DESIGN AND IN VITRO EVALUATION OF PROCHLORPERAZINE MALEATE BUCCOADHESIVE TABLETS AND COMPARISON OF MONOLAYER, BILAYER AND COMPRESSED COATED TABLETS

Buccoadhesive tablets have long been employed to improve the bioavailability of drugs undergoing significant first pass hepatic metabolism. Prochlorperazine maleate is an anti-emetic drug. It was under goes extensive first pass metabolism resulting in an oral bioavailability of 0 to 16 % and it shows variable absorption from GIT. Hence in the present work Buccoadhesive bilayered tablets of Prochlorperazine maleate were prepared with the objective of avoiding first pass metabolism and controlling the release of drug for prolog period of time. Controlled release buccoadhesive bilayered tablets containing Prochlorperazine Maleate was prepared using a 3² full factorial design. Amount of HPMC K4M CR and Carbopol 974 P NF were taken as the formulation variables (factors) for optimizing Bioadhesive strength and percentage release of drug. The bilayered buccoadhesive tablets were evaluated for Physical characterization, Assay, Swelling index, Adhesion study, In-vitro residence time, Microenvironment pH, In-vitro drug release and In-vitro permeation. The formulation with 5 mg HPMC and 7.5 mg Carbopol was consider as a best product with respect to Adhesive strength, in vitro residence time, in vitro drug release and in vitro permeation study. The drug release pattern of this formulation was found to be non-fickian and approaching zero order kinetics. This product was further subjected to stability study, the results of which indicated no significant change with respect to Adhesive strength, in vitro residence time, in vitro drug release and in vitro permeation study.