Emerging Role Of Biopharmaceutical Classification And Biopharmaceutical Drug Disposition System In Dosage Form Development: A Systematic Review

Abstract

The biopharmaceutical classification system (BCS) is an advanced tool used for classifying medicines based on dissolution, water solubility, and intestinal permeability, which affect the absorption of active pharmaceutical ingredients (API) from immediate-release solid oral dosage forms. It is useful to formulation researchers to develop novel dosage forms based on modernistic rather than experimental approaches. The current review focuses on the fundamentals, objectives of BCS, their importance, and applications of BCS. Biowaiver extensions for drug or active pharmaceutical ingredient from different BCS classes with scientific basis are discussed as the current BCS guidelines by World Health Organization, Unites State Food and Drug Administration and European Medicines Agency allows for biowaivers based on conservative criteria. The potential applications of BCS in drug discovery, drug delivery, and drug research, as well as extensions for BCS, are discussed.