Journal Article

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

in Journal of Antimicrobial Chemotherapy

Volume 55, issue 5, pages 796-799
Published in print May 2005 | ISSN: 0305-7453
Published online May 2005 | e-ISSN: 1460-2091 | DOI: http://dx.doi.org/10.1093/jac/dki082
Impact of pharmaceutical dosage forms on the pharmacokinetics of roxithromycin in healthy human volunteers

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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

Journal Article.  2348 words.  Illustrated.

Subjects: Medical Oncology ; Critical Care

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