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Determination of antiretroviral drugs for buyers’ club in Switzerland using capillary electrophoresis methods
Electrophoresis ( IF 3.0 ) Pub Date : 2020-12-07 , DOI: 10.1002/elps.202000216
Nicolas Guichard 1, 2 , Elena Tobolkina 1, 2 , Lamyae El Morabit 1, 2 , Pascal Bonnabry 1, 2, 3 , Nathalie Vernaz 3 , Serge Rudaz 1, 2
Affiliation  

Human immunodeficiency virus‐acquired immunodeficiency syndrome continues to be a major global public health issue, having claimed almost 33 million lives to date. Due to the high cost of antiretroviral treatment, access to these drugs remains difficult for vulnerable populations, such as migrants and people living in prisons, who often do not have health insurance. These factors lead to poorer health outcomes and higher transmission rates. The personal importation scheme for unapproved generics from foreign countries is one option to access affordable human immunodeficiency virus treatment. However, the risk of importing falsified medicine remains high, and the quality control of unapproved drugs is lacking. In this context, three CE methods for the analysis of nine antiviral drugs found in commercial pharmaceutical formulations were evaluated. The selected compounds were emtricitabine, tenofovir disoproxil, tenofovir alafenamide, rilpivirine, efavirenz, raltegravir, dolutegravir, abacavir, and lamivudine. The developed methods were successfully applied to determine the active pharmaceutical ingredients of commercial formulations and unapproved generics. The quality control of unapproved generics by CE is an attractive approach due to its good standard of quality, low cost, ecofriendliness, and ease of implementation.

中文翻译:

毛细管电泳法测定瑞士买手俱乐部抗逆转录病毒药物

人类免疫缺陷病毒获得性免疫缺陷综合征仍然是一个主要的全球公共卫生问题,迄今已夺走了近 3300 万人的生命。由于抗逆转录病毒治疗费用高昂,弱势群体仍然难以获得这些药物,例如移民和监狱里的人,他们往往没有医疗保险。这些因素导致较差的健康结果和较高的传播率。从国外未经批准的仿制药个人进口计划是获得负担得起的人类免疫缺陷病毒治疗的一种选择。但是,进口假药的风险仍然很高,对未经批准的药品质量控制不力。在此背景下,评估了用于分析商业药物制剂中发现的九种抗病毒药物的三种 CE 方法。选定的化合物是恩曲他滨、替诺福韦地索普西、替诺福韦艾拉酚胺、利匹韦林、依法韦仑、拉特拉韦、多替拉韦、阿巴卡韦和拉米夫定。开发的方法已成功应用于确定商业制剂和未批准仿制药的活性药物成分。由于其良好的质量标准、低成本、生态友好和易于实施,CE 对未经批准的仿制药进行质量控制是一种有吸引力的方法。
更新日期:2020-12-07
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