Preparatıon and Evaluatıon of a Sustaıned Release Formulatıon of Metoclopramıde Hydrochlorıde Hpmc Tablets

Abstract

The objective of the present study was to develop "once daily" sustained release tablets of metoclopramide hydrochloride by direct compression using hydroxypropyl methylcellulose (HPMC). No significant changes in terms of peak shifting, appearance or disappearance of peaks were noted with pure drug, polymers and mixtures. The developed sustained release and marketed immediate release of metoclopramide hydrochloride were appraised for physico-chemical parameters such as appearance, weight variation, thickness, hardness, friability and in vitro release study. Developed sustained release tablets of metoclopramide hydrochloride with respect to its physicochemical parameters and drug content are stable at long term storage conditions at 25 o C and 60% RH, and accelerated conditions at 40 o C and 75% RH for a period of six months. The in vitro drug release of Metoclopramide hydrochloride sustained release was compared with the marketed immediate release. The sustained release tablets of metoclopramide hydrochloride were well absorbed and the extent of absorption was higher than that of the marketed tablet. The Cmax and tmax data showed higher for immediate release compared to sustain release formulation. Developed Metoclopramide hydrochloride sustained release tablets demonstrated higher AUC, half-life and lower elimination rate constant values is indicative, that drug leftover in the body for extended period of time and showed signs of prolonged effect. The sustained and efficient drug delivery system developed in the present study will maintain plasma Metoclopramide hydrochloride levels better, which resolve the drawbacks related with the conventional therapy.