Dumping test: In vitro predictive tool for bioequivalence of Telmisartan formulations

Abstract

Background: The "dumping" test is a simple dynamic dissolution methodology widely studied as a useful tool in bioequivalence trials for class II drug products. Objective: This study aimed to evaluate the dumping test as an in vitro method to predict the in vivo behavior of Telmisartan formulations. A one-step level A IVIVC was developed for three immediate-release formulations (Micardis® as the reference and two generics, X1 and X2) using this transfer model. Methods: Dumping tests were performed by placing drug products in 20 mL of HCl 0.01 N and sampling for 20 min at 37 °C in an orbital shaker. The contents were then transferred to a USP 2 apparatus with 480 mL of pH 6.8 phosphate buffer, maintaining 37 °C and 50 rpm stirring. Bioequivalence was assessed using the similarity factor f2. Results: The f2 values were 46.47 between REF and NBE (non-similar) and 57.43 between REF and BE (similar). The IVIVC study confirmed a level A correlation, supporting the in vitro dissolution results. Conclusions: The dynamic dissolution dumping test proved to be a valuable tool for studying the complex in vivo dissolution process of Telmisartan immediate-release formulations.