Application of the Biopharmaceutical Classification System to Complementary and Alternative Medicines – A Systematic Review

Abstract

The Biopharmaceutical Classification System (BCS) has become a valuable tool in drug regulation around the world. Not only synthetic entities, but also herbal medicines (HMP) intended for oral and systemic use should fit into BCS. In the case of HMPs, the BCS is often missing due to the complex composition of their ingredients, the extensive metabolism of their chemical constituents, and analytical estimation problems that have led to adverse effects, toxicity, and interactions. It is therefore essential to regulate pharmaceutical standards for HMPs. Currently; research is focused on the integration of HMPs into BCS to determine the legal status of medicinal plants. With this in mind, several scientists have preliminarily installed HMPs in the BCS to overcome the solubility and permeability issues associated with HMPs, to establish quality standards for maximum therapeutic benefits. Our review article critically highlights relevant information for HMPs included in BCS and explained different formulation strategies.