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Optimization of Primary Drying Condition for Pharmaceutical Lyophilization Using a Novel Simulation Program with a Predictive Model for Dry Layer Resistance
https://stella.repo.nii.ac.jp/records/454
https://stella.repo.nii.ac.jp/records/454ff4007ca-a129-4437-9127-721818fb5377
| 名前 / ファイル | ライセンス | アクション |
|---|---|---|
ChemPharmBull_62‐2_p153.pdf (673.9 kB)
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| Item type | 学術雑誌論文 / Journal Article(1) | |||||||||||||||||||
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| 公開日 | 2016-02-01 | |||||||||||||||||||
| タイトル | ||||||||||||||||||||
| タイトル | Optimization of Primary Drying Condition for Pharmaceutical Lyophilization Using a Novel Simulation Program with a Predictive Model for Dry Layer Resistance | |||||||||||||||||||
| 言語 | en | |||||||||||||||||||
| 言語 | ||||||||||||||||||||
| 言語 | eng | |||||||||||||||||||
| キーワード | ||||||||||||||||||||
| 言語 | en | |||||||||||||||||||
| 主題Scheme | Other | |||||||||||||||||||
| 主題 | simulation | |||||||||||||||||||
| キーワード | ||||||||||||||||||||
| 言語 | en | |||||||||||||||||||
| 主題Scheme | Other | |||||||||||||||||||
| 主題 | dry layer mass transfer resistance | |||||||||||||||||||
| キーワード | ||||||||||||||||||||
| 言語 | en | |||||||||||||||||||
| 主題Scheme | Other | |||||||||||||||||||
| 主題 | maximum product temperature | |||||||||||||||||||
| キーワード | ||||||||||||||||||||
| 言語 | en | |||||||||||||||||||
| 主題Scheme | Other | |||||||||||||||||||
| 主題 | primary drying time | |||||||||||||||||||
| 資源タイプ | ||||||||||||||||||||
| 資源タイプ識別子 | http://purl.org/coar/resource_type/c_6501 | |||||||||||||||||||
| 資源タイプ | journal article | |||||||||||||||||||
| 著者 |
Kodama, Tatsuhiro
× Kodama, Tatsuhiro
× Sawada, Hiroyuki
× Hosomi, Hiroshi
× Takeuchi, Masahito
× Wakiyama, Naoki
× Yonemochi, Etsuo
× Terada, Katsuhide
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| 抄録 | ||||||||||||||||||||
| 内容記述タイプ | Abstract | |||||||||||||||||||
| 内容記述 | The purpose of this study was to develop a novel simulation program to accurately predict the maximum product temperature and the primary drying time in lyophilization using the predictive model for dry layer resistance, which is the resistance of dried cake against water vapor flow. Ten percent sucrose aqueous solution was selected as a model formulation. It was demonstrated that the deviations between the predicted and measured maximum product temperature were attributed to the error of dry layer resistance at a given drying condition, which was different from the measured dry layer resistance in a preliminary lyophilization run for the simulation program. However, when the predictive model of dry layer resistance was used for the simulation program, the model remarkably enhanced the accuracy of the simulation program to predict the maximum product temperature and primary drying time under various operating conditions. Furthermore, the primary drying condition required for minimized drying at a close collapse temperature was successfully discovered through one preliminary run. Therefore, it is expected that the developed simulation program is useful for designing the lyophilization cycle without a trial and error approach. | |||||||||||||||||||
| 書誌情報 |
Chemical and Pharmaceutical Bulletin 巻 62, 号 2, p. 153-159, 発行日 2014 |
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| 出版者 | ||||||||||||||||||||
| 出版者 | 日本薬学会 | |||||||||||||||||||
| ISSN | ||||||||||||||||||||
| 収録物識別子タイプ | ISSN | |||||||||||||||||||
| 収録物識別子 | 0009-2363 | |||||||||||||||||||
| 論文ID（NAID） | ||||||||||||||||||||
| 関連タイプ | isIdenticalTo | |||||||||||||||||||
| 識別子タイプ | NAID | |||||||||||||||||||
| 関連識別子 | 130003390757 | |||||||||||||||||||
| DOI | ||||||||||||||||||||
| 関連タイプ | isIdenticalTo | |||||||||||||||||||
| 識別子タイプ | DOI | |||||||||||||||||||
| 関連識別子 | info:10.1248/cpb.c13-00674 | |||||||||||||||||||
| 権利 | ||||||||||||||||||||
| 権利情報 | 日本薬学会 | |||||||||||||||||||
| フォーマット | ||||||||||||||||||||
| 内容記述タイプ | Other | |||||||||||||||||||
| 内容記述 | application/pdf | |||||||||||||||||||
| 著者版フラグ | ||||||||||||||||||||
| 出版タイプ | VoR | |||||||||||||||||||
| 出版タイプResource | http://purl.org/coar/version/c_970fb48d4fbd8a85 | |||||||||||||||||||
