Development of an In Vitro Release Test (IVRT) for a Vaginal Microbicide Gel

Abstract

Sensitive and reproducible methods to assess in vitro release rates from semisolid products can provide significant value during drug development. The purpose of the present study was to develop and validate an in vitro release test (IVRT) for a topical gel formulation of an HIV microbicide. The method was developed using a vertical diffusion cell system, commercially available synthetic membranes, and HPLC with UV detection. The IVRT method was robust, reproducible, and sensitive to some of the formulation parameters evaluated. The method was applied to evaluate release rates of the active pharmaceutical ingredient from formulations during stability studies.