Evaluation of the Equivalence in Dissolution Profiles of Brands of Metronidazole Tablet in Nigeria

Abstract

The purpose of this study was to evaluate whether optimum metronidazole preparations are used for the second-line eradication therapy for Helicobacter pylori infection. The regimen uses a combination of antibiotics that includes amoxicillin and metronidazole. Erratic release of metronidazole, leading to sublethal concentration of the drug within the GIT, between different formulations is proposed as a possible reason for acquisition of resistance in H. pylori. A generic brand of metronidazole was compared to the innovator brand, Flagyl. The evaluation was performed by dissolution test and estimation for intragastric drug concentrations was done based on the dissolution data. The dissolution tests were performed using the paddle method of British Pharmacopoeia. The data obtained were used for the evaluation of similarity in intragastric concentrations of metronidazole following drug release. In the study, the time taken to achieve maximum concentration of metronidazole in the simulated gastric fluid, for Flagyl was less than that for the test drug. The reference and test products were found to be similar, both achieving more than 85% release of drug content in 20minutes in the simulated intestinal fluids. This result implies that the test product can be substituted for Flagyl use in H. pylori eradication therapy in Nigeria.