Effect of fixed-dose sizes on in vitro properties of artemether-lumefantrine tablets
The World Health Organization recommends artemisinin combination therapy (ACT) for the treatment of uncomplicated malaria. Artemether-lumefantrine (A-L) is a fixed-dose combination (FDC) of two active antimalarial ingredients. Pharmaceutical equivalence (PE) of three FDC: Coartem® (20/120 mg); B (40/240 mg) and C (80/480 mg) were investigated. Assay was performed for A-L separately with a validated HPLC method. Assay for artemether in Coartem®, B and C were 93.34%, 98.27% and 100.78% while for lumefantrine 96.44 %, 97.34 % and 93.52 % respectively were obtained. From the dissolution test, the mean percent of artemether released after 1 h for Coartem®, B, and C were 38.67%, 32.86% and 50.74% respectively. Lumefantrine after 45mins gave 93.89%, 64.39% and 64.76% respectively. The data obtained were compared using ANOVA which was not statistically significant (P>0.05). The f2 values for B & C was greater than 50 suggesting their similarity with Coartem®. The focus of this study is to evaluate their in vitro properties and their overall performance.
Keywords: Artemether-lumefantrine tablets; Fixed-dose combination; Pharmaceutical equivalence; Antimalarial