Siraj Ebrahim Abdela, Ambaye Abyou Seyfu, Tebabal Adugna Tasew, Tafere Chernet, Tessema Tewodros Ayalew, Zewdie Segenet, Mekuria Basazinew, Yimer Selamawit, Addisu Zenaw Debasu, Yayehrad Ashagrachew Tewabe
Department of Pharmacy, College of Medicine and Health Sciences, Bahir Dar University, Bahir Dar, Ethiopia.
Department of Pharmacy, Asrat Woldeyes Health Science Campus, Debre Berhan University, Debre Berhan, Ethiopia.
Ann Med Surg (Lond). 2025 Jun 16;87(8):4888-4896. doi: 10.1097/MS9.0000000000003459. eCollection 2025 Aug.
The prevalence of chronic disease such as diabetes is increasing in developing countries like Ethiopia. Metformin has been the most widely used first-line agent for the treatment of type II diabetes for more than 10 decades. Generic substitution is a common practice in community pharmacies. Therefore, ongoing bioequivalence evaluations are needed to ensure therapeutic equivalence among the brands. The main objective of this study is to evaluate and compare the common physicochemical properties and drug release profiles of six brands of metformin HCL 500 mg tablets available in community drug retailers in Bahir Dar city, Ethiopia. To achieve this objective, official and non-official compendial tests were conducted among the sampled brands. The results of the analysis demonstrated that all tested products complied with the specifications of the main test parameters as stipulated in the pharmacopoeias. Hence, the available brands can be regarded as acceptable substitutes for each other. However, an bioequivalence study may be needed for a final assessment of the similarity in efficacy of the generic formulations. Strict abidance to regulatory recommendations and progressive post-market surveillance are still required to promote the rational use of branded drugs and ensure safe and effective pharmacotherapy.
在埃塞俄比亚等发展中国家，糖尿病等慢性病的患病率正在上升。二甲双胍在超过10年的时间里一直是治疗II型糖尿病最广泛使用的一线药物。通用名替换是社区药房的常见做法。因此，需要持续进行生物等效性评估，以确保各品牌之间的治疗等效性。本研究的主要目的是评估和比较埃塞俄比亚巴赫达尔市社区药品零售商处可得的六个品牌的500毫克盐酸二甲双胍片的常见物理化学性质和药物释放曲线。为实现这一目标，对抽样品牌进行了官方和非官方药典测试。分析结果表明，所有测试产品均符合药典规定的主要测试参数规格。因此，现有品牌可被视为彼此可接受的替代品。然而，可能需要进行生物等效性研究，以最终评估通用制剂疗效的相似性。仍需严格遵守监管建议并进行持续的上市后监测，以促进品牌药物的合理使用，并确保安全有效的药物治疗。
