In-vitro Fundamental Assessment of Disintegration and Dissolution Profile of Enteric Coated Rabeprazole Tablet Commercially Accessible in Bangladesh

Objective: An assortment of commercially accessible enteric coated rabeprazole tablets were evaluated comparatively in vitro disintegration and dissolution profile in association with its’ drug content.
Methods: In-vitro disintegration and dissolution profiling of our selected all enteric coated rabeprazole brands in Bangladesh were carried out using a dissolution apparatus USP at a paddle speed of 100 rpm and UV-VIS spectrophotometer. BP method was used to determine the time required for tablet to disintegrate in acid stage, pH 1.2 and buffer stage, pH 6.8.
Results: The in vitro disintegration and dissolution time were found to be varying for each tablet, but within the B.P. prescribed limit. Brand10 showed the fastest disintegration. All the brands showed no disintegration, cracks or swelling in 0.1 N HCl, except brand 4 and 10, which showed cracks, leakage, and blackspot after 120 min. However, the disintegration of all the products in phosphate buffer meets B.P requirements. Dissolution of tablets in 0.1 N HCl showed less than 10% drug release after 120 minutes. Moreover, the comparison of percentage drug release on the basis of dissolution study demonstrated that Brand 1, 2, 4, 5, 6, 7, 8, 9, and 10 (80% drug release) complied best whereas Brand 3 (78.16% drug release) does not fulfill with pharmacopoeial specification.
Conclusion: All the brands (10) of rabeprazole tablets tested in vitro assessment of disintegration and dissolution were showed pharmacopoeial specification except brand 3, 4 & 10. So, this study helps to make pharmacopoeial specified rabeprazole tablets.