Post-market surveillance (PMS) of artemether-lumefantrine fixed-dose Combinations marketed in Benin

Abstract

In Benin, several studies still confirm the circulation of low-quality anti-malarial drugs, despite efforts to improve the supply chain. It is, therefore, necessary to carry out post-market quality surveillance of the same to ensure that only quality and efficacious medicines are sold to the general populace. The aim of this work was to evaluate the post-market quality of fixed-dose combinations of artemether-lumefantrine marketed in Benin. This descriptive and analytical study was executed in four stages over fourteen months, from December 2019 to January 2021. Thirty samples of artemether-lumefantrine (80/480 mg) fixed-dose combination tablets were collected from sixteen pharmacies in Cotonou and Porto Novo. The various quality control activities and tests conducted were: visual identification, pharmacopoeial tests (weight uniformity and disintegration tests), identification tests, in-vitro comparative dissolution tests and active ingredients content determination by HPLC-UV. The results of our analyses showed that none of the samples passed the visual identification test; all the samples passed the weight uniformity test in accordance with the specifications of the European pharmacopeia (Eur Ph). Regarding the identification tests of the active substances, we noted a clear overlap between the spectra of the reference and all the samples. However, one sample had a low content of the active ingredients (acceptance criteria of 90-110% for both lumefantrine and artemether). Also, two samples did not pass the disintegration test). The dissolution profiles of lumefantrine in these 3 samples, compared to that of Coartem® Princeps, were different (ƒ2A = 19.59 ƒ2B = 9.91 ƒ2C = 41.42; <50).This study confirms the circulation of substandard drugs and the need for post-market surveillance of other pharmaceuticals sold in Benin in order to guarantee that only drugs that meet the quality standards are sold to consumers.