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JAC Advance Access originally published online on March 10, 2005
Journal of Antimicrobial Chemotherapy 2005 55(5):796-799; doi:10.1093/jac/dki082
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© The Author 2005. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions{at}oupjournals.org

Impact of pharmaceutical dosage forms on the pharmacokinetics of roxithromycin in healthy human volunteers

Jin Sun, Tianhong Zhang, Feng Qiu, Yu Liu, Jingling Tang, Haihua Huang and Zhonggui He*

Department of Biopharmaceutics, School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, 110016, Liaoning Province, China

* Corresponding author. Tel/Fax: +86-24-23843711, ext 3969; Email: hezhgui{at}mail.sy.ln.cn

Objectives: The impact of two different pharmaceutical preparations on the pharmacokinetics of roxithromycin was investigated in healthy human volunteers.

Methods: The degradation kinetics and products of roxithromycin were investigated in simulated gastric fluid and simulated intestinal fluid. Two oral dosage forms of roxithromycin were employed: enteric-coated pellets and dispersible tablets.

Results: The degradation half-time of roxithromycin in simulated gastric fluid was 0.23 h, and three main degradation products were characterized. In contrast, roxithromycin was stable in simulated intestinal fluid and remained unchanged after a 1.00 h incubation. The roxithromycin enteric-coated pellets exhibited higher bioavailability and a more potent serum antibacterial activity than the dispersible tablets.

Conclusions: The type of oral dosage forms of roxithromycin altered its pharmacokinetics. Whether or not this affects the in vivo antibacterial efficacy requires further study.

Keywords: stability , macrolides , pharmaceutical preparations


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