World Journal of
Pharmaceutical and Life Sciences

An International Peer Reviewed Journal for Pharmaceutical and Life Sciences
An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)
World Journal of Pharmaceutical and Life Sciences (WJPLS) has indexed with various reputed international bodies like : Google Scholar, Index Copernicus, Indian Science Publications, SOCOLAR, China, Cosmos Impact Factor, Research Bible, Fuchu, Tokyo. JAPAN, Scientific Indexing Services (SIS), Jour Informatics (Under Process), UDLedge Science Citation Index, Global Impact Factor (In Process), International Impact Factor Services, International Scientific Indexing, UAE, International Society for Research Activity (ISRA) Journal Impact Factor (JIF), Science Library Index, Dubai, United Arab Emirates, International Innovative Journal Impact Factor (IIJIF), Scientific Journal Impact Factor (SJIF), Eurasian Scientific Journal Index (ESJI), Indian citation Index (ICI), IFSIJ Measure of Journal Quality, International Scientific Indexing, UAE (ISI), Web of Science Group (Under Process), Directory of Research Journals Indexing, 

Abstract

THE SHELF LIFE OF ARTEMETHER+ LUMEFANTRINE TABLETS AT THE DISTRIBUTION CHANNELS OF SUDAN

Dr. Abdrhman Mahmoud Gamil*

ABSTRACT

Distribution and storage conditions are the critical factors in prediction of a pharmaceutical product shelf-life. Artemether and Lumfantrine combination tablets is one of the most important pharmaceutical product in Sudan as it is used in the treatment of the endemic disease, Malaria. To evaluate the distribution and storage conditions and their impacts on the shelf life of this product, samples with dataloggers were analyzed initially then transported and stored at five selective cities for 12 months while logging temperature and humidity every 90 minutes. samples were returned back to the centre and subjected to chemical analysis at intervals I month, 6 months and 12 months. The Reference Thermal Exposure is nearly 8000 hours. The active contents of the tablets were obtained at each time interval using gradient HPLC and then the LSRLs were plotted and the results were computed according to the ICH guidelines using Woolf’s Equation for inverse prediction to obtain X at a given Y. Lumefantrine was found to be stable and its shelf life can be extended to 3 years, but the other part of the tablets, the Artemether component, is the determinant component for the shelf-life. Artemether was found that, it may lose 2 – 6 months from its labelled shelf life because it had been subjected to thermal exposure above 25 for 51 - 61% of the total exposure period. The product retains its physical and microbiological characters indicating GMP compliance.

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