Abstract
BackgroundThe ineffectiveness of artesunate and amodiaquine tablets in malaria treatment remains a health burden to WHO and governments of malaria-endemic countries, including Ghana. The proliferation of illegitimate anti-malarial drugs and its use by patients is of primary concern to international and local drug regulatory agencies because such drugs are known to contribute to the development of the malaria-resistant parasites in humans. No data exist on quality of these drugs in the fishing village communities in Ghana although the villagers are likely users of such drugs. A pilot study on the quality of anti-malarial tablets in circulation during the major fishing season at a malarious fishing village located along the coast of Tema in southern Ghana was determined.MethodsBlisterpacks of anti-malarial tablets were randomly sampled. The International Pharmacopoeia and Global Pharma Health Fund Minilab protocols were used to assess the quality of anti-malarial tablets per blisterpacks allegedly manufactured by Guilin Pharmaceutical Co Ltd, China (GPCL) and Letap Pharmaceuticals Ltd, Ghana (LPL) and sold in chemical sales outlets at Kpone-on–Sea. Ferric chloride and cobaltous thiocyanate tests confirmed the presence of active ingredients in the tablets. A confirmatory test for the active ingredient was achieved with artesunate (ICRS1409) and amodiaquine (ICRS0209) reference standards. A high performance liquid chromatography analysis confirmed the amount of artesunate found in tablets.ResultsBased on the International Pharmacopoeia acceptable range of 96/98 to 102% for genuine artesunate per tablet, 10% [relative standard deviation (RSD): 3.2%] of field-selected artesunate blisterpack per tablets manufactured by GPCL, and 50% (RSD: 5.1%) of a similar package per tablet by LPL, passed the titrimetric test. However, 100% (RSD: 2.2%) of amodiaquine blisterpack per tablet by GPCL were found to be within the International Pharmacopeia acceptable range of 90 to 110% for genuine amodiaquine in tablet, whilst 17% of a similar package per tablet by LPL failed spectrophotometric testing.ConclusionInadequate amounts of artesunate and amodiaquine detected in the tablets suggest that both pharmaceutical companies may not be following recommended drug formulation procedures, or the active pharmaceutical ingredients might have been degraded by improper storage conditions. Thus, drugs being sold at Kpone-on-Sea, Ghana may likely be classified as substandard drugs and not suitable for malaria treatment.
Highlights
The ineffectiveness of artesunate and amodiaquine tablets in malaria treatment remains a health burden to World Health Organization (WHO) and governments of malaria-endemic countries, including Ghana
Qualitative analysis of anti-malarial tablets manufactured by pharmaceutical companies All the artesunate and amodiaquine tablets manufactured by GPCL and LPL were found to contain some amount of their respective active pharmaceutical ingredients (API)
Quantitative analysis of tablets manufactured by GPLC, China and LPL, Ghana, which was reviewed under the International Pharmacopoeia standards for anti-malarial drugs, found variable amounts of artesunate-active ingredients in their tablets
Summary
The ineffectiveness of artesunate and amodiaquine tablets in malaria treatment remains a health burden to WHO and governments of malaria-endemic countries, including Ghana. Counterfeit or substandard anti-malarial drug proliferation on the Ghanaian market is a public health concern to the individual, the community and government. The report predicts that over 250 million new cases of malaria occur each year and about half the world’s population is at risk of malaria. This public health hazard has attracted attention from WHO and country-specific drug and healthcare regulatory agencies that seek to reverse the trend of antimalarial drug counterfeiting. WHO defines counterfeit drugs as: “one which is deliberately and fraudulently mislabelled with respect to identity and/or source Counterfeiting applies to both branded and generic products; counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredient or with fake packaging” [3,4]. The percent API in genuine medicines may be reduced if they are degraded by extremes of temperature and humidity
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