Practical considerations for the development of a robust two-step dissolution test for enteric-coated immediate- and extended-release solid oral dosage formulations

Abstract

The following describes the practical details for developing a robust two-step dissolution test for enteric-coated, immediate- and extended-release solid oral dosage forms with fast HPLC analysis. Two-step dissolution methods for poorly soluble compounds require special considerations, two of which are the addition of surfactant to one (or both) of the dissolution media to achieve sink conditions and the choice of technique utilized to switch medium pH during the test. Robust and repeatable performance should be expected if the proper tools and techniques are utilized. In addition, two-step dissolution methods should provide information about the coating quality as well as the potential for coating failure in the acid step. Finally, the surfactant concentration present in either the acid or buffer stage needs to be optimized and justified.