León MG, Osorio FMR, Matiz MGE

Language: Spanish
References: 17
Page: 630-640
PDF size: 166.49 Kb.

ABSTRACT

Objective: to determine the biopharmaceutical equivalency of eleven brands of 500 mg acetaminophen tablets available on the Colombian market.
Methods: eleven brands of 500 mg acetaminophen tablets obtained from drugstores and pharmacies in Bogota, Cali, Medellin, Barranquilla and Cartagena were evaluated in terms of physical, chemical and biopharmaceutical characteristics were evaluated, such as weight variation hardness, disintegration, dissolution test, dissolution profile and efficiency and quantitation of active principle; the pharmacopeial assays were evaluated according to the USP 37. The result analysis was used to establish statistically significant differences and possible interchangeability among the evaluated products.
Results: the comparative analysis of products allowed showing marked differences in terms of the in vitro release of the active principle; however none of the evaluated products fail to comply with this important quality parameter. It is worth noting that all tested products comply with the official specifications of identification and measurement of the active ingredient, dosage uniformity and disintegration time.
Conclusions: the results of this study provide valuable information for health authorities and patients who take these products because they show reliability in terms of drug effectiveness.

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