Abstract

FORMULATION AND IN VITRO EVALUATION OF RABEPRAZOLE SODIUM DELAYED RELEASE TABLETS

Bhavani K.* and Matsyagiri L.

Abstract

The main objective of this research work was to formulate and evaluate the delayed release tablets of rabeprazole sodium, an anti ulcer drug like peptic ulcer and duodenal ulcer. Rabeprazole was class- I proton pump inhibitor to gain FDA approval. Rabeprazole sodium delayed release tablets were prepared by direct compression technique and dry granulation method. All the Excipients are tested for compatibility with drug, which revealed that there was no physical and chemical interaction occurred. During film coating Appearance, average weight, hardness, thickness, disintegration and during film coating appearance of film coating, Average weight of film coating tablet, disintegration time and during enteric coating appearance and average weight of enteric coated tablets acid resistance this parameters were performed like wt variation test, hardness, friability, disintegration time. Among all formulations, formulation F12 was found to be best of all the formulations showing drug release matching the innovator product so to that formulation all the quality control tests were done for conformation. Stability study is carried out for 3 months at 25°C; 60% RH: and 40°C; 75% RH, according to ICH guidelines. The effect of these variables on drug release also studied. The in vitro drug release studied was performed in the disintegration apparatus.

Keywords: Anti ulcer drug, Delayed release, Rabeprazole sodium.