PHARMACEUTICAL EQUIVALENCE ASSESSMENT OF YEMENI AND NON-YEMENI METFORMIN TABLETS MARKETED IN YEMEN

Objectives: This study aimed to evaluate the pharmaceutical equivalence of Yemeni and Non-Yemeni metformin tablets marketed in Yemen by assessing key quality control parameters. Methods: Both official USP and unofficial pharmacopeial tests were performed to assess weight uniformity, thickness, friability, hardness, disintegration, and dissolution. All experiments were conducted in triplicate, and results were expressed as mean ± standard deviation. Statistical comparisons between the two formulations were performed using Student’s independent t-test, with significance set at p < 0.05. Results: Both formulations met USP specifications for weight, thickness, friability, disintegration, and dissolution. The hardness of Non-Yemeni tablets (19.2 ± 2.3 kg/cm²) was significantly higher than Yemeni tablets (11.6 ± 2.4 kg/cm²; p < 0.05), and both exceeded the recommended range for immediate-release tablets (4–8 kg/cm²). Disintegration times were within the pharmacopeial limit of 15 minutes, with Yemeni tablets disintegrating faster than Non-Yemeni tablets (p < 0.05). Dissolution efficiency was satisfactory for both products (>90%). Conclusion: Both Yemeni and Non-Yemeni metformin tablets met USP quality standards across all evaluated parameters, confirming the pharmaceutical equivalence of Yemeni-manufactured and Non-Yemeni sourced metformin tablets.