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Quality of artemisinin-based antimalarial drugs marketed in Nigeria.
Trans R Soc Trop Med Hyg. 2017 02 01; 111(2):90-96.TR

Abstract

Background

Artemisinin combination therapy is first-line therapy for treatment of malaria, which is one of the most significant public health problems in Nigeria. With the increasing level of use of these drugs coupled with the emergence of resistance, there is a need for regular post-market surveillance.

Method

Twenty different brands of artesunate-containing antimalarial drugs and 10 brands of artemether-lumefantrine were multi-sourced in the south western part of Nigeria and were subjected to identification, weight uniformity test, and assay using United State pharmacopoeia and International Pharmacopoeia monographs. In vitro-dissolution test of the artemether tablets was also investigated.

Results

All 10 brands (100%) of the artemether-lumefantrine tablets met the assay requirement for artemether and 8 (80%) met the assay requirement for lumefantrine, but only 4 brands (40%) met the requirement for artemether dissolution. One of these brands failed the weight uniformity test. Of the 20 brands of artesunate-containing brands included in this study, 15 (75%) met the standard assay requirement for artesunate and two failed the weight uniformity test.

Conclusions

There is evidence of the presence of substandard artemisinin products in the Nigerian market.

Authors+Show Affiliations

Department of Pharmaceutical Chemistry, Obafemi Awolowo University, Ile-Ife, Nigeria.Department of Pharmaceutical Chemistry, Obafemi Awolowo University, Ile-Ife, Nigeria.Department of Pharmaceutical Chemistry, Obafemi Awolowo University, Ile-Ife, Nigeria.Department of Pharmaceutical Chemistry, Obafemi Awolowo University, Ile-Ife, Nigeria.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

28460126

Citation

Izevbekhai, Oisaemi, et al. "Quality of Artemisinin-based Antimalarial Drugs Marketed in Nigeria." Transactions of the Royal Society of Tropical Medicine and Hygiene, vol. 111, no. 2, 2017, pp. 90-96.
Izevbekhai O, Adeagbo B, Olagunju A, et al. Quality of artemisinin-based antimalarial drugs marketed in Nigeria. Trans R Soc Trop Med Hyg. 2017;111(2):90-96.
Izevbekhai, O., Adeagbo, B., Olagunju, A., & Bolaji, O. (2017). Quality of artemisinin-based antimalarial drugs marketed in Nigeria. Transactions of the Royal Society of Tropical Medicine and Hygiene, 111(2), 90-96. https://doi.org/10.1093/trstmh/trx019
Izevbekhai O, et al. Quality of Artemisinin-based Antimalarial Drugs Marketed in Nigeria. Trans R Soc Trop Med Hyg. 2017 02 1;111(2):90-96. PubMed PMID: 28460126.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Quality of artemisinin-based antimalarial drugs marketed in Nigeria. AU - Izevbekhai,Oisaemi, AU - Adeagbo,Babatunde, AU - Olagunju,Adeniyi, AU - Bolaji,Oluseye, PY - 2017/01/24/received PY - 2017/04/03/accepted PY - 2017/5/2/pubmed PY - 2018/2/22/medline PY - 2017/5/2/entrez KW - Artemisinin KW - Lumefantrine KW - Malaria KW - Nigeria SP - 90 EP - 96 JF - Transactions of the Royal Society of Tropical Medicine and Hygiene JO - Trans R Soc Trop Med Hyg VL - 111 IS - 2 N2 - Background: Artemisinin combination therapy is first-line therapy for treatment of malaria, which is one of the most significant public health problems in Nigeria. With the increasing level of use of these drugs coupled with the emergence of resistance, there is a need for regular post-market surveillance. Method: Twenty different brands of artesunate-containing antimalarial drugs and 10 brands of artemether-lumefantrine were multi-sourced in the south western part of Nigeria and were subjected to identification, weight uniformity test, and assay using United State pharmacopoeia and International Pharmacopoeia monographs. In vitro-dissolution test of the artemether tablets was also investigated. Results: All 10 brands (100%) of the artemether-lumefantrine tablets met the assay requirement for artemether and 8 (80%) met the assay requirement for lumefantrine, but only 4 brands (40%) met the requirement for artemether dissolution. One of these brands failed the weight uniformity test. Of the 20 brands of artesunate-containing brands included in this study, 15 (75%) met the standard assay requirement for artesunate and two failed the weight uniformity test. Conclusions: There is evidence of the presence of substandard artemisinin products in the Nigerian market. SN - 1878-3503 UR - https://www.unboundmedicine.com/medline/citation/28460126/Quality_of_artemisinin_based_antimalarial_drugs_marketed_in_Nigeria_ L2 - https://academic.oup.com/trstmh/article-lookup/doi/10.1093/trstmh/trx019 DB - PRIME DP - Unbound Medicine ER -