Quality of fixed dose artemether/lumefantrine products in Jimma Zone, Ethiopia

• Published in: Malaria Journal
• Main Authors: Sileshi Belew, Sultan Suleman, Tesfaye Mohammed, Yimer Mekonnen, Markos Duguma, Henok Teshome, Bikila Bayisa, Evelien Wynendaele, Matthias D’Hondt, Luc Duchateau, Bart De Spiegeleer
• Format: Article in Journal/Newspaper
• Language: English
• Published: BMC 2019
• Subjects: Quality; Anti-malarials; Artemether; Lumefantrine; Jimma; Ethiopia; Arctic medicine. Tropical medicine; RC955-962; Infectious and parasitic diseases; RC109-216; Arctic
• Online Access: https://doi.org/10.1186/s12936-019-2872-1; https://doaj.org/article/bde8a60655fa44a2abd9b34dec931d30

Abstract Background Malaria caused by Plasmodium vivax and Plasmodium falciparum is among the major public health problems in most endemic areas of the world. Artemisinin-based combination therapy (ACT) has been recommended as a first-line treatment for uncomplicated Plasmodium falciparum malaria almost in all endemic regions. Since ineffectively regulated medicines in resource limited settings could favour infiltration of poor quality anti-malarial medicines into pharmaceutical supply chain and jeopardize a positive treatment outcome, regular monitoring of the quality of anti-malarial medicines is critical. Thus, the aim of this study was to assess the quality of fixed dose combination (FDC) artemether (ART)/lumefantrine (LUM) tablets available in Jimma zone, Ethiopia. Methods This study was conducted in Jimma zone, Ethiopia. A total of 74 samples of FDC ART/LUM (20 mg ART/120 mg LUM) tablets were collected from 27 public facilities. All samples were subjected to visual inspection and the relevant information was recorded. The samples were transported to Jimma University Laboratory of Drug Quality (JuLaDQ) and stored at ambient temperature (20 °C to 25 °C) until analysis. The Pharmacopoeial conform/non-conform methods and the risk-based Derringer’s desirability function approach were employed to assess the pharmaceutical quality of the investigated products. Results The visual inspection results revealed that there were no signs of falsified in the investigated products. Identification test results of samples indicated that all samples contained the stated active pharmaceutical ingredients (APIs). The results of uniformity of mass indicated that all samples complied with International Pharmacopoeial specification limits. The assay results, expressed as percent label claim (%lc) of ART (89.8 to 108.8%, mean ± SD = 99.1 ± 3.9%) and LUM (90.0 to 111.9%, mean ± SD = 98.2 ± 3.8%) revealed that, all samples complied with International Pharmacopoeia acceptance specification limits (i.e. 90–110%lc), except one generic ...