Formulation Development and Evaluation of Mebeverine extended release Pellets

Abstract

The present study was aimed to formulate and evaluate extended release Mebeverine hydrochloride pellets using surface layering technique. Mebeverine hydrochloride, an anti-spasmodic drug being highly water soluble with a half-life of 2h is suitable to develop extended action for treatment of irritable bowel syndrome. The drug polymer compatibility was defined by the FTIR studies in preformulation study. Calibration curve for the drug is plotted and checked the physicochemical properties. Five formulations (F1-F5) of Mebeverine hydrochloride pellets were prepared using different quantities of talc and other standard excipients. The prepared pellets were subjected to micrometric properties study and physicochemical characterization. In vitro drug release studies were performed for the pellets for 1.5, 3, 6, 12hrs. The optimized formulation F5 showed 93.32% drug release after 12h showing that talc act as rate controlling agent. Scanning electron microscopy (SEM) studies revealed that the prepared pellets for Mebeverine hydrochloride are spherical in shape. The release profile for optimized formulation F5 was comparable with that of marketed formulation (MEVA SR) for Mebeverine hydrochloride. Accelerated stability study for the selected formulation was performed and resulted with unchanged results. Absorption kinetics showed that the drug release of the selected formulation follow First order kinetics with zero order mechanism.