Objective To evaluate the in vitro dissolution behaviors and in vivo bioequivalence of generic formulation of Glimepiride compared with the reference formulation to verify their consistency in quality.Methods A validated method for dissolution testing was employed for in vitro studies.The dissolution curves were measured in three different media:pH 1.2 hydrochloric acid solution+1%Tween 80,pH 6.8 phosphate buffer,and pH 7.8 phosphate buffer.Consistency was analyzed using the similarity factor(f2).An open-label,two-period,randomized crossover bioequivalence trial was employed for in vivo studies,involving healthy subjects in both fasting and fed states.Pharmacokinetic parameters such as Cmax,AUC0-t,and AUC0-∞ were measured,and the 90%confidence intervals of the geometric mean ratios were assessed.Results The dissolution curves of the generic and the reference preparations in three dissolution media were similar(f2>50),indicating consistent in vitro dissolution behaviors.The 90%confidence intervals of the geometric mean ratios for Cmax,AUC0-t,and AUC0-∞were 98.89%-124.98%and 83.53%-100.61%under fasting conditions,and 96.13%-103.86%under fed conditions,respectively,all of which met the bioequivalence criteria of 80.00%-125.00%.Safety was good during the trial,with no serious adverse events reported.Conclusion The consistency of in vitro dissolution behaviors and in vivo pharmacokinetic parameters revealed that the quality of generic formulation of Glimepiride was equivalent to the reference formulation,providing a safe and cost-effective alternative for clinical use.
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