Quality Evaluation of Different Brands of Metformin Hydrochloride 500 Mg and 850 Mg Tablets Available in Mekelle City

Abstract

Introduction: Metformin is the most commonly prescribed drug. The accessibility of substandard and falsified metformin products in the market lead to treatment failure, increased mortality, and morbidity. Ethiopia has a low port control and a weak regulatory system. Additionally, in Tigray, several brands of metformin tablets have been released into the market for the past three years without proper regulatory systems. To address this concern, this study was conducted. Objective: This study aims to assess and compare the quality of different brands of metformin 500 mg and 850 mg tablets available in Mekelle City, Tigray, Ethiopia. Method: Quality parameter tests such as physical characteristics, friability, dissolution, disintegration, weight variation, assay, and hardness tests were conducted as per British Pharmacopeia (BP), World Health Organization (WHO), and non-official standards. Data were analyzed using Origin Pro 2024 and one-way analysis of variance (ANOVA). To compare the dissolution profile of the tested product against the innovator, similarity factor (f2), and difference factor (f1) was used. Result: Except for one brand, they all had online EFDA registration numbers. For metformin 500 mg brands: Weight variation ranges from -3.96 % to 2.22 %, assay value ranges from 95.2% to 102.1%, and dissolution value ranges from 90.4 % to 99.7 % at 45 minutes. For metformin 850 mg brands: Weight variation ranges from -2.1 % to 2.6 %, assay value ranges from 97.9% to 103.7%, and dissolution value ranges from 97.9 % to 101.6. % at 45 minutes. Conclusion: Except for the hardness test, all the tested brands of metformin hydrochloride 500 mg and 850 mg tablets met the official BP and WHO specifications. This study could help to patients, EFDA, independent research groups, and other concerned bodies to get updated information on the quality status of metformin 500 mg and 850 mg tablets.