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Evaluation of In-Vitro Dissolution and In-Vivo Absorption for Two Different Film-Coated Pellets of Clarithromycin  

Zhang Xiang-rong (Department of Pharmacy, Laboratory of Drug Metabolism and Pharmacokinetics, Shenyang Pharmaceutical University)
Chen Xiao-yan (Department of Pharmacy, Laboratory of Drug Metabolism and Pharmacokinetics, Shenyang Pharmaceutical University)
Hu Lian-Dong (Department of Pharmaceutics, Shenyang Pharmaceutical University)
Tang Xing (Department of Pharmaceutics, Shenyang Pharmaceutical University)
Li San-Ming (Department of Pharmaceutics, Shenyang Pharmaceutical University)
Zhong Da-fang (Department of Pharmacy, Laboratory of Drug Metabolism and Pharmacokinetics, Shenyang Pharmaceutical University)
Publication Information
Archives of Pharmacal Research / v.28, no.8, 2005 , pp. 977-982 More about this Journal
Abstract
The aim of this study was to compare two formulations of film-coated pellets containing c1arithromycin after single oral dose study in healthy male volunteers. Two formulations with different coating polymers were prepared: formulation-1 (F-1) was prepared by incorporating three kinds of pH-dependent gradient-release coated pellets into capsules and formulation-2 (F-2) was prepared by coated with an insoluble semiosmotic film. Release profiles of filmcoated pellets were evaluated using paddle method under different conditions. Pharmacokinetic profiles of these formulations were obtained in three healthy male volunteers and compared to commercially available immediate release (IR) tablets. The relative bioavailability based on the $AUC_{0-24h}$ was found to be $96.2\%\;and\;58.7\%$ for F-1 and F-2 compared with IR, and the $T_{max}$ was delayed.
Keywords
Clarithromycin; Film-coated pellets; In-vitro; In-vivo;
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