A Solution To Ensure Quantity & Quality Of The Excipient Polysorbate-80 In Drug Formulations

Excipients are utilized during drug manufacture for a variety of purposes, including stabilization, bulking up or enhancing of the active pharmaceutical ingredient (API). Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability, and there is inconsistency in the quality and composition of PS-80 provided by different vendors. To address these issues, Catalent developed a two-method approach to quantitate and characterize PS-80 supplied by multiple vendors and exposed to a variety of environmental stressors. Using high-performance liquid chromatography (HPLC) and charged aerosol detection (CAD), Catalent was able to detect degradation and differences in chemical composition in treated samples. This novel approach has multiple applications for drug developers looking to utilize PS-80 in their final product.