In vitro bioequivalence study of newly formulated metronidazole tablets and generic brands (200 mg): A quality control tool

The focus of the present study was to investigate the in vitro dissolution profile of newly formulated fast disintegrating tablets (FDT) and conventional marketed brands of metronidazole. Comparative dissolution was conducted by using USP type I dissolution apparatus operated at 100 rpm for 60 min. Studies were performed in three dissolution mediums (DM), pH 1.2, 4.5, and 6.8 buffers. For kinetics of drug, models dependent and independent were used to confirm the releasing behavior of drug from its dosage form. The drug release was effectively described by Hixson-Crowell, first-order, and Weibull with R² ≥ 0.95. The results of ANOVA in three DM indicated the distance between the mean of test and the reference batches. The value of F at p > 0.05 levels is 2.324 for all three DM and calculated value for F is smaller than that, indicating there are no significant differences in samples means. It was concluded that newly formulated FDT were as good in quality as different brands of metronidazole present in local markets. Moreover, the study also recommends evaluation of the post marketed brands from time to time for maintaining and improving the quality of products.