Abstract

DEVELOPMENT AND IN VITRO EVALUATION OF SUSTAINED RELEASE MUCOADHESIVE TABLETS OF ITOPRIDE HYDROCHLORIDE

Santosh U. Zate*, Jaywant N. Pawar, Pramod R. shinde, Sanjay P. Anantwar

ABSTRACT

The present investigation concerns the development of oral sustained release gastric mucoadhesive drug delivery of Itopride hydrochloride, and optimize the drug release profile and bioadhesion using response surface methodology. A 32 full factorial design was employed to systematically optimize the drug release profile and bioadhesive strength. Carbopol 71G and Sodium carboxymethoxycellulose were taken as the independent variables. Tablets were prepared by direct compression and evaluated for time required for 50% drug release (t50), time required for 90% drug release (t90), % drug release after 12 hours (Q12) and Mucoadhesive strength. Both the polymers had significant effect on the drug release and adhesion strength of the tablets, measured as detachment force against goat gastric mucosa. The investigation shows that Carbopol 71G had prominent role in drug release and adhesion strength of tablets. Response surface plots and contour plots were generated using Design Expert Software; the optimum formulation was achieved by numerical and graphical optimization. The desirability function was used to study the combined effect of all responses. Most of the formulations including the optimized formulation followed Higuchi kinetics and the drug release mechanism was found to be anomalous. For the developed formulation, the value of n was found to be 0.5258 indicating the anomalous transport.

Keywords: Mucoadhesive tablet, Sustained release, Factorial design, Itopride Hydrochloride,