Biowaiver monograph for immediate-release solid oral dosage forms: Empagliflozin.

The objective of this monograph is to assess the applicability of the BCS-based biowaiver for empagliflozin, a sodium glucose co-transporter (SGLT2) inhibitor indicated for the oral management of Type 2 diabetes mellitus. In this assessment, published evidence on membrane permeability, solubility, and formulation performance was examined to determine whether the BCS-based biowaiver can be applied. Empagliflozin is highly soluble but not highly permeable. Therefore, it was concluded that empagliflozin is a BCS class III drug. In cases where a test formulation has a formulation similar to that of the innovator product (Jardiance) and both formulations show very rapid dissolution with 85 % or more in 15 min, immediate-release solid oral formulation containing empagliflozin are eligible for a waiver of clinical studies. The ability to apply the biowaiver concept to empagliflozin, as proposed in this monograph, would contribute to the streamlined approval of generic versions of this essential medicine around the world.