Estudo de bioequivalencia entre duas formulações de azitromicina utilizando a cromatografia liquida de alta eficiencia acoplada ao espectrometro de massa (LC-MS-MS)

AUTOR(ES)
DATA DE PUBLICAÇÃO

2005

RESUMO

Objective: To assess the bioequivalence of two azithromycin tablet formulations (Azitromicina 500 mg tablet fromEMS Indústria Farmacêutica, Brazil as test formulation and Zitromax@500 mg tablet from Laboratórios Pfizer, Brazil as reference formulation) in 25 healthy volunteers of both sexes. The study was conducted using an open, randomized two-period crossover design with a 3-week washout interval. Plasma samples were obtained over a 336 h period. Plasma azithromycin concentrations were analyzed by combined liquid chromatography coupled to tandem mass spectrometry (LC-MS-MS) with positive ion electrospray ionization using Multiple Reaction Monitoring (MRM). From the azithromycin plasma concentration vs. time curves the following pharmacokinetic parameters were obtained: AUClast, AUCO-infand Crnax.The statistical interval proposed was 80-125% according to the US Food and Drug Administration Agency. The limit of quantification was 5.0 nglrnL for plasma azithromycin analysis. The geometric mean and the 90% CI test/reference ratios were 105.3 (92.4 - 120.0%) for AUC1ast,106.4 (94.0 -120.3%) for AUCo-infand 92.7 (81.8 -105.1%) for Crnax. Since the 90% CI for AUClast,AUCo-infand Crnaxratios were within in the 80-125% interval proposed by the US FDA, it was concluded that Azitromicina 500 mg tablet (test formulation) was bioequivalent to Zitromax@500 mg tablet, in terms of both rate and extent of absorption.

ASSUNTO(S)

cromatografia liquida de alta eficiencia espectroscopia de massa farmacocinetica azitromicina

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