In Vitro and in Vivo Characterization of a Newly Developed Clonidine Transdermal Patch for Treatment of Attention Deficit Hyperactivity Disorder in Children(Biopharmacy)
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概要
- 論文の詳細を見る
The aim of this study was to characterize a newly developed clonidine transdermal patch, KBD-transdermal therapeutic system (TTS), for the treatment of attention deficit hyperactivity disorder in children. In vitro release, penetration, and in vivo pharmacokinetics in rabbits were investigated. The smaller size of KBD-TTS (2.5 mg/2.5 cm^2) showed a similar in vitro penetration to those of Catapres-TTS (2.5 mg/3.5 cm^2, a clonidine transdermal patch used for the treatment of hypertension, Alza Corporation, U. S. A.). The transdermal penetration rate of clonidine was mainly controlled by the ethylene vinylacetate membrane used in the patch. The skin layer may be only a minor rate-limiting barrier after the topical skin layer at the dosing site is saturated with penetrating clonidine in the initial phase (0 to 12 h). A sensitive liquid chromatography-mass spectrometry method for the quantification of clonidine in rabbit plasma was developed using solid-phase extraction and gradient elution on LC combined with the selected-ion monitoring (SIM) mode. A single dose of clonidine transdermal patch (KBD-TTS) or Catapres-TTS was transdermally administered to rabbits (n=6 each) and removed after 168 h. The average half-life, T_<max>, C_<max> and C_<55> values of clonidine in rabbits following administration of KBD-TTS were 19.27±4.68 h, 52.56±25.77 h, 27.39±9.03 ng/ml, and 25.82±9.34 ng/ml, similar to those of Catapres-TTS, respectively. The clonidine plasma concentration of KBD-TTS reached a steady state at 24 h through 168 h. The in vitro release rate of the clonidine from KBD-TTS significantly correlated with the in vivo absorption rate (p<0.001).
- 社団法人日本薬学会の論文
- 2005-02-01
著者
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ZHANG Qiang
School of Sciences, Southwest Petroleum University
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Wang Li
State Key Laboratory Of Natural And Biomimetic Drugs And School Of Pharmaceutical Sciences Peking Un
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Zhang Qiang
中華人民共和国
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Zhang Q
State Key Laboratory Of Natural And Biomimetic Drugs And School Of Pharmaceutical Sciences Peking Un
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Zhang Q
School Of Pharmaceutical Sciences Peking University
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Zhang Xuan
State Key Laboratory Of Natural And Biomimetic Drugs And School Of Pharmaceutical Sciences Peking Un
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ZHANG Xuan
School of Pharmaceutical Sciences, Peking University
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KE Guang-Ming
College of Science, Beijing University of Chemical Technology
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WANG Li
Beijing Kangbeide Pharmaceuticals, Ltd.
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XUE Hui-Yong
Beijing Kangbeide Pharmaceuticals, Ltd.
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LU Wan-Liang
School of Pharmaceutical Sciences, Peking University
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GUO Hong-You
College of Science, Beijing University of Chemical Technology
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Zhang Qiang
School Of Pharmaceutical Sciences And State Key Laboratory Of Natural And Biomimetic Drugs Peking Un
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Zhang X
State Key Laboratory Of Natural And Biomimetic Drugs And School Of Pharmaceutical Sciences Peking Un
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Zhang Xuan
Department Of Pharmaceutics Peking University School Of Pharmaceutical Sciences
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Lu Wan-liang
中華人民共和国
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Guo Hong-you
College Of Science Beijing University Of Chemical Technology
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Lu Wan-liang
School Of Pharmaceutical Sciences And State Key Laboratory Of Natural And Biomimetic Drugs Peking Un
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Xue Hui-yong
Beijing Kangbeide Pharmaceuticals Ltd.
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Ke Guang-ming
College Of Science Beijing University Of Chemical Technology
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ZHANG Xuan
School of Mathematics and Quantitative Economics, Shandong University of Finance and Economics
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