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Effect of Hyperlipemic Food on the Comparative Bioavailability of Two Bupropion Formulations after Administration of a Single Oral Dose of 150 mg in Healthy Human Volunteers

Author(s): Roberto F. Moreira | Hamilton M. Rigato | Bruno C. Borges | Carlos E. Sverdloff | Rogério A. Oliveira, et al.

Journal: Journal of Bioequivalence & Bioavailability
ISSN 0975-0851

Volume: 01;
Issue: 04;
Start page: 103;
Date: 2009;
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Keywords: Bupropion | Hydroxybupropion | Pharmacokinetics | HPLC | Mass spectrometry | Bioavailability

A specific, fast and sensitive LC–MS/MS assay was developed for the determination of bupropion and its metabolite hydroxybupropion in human plasma using lidocaine as the internal standard. The limit of quantification was 3.13 ng/ml for bupropion and 7.81 ng/ml forhydroxybupropion. The method was linear in the studied range of 3.13 – 400.00 ng/ml for bupropion and 7.81 – 1000 ng/ml for hydroxybupropion. This analytical method was applied to a comparative pharmacokinetic study, in which seventy eight volunteers (39 men and 39 female) aged between 18 and 50 years received a single oral doseof 150 mg of reference and test bupropion formulation, in an open, two-period, balanced randomized, crossover protocol. Group 1 received the medication without any additional meal. Group two received a hyperlipemic meal 30 min before the medication. Based on the 90% confidence interval of the individual ratios for Cmax and AUC0-inf, it was concluded that the test formulation is bioequivalent to the reference formulation with respect to the rate and extent of absorption of both bupropion and hydroxybupropion and that food intake before the drug administration had no effect in the relative pharmacokinetic parameters. However, the hyperlipemic meal significantly increased the bupropion absorption.
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