Quality and stability of artemether-lumefantrine stored under ambient conditions in rural Mali

Malaria Journal

Research

John Gitua¹  Aaron Beck²  John Rovers² 

[1] College of Arts and Sciences, Drake University, 2507 University Avenue, IA 50311, Des Moines, USA;College of Pharmacy and Health Sciences, Drake University, 2507 University Avenue, IA 50311, Des Moines, USA;

关键词: Drug stability;    Artemisinins;    Infrared spectrophotometry;    Magnetic resonance spectroscopy;    Pharmacists;   

DOI  :  10.1186/1475-2875-13-474

 received in 2014-05-11, accepted in 2014-11-24,  发布年份 2014

来源: Springer

【 摘 要 】

BackgroundThe quality and stability of anti-malarial drugs in the Global South has long been of significant concern. Drug quality can be affected by poor or fraudulent manufacturing processes, while drug stability is affected by temperature and humidity. Knowledge of drug quality and stability is often the unique contribution of pharmacists volunteering on short-term medical mission trips.ObjectiveTo determine the quality and stability of artemether-lumefantrine 20/120 mg under ambient storage conditions in rural Mali.MethodsOne unopened blister pack of artemether-lumefantrine 20/120 mg (IPCA Laboratories, Mumbai) was stored under ambient conditions in a warehouse in a Malian village for one year. A second pack from the same lot number was stored under temperature and humidity controlled conditions in a university laboratory. The active ingredients of tablets from both packages were analysed using thin layer chromatography, nuclear magnetic resonance and infrared spectroscopy. The IPCA samples were referenced for drug identity and content to an identical American made product (Coartem ®, Novartis Pharmaceuticals).ResultsThin layer chromatographs, nuclear magnetic resonance and infrared spectroscopy results were identical for both IPCA samples and the reference product.ConclusionsThe IPCA products contained the same drugs in the same amount as on their package label and were identical to the reference product. It is concluded that they were of good quality. Spectroscopy results demonstrate the sample stored in Mali was stable for one year. Pharmacists volunteering on medical mission trips may dispense this product with confidence. At the end of a mission trip, pharmacists may store left over artemether-lumefantrine under ambient conditions for up to one year without concern for significant degradation of the active ingredients.

【 授权许可】

Unknown   
© Gitua et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.