Abstract
BackgroundEven though the international combat against Neglected Tropical Diseases such as schistosomiasis or soil-transmitted helminthiases depends on reliable therapeutics, anthelminthic pharmacovigilance has been neglected on many national African drug markets. Therefore, quality and composition of Albendazole, Mebendazole and Praziquantel locally collected in Burkina Faso, Côte d’Ivoire, Ghana and Tanzania were analysed.MethodsSamples of 88 different batches were obtained from randomly selected facilities. Sampling took place in Northwest Tanzania, Western Burkina Faso, Southeast Côte d’Ivoire and Southwest Ghana. Visual examination of both packaging and samples was performed according to the WHO ‘Be Aware’ tool. Products were then screened with the GPHF Minilab, consisting of tests of mass uniformity, disintegration times and thin-layer chromatography (TLC). Confirmatory tests were performed according to international pharmacopoeiae, applying assays for dissolution profiles and high-performance liquid chromatography (HPLC).FindingsDespite minor irregularities, appearance of the products did not hint at falsified medicines. However, 19.6% of the brands collected in Ghana and Tanzania were not officially licensed for sale. Mass uniformity was confirmed in 53 out of 58 brands of tablets. 41 out of 56 products passed disintegration times; 10 out of the 15 failing products did not disintegrate at all. Evaluating TLC results, only 4 out of 83 batches narrowly missed specification limits, 18 batches slightly exceeded them. Not more than 46.3% (31 / 67) of the tablets assayed passed the respective pharmaceutical criteria for dissolution. HPLC findings confirmed TLC results despite shifted specification limits: 10 out of 83 tested batches contained less than 90%, none exceeded 110%.ConclusionIn the four study countries, no falsified anthelminthic medicine was encountered. The active pharmaceutical ingredient was not found to either exceed or fall below specification limits. Galenic characteristics however, especially dissolution profiles, revealed great deficits.
Highlights
Succeeding the 8 Millennium Development Goals (MDGs) that had been resolved back in September 2000, 17 Sustainable Development Goals (SDGs) were framed in 2015 to terminate global inequality and poverty [1]
Considering the fact that both diseases are found in tropical zones around the world and affect people of all ages, the World Health Organization (WHO) alongside numerous governmental and non-governmental organisations have been increasing their efforts in combatting these diseases [6,7,8]
Unlike in countries not experiencing these Neglected Tropical Diseases (NTDs) on a regular base, many disparate brands of especially ABZ and MBZ can be found on local markets, which are manufactured in different parts of the world
Summary
Succeeding the 8 Millennium Development Goals (MDGs) that had been resolved back in September 2000, 17 Sustainable Development Goals (SDGs) were framed in 2015 to terminate global inequality and poverty [1]. According to national and WHO action plans, these medicines are distributed (bi-)annually to (pre-)school children and people at risk as single dose of 400 mg of ABZ, 500 mg of MBZ and 40 mg per kg of PZQ [7] - the anthelminthics for preventive chemotherapy are donated under the London Declaration of 2012 by international pharmaceutical companies [9]. Since public knowledge of typical and striking symptoms of schistosomiasis and STH is not ubiquitous, many patients are prone to not being treated appropriately [14] Should they be advised to try anthelminthic treatment after a prolonged course of disease, they have to rely on products locally available. Even though the international combat against Neglected Tropical Diseases such as schistosomiasis or soil-transmitted helminthiases depends on reliable therapeutics, anthelminthic pharmacovigilance has been neglected on many national African drug markets. Quality and composition of Albendazole, Mebendazole and Praziquantel locally collected in Burkina Faso, Cote d’Ivoire, Ghana and Tanzania were analysed
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