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

ISSN:0975-0851 JBB, an open access journal Research ArticleOPEN ACCESS Freely available onlinedoi:10.4172/jbb.1000016 A specific, fast and sensitive LC–MS/MS assay was de-veloped for the determination of bupropion and its me-tabolite hydroxybupropion in human plasma using lidocaine as the internal standard. The limit of quantifica-tion was 3.13 ng/ml for bupropion and 7.81 ng/ml for hydroxybupropion. 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 dose of 150 mg of reference and test bupropion formulation, in an open, two-period, balanced randomized, crossover pro-tocol. Group 1 received the medication without any addi-tional meal. Group two received a hyperlipemic meal 30 min before the medication. Based on the 90 % confidence interval of the individual ratios for C max 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 pharmacoki-netic parameters. However, the hyperlipemic meal signifi-cantly increased the bupropion absorption