Evaluación y Análisis de Parámetros de Calidad de Comprimidos de Paracetamol

OPERTO, M. A.; CASTELLANO, P. M.; KAUFMAN, T. S.

ACTA FARM. BONAERENSE

CFPBA

Lugar: Buenos Aires; Año: 2008 vol. 27 p. 603 - 607

0326-2383

With the aim of  performing a comparative evaluation of quality characteristics of acetamoniphen tablets (500 mg), mechanic,  bioavailability and posology-related quality parameters were studied on 10 different commercial brands, employing  tests prescribed by the USP 30, the BP 2007 and the FA VII Ed. These included friability, disintegration, dissolution  and uniformity of dose units, besides the assay of the active principle. Nine of the brands complied with  all of the tests, while one brand failed in the friability test. Despite that all brands complied with the dissolution  test, notorious variations in their dissolution profiles were observed, probably as a result of differences in the  quali-quantitative composition of the excipients in the formulae and the pharmaceutical technology employed