Evaluation of The Quality OF Arthemeter-Lumefantrine Brands Used in The Treatment Of P. Falciparum Malaria in Children Below Five Years in Delta State
Keywords:
Arthemeter-Lumefantrine, ACTs, brands, fake, substandard, counterfeitAbstract
Background: There have been records of widespread resistance with the use of mono-therapy in the management of malaria. Nigeria initiated the use of Arthemisinin-based combination therapy (ACT) in 2005 following the WHO recommendation. Globally and in particular Nigeria, there is high risk of resistance to the ACTs due to the faking, act of counterfeiting and substandard drugs. This can pose serious problem that needs redress, hence the need for this study to check for any substandard or counterfeit Arthemeter-Lumefantrinetabletsin Delta State.
Objective: The objective was to assess the quality of5 different brands ofACTs containing
arthemeter 20mg and lumefantrine 120mg packed by 6 or1 2 tablets for malarial treatment for
children below 5 years.
Methods: A total of five different brands of Arthemeter-Lumefantrine were purchased from retail outlets in major cities of the state and qualitative tests which include general appearance,
friability, weight uniformity, disintegration, hardness, diameter were carried out following the
United State and British Pharmacopeia test procedures while dissolution test was carried out using the Copley dissolution test apparatus, England.
Results: The qualitative test for the 5 different brands showed that all had uniform weight,
hardness were within range of 1.9—7.1 KgF, thickness was within the range of 3.7 — 4.5 mm while the diameter was within the range of 9 — 10 mm. Result for friability showed that brands CB, LT, and LM met required standard while GV and CM did not.The tablets disintegrated at a prescribed limit which was in the range of 1.68—45.88 secs. For dissolution of the five brands, LM released more than 50%, CB released 50%, GV released 34.1% and CM released 25.4% at 60 minutes usin g lumefantrine as the experimental marker.
Conclusion: From the results of this study, LM is the optimized brand as it passed the various test for quality with values within specifications.
References
World Health Organization (2006). WHO guidelines for the treatment of malaria 2006 http://www.who.int/malaria/docs/TreatmentGuidelines2006.pdf. Accessed July 24, 2018.
Newton PN, White NJ, Rozendaal JA and Green MD (2002). Murder by fake drugs: time for international action. Brit Med J, 324(7341); 800—801.
Dondorp AM, Newton PN, Mayxay M, Van Damme W, Smithuis FM, Yeung S, Petit A, Lynam AJ, Johnson
A, Hien TT, McGready R, Farrar JJ, Looareesuwan S, Day NP, Green MD, White NJ (2004). Fake antimalarials in Southeast Asia are a major impediment to malaria control: multinational cross-sectional survey on the prevalence of fake antimalarials. Trop Med & Int Health, 9(12); 1241—1246.
Nosten F and White NJ (2007). Artemisinin-based combination treatment of falciparum malaria.
Am J Trop Med & Hyg, 77(6); 181—192.
Tabernero P, Fernandez FM, Green M, Guerin PJ, Newton PN (2014). Mind the gaps—the pidemiology of poor-quality anti-malarials in the malarious world—analysis of the World Wide Antimalarial Resistance Network database. MalarJ, 13;139
Newton P, Proux S, Green M, Smithuis F, Rozendaal J, Prakongpan S, Chotivanich K, Mayxay M,
Looareesuwan S, Farrar J and Nosten F (2001). Fake artesunate in southeast Asia. The Lancet,
(9272); 1948—1950.
WHO/IFPMA Workshop, 1992,http://www.who.int/medicines/services/counterfeit/overview/en/ Accessed 30 July, 2018.
WHO IMPACT Meeting Tunisia,2008,http://www.who.int/impact/news/BonnMeeting Draft Principles.pdf. Accessed 30 July, 2018.
World Health Assembly(2012).Substandard/Spurious/Falsely-labelled/falsified Medical Products. Resolution WHA65.19, http://apps.who.int/qb/e/e_wha65.html. Accessed 30 July, 2018.
Clift C.(2007). Combating counterfeit, falsified and substandard medicines: defining the way forward? Briefing Paper GH BP 2010/012010, Chatham House, London, UK.
Buabeng KO, Duwiejua M, Matowe LK, Smith F and Enlund H(2008). Availability and choice of
antimalarials at medicine outlets in Ghana: the question of access to effective medicines for
malaria control. Clin Pharma Therap, 84(5); 613—619.
United States Pharmacopoeia. The United States Pharmacopoeial Convention, Inc. Rockville, 2003 26: 399, 2125, 2407 — 2540.
British Pharmacopoeia. Version 1 1.0, Appendices: XII A,XII G, XVII G, 2009
James P, Elvis 0A, Richmond A, Patrick F, Ernest 0-D and Johnson NB (2016). Quality Assessment of Artemether-Lumefantrine Samples and Artemether Injections Sold in the Cape Coast Metropolis. J Trop Med, Article ID8602619,6.
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