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

Abstract

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.

Degradation Study on the Effects of Storage Conditions on Active Ingredient of an ACT- Based Anti-malarial Drugs

“…Table 5 shows the result of the concentration of Artemethar in XYZ drug stored using different ventilation condition. From the Table above FCV Drug quality and stability in the developing countries is a serious concern due to poverty and literacy levels as well as prevailing weather conditions [19]. This study evaluated the effects of different storage temperatures and ventilation conditions on the active pharmaceautical ingredient of a branded antimalarial drug (Artemether; 80 mg and Lumefanthrine; 480 mg).…”