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Type: Artigo de periódico
Title: Comparative bioavailability of cefuroxime axetil suspension formulations administered with food in healthy subjects
Author: MENDES, Gustavo D.
VAL, Ligia de Cassia
PATNI, Anil K.
REYAR, Simrit
MONIF, Tausif
SERENO, Daiene
ORELLANA, Ana Maria M.
NUCCI, Gilberto De
Abstract: Objective: To assess the comparative bioavailability of two formulations (250 mg/5 mL suspension) of cefuroxime axetil (CAS 64544-07-6), administered with food, in healthy volunteers of both sexes. Methods: The study was conducted using an open, randomized, two-period crossover design with a 1-week washout interval. Plasma samples were obtained for up to 12 h post dose. Plasma cefuroxime axetil concentrations were analyzed by liquid chromatography coupled with tandem mass spectrometry (LC-MS-MS) with negative ion electrospray ionization using multiple reactions monitoring (MRM). From the cefuroxime axetil plasma concentration vs. time curves, the following pharmacokinetic parameters were obtained: AUC(last) and C(max). Results: The limit of quantification was 0.1 mu g/mL for plasma cefuroxime axetil analysis. The geometric mean and 90% confidence interval CI of test/reference product percent ratios were: 106.1% (100.8%-111.8%) for C(max), 109.4% (104.8%-114.2%) for AUC(last). Conclusion: Since the 90% Cl for AUC(last) and C(max) ratios were within the 80-125 % interval proposed by the US FDA, it was concluded that cefuroxime axetil (test formulation, 250 mg/5 mL suspension) was bioequivalent to a reference formulation under fed conditions, for both the rate and extent of absorption.
Subject: Antibacterial
CAS 64544-07-6
Cefuroxime axetil, bioavailability, administration with food, pharmacokinetics
Tandem mass spectrometry, LC/MS/MS
Country: Alemanha
Rights: fechado
Date Issue: 2010
Appears in Collections:FCM - Artigos e Outros Documentos

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