Biological Classification System (BCS), its Significance on Dissolution Study and Application in Dosage Form Development

Abstract

Bioavailability (BA) has an important role in new drug discovery and product development in pharmaceutical field. The solubility and permeability are important parameters of biopharmaceutics and have central role in lead optimization by controlling the pharmacokinetic parameters to give better therapeutic activity. Biopharmaceutical classification system (BCS) is a drug development tool that is based on correlation of solubility and permeability with bioavailability of drug in human body. The principles of BCS are widely applicable in development of new drug and new drug product as the scientific approach for testing of waiver on clinical study and bioavailability of drug and in regulatory approvals of drug. This review article gives an overview of BCS with special emphasis on concept, classification, class boundaries determination, extension and BDDCS with brief idea on applications. Finally, future prospects and limitations are pointed out.

Keywords: Biopharmaceutical classification system, solubility, bioavailability, intestinal permeability, bioequivalence, product development, BDDCS

Chavda Vivek P, Sanjay Desai, Moinuddin Soniwala. Biological Classification System (BCS), its Significance on Dissolution Study and Application in Dosage Form Development. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2017; 4(2): 1–16p.