ASSESSMENT OF A DISSOLUTION VESSEL DESIGNED FOR USE WITH FLOATING ANDERODIBLE DOSAGE FORMS

A standard dissolution vessel was modified for the purpose of assessin g more reliably the performance of floating dosage forms, particularly those which rely on erosional mechanisms to control drug release rate . The floating dosage form was placed under a supported stainless stee l mesh, situated 72 mm from the base of the vessel, and the dissolutio n test carried out with the paddles set 10 mm above the mesh. The perf ormance of the modified dissolution vessel was explored using two diff erent floating dosage forms; liquid-filled HALO (TM)-propranolol capsu les with biphasic rapid and sustained-release characteristics and a ra pid-release only floating dosage form consisting of lipidic granule-fi lled Macrotonin (TM) capsules. In the case of HALO (TM)-propranolol ca psules, performance of the novel dissolution vessel was compared with an existing dissolution method for floating dosage forms in which the paddles are set to the surface of the dissolution medium in the vessel , and the use of wire sinkers. The results showed that the modified di ssolution vessel provided a more reproducible dissolution profile, eli minated the risk of floating dosage forms adhering to the paddles and simplified sampling procedures, while retaining the ability to differe ntiate between acceptable and unacceptable dissolution performance. (C ) 1998 Elsevier Science B.V.