Application of the Correlation of in Vitro Dissolution Behavior and in Vivo Plasma Concentration Profile (IVIVC) for Soft-Gel Capsules : a Pointless Pursuit?(Biopharmacy)
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概要
- 論文の詳細を見る
Plasma concentration profiles of arundic acid ((R)-(-)-2-propyloctanoic acid), an oil-like medicine, administered as soft-gel capsules in human clinical tests were predicted from the dissolution test data of the soft-gel capsules with different storage terms (short- and long-term stored drugs) by applying the in vitro-in vivo correlation (IVIVC). We established two linear-regression IVIVCs, which were characterized by either the in vitro dissolution behaviors against the pH 8.0 dissolution medium or the pH 6.8 dissolution medium containing 2% sodium dodecyl sulfate (SDS), in this study. Also, the prediction accuracies for the in vivo plasma profiles in humans for these two IVIVCs were compared. Regarding dissolution from the long-term stored capsule in pH 8.0 dissolution medium without surfactant, the prediction accuracies of the in vivo plasma profiles in humans were not satisfactory for the obtained IVIVC. The use of pH 6.8 dissolution medium containing 2% SDS, according to the Japanese guideline, improved the dissolution of the long-term stored capsule. Furthermore, the prediction accuracies for the in vivo plasma profiles in humans for these two IVIVCs were compared. The IVIVC established by the in vitro dissolution data obtained with the dissolution medium containing surfactant more effectively predicted the plasma drug concentration profiles following oral administrations of the soft-gel capsules under both storage conditions.
- 社団法人日本薬学会の論文
- 2007-11-01
著者
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TAKEDA Kazuhisa
Pharmaceutical Development Laboratories, Ono Pharmaceutical Co., Ltd.
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NAKADE Susumu
Pharmacokinetic Research Laboratories, Ono Pharmaceutical Co., Ltd.
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Aiba Tetsuya
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
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Kurosaki Yuji
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
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Aiba Tetsuya
Graduate School Of Medicine Dentistry And Pharmaceutical Sciences Okayama University
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Nakade Susumu
Pharmaceutical Development Laboratories Ono Pharmaceutical Co. Ltd.
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NISHIMURA Hidekatsu
Graduate School of Natural Science and Technology, Okayama University
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HAYASHI Chiaki
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
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OKAMOTO Ichiro
Pharmaceutical Development Laboratories, Ono Pharmaceutical Co., Ltd.
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MIYAMOTO Yuji
Pharmaceutical Development Laboratories, Ono Pharmaceutical Co., Ltd.
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Takeda Kazuhisa
Pharmaceutical Development Laboratories Ono Pharmaceutical Co. Ltd.
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Aiba Tetsuya
Graduate School Of Medicine Dentistry And Pharmaceutical Sciences Okayama Univ.
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Kurosaki Yuji
Graduate School Of Medicine Dentistry And Pharmaceutical Sciences Okayama University
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Okamoto Ichiro
Pharmaceutical Development Laboratories Ono Pharmaceutical Co. Ltd.
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Hayashi Chiaki
Graduate School Of Medicine Dentistry And Pharmaceutical Sciences Okayama University
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Nishimura Hidekatsu
Graduate School Of Natural Science And Technology Okayama University:pharmaceutical Development Labo
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Miyamoto Yuji
Pharmaceutical Development Laboratories Ono Pharmaceutical Co. Ltd.
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Miyamoto Yuji
Pharmaceutical Dev. Laboratories Ono Pharmaceutical Co. Ltd.
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