Comparative Quality Evaluation of Different Brands of Metformin Hydrochloride 500 mg Tablets Marketed in Jimma Town.

Abstract

Metformin hydrochloride, classified under the class of biguanide is an oral antihyperglycemic agent and it is a mechanism of action that is sensitizing insulin. Metformin has hydrophilic properties and a low diffusion rate through the cell membrane. Objective: - The aim of the study is to compare the quality of different brands of metformin hydrochloride 500 mg tablets. Method: - The study was conducted in Jimma town. Different In-vitro tests such as weight variation, friability, dissolution rate, and assay were performed. Data were analyzed using mini tab 19 and one-way ANOVA was used for comparing dissolution profile, assay and weight variation of drugs with the comparator. Similarity factor (f2), difference factor (f1) and dissolution efficiency were also used for comparative study and KinetDS software was used for pharmacokinetic study. Result: - Insumet was failed weight variation test. None of the tested brands were failed friability test. All brands have a statistically significant difference in mean weight from the comparator (P<0.001). Glyformin had the lowest assay value of all brands (84.96%). There was a statistically significant mean difference (P=0.029) in the drug content among different brands. Glucomet and glyformin release 61.7% and 75.9% of active ingredient at the specified time of 30 minutes respectively. Statistically, no significant mean difference in the dissolution profile was observed (P=0.929). Three of the brands had a similarity factor of (f2=50-100) and five brands had a difference in dissolution efficiency of ±10%. The drug release model showed that only etform follow the Weibull model (r2 =0.9887). Conclusion: - Comparatively, the quality of different brands of metformin hydrochloride included in the study was good. Insumet, metformin denk, brot, etform, and metformin can be used interchangeably with comparator drug Glucophage. Except for etform all of the tested brands follow Michaelis–Menten with Lag model for the release drug of drug substance.