THE BIOPHARMACEUTICAL CLASSIFICATION SYSTEM (BCS): PRESENT STATUS AND FUTURE PROSPECTIVES

Abstract

The Biopharmaceutical classification system (BCS) was introduced By Amidon et al., (1995) as a method for classifying drug substances based on their dose/solubility ratio and intestinal permeability. It allows predicting the in vivo pharmacokinetic performance of drug products. The drug can be categorized into four classes of BCS, namely, High solubility high permeability, low solubility high permeability, High solubility low permeability and low solubility low permeability. An objective of BCS approach is to determine the equilibrium solubility of drug substances under physiological environment. The BCS helps in mathematically analyzing the kinetics and dynamics of drug in gastrointestinal tract (GIT) for New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA) filings and biowaivers. This step reduces time in the new drug development process. Further it helps to decide when the dissolution rate is likely to be the rate determining step. It also helps in the prediction of potential of inactive ingredients in the dosage form to alter the dissolution / absorption of the drug. The present review, apart from giving a brief overview of BCS classification system, highlights these and some of the more recent applications of BCS classification system.