Abstract

ASSESSMENT OF QUALITY OF COMMERCIALLY AVAILABLE ARTEMETHER–LUMEFANTRINE TABLETS IN RIVERS STATE, NIGERIA

*Mgbahurike A. A., Azike N. R. and Ukweze S.E.

Abstract

Background: The war against fake and counterfeit medicines is one that the National Agency for Food, Drug Administration and Control has fought for several years. Malaria is a major public health problem in Nigeria and accounts for an estimated 225,000 deaths annually. Artemether- lumefantrine combination, one of the artemether- combination therapy (ACT), is currently WHO recommended first line treatment for malaria. Numerous brands of these medicines manufactured in various countries are commercially available in Nigeria. Objective of study: This study aimed to assess the quality of these various brands of artemether-lumefantrine, and to determine if these products contain the level of active ingredient claimed on the label, and are in conformity with specified requirements in the Pharmacopoeia. Method: Physical assessment studies and Pharmacopoeial tests (weight uniformity, hardness, disintegration, and friability tests) were carried out on the various brands of artemether–lumefantrine tablets. Dissolution test was carried out using paddle method in simulated gastric fluid, and the dissolution efficiency/percentage predicated availability equivalence estimated, and percentage content of the active ingredients obtained. Obtained data were analyzed with SSPS software. Result: The physical assessment tests showed that all the artermether-lumefantrine brands conformed to NAFDAC stipulations for packaging and labeling. All the brands passed weight uniformity test, disintegration, and friability tests, while 50% of the sampled brands failed the hardness test. Dissolution test showed that the brands had dissolution efficiency (DE) at AUC 120mins ranged 29% - 44% with percentage Predicated Availability Equivalent (%PAE) above 80% for all the brands. Assay of active ingredients showed that only 30% of the brands met the International Pharmacopoeial percentage content requirement of 90% - 110% for both artemether and lumefantrine. Conclusion: The need to continuously assess the quality of commercially available medicines remains very crucial.

Keywords: Artemether- lumefantrine artemether-lumefantrine,; dissolution efficiency; %PAE.