Comparative Evaluation of Quality Attributes and In Vitro Dissolution Profile Similarity of Metformin Hydrochloride 500 mg Tablets Marketed in Sudan: Implications for Bioequivalence and Generic Interchangeability
Abstract
Abstract This study evaluated the physicochemical quality attributes and in vitro dissolution characteristics of five commercial brands of metformin hydrochloride 500 mg tablets (A–E) marketed in Khartoum, Sudan, to assess their quality and potential interchangeability with the innovator product (Brand A). Quality control tests were performed according to British Pharmacopoeia (BP) and United States Pharmacopeia (USP) specifications, including weight variation, hardness, friability, disintegration, assay by UV spectrophotometry, and dissolution profiling. Data were analyzed using one-way analysis of variance (ANOVA) followed by Tukey’s post hoc test, while dissolution profile similarity was assessed using the similarity factor (f₂). All brands complied with pharmacopeial requirements for weight uniformity, hardness, friability (0.0002–0.039%), and disintegration (
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Evidence Hub reads this as a preprint, done in cell cultures (in vitro), not in people. Its evidence level is 5 of 5 (Very low · case / narrative / animal / in vitro / in silico). Case reports, narrative reviews, and animal, cell or computer-model studies give the weakest evidence for human health.
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