Formulation and Evaluation of Cinitapride Controlled Release Tablets

Abstract

The present study aimed at Formulation Development and Evaluation of controlled release tablets of Cinitapride for the treatment of ulcer. Cinitapride is a gastroprokinetic agent and antiulcer agent of the benzamide class. It act as an agonist of the 5-HT1 and 5-HT4 receptors and an antagonist of the 5-HT2 receptors. It is used in the treatment of gastrointestinal disorders associated with motility disturbances such as gastro esophageal reflux disease, non-ulcer dyspepsia and delayed gastric emptying. The matrix tablets of Cinitapride were prepared using wet granulation. Physical characterization of tablet and powder blends used to form the matrix tablet was under taken using a range of experimental techniques. Granules were evaluated for Bulk density, Tapped density, Compressibility index and Hausner's ratio. Tablets were tested for weight variation, hardness, thickness and friability as per official procedure. The tablets were evaluated for in-vitro drug release profile. Dissolution studies of Cinitapride controlled release tablets in media with different dissolution media 0.1N HCl, Phosphate buffer pH (6.8) as per US Pharmacopoeia. The dissolution data revealed that the ratio of polymers is very important to achieve a optimum formulation. The formulation of Cinitapride CR tablets shown that formulation F23 with Methocel K100M (20%) shown good drug release profile. Formulation F23, shown similar dissolution profile when compared with the marketed product (Cintapro). Stability study of the formulation F23 indicated no significant difference in release profile after a period of 3 months.