Abstract
The purpose of the present investigation was to produce a quick/slow biphasic delivery system for metoclopramide hydrochloride using the superdisintegrant Ac-di-sol for the fast release layer and hydroxypropyl methylcellulose K100M and Ucarflock 302 to modulate the release of the drug. A dual component tablet made up of a sustained release and an immediate release layer was prepared by direct compression. A 32 full factorial design was applied to systematically optimize the drug release profile of the sustained release layer. The results of the full factorial design indicate that a small amount of HPMC K100M and a large amount of Ucarflock 302 favor sustained release of the metoclopramide hydrochloride vaginal dual component system. The ex vivo residence time reveals that the formulation was retained for more than 10 h. The formulation gave an initial burst effect to provide the loading dose of the drug followed by sustained release for 12 h, thus solving the problem of repeated administration, especially in pregnancy.