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

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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 (20mg ART/120mg 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 degrees C to 25 degrees 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%, meanSD=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 product (IPCA Laboratories Ltd., India) which contains excessive LUM (111.9 +/- 1.7%lc). The risk priority number (RPN) results revealed that assay (RPN=392) is relatively the most critical quality attribute followed by identity (RPN=280) and mass uniformity (40). Quality evaluation based on psycho-physical Harrington's scale revealed that more than 96% of samples were within the acceptable ranges (D >= 0.7-1.0). Conclusions: Both Pharmacopoeial and risk-based desirability function approaches to quality evaluation applied to the investigated products revealed that above 96% FDC ART/LUM tablets circulating in public settings of Jimma zone are of good quality.
Keywords
PLASMODIUM-FALCIPARUM, FAKE ARTESUNATE, POOR-QUALITY, MALARIA, RESISTANCE, Quality, Anti-malarials, Artemether, Lumefantrine, Jimma, Ethiopia

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MLA
Yohannes, Sileshi Belew, et al. “Quality of Fixed Dose Artemether/Lumefantrine Products in Jimma Zone, Ethiopia.” MALARIA JOURNAL, vol. 18, 2019.
APA
Yohannes, S. B., Suleman, S., Mohammed, T., Mekonnen, Y., Duguma, M., Teshome, H., … De Spiegeleer, B. (2019). Quality of fixed dose artemether/lumefantrine products in Jimma Zone, Ethiopia. MALARIA JOURNAL, 18.
Chicago author-date
Yohannes, Sileshi Belew, Sultan Suleman, Tesfaye Mohammed, Yimer Mekonnen, Markos Duguma, Henok Teshome, Bikila Bayisa, et al. 2019. “Quality of Fixed Dose Artemether/Lumefantrine Products in Jimma Zone, Ethiopia.” MALARIA JOURNAL 18.
Chicago author-date (all authors)
Yohannes, Sileshi Belew, Sultan Suleman, Tesfaye Mohammed, Yimer Mekonnen, Markos Duguma, Henok Teshome, Bikila Bayisa, Evelien Wynendaele, Mathias D’Hondt, Luc Duchateau, and Bart De Spiegeleer. 2019. “Quality of Fixed Dose Artemether/Lumefantrine Products in Jimma Zone, Ethiopia.” MALARIA JOURNAL 18.
Vancouver
1.
Yohannes SB, Suleman S, Mohammed T, Mekonnen Y, Duguma M, Teshome H, et al. Quality of fixed dose artemether/lumefantrine products in Jimma Zone, Ethiopia. MALARIA JOURNAL. 2019;18.
IEEE
[1]
S. B. Yohannes et al., “Quality of fixed dose artemether/lumefantrine products in Jimma Zone, Ethiopia,” MALARIA JOURNAL, vol. 18, 2019.
@article{8624979,
  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 (20mg ART/120mg 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 degrees C to 25 degrees 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%, meanSD=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 product (IPCA Laboratories Ltd., India) which contains excessive LUM (111.9 +/- 1.7%lc). The risk priority number (RPN) results revealed that assay (RPN=392) is relatively the most critical quality attribute followed by identity (RPN=280) and mass uniformity (40). Quality evaluation based on psycho-physical Harrington's scale revealed that more than 96% of samples were within the acceptable ranges (D >= 0.7-1.0).
Conclusions: Both Pharmacopoeial and risk-based desirability function approaches to quality evaluation applied to the investigated products revealed that above 96% FDC ART/LUM tablets circulating in public settings of Jimma zone are of good quality.},
  articleno    = {236},
  author       = {Yohannes, Sileshi Belew and Suleman, Sultan and Mohammed, Tesfaye and Mekonnen, Yimer and Duguma, Markos and Teshome, Henok and Bayisa, Bikila and Wynendaele, Evelien and D'Hondt, Mathias and Duchateau, Luc and De Spiegeleer, Bart},
  issn         = {1475-2875},
  journal      = {MALARIA JOURNAL},
  keywords     = {PLASMODIUM-FALCIPARUM,FAKE ARTESUNATE,POOR-QUALITY,MALARIA,RESISTANCE,Quality,Anti-malarials,Artemether,Lumefantrine,Jimma,Ethiopia},
  language     = {eng},
  pages        = {11},
  title        = {Quality of fixed dose artemether/lumefantrine products in Jimma Zone, Ethiopia},
  url          = {http://dx.doi.org/10.1186/s12936-019-2872-1},
  volume       = {18},
  year         = {2019},
}

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