[Biopharmaceutical classification system--experimental model of the prediction of drug bioavailability]

Abstract

Biopharmaceutical classification system (BCS) is based on solubility tests; for various drugs they correlate with their bioavailability in human body. It is widely used in design and development of innovation drugs, new dosage forms (permeability amplifiers), in clinical pharmacology (drug-drug, drug-food interaction) and also by regulation agencies of several countries as the scientific approach, for testing of waiver on bioavailability. Review considers modern concepts and theoretical bases for prediction of bioavailability according to BCS. It gives characteristics of fundamental parameters of the system: absorption number, solubility number and the ratio of dose to the soluble part of the drug. Possible versions of BCS modification for its subsequent optimization are discussed.