BIOPHARMACEUTICAL CLASSIFICATION SYSTEM AND BIOWAVER: AN OVERVIEW

Abstract

The biopharmaceutical classification system (BCS) has been developed to provide a scientific approach for classifying drug compounds based on solubility as related to dose and intestinal permeability in combination with the dissolution properties of the oral immediate release dosage form. BCS is to provide a regulatory tool for replacing certain bioequivalence (BE) studies by accurate in vitro dissolution tests. This review gives three dimensionless numbers which are used in BCS are absorption number, dissolution number, dose number.

Biowaver is an important tool for formulation development. Bioavailability (BA) and BE play a central role in pharmaceutical product development, and BE studies are presently being conducted for New Drug Applications (NDAs) of new compounds, in supplementary NDAs for new medical indications and product line extensions, in Abbreviated New Drug Applications (ANDAs) of generic products, and in applications for scale-up and post-approval changes. The principles of the BCS classification system can be applied to NDA and ANDA approvals as well as to scale-up and post approval changes in drug manufacturing. BCS classification can therefore save pharmaceutical companies a significant amount in development time and reduce costs. The aim of the present review is to present the status of BCS and discuss its future application in pharmaceutical product development.