Arzneimittelforschung 2010; 60(2): 101-105
DOI: 10.1055/s-0031-1296256
Antibiotics · Antimycotics · Antiparasitics · Antiviral Drugs · Chemotherapeutics · Cytostatics
Editio Cantor Verlag Aulendorf (Germany)

Comparative bioavailability of cefuroxime axetil suspension formulations administered with food in healthy subjects

Gustavo D Mendes
1   Department of Pharmacology, Faculty of Medical Sciences, State University of Campinas (UNICAMP), Campinas, SP, (Brazil)
2   Faculty of Odontology, University Camilo Castelo Branco (UNICASTELO), São Paulo, SP, (Brazil)
3   Cartesius Analytical Unit, Department of Pharmacology ICB–USP, Sao Paulo, SP, (Brazil)
,
André Borges
1   Department of Pharmacology, Faculty of Medical Sciences, State University of Campinas (UNICAMP), Campinas, SP, (Brazil)
,
Ligia de Cássia Val
1   Department of Pharmacology, Faculty of Medical Sciences, State University of Campinas (UNICAMP), Campinas, SP, (Brazil)
,
Anil K Patni
4   Ranbaxy Laboratories Ltd, Haryana, (India)
,
Simrit Reyar
4   Ranbaxy Laboratories Ltd, Haryana, (India)
,
Tausif Monif
4   Ranbaxy Laboratories Ltd, Haryana, (India)
,
Daiene Sereno
5   Faculty of Pharmacy, State University of Campinas (UNICAMP), Campinas, SP, (Brazil)
,
Ana-Maria M Orellana
5   Faculty of Pharmacy, State University of Campinas (UNICAMP), Campinas, SP, (Brazil)
,
Gilberto De Nucci
1   Department of Pharmacology, Faculty of Medical Sciences, State University of Campinas (UNICAMP), Campinas, SP, (Brazil)
3   Cartesius Analytical Unit, Department of Pharmacology ICB–USP, Sao Paulo, SP, (Brazil)
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Publikationsverlauf

Publikationsdatum:
09. Dezember 2011 (online)

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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: AUClast and Cmax.

Results:

The limit of quantification was 0.1 μg/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 Cmax, 109.4%(104.8 %–114.2%) for AUClast.

Conclusion:

Since the 90% CI for AUClastand Cmax 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.