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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References
Obokoh A (2017). WHO reports 62% decline in malaria death rates in 15 years. Business day. Available at : https://alphaplusmag.com/whoreports-62-decline-in-malaria-death-rates-in-15-years/. Accessed 24 May, 2019.
Dada T and Oguntola T (2015). World Malaria Day: Nigeria Ranks Highest in Death Rate – US. Leadership Newspaper. Available at: http://leadership.ng /news/428563/worldmalaria-day-nigeria-ranks-highest-in-death-rateus. Accessed 24 May, 2019.
Harisha KM, Balaji A, Kumar UG (2014). Development characterization and evaluation of solid dispersions of artemether and lumefantrine
by solvent evaporation method using hydrophilic polymers. International Journal of Pharmacy and Pharmaceutical Sciences. 6: (2) 180.
Nyarko EA, Nettey H (2013). Quality Assessment of artemether/lumefantrine Tablets Sampled from Pharmacies in Accra, Using the M V H image P C v 8. exeColor Software. Pharmacology & Pharmacy. 4: 567-572.
Asante KP, Owusu R, Dosoo D, Awini E, Adjei G, Etego SA, Chandramohan D, Owusu-Agyei S (2009). Adherence to artesunate-amodiaquine
therapy for uncomplicated malaria in rural Ghana: a randomized trial of supervised versus unsupervised drug administration. Journal of
Tropical Medicine Vol. 2009: 529-583.
National Guidelines for Diagnosis and Treatment of Malaria (2015). Federal Ministry of Nigeria. National Malaria and Vector Control Division. 3rd Edition. Available at: https://www.severemalaria.org/sites/mmvsmo/files/content/attachments/2017-0206/Nigeria%202015%20National%20Guidelines%20for%20Diagnosis%20and%20Treatment%20of%20%20Malaria%20%20%20May%202015.pdf. Accessed 6 March 2019.
Ajayi IO, Falade CO, Olley BO, Yusuf B, Gbotosho S, Iyiola T, Olaniyan O, Happi C, Munguti K, and Pagnoni F (2008). A qualitative study of the
feasibility and community perception on the effectiveness of artemether-lumefantrine use in the context of home management of malaria in south-west Nigeria. BMC Health Services Research. 8:119.
Izevbekhai O, Adeagbo B, Olagunju A and Bolaji O. (2017) Quality of artemisinin-based antimalarial drugs marketed in Nigeria. Transactions of the Royal Society of Tropical Medicine and Hygiene. 111: 90–96
Mgbahurike AA, Azike NR and Ukweze SE (2017). Assessment of quality of commercially available artemether-lumefantrine tablets in Rivers state, Nigeria. World Journal of Pharmaceutical Research 6,4: 274 – 290
Awofisayo SO, Okhamafe AO, Arhewoh MI (2015) Assessment of Compressive Characteristics of Some Brands of artemether -Lumefantrine Double Strength Tablets. International Journal of Biomedical and Advance Research. 6(02): 154 - 158.
Bate R. and Hess K. (2010). Anti-malarial drug quality in Lagos and Accra – A comparison of various quality assessments. Malaria Journal.
:157.
United states Pharmacopeia and National Formulary USP 37-NF 32, (2014). The United states Pharmacopoeial Convention, Inc.: Rockville, MD, vol. 1:2232.
Okpanachi G, Musa H, Mohammed Y, Emenike I and Mahmud G (2016). Assessment of physicochemical properties of eight brands of
alpha methyldopa tablets marketed in Zaria. Mintage Journal of Pharmaceutical and Medical Sciences. 5(1): 9-11.
Azad AK, Islam MA, Azizi WS (2013). Appraisement of Ranitidine Hydrochloride tablet (USP 150mg) preparations from few selected companies in Bangladesh. Pakistan Journal of Nutrition. 12 (11): 966-972.
British Pharmacopoeia (2014). Vol I and II . London : Her Majesty's Stationery office.
Vinodh M, Vinayak M, Pankaj P, Rahul K and Renita M (2013). Analytical method development and validation for simultaneous estimation of artemether and lumefantrine in pure and pharmaceutical dosage form using RP-HPLC method. Malaysian Journal of Analytical Sciences.
(17) 3: 348 – 358.
Prah J, Ameyaw EO, Afoakwah R, Fiawoyife P, Oppong- Danquah and Boampong JN (2016). Quality assessment of artemether-lumefantrine samples and artemether injections sold in cape coast metropolis. Journal of Tropical Medicine. Volume 2016, article ID 8602619, 6 pages.
WHO (2011).Revision of Monograph on Tablets. Final text for Addition to the International P h a r m a c o p o e i a . Q A S / 0 9 . 3 2 4 .
http://www.who.int/medicines/publications/pharmacopoeia/Tabs-GeneralMono-rev-FINAL_31032011.pdf. Accessed 27 January, 2018.
Novit ES (2017). Product identification: The evolution of no-dose product identification. Tablets and Capsules. 33 - 37. Available at : www.edigitaleditions.com/i/883179-tc1017/41? Accessed 11th December, 2019.
Belew S , Suleman S*, Mohammed 2, Mekonnen Y, Duguma M, Teshome H, Bayisa B, Wynendaele E, D'Hondt M, Duchateau L and De Spiegeleer B (2019) Quality of fixed dose artemether/lumefantrine products in Jimma Zone, Ethiopia. Malaria Journal. 18:236
Salako KS, Ayininuola OJ, Badejo RO and Akinleye MO (2019). Quantitative assay of ten brands of methyldopa tablets marketed in Lagos, Nigeria. Journal of Pharmaceutical and Allied Sciences. 16: (1) 2884 – 2893.
Ahmed F, Das AK, Karmakar UK Khaleque T and Shill MC (2003). Quality of marketed metronidazole preparations in Bangladesh-an
analytical overview. Journal of Biological Science. 3: 940-950.
Deshpande RD, Gowda DV, Mahammed N And Maramwar DN (2011). Bi-Layer Tablets- An Emerging Trend: A Review. International Journal of Pharmaceutical Sciences and Research. 2(10): 2534-2544.
Mis M and Russell R (2015). Substandard drugs, not fakes, undermine fight against malaria. Reuters. Available at:
http://mobile.reuters.com/article/idUSKBN0NB1TS20150420?irpc=932. Accessed 18th May, 2019