Background: Dissolution is the critical quality control parameter and used to predict an in vivo oral bioavailability, and it is used to support bio-waiver.
Aim: To evaluate and compare the dissolution profile of eight brands of metformin HCL 500 mg tablets available in Jimma town, Southwest Ethiopia.
Methods: The study was conducted in Jimma town, Ethiopia. Eight (seven brands and one comparator) metformin HCL 500 mg tablets were included. The dissolution study was conducted as per United States Pharmacopeia, and the dissolution profile was compared by one-way ANOVA, model-dependent and model-independent approaches.
Results: All of the included tablet brands complied with single-point dissolution study specification. Statistical comparisons of the dissolution profile by one-way ANOVA revealed that all brands had similar dissolution profiles (p=0.89). All of the brands had a similarity factor (f₂) > 50% and the difference factor (f₁) < 15. The entire brands followed the Weibull curve approach (the highest coefficient of determination and lowest Akaike Information Criteria) for the release of an active pharmaceutical ingredient.
Conclusion: All of the brands complied with single point dissolution study and all of them could be used interchangeably with the innovator drug. All brands followed the Weibull method for the release of the drug substance.



中文翻译：

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埃塞俄比亚西南部吉马市八种品牌盐酸二甲双胍片的溶出度评价

背景：溶出度是关键的质量控制参数，用于预测体内口服生物利用度，并用于支持生物豁免。
目的：评估和比较埃塞俄比亚西南部吉马镇 8 个品牌的盐酸二甲双胍 500 mg 片剂的溶出度。
方法：该研究在埃塞俄比亚吉马镇进行。包括八（七个品牌和一个比较）盐酸二甲双胍 500 毫克片剂。溶出度研究按照美国药典进行，溶出曲线通过单因素方差分析、模型依赖和模型独立方法进行比较。
结果：所有包含的片剂品牌均符合单点溶出研究规范。通过单因素方差分析对溶出曲线的统计比较显示，所有品牌的溶出曲线都相似（p = 0.89）。所有品牌的相似因子 (f ₂ ) > 50%，差异因子 (f ₁ ) < 15。整个品牌遵循 Weibull 曲线方法（决定系数最高，Akaike 信息标准最低）发布一种活性药物成分。
结论：所有品牌均符合单点溶出度研究，可与原研药互换使用。所有品牌都遵循 Weibull 方法释放原料药。