Kassahun Haile, Asres Kaleab, Ashenef Ayenew
Department of Pharmacy, College of Health Sciences, Wollo University, P.O. Box. 1145, Dessie, Ethiopia.
Department of Pharmaceutical Chemistry and Pharmacognosy, School of Pharmacy, College of Health Sciences, Addis Ababa University, P.O. Box. 1176, Addis Ababa, Ethiopia.
J Pharm (Cairo). 2018 Jul 18;2018:7916368. doi: 10.1155/2018/7916368. eCollection 2018.
Good quality drugs fulfilling the regulatory parameters and produced per the current good manufacturing (CGMP) standards are very critical for best therapeutic outcome in patient therapy. Hence, this study assesses quality as well as physicochemical bioequivalence of five brands of glibenclamide tablets marketed in Addis Ababa using and methods. Friability, disintegration, dissolution, and assay for the content of active ingredients were evaluated using the methods described in the British Pharmacopeia (2009) and United States Pharmacopeia (2007). All the brands of glibenclamide tablets complied with the official specification for hardness, friability, disintegration, and assay. Difference factor (f1) values were less than 15 and similarity factor (f2) values were greater than 50 for all products of glibenclamide. The hypoglycemic effect of different products of glibenclamide tablets was evaluated on normoglycemic mice. The studies indicated that there is no significant difference in percent reduction of blood glucose level between the brands of glibenclamide and the innovator product (p > 0.05). Hence, based on the results and dissolution studies, the brands might be substituted with the innovator product in clinical practice.
符合监管参数并按照现行药品生产质量管理规范（CGMP）标准生产的优质药物对于患者治疗获得最佳治疗效果至关重要。因此，本研究采用[具体方法1]和[具体方法2]评估在亚的斯亚贝巴市销售的五个品牌格列本脲片的质量以及物理化学等效性。使用英国药典（2009年版）和美国药典（2007年版）中描述的方法评估脆碎度、崩解度、溶出度以及活性成分含量测定。所有品牌的格列本脲片均符合硬度、脆碎度、崩解度及含量测定的官方标准。所有格列本脲产品的差异因子（f₁）值均小于15，相似性因子（f₂）值均大于50。在血糖正常的小鼠身上评估了不同品牌格列本脲片的降血糖效果。[相关]研究表明，各品牌格列本脲与创新产品之间血糖水平降低百分比无显著差异（p>0.05）。因此，基于[相关]结果和[溶出度]研究，在临床实践中这些品牌的产品可被创新产品替代。
