Department of Pharmacy, College of Medicine and Health Sciences, Wollo University, Dessie, Ethiopia.
Chagni Primary Hospital, Chagni, Amhara Region, Ethiopia.
Drug Des Devel Ther. 2020 Nov 24;14:5119-5128. doi: 10.2147/DDDT.S280203. eCollection 2020.
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.
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.
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.
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.
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.
使用无效和劣质药物会危及治疗效果，并可能导致治疗失败。为了达到理想的治疗效果，药物应含有适当剂量的活性药物成分和所需的物理特性。
本研究旨在评估在埃塞俄比亚西北部巴赫达尔市销售的不同品牌呋塞米片的质量和理化生物等效性。
从巴赫达尔市社区药店购买了 5 种不同品牌的呋塞米片。通过鉴别、重量差异、崩解、含量测定和溶出度试验来确定呋塞米片的质量控制参数，并与 USP 和 BP 药典标准进行比较。计算差异（f1）和相似（f2）因子，以评估体外生物等效性要求。
鉴别试验结果表明，所有样品均含有规定的活性药物成分。重量差异试验结果表明，所有样品均符合 USP 规格限制。活性药物成分定量测定表明，所有呋塞米片品牌均在标签声称的 90%至 105%范围内。同样，所有样品均符合崩解时间（即，≤30 分钟）和溶出度耐受性限制（即，Q≥60 分钟时 80%）。因此，没有一个样品被发现是假冒伪劣产品。所有测试品牌的呋塞米片的差异因子（f1）值均<15，相似因子（f2）值均>50。
本研究表明，所有呋塞米品牌均符合重量差异、硬度、脆碎度、溶出度、崩解度和含量测定的质量规格。研究还表明，这些呋塞米片品牌的溶出曲线与原研产品相似。因此，在临床实践中，所有这些仿制药品牌都可以替代原研产品。
