PHARMACOKINETIC STUDIES OF RANITIDINE TABLETS ON HEALTHY HUMAN SUBJECTS USING TWO BINDERS

Abstract

Ranitidine is an effective H2 receptor antagonist. Ranitidine is a specific, long acting H2 receptor antagonist. It is indicated for the treatment of duodenal ulcer, gastric ulcer, GERD and ZollingerEllison syndrome. In this study two formulations of Ranitidine 300 mg tablets were prepared and film coated. Starch and poly vinyl pyrolidone were used as binding agents to check the effect of the binding materials on the pharmacokinetic parameters of Ranitidine tablets. Different in vitro tests were used to evaluate Ranitidine tablets like disintegration test and dissolution test. Then in vivo evaluation was performed on these two formulations. Tablets were administered to eight normal human subjects comprising of two groups, each group consisted of four normal human subjects one by one in a crossover manner after one week washout period. Blood samples were collected and plasma was obtained and analyzed by HPLC. Statistical analysis was performed and the values for Cmax for formulation 1 were found to be 4.63 ± 0.47 µg/ml, and for formulation 2 it was 4.76 ± 1.02 µg/ml. The value for Tmax for formulation 1 was found to be 2.0 ± 0.37 hours, and for formulation 2 it was 1.5 ± 0.46 hours. The value for AUC for formulation 1 was found to be 18.57 ± 6.122 µg/hr/ml and for formulation 2 it was 26.43 ±22.38 µg/hr/ml. It was also concluded that different binders affect the bioavailability of the tablets and Ranitidine tablets prepared by polyvinyl pyrolidine have better bioavailability than those tablets prepared by starch as binding agent.