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ABSTRACT
The present research endeavour was directed towards the development of a sustained release tablet of Mebeverine hydrochloride. Mebeverine hydrochloride causes direct relaxation of vascular and uterine smooth muscles. It has a short half life of 2 to 2.5 hrs and is very soluble in water. Sustained release tablets were prepared using hydroxy propyl methylcellulose (Methocel K15M and K100M) and Polyethylene oxide (Polyox) 303. All these polymers were used in the concentration of 10%, 20%, 30% and 40% of the tablet weight. Powder blends were prepared using the necessary excipients. The prepared powder blends were then compressed by direct compression technique in a multistation rotary press. The tablets were evaluated for thickness, weight variation, drug content, hardness, friability and in vitro drug release. The formulations containing Methocel K15M (20%w/w), Methocel K100M (10%w/w) and PEO-303 (20%w/w) could retard drug release similar to marketed preparation (COLOSPARetard IP) upto 12 hrs. The results indicated that Methocel K15M, Methocel K100 M and Polyethylene oxide (Polyox) 303 are potential carriers in the design of oral sustained release tablet of Mebeverine hydrochloride.
Key words: Sustained release, HPMC, Polyethylene oxide 303, Direct Compression.
INTRODUCTION
Mebeverine hydrochloride is one of the musculotropic anti-spasmodic agent used for the symptomatic treatment of abdominal pain, bowel disturbances and intestinal discomfort associated with Irritable Bowel Syndrome. Mebeverine hydrochloride exerts an anti-spasmodic effect by reducing the sodium ion permeability of smooth muscles cells and also indirectly reducing potassium ion efflux, thus avoiding hypertonia1. Mebeverine hydrochloride is highly soluble in water and is readily absorbed into the systemic circulation from upper GIT. It has mean plasma half time of 2.5 hrs. A dose of 135 mg Mebeverine appears to provide effective relief from the symptoms of irritable bowel syndrome but higher frequency of administration of drug may lead to high plasma concentration, resulting in to systemic side effects like decreased heart rate and blood pressure. Sustained- release oral drug delivery systems are designed to achieve therapeutically effective concentrations of drug in the systemic circulation over an extended period of time, thus achieving better patient compliance and allowing a reduction of both the total dose of drug administered and the incidence of adverse side effects2. Considering this aspect, it is desirable to develop a 12 hrs sustained release...