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Quality Assessment of Artemether/Lumefantrine Tablets Sampled from Pharmacies in Accra, Using the MVHimagePCv8.exe Color Software

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DOI: 10.4236/pp.2013.48081    5,143 Downloads   7,356 Views   Citations

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.

Conflicts of Interest

The authors declare no conflicts of interest.

Cite this paper

E. Nyarko and H. Nettey, "Quality Assessment of Artemether/Lumefantrine Tablets Sampled from Pharmacies in Accra, Using the MVHimagePCv8.exe Color Software," Pharmacology & Pharmacy, Vol. 4 No. 8, 2013, pp. 567-572. doi: 10.4236/pp.2013.48081.

References

[1] A. O. Ajibola, “Essential Medicinal Chemistry,” 3rd Edition, Hope, Ibadan, 2005, pp. 404-429.
[2] Hazel, et al., “Malaria Case Management in Ghana, Training Manual for Pharmacist,” 2009, p. 8.
http://en.wikipedia.org/wiki/Malaria#History
[3] WHO, “Report of an Informal Consultation,” Geneva, 13-17 November 2000.
[4] GHS, “Training Manual for the Management of Malaria at Health Facilities in Ghana,” 2009, pp. 7-10.
[5] J. D. Michele Forzley, “Combating Counterfeit Drugs: A Concept Paper for Effective International Collaboration,” 2005, p. 2.
[6] R. B. Taylor, O. Shakoor, R. H. Behrens, M. Everard, A. S. Low, J. Wangboonskul, R. G. Reid and J. A. Kolawole, “Pharmacopoeial Quality of Drugs Supplied by Nigerian Pharmacies,” Lancet, Vol. 357, No. 9272, 2001, pp. 1933-1936.
http://dx.doi.org/10.1016/S0140-6736(00)05065-0
[7] M. D. Green, H. Nettey, O. V. Rojas, C. Pamanivong, L. Khounsaknalath, M. G. Ortiz, P. N. Newton, F. M. Fernández, L. Vongsack and O. Manolin, “Use of Refractometry and Colorimetry as Field Methods to Rapidly Assess Antimalarial Drug Quality,” Journal of Pharmaceutical and Biomedical Analysis, Vol. 43, No. 1, 2007, pp. 105-110. http://dx.doi.org/10.1016/j.jpba.2006.06.047
[8] M. D. Green, F. Atieli and M. Akogbeto, “Rapid Colorimetric Field Test to Determine Levels of Deltametrin on PermaNet Surfaces: Association with Mosquito Bioactivity,” Tropical Medicine and International Health, Vol. 14, No. 4, 2009, pp. 381-388.
http://dx.doi.org/10.1111/j.1365-3156.2009.02247.x
[9] United States Pharmacopeia, 2009.
[10] J.-M. Caudron, N. Ford, M. Henkens, C. Mace, R. Kiddle-Monroe and J. Pinel, “Substandard Medicines in Resource-Poor Settings: A Problem That Can No Longer Be Ignored,” Tropical Medicine & International Health, Vol. 13, No. 8, 2008, pp. 1062-1072.
[11] F. E. Lytle, et al., “Incurred Sample Reanalysis: Enhancing the Bland-Altman Approach with Tolerance Intervals,” Bioanalysis, Vol. 1, No. 4, 2009, pp. 705-714.

  
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