Bioequivalence of Two Oral Formulations of Ciprofloxacin 250 mg Tablets in Healthy Mexican Volunteers

Abstract

Background. There are numerous reports of low-quality formulations of ciprofloxacin in the market, which has been associated with therapeutic failure and the development of microbial resistance. Objective. The aim of this study is evaluating the bioequivalence between two oral immediate-release ciprofloxacin 250 mg tablets. Material and Methods. The study was performed in 24 Mexican healthy volunteers following a randomized cross over 2 × 2 design. Single doses of a test formulation Lemyflox® (Lemery Laboratories, Mexico) and the reference formulation Ciproxina® (Bayer, Mexico) were administered; blood samples were obtained during a 12 h period. Ciprofloxacin plasma concentrations were quantified using a validated High-Pressure Liquid Chromatography (HPLC) method, plasma concentration against time curves were constructed and pharmacokinetic parameters were determined by non-compartmental analysis. In order to determine bioequivalence, test/reference ratios of Cmax, AUC0-t and AUC0-inf were compared using analysis of variance (ANOVA), followed by the 90 % confidence intervals and the Schuirmann bilateral test. Results. The 90 % confidence intervals limits ranged from 82.92 to 100.88 % for Cmax, from 93.05 to 109.15 % for AUC0-t and from 97.76 to 114.99 % for AUC0-inf, all cases were within bioequivalence acceptance range of 80 - 125 %. Schuirmann test confirmed such observation as the probability that Cmax, AUC0-t and AUC0-inf ratios were beyond 80 - 125 % was lower than 0.05. Conclusions. The results obtained demonstrate bioequivalence between the test and reference formulations.