In-Process Quality Checks and Post-Market Surveillance of Artemether-Lumefantrine Fixed-dose Combination Tablets and Suspensions: Current Procedures, Successes, Advances, and Challenges
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.
*Author to whom correspondence should be addressed.
Abstract
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.
Keywords: Post-market surveillance, quality assessment, antimalarials, artemether, lumefantrine, fixed-dose, pharmacovigilance