Bioequivalence of commercial ranitidine tablets

ABSTRACT

Bioequivalence of two different marketed ranitidine tablets, Tanidina [150 mg, Ferrer, Spain] and Antagonin [150 mg, Arab Pharmaceuticals, Jordan] was compared to the innovate product, Zantac [150 mg, Glaxo, UK]. In vitro results were similar for the three br and s as specified in USP XXII monograph for ranitidine tablets. A three-way r and omized crossover study was conducted on 18 healthy male volunteers. The three products were administered, each as a single oral dose of 150 mg, separated by a one week washout period. After dosing, serial blood samples were collected up to 9 hours. Plasma was analyzed for ranitidine by a sensitive and accurate high performance liquid chromatographic [HPLC] method. Plasma concentration data were subjected to statistical pharmacokinetic analysis for subjects, periods and formulation using analysis of variance. Paired t-test and least significant difference [LSD] were also performed on the derived pharmacokinetic parameters and on plasma concentrations at each sampling time. In vitro studies showed that all three products, Tanidina, Antagonin and Zantac, were pharmaceutically equivalent. In vivo investigations indicated no statistically significant differences between the three products in any of the pharmacokinetic characteristics used to asses bioequivalency. It was concluded that the three br and s of ranitidine tablets [Tanidina, Antagonin, and Zantac] are bioequivalent