In Southeast Asia and Sub-Saharan Africa, approximately 35% of antimalarial drugs are of substandard quality. Counterfeit and substandard medications constitute 10% of the global pharmaceutical trade. The World Health Organization (WHO) recommends artemether-lumefantrine (AL) as the first-line treatment for acute falciparum malaria in endemic regions. However, there is a lack of validated analytical methods to simultaneously determine the content of artemether and lumefantrine in these formulations, particularly in resource-limited settings. This paper focuses on quality concepts related to AL tablets and suspensions. It provides an overview of quality assessment techniques, including visual inspection, weight uniformity, content assay, and dissolution tests. Regulatory requirements and case studies are also discussed. By rigorously assessing AL quality, regulatory agencies, pharmaceutical companies, and healthcare professionals can ensure compliance with established standards and regulations.
Author(s) Details:
Daniel Gyamfi
School of Medicine, University for Development Studies, Tamale, Ghana.
Julius Caesar Mahama
Furness General Hospital, LA14 5LF, Barrow-in-Furness, UK.
Ahmed S.B.I Fawzy
Upper West Regional Hospital, Wa, Upper West Region, Ghana.
Alfred Gyimah
Tamale Teaching Hospital, Tamale, Ghana.
Faridu Abdul-Wadudu
Department of Social and Behavioural Change, School of Public Health, University for Development Studies, Ghana.
Nobert Mantu Kipo
Tamale Teaching Hospital, Tamale, Ghana.
Bright Arhin
Mathias Catholic Hospital, Yeji, Ghana.
Bless Hayford Addo
Department of Health Promotion, College of Health, Yamfo, Ghana.
Simon Nyarko
Department of Pharmaceutics, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.
Comfort Wetani Aseyuure
Department of Nursing and Midwifery, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.
Recent Global Research Developments in Quality Evaluation of Artemether-Lumefantrine in Cape Coast
Efficacy and Safety in Mainland Tanzania:
A study conducted in mainland Tanzania assessed the efficacy and safety of AL1.
AL is the most widely adopted first-line artemisinin-based combination therapy (ACT) for malaria in sub-Saharan Africa.
The trial involved febrile patients aged 6 months to 10 years who received a 6-dose AL regimen.
Results showed adequate efficacy (ranging from 63.4% to 100%) and good safety profiles.
No serious adverse events were reported.
Meta-Analysis Across Sub-Saharan Africa:
A meta-analysis reported high treatment success rates for AL, along with other ACTs, in Sub-Saharan Africa2.
AL performed well above the World Health Organization (WHO) threshold value for malaria treatment success.
Monitoring Therapeutic Efficacy in Niger:
In Niger, AL remains the first-line treatment for uncomplicated malaria3.
Regular monitoring of therapeutic efficacy is crucial to ensure its continued effectiveness.
References
- Ngasala, B., Chiduo, M.G., Bushukatale, S. et al. Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in mainland Tanzania, 2018. Malar J 23, 95 (2024). https://doi.org/10.1186/s12936-024-04926-x
- Marwa, K., Kapesa, A., Baraka, V., Konje, E., Kidenya, B., Mukonzo, J., … & Swedberg, G. (2022). Therapeutic efficacy of artemether-lumefantrine, artesunate-amodiaquine and dihydroartemisinin-piperaquine in the treatment of uncomplicated Plasmodium falciparum malaria in Sub-Saharan Africa: A systematic review and meta-analysis. PloS one, 17(3), e0264339.
- Laminou, I.M., Issa, I., Adehossi, E. et al. Therapeutic efficacy and tolerability of artemether–lumefantrine for uncomplicated Plasmodium falciparum malaria in Niger, 2020. Malar J 23, 144 (2024). https://doi.org/10.1186/s12936-024-04945-8
To Read the Complete Article See Here