Acceptable analytical practices for dissolution testing of poorly soluble compounds

This article, based on material from a 2003 PhRMA workshop on acceptable analytical practices, provides guidance for developing dissolution testing for poorly soluble compounds. Identifying a single dissolution or appropriate physical test method to provide a measure of product consistency as well as bioavailability remains a significant challenge for dosage forms containing poorly soluble compounds. Dissolution test method development should consider the design and matrix (cohesive properties of formulated drug) of the dosage form as well as the physicochemical (intrinsic) properties of the active pharmaceutical ingredient. The design of the dissolution test method also depends on its purpose. For example, the test may facilitate formulation screening at the early development stage and evaluating manufacturing process parameters at the later stages. The dissolution test media selection should be justified for pH (recommended range pH 1.2-7.5) as well as surfactant type (ionic versus non-ionic) and level.