Development of a Discriminative Dissolution Method for Mebendazole Suspensions

Introduction:Studying the dissolution profile is a suitable method for the comparison of novel or special dosage forms, including oral and parenteral suspensions, soft gel capsules, and transdermal patches.Mebendazole is a broad-spectrum benzimidazole approved by United States Food and Drug Administration to treat different parasitic diseases.Despite its wide use, there is no compendial dissolution requirement for oral suspensions.The objective of this study was to develop a discriminatory in vitro release test for mebendazole suspensions.Methods: United States Pharmacopeia (USP) apparatus 2 (paddle) and 4 (flow-through cell) were selected, and 0.1 N hydrochloric acid with 1% sodium lauryl sulfate was used as the dissolution medium.In apparatus 2, a 50-rpm agitation rate and sample insertion mode in the dissolution vessel were evaluated.In apparatus 4, flow rate, bed size, and open and closed configurations were assessed.Dissolution profiles of three commercial products were analyzed.Results: Dissolution studies using USP apparatus 2 showed that all products complied with very rapid dissolution criteria, and the method was not able to discriminate between products.For apparatus 4, a flow rate of 16 mL/min was selected.No differences in dissolution behavior for the reference product were found between open and closed-loop configuration.Statistical differences in dissolution profiles were found among products using the open-loop configuration.Conclusion: USP apparatus 4 with the open-loop configuration had more discriminatory power than apparatus 2 in assessing the dissolution release from oral mebendazole suspension products.The developed method could be suitable for quality control and dissolution profile comparison of mebendazole commercial formulations.