Quality assessment of amoxicillin-clavulanate potassium tablets in Lagos, Nigeria
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Date
2012
Authors
Odulaja, J.O.
Azubuike, C.P.
Akinleye, M.O.
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Abstract
Amoxicillin clavulanate potassium is a broad spectrum antibiotic used in the management of most bacterial infections. The innovator brand, Augmentin, is expensive, hence the need to substitute them with much cheaper generic brands. This brings about the question of bioequivalency, an essential biopharmaceutic factor that provides option for generic substitution especially in underdeveloped countries such as ours. A study on quality assessment of six generic brands in comparison with the innovator brand was carried to ascertain the quality of the generic brands that are available in Nigerian drug market. Assessment of their bioequivalence was done vis-a-vis the evaluation of physicochemical characteristics such as uniformity of weight, friability, hardness, disintegration, dissolution rate and assay of the brands, using both official and non-official methods. All the brands studied complied with the official specifications on uniformity of weight and friability but the brands AC-2 and AC-7 failed the disintegration time test. Brand AC-7 exhibited a very high crushing strength which consequently affected it's dissolution rate negatively and did not comply with USP specification on dissolution. Out of the six generic brands tested, five of them were considered bioequivalent with the innovator brand with the exception of brand AC-7. Any reported case of therapeutic failure concerning the brands that complied with specification most likely, might be related to bad patient compliance, physiological and pharmacokinetic conditions relating to the patients using the drug and inadequate advice to patients on the part of the healthcare professionals.
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Staff publications
Keywords
Amoxicillin clavulanate potassium , bioequivalence , dissolution test , therapeutic failure , patient compliance , Research Subject Categories::NATURAL SCIENCES::Chemistry
Citation
Odulaja J.O, Azubuike C.P. and Akinleye M. O. (2012). Quality assessment of amoxicillin-clavulanate potassium tablets in Lagos, Nigeria. Journal of Chemical and Pharmaceutical Research, Vol.4(12): 5032-5038pp.