AREMETER LUMEFANTRINE

Background: Artemether-lumefantrine (AL) is the first-line treatment for uncomplicated malaria throughout Nigeria. The rise of substandard and falsified medicines endangers patient safety, effective treatment, and antisubstitution for decreased susceptibility to effective treatment. This study evaluated in-vitro pharmaceutical quality of artemether￾lumefantrine brands that are marketed in Benin City. Methods: Sixteen (16) brands of artemether-lumefantrine tablets were procured from Patented and Proprietary Medicine Vendors (PPMVs) and retail pharmacies licensed through NAFDAC throughout Benin City. Samples were evaluated based on pharmacopoeial standards of visual/organoleptic packaging and tablet assessment, weight uniformity, tablet hardness, friability, disintegration time, in-vitro dissolution and assay for % purity of active pharmaceutical ingredients. Results: All 16 brands were NAFDAC-approved and presently active. All samples passed critical evaluative tests associated with weight uniformity, dissolution (all >80% in 60 min), and % purity (assay) with all brands within pharmacopoeial standards of 90.0% - 110.0% meaning active pharmaceutical ingredients are accounted for. However, significant quality concerns were raised as 1 brand (Biolumefar) failed the friability test (3.00% weight loss) due to compromised mechanical integrity. 1 brand (Contrine plus) failed disintegration time analysis as the average time elapsed was >30 min according to pharmacopoeial standards. Finally, a statistically significant difference was found in tablet hardness across all brands (range: 6.50 LP to 11.33 kP). xi
Conclusion: Overall, findings present inconsistent quality. While it is a positive outcome that no brands failed the assay for content of active ingredients, the failure of two brands in the most critical physical assessments - one for friability and one for disintegration -indicates inferior manufacturing processes and quality control standards. Therefore, there is a continued need for post-market surveillance from NAFDAC to ensure all AL products in circulation are quality compliant to avoid malarial treatment failures secondary to drug resistance