Jimma Medical Center, Hospital Pharmacy Unit, Jimma, Oromia, Ethiopia.
School of Pharmacy and Laboratory of Drug Quality (JuLaDQ), Jimma University, Jimma, Oromia, Ethiopia.
PLoS One. 2024 Nov 19;19(11):e0310828. doi: 10.1371/journal.pone.0310828. eCollection 2024.
The incidence of hypertension in persons 25 years of age and older is estimated to be 46% in Africa, where it is still very common. This concerning rate could be explained by the pharmaceutical markets' accessibility to poor quality antihypertensive drugs. Thus, the purpose of this study was to evaluate and compare the quality different brands of Amlodipine Tablets Commercially available in Jimma Town, South-western Ethiopia.
The quality control test was conducted from August 30, 2019 to February 27, 2020 at Jimma University in the Laboratory of Drug Quality Control (JuLaDQ). The laboratory test was carried out in accordance with WHO inspection guidelines and United States Pharmacopeia. A statistically significant was considered when P<0.05. For further comparison of the in-vitro dissolution profiles of amlodipine tablets, model-independent model-dependent parameters and statistical Dunnetts tests for ensuring bioequivalence were used to further compare the in-vitro dissolution profiles.
With the exception of brand AMD-5 (1/10), the remaining nine (n = 9) brands were within WHO visual inspection criteria. The quality control parameters such as friability, weight variation, identity, assay, and dissolution test were within the United States Pharmacopeia. The model independent parameters (f1, and f2) confirmed that, all generic products were bio-equivalence, and interchangeable with comparator product. The model dependent approaches revealed the Weibull model (AMD-10), the Zero order (AMD-3), and the Korsemeyer-Peppas models were the most effective predictions for the release of the pharmaceutical substance from the dosage form. The Korsemeyer-Peppas model (r2 ≥0.9695) was the best descriptive model for determining the amlodipine drug kinetics from the point of view of all brands examined. The evaluated amlodipine brand tablets were in line with quality standards. The model independent methods confirmed that the generic brand tablets were interchangeable in clinical practice. The tested products follow more than two drug release kinetics.
The study revealed a manifest discrepancy in the dissolution profiles' releases. Therefore, it is strongly advised to use appropriately designed dissolution profile evaluation methods with various pH values in the dissolution media, as well as to do comprehensive visual inspections. This will make it easier to do a thorough investigation of any potential quality issues that might be related to various generic products available in the pharmaceutical market.
在非洲，25 岁及以上人群的高血压发病率估计为 46%，这仍然非常普遍。这种令人担忧的发病率可能是由于药品市场上可获得的降压药质量较差。因此，本研究的目的是评估和比较在埃塞俄比亚西南部的吉姆马镇市售的不同品牌氨氯地平片的质量。
质量控制测试于 2019 年 8 月 30 日至 2020 年 2 月 27 日在吉姆马大学的药物质量控制实验室（JuLaDQ）进行。实验室测试按照世界卫生组织检查指南和美国药典进行。当 P<0.05 时，认为具有统计学意义。为了进一步比较氨氯地平片的体外溶出曲线，使用模型独立和模型依赖参数以及统计 Dunnetts 检验来进一步比较体外溶出曲线。
除了品牌 AMD-5（1/10）外，其余 9 个（n=9）品牌均符合世界卫生组织的外观检查标准。质量控制参数，如脆碎度、重量差异、鉴别、含量测定和溶出度试验均符合美国药典。模型独立参数（f1 和 f2）证实，所有仿制药均具有生物等效性，可与参比产品互换。模型依赖方法表明，威布尔模型（AMD-10）、零级（AMD-3）和 Korsemeyer-Peppas 模型是预测药物从剂型中释放的最有效方法。从所有检查品牌的角度来看，Korsemeyer-Peppas 模型（r2≥0.9695）是确定氨氯地平药物动力学的最佳描述模型。评估的氨氯地平品牌片剂符合质量标准。模型独立方法证实，在临床实践中，仿制药品牌片剂可互换。测试产品遵循超过两种药物释放动力学。
本研究揭示了溶出曲线释放的明显差异。因此，强烈建议使用在溶出介质中具有不同 pH 值的适当设计的溶出曲线评价方法，并进行全面的外观检查。这将更容易全面调查可能与药品市场上各种仿制药有关的任何潜在质量问题。
