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JAC Advance Access published online on March 10, 2005
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dki082
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JAC © The British Society for Antimicrobial Chemotherapy 2005; all rights reserved
Received August 28, 2004
Revised January 26, 2005
Accepted February 2, 2005

Brief report

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

Jin Sun 1, Tianhong Zhang 1, Feng Qiu 1, Yu Liu 1, Jingling Tang 1, Haihua Huang 1, and Zhonggui He 1*

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

* To whom correspondence should be addressed.
Zhonggui He, E-mail: hezhgui{at}mail.sy.ln.cn


  Abstract

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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