Quality assessment of fifteen brands of artemether-lumefantrine tablets in Lagos metropolis, Nigeria
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Abstract
Background: Nigeria has been shown to have the highest number of malaria casualties worldwide. Due to the increased demand for anti-malarial drugs, the Nigerian pharmaceutical market is flooded with a wide range of generic drugs whose quality must be regularly checked.
Objectives: The objective of this research was to carry out quality assessment of artemether-lumefantrine tablets marketed in Lagos metropolis, Nigeria.
Methods: Fifteen different brands of artemether-lumefantrine tablets gotten from five local government areas (Mushin, Oshodi-Isolo, Surulere, Ikorodu and Lagos Island) in Lagos were evaluated for weight variation, diameter, thickness, disintegration, hardness, friability according to the methods specified in the British Pharmacopoeia (2014) and the United States Pharmacopoeia (2014). The quantitative assay was carried out according to a previous research by Vinodh et al., (2013) with some modifications.
Results: The results showed that 100 % of the tested brands of artemether - lumefantrine tablets passed the weight variation test, disintegration test (30 minutes) and diameter test (±5% and ±3%,≤12.5mm and >12.5 mm respectively). It was observed that 87 % of the brands tested passed the friability test (≤1%) and thickness test (±5% deviation) while 80 % conformed to the standard limit (4– 10kp) for hardness. Only, 67% of the brands tested conformed to the quantitative assay standard limit (90- 110%). Summarily, the results indicated that only 47 % of all the brands which included the innovator brand, passed all the tests carried out on them.
Conclusion: This study has been able to show that of all the brands of artemether-lumefantrine tablets assessed, 53% of the brands did not pass all the quality tests that they were subjected to. Hence, the importance of continuous monitoring of the safety and efficacy of drugs.
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