Background: The use of ineffective and poor quality drugs endangers therapeutic treatment and may lead to treatment failure. For desired therapeutic effect, drugs should contain the appropriate amount of active pharmaceutical ingredient and the required physical characteristics.
Aim: The aim of this study was to evaluate quality as well as physicochemical bioequivalence of different brands of furosemide tablets marketed in Bahir Dar, Northwest Ethiopia.
Methods: Five different brands of furosemide tablets were purchased from community pharmacies in Bahir Dar city, Northwest Ethiopia. The quality control parameters of furosemide tablets were determined by identification, weight variation, disintegration, assay and dissolution tests and the results were compared with USP and BP pharmacopoeial standards. Difference (f1) and similarity (f2) factors were calculated to assess in vitro bioequivalence requirements.
Results: Identification test results revealed that all samples contained the stated active pharmaceutical ingredients. The results of weight variation tests indicated that all samples complied with USP specification limits. The active pharmaceutical ingredients quantitative assay showed that all the brands of furosemide tablets were between the 90% and 105% limit of label claim. Similarly, all samples fulfilled disintegration time (i.e., ≤ 30 min) and dissolution tolerance limits (i.e., Q ≥ 80% at 60 min). Hence, none of the samples were found to be counterfeit and/or substandard. Difference factor (f1) values were < 15 and similarity factor (f2) values were > 50 for all the tested brands of furosemide tablets.
Conclusion: This study revealed that all the furosemide brands met the quality specification of weight variation, hardness, friability, dissolution, disintegration and assay. The study also indicated similarity in the dissolution profile of the brands of furosemide tablets with the innovator product. Hence, all of these generic brands could be substituted with the innovator product in clinical practice.



中文翻译：

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在埃塞俄比亚西北部销售的不同品牌速尿片的体外质量比较评估

背景：使用无效和劣质药物会危及治疗，并可能导致治疗失败。为了达到预期的治疗效果，药物应含有适量的活性药物成分和所需的物理特性。
目的：本研究的目的是评估在埃塞俄比亚西北部巴赫达尔市销售的不同品牌速尿片的质量和物理化学生物等效性。
方法：从埃塞俄比亚西北部巴赫达尔市的社区药房购买了五种不同品牌的速尿片。通过鉴别、重量变异、崩解、含量和溶出试验确定速尿片的质量控制参数，并将结果与​​USP和BP药典标准进行比较。计算差异 (f1) 和相似性 (f2) 因子以评估体外生物等效性要求。
结果：鉴定测试结果显示，所有样本均含有所述活性药物成分。重量变化测试的结果表明所有样品均符合 USP 规格限制。活性药物成分定量分析表明，所有品牌的速尿片均在标签声称的90%至105%之间。同样，所有样品都满足崩解时间（即≤30 分钟）和溶出度容限（即60 分钟时Q ≥ 80%）。因此，没有发现任何样本是假冒和/或不合格的。所有测试品牌的速尿片的差异因子 (f1) 值 < 15，相似因子 (f2) 值 > 50。
结论：该研究表明，所有速尿品牌均符合重量变化、硬度、脆碎度、溶出度、崩解度和含量的质量规范。该研究还表明速尿片品牌与创新产品的溶出曲线相似。因此，在临床实践中，所有这些通用品牌都可以用创新产品替代。