Abstract
Background: Widespread resistance has been recorded with the use of monotherapy in the management of malaria. In 2000, Ghana initiated the process of using Artemisinin-based combination therapy (ACT) following the World Health Organization’s (WHO) recommendation. Globally and in Ghana, there stands a high risk of development of resistance to the ACTs due to the act of counterfeiting or substandard drugs. In 2009, there was a report that fake Coartem, an ACT had been found in Ghana by the Drug Quality and Information (DQI) Program; this is a serious national problem that needs redress thus the need to conduct this study to check if there are any substandard or counterfeit Artemether/ Lumefantrine tablets on the Ghanaian market. Method: Using Representative sampling method, a total of nine different brands or samples of artemether/lumefantrine tablets were sampled from nine different Pharmacies in Accra. The samples were analyzed using a validated MVHimagePCv8.exe colour software technology. Results: The International Conference on Harmonization (ICH) and United States Pharmacopoeia (USP) recommend that for assay of tablets, the percentage concentration should fall within 80%-120%. After the analysis, seven out of the nine samples passed the test to varying degrees. Two samples (AL-S4 and AL-S6) however failed the test with AL-S4 recording artemether concentration (126.07%) above and Lumefantrine concentration (78.38%) below the recommended figure while AL-S6’s 51.53% failed to meet the minimum allowable concentration for lumefantrine in a tablet. Conclusion: The results presented show that some Artemether/Lumefantrine tablets on the Ghanaian market still have issues with regards to quality or level of active ingredients. There would therefore be the need for further studies to be conducted into these products especially those that failed the test.
Highlights
Malaria is a potentially fatal blood-borne disease caused by a eukaryotic protoctist of the genus Plasmodium, a parasite that is transmitted to human and animal hosts by the female Anopheles mosquito.There are four main species of the parasite (P. falciparum, vivax, ovale, and malariae) that are known to affect man [1]
The results showed a trend that looked like artemether concentrations are being increased at the expense of lumefantrine probably due to cost
This is an unacceptable practice because the role of lumefantrine in its right amount is important in this combination therapy and cannot be compromised
Summary
Malaria is a potentially fatal blood-borne disease caused by a eukaryotic protoctist of the genus Plasmodium, a parasite that is transmitted to human and animal hosts by the female Anopheles mosquito.There are four main species of the parasite (P. falciparum, vivax, ovale, and malariae) that are known to affect man [1]. Management of the disease in Ghana and other parts of the continent has moved from single drug therapies like chloroquine to the new artemisinin based combination therapy (ACT) due to the issue of resistance to monotherapy. In 2009, there was a report that fake Coartem, an ACT had been found in Ghana by the Drug Quality and Information (DQI) Program; this is a serious national problem that needs redress the need to conduct this study to check if there are any substandard or counterfeit Artemether/ Lumefantrine tablets on the Ghanaian market. Two samples (AL-S4 and AL-S6) failed the test with AL-S4 recording artemether concentration (126.07%) above and Lumefantrine concentration (78.38%) below the recommended figure while AL-S6’s 51.53% failed to meet the minimum allowable concentration for lumefantrine in a tablet. There would be the need for further studies to be conducted into these products especially those that failed the test
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
