Quality And Composition Of Albendazole, Mebendazole And Praziquantel Available In Burkina Faso, Cote D'Ivoire, Ghana And Tanzania

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, Cote 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 Cote 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. No 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.Author summaryAmong Neglected Tropical Diseases, schistosomiasis and soil-transmitted helminthiases are still highly prevalent and affect more than 1.5 billion people on our planet. Key players in the combat against these entities are the anthelminthic medicines Albendazole, Mebendazole and Praziquantel, which are applied in therapy and preventive chemotherapy likewise. Despite widely available in tropical regions and, particularly for both benzimidazoles, relatively cheap, their quality has been poorly monitored. By this study, we illuminated products from East (Tanzania) and West Africa (Burkina Faso, Cote d'Ivoire and Ghana) and thus extended the African map of reproducibly assessed deworming drugs. Although containing sufficient active pharmaceutical ingredient, a failure of more than 50% in galenic features significantly mars a thorough elimination of parasites from patients. Our findings emphasize the need for quality-assured products. Regular local screening, efficient and expressive confirmation of irregularities and a swift appropriate reaction by governmental authorities contribute to a successful fight against these infectious diseases. Otherwise, their sequelae pose a tremendous burden to the development and prosperity of afflicted regions-not only in heavily affected Africa but around the globe.