
Pharmacokinetics drug interaction and their significance in combination therapy. 
Clinical pharmacokinetics: dosage adjustment in patient with and without renal and hepatic failure. 

Compartment models 
Basic concepts, one & two compartment models- pharmacokinetics of drug absorption, distribution and elimination under following conditions: 
 i) Intravenous bolus injection 
ii) Intravenous infusion 
iii) Oral single dose 
Application of pharmacokinetic principles & computation of parameters by graphical approach.