Quality assessment of fifteen brands of artemether-lumefantrine tablets in Lagos metropolis, Nigeria

Background: Nigeria has been shown to have the highest number of malaria casualties worldwide. Due to the increased demand for anti-malarial drugs, the Nigerian pharmaceutical market is flooded with a wide range of generic drugs whose quality must be regularly checked.

Objectives: The objective of this research was to carry out quality assessment of artemether-lumefantrine tablets marketed in Lagos metropolis, Nigeria.

Methods: Fifteen different brands of artemether-lumefantrine tablets gotten from five local government areas (Mushin, Oshodi-Isolo, Surulere, Ikorodu and Lagos Island) in Lagos were evaluated for weight variation, diameter, thickness, disintegration, hardness, friability according to the methods specified in the British Pharmacopoeia (2014) and the United States Pharmacopoeia (2014). The quantitative assay was carried out according to a previous research by Vinodh et al., (2013) with some modifications.

Results: The results showed that 100 % of the tested brands of artemether - lumefantrine tablets passed the weight variation test, disintegration test (30 minutes) and diameter test (±5% and ±3%,≤12.5mm and >12.5 mm respectively). It was observed that 87 % of the brands tested passed the friability test (≤1%) and thickness test (±5% deviation) while 80 % conformed to the standard limit (4– 10kp) for hardness. Only, 67% of the brands tested conformed to the quantitative assay standard limit (90- 110%). Summarily, the results indicated that only 47 % of all the brands which included the innovator brand, passed all the tests carried out on them.

Conclusion: This study has been able to show that of all the brands of artemether-lumefantrine tablets assessed, 53% of the brands did not pass all the quality tests that they were subjected to. Hence, the importance of continuous monitoring of the safety and efficacy of drugs.

研究背景：现有研究表明，尼日利亚是全球疟疾死亡病例最多的国家。由于抗疟药物需求持续攀升，尼日利亚医药市场充斥着各类仿制药，亟需对其质量开展定期抽检。
研究目的：本研究旨在对尼日利亚拉各斯大都会市流通的蒿甲醚-本芴醇片（artemether-lumefantrine tablets）开展质量评估。
研究方法：研究人员从拉各斯市5个地方政府区域（穆辛、奥绍迪-伊索洛、苏鲁雷、伊科罗杜及拉各斯岛）采集了15个不同品牌的蒿甲醚-本芴醇片，按照《英国药典（2014版）》（British Pharmacopoeia 2014）与《美国药典（2014版）》（United States Pharmacopoeia 2014）规定的方法，对其重量差异、直径、厚度、崩解时限、硬度及脆碎度开展检测。含量测定参照Vinodh等人2013年的研究方法并进行了部分修改。
研究结果：所有受试的蒿甲醚-本芴醇片品牌均通过了重量差异检测、崩解时限检测（30分钟内）及直径检测（分别满足±5%、±3%的偏差要求，且直径≤12.5mm或＞12.5mm）。结果显示，87%的受试品牌通过了脆碎度检测（脆碎度≤1%）及厚度检测（偏差≤±5%）；80%的受试品牌符合硬度标准限值（4~10kp）；仅67%的受试品牌符合含量测定标准限值（90%~110%）。综合来看，包括原研品牌在内的所有受试品牌中，仅有47%通过了全部检测项目。
研究结论：本研究证实，在所有受试的蒿甲醚-本芴醇片品牌中，53%的品牌未通过全部质量检测项目。由此可见，持续开展药物安全性与有效性监测工作至关重要。