ABSTRACT

Extension of in vitro dissolution methodology to semisolid dosage forms (topical dermatological drug products such as creams, ointments, gels, and lotions) has been the subject of both substantial effort and debate. A simple, reliable, reproducible, relevant, and generally acceptable in vitro method to assess drug release from a semisolid dosage form would be highly valuable for the same reasons that such methodology has proved valuable in the development, manufacture, and batch-to-batch quality control of solid oral dosage forms.