Comparative evaluation of quality attributes among six different brands of metformin hydrochloride tablets marketed in Bahir Dar city, Ethiopia.
| Title: | Comparative evaluation of quality attributes among six different brands of metformin hydrochloride tablets marketed in Bahir Dar city, Ethiopia. |
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| Authors: | Siraj EA; Department of Pharmacy, College of Medicine and Health Sciences, Bahir Dar University, Bahir Dar, Ethiopia.; Ambaye AS; Department of Pharmacy, Asrat Woldeyes Health Science Campus, Debre Berhan University, Debre Berhan, Ethiopia.; Tebabal AT; School of Medicine, GAMBY Medical and Business College, Bahirdar, Ethiopia.; Tafere C; Department of Pharmacy, College of Medicine and Health Sciences, Bahir Dar University, Bahir Dar, Ethiopia.; Tessema TA; Department of Pharmaceutics and Social Pharmacy, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.; Zewdie S; Department of Pharmacy, College of Medicine and Health Sciences, Injibara University, Injibara, Ethiopia.; Mekuria B; Department of Pharmacy, College of Medicine and Health Sciences, Injibara University, Injibara, Ethiopia.; Yimer S; Department of Pharmacy, College of Medicine and Health Sciences, Bahir Dar University, Bahir Dar, Ethiopia.; Addisu ZD; Department of Pharmacy, College of Medicine and Health Sciences, Bahir Dar University, Bahir Dar, Ethiopia.; Yayehrad AT; Department of Pharmacy, College of Medicine and Health Sciences, Bahir Dar University, Bahir Dar, Ethiopia. |
| Source: | Annals of medicine and surgery (2012) [Ann Med Surg (Lond)] 2025 Jun 16; Vol. 87 (8), pp. 4888-4896. Date of Electronic Publication: 2025 Jun 16 (Print Publication: 2025). |
| Publication Type: | Journal Article |
| Language: | English |
| Journal Info: | Publisher: Wolters Kluwer Country of Publication: England NLM ID: 101616869 Publication Model: eCollection Cited Medium: Print ISSN: 2049-0801 (Print) Linking ISSN: 20490801 NLM ISO Abbreviation: Ann Med Surg (Lond) Subsets: PubMed not MEDLINE |
| Imprint Name(s): | Publication: 2023- : [London] : Wolters Kluwer; Original Publication: London : Surgical Associates Ltd., 2012- |
| Abstract: | 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 in vivo 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.; (Copyright © 2025 The Author(s). Published by Wolters Kluwer Health, Inc.) |
| Competing Interests: | Sponsorships or competing interests that may be relevant to the content are disclosed at the end of this article. The authors declare that they have no competing interests. |
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| Contributed Indexing: | Keywords: Bahir Dar city; in vitro evaluation; metformin HCl tablet; quality |
| Entry Date(s): | Date Created: 20250811 Latest Revision: 20250813 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC12333786 |
| DOI: | 10.1097/MS9.0000000000003459 |
| PMID: | 40787499 |
| Database: | MEDLINE |
Journal Article