Abstract:

The objective of this study was to develop formulation of ranitidine 150 mg film coated tablets; compare in-vitro evaluation of self designed formulation with innovator brand of Ranitidine (Zantac) & other four different available brands and to compare the physicochemical equivalency of the five brands. The tablets were prepared by using dry granulation method. All the coated tablets passed weight variation test as the percentage of weight variation was within USP limits of ± 7.5% of the average weight. The chemical assay test of all the tablets showed that none had potency less than the required specifications of USP. The in vitro dissolution test results were found within the USP recommended limits for ranitidine 150 mg film coated tablets. The comparative in-vitro study of F_R with innovator & four different brands showed that F_R has almost comparable characteristics with these brands. This study also proved the physicochemical equivalency of the innovator & four different brands. So if one brand is not available in the market then any of the other four brands can be taken in place of that unavailable brand.

Keywords: Ranitidine, Innovator Drug, In-Vitro Study, Dissolution, Physicochemical Equivalency.