In-Process Quality Checks and Post-Market Surveillance of Artemether-Lumefantrine Fixed-dose Combination Tablets and Suspensions: Current Procedures, Successes, Advances, and Challenges

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.