A recent study published, today, in Orapuh Journal brings encouraging news in the fight against malaria in the Democratic Republic of the Congo (DRC). The research, led by Gloria Bujo Dhimbe from the Laboratory of Drug Analysis, Department of Galenic Pharmacy, Faculty of Pharmaceutical Sciences, University of Kinshasa, evaluates the pharmaceutical quality of artemether–lumefantrine brands available on the Congolese market.
Malaria remains a major public health burden in Africa, with the DRC among the hardest-hit countries. Despite national and international efforts, the disease continues to cause high morbidity and mortality rates. One critical contributor to this ongoing challenge is the circulation of substandard antimalarial drugs, which can lead to treatment failure and the emergence of drug-resistant strains of Plasmodium.
Artemether–lumefantrine is a frontline oral antimalarial therapy widely used in the DRC. However, the proliferation of generic formulations has raised concerns about their quality and therapeutic efficacy.
In this timely study, Dhimbe and her team subjected 16 brands of artemether–lumefantrine tablets – 14 at 80/480 mg and 2 at 20/120 mg strengths – to a series of pharmaceutical quality control tests. These included mass uniformity, friability, and disintegration, along with sophisticated high-performance liquid chromatography with diode-array detection (HPLC-DAD) for qualitative and quantitative analysis. Dissolution testing, which assesses how quickly and efficiently a drug releases its active ingredients, was also conducted using standardised methods.
The results are reassuring: all tested samples met pharmaco-technical standards and showed dissolution profiles comparable to the reference product. With similarity factor (f₂) values ≥ 50 and difference factor (f₁) values < 15, the generics demonstrated bioequivalence in vitro, suggesting they can be safely substituted for the reference formulation.
Implications for Public Health
This study has critical implications for public health in the DRC and other malaria-endemic regions. It provides scientific evidence that the artemether–lumefantrine generics sold in Kinshasa are of acceptable quality, offering a cost-effective alternative for patients and healthcare systems.
Moreover, the findings support regulatory confidence in the local pharmaceutical supply chain and may help curb the spread of drug-resistant malaria strains by ensuring consistent therapeutic outcomes.
As the DRC continues to battle malaria, this research – published in Orapuh Journal – underscores the importance of rigorous drug quality assessment and highlights the valuable role of academic institutions in safeguarding public health.