Published Paper Details:

The Biopharmaceutical Classification System (BCS) was created to minimise the need for in vivo bioequivalence studies and to enable in vitro dissolution experiments to be used as a proxy for in vivo bioequivalence studies. The biopharmaceutical classification system classifies pharmacological compounds based on their solubility ratio, dissolution, and intestinal permeability. It enables drug products' in vivo pharmacokinetic performance to be predicted. The BCS categorization system's concepts may be used to NDA and ANDA approvals, as well as scale-up and post-approval drug manufacturing adjustments. As a result, pharmaceutical businesses may save a substantial amount of time and money on product development. The drug can be classified into four classes of the BCS namely, high solubility high permeability, low solubility high permeability, high solubility low permeability, low solubility low permeability. The formulation scientist can use BCS knowledge to produce appropriate dose forms based on mechanistic rather than empirical methodologies. Solubility- and dissolution-enhancing formulation strategies based on the supersaturation principle to enhance the extent of drug absorption, along with the applications of the BDDCS to the understanding of disposition phenomena are reviewed. Finally, recent classification systems relevant either to the BCS or the BDDCS are presented.