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A Novel Approach to Establishing the Design Space for the Oral Formulation Manufacturing Process
https://stella.repo.nii.ac.jp/records/462
https://stella.repo.nii.ac.jp/records/462d3585e5e-10b6-45dc-9d7f-afd0eb4bdc80
| 名前 / ファイル | ライセンス | アクション |
|---|---|---|
ChemPharmBull_61‐1_p39.pdf (2.0 MB)
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| Item type | 学術雑誌論文 / Journal Article(1) | |||||||||||||||||||
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| 公開日 | 2016-02-03 | |||||||||||||||||||
| タイトル | ||||||||||||||||||||
| タイトル | A Novel Approach to Establishing the Design Space for the Oral Formulation Manufacturing Process | |||||||||||||||||||
| 言語 | en | |||||||||||||||||||
| 言語 | ||||||||||||||||||||
| 言語 | eng | |||||||||||||||||||
| キーワード | ||||||||||||||||||||
| 言語 | en | |||||||||||||||||||
| 主題Scheme | Other | |||||||||||||||||||
| 主題 | design space | |||||||||||||||||||
| キーワード | ||||||||||||||||||||
| 言語 | en | |||||||||||||||||||
| 主題Scheme | Other | |||||||||||||||||||
| 主題 | experimental design | |||||||||||||||||||
| キーワード | ||||||||||||||||||||
| 言語 | en | |||||||||||||||||||
| 主題Scheme | Other | |||||||||||||||||||
| 主題 | response surface method | |||||||||||||||||||
| キーワード | ||||||||||||||||||||
| 言語 | en | |||||||||||||||||||
| 主題Scheme | Other | |||||||||||||||||||
| 主題 | multivariate statistical analysis | |||||||||||||||||||
| キーワード | ||||||||||||||||||||
| 言語 | en | |||||||||||||||||||
| 主題Scheme | Other | |||||||||||||||||||
| 主題 | confidence interval | |||||||||||||||||||
| キーワード | ||||||||||||||||||||
| 言語 | en | |||||||||||||||||||
| 主題Scheme | Other | |||||||||||||||||||
| 主題 | critical quality attribute | |||||||||||||||||||
| 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 |
Norioka, Tadashi
× Norioka, Tadashi
× Hayashi, Yoshihiro
× Onuki, Yoshinori
× Andou, Hirotaka
× Tsunashima, Daisuke
× Yamashita, Kazunari
× Takayama, Kozo
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| 抄録 | ||||||||||||||||||||
| 内容記述タイプ | Abstract | |||||||||||||||||||
| 内容記述 | A novel approach to establishing the design space for the oral formulation manufacturing process was investigated. A response surface method incorporating multivariate spline interpolation was applied to overcome the nonlinear problem, which is always problematic in pharmaceutical development studies, and a bootstrap resampling technique, polynomial approximation technique, and 95% confidence intervals based on a nonparametric approach were applied to estimate the reliability of the established design space derived from the nonlinear response surface model. The critical quality attributes (CQAs) of intermediate material rather than the critical process parameters (CPPs) were chosen as the causal factors for the response variables, which were CQAs of the final product to avoid scale-gap and equipment-gap. This enabled the effective use of data sets accumulated during all pharmaceutical development studies. It was confirmed that a conservative border as well as an optimistic border of the design space for practical use was obtained considering the variability of the border of the design spaces on nonlinear response surfaces. Furthermore, the nonlinear response surface model using CQAs of intermediate material derived from data sets of a laboratory scale study and pilot scale studies could predict the CQA of the final product (2.5 h dissolution of commercial-scale study) with high accuracy. Consequently, the proposed novel approach overcame all of the difficulties for the manufacturing process development of oral formulations and this is the first study to demonstrate the effectiveness of the design space using CQA of intermediate material for the oral formulation manufacturing process. | |||||||||||||||||||
| 書誌情報 |
Chemical and Pharmaceutical Bulletin 巻 61, 号 1, p. 39-49, 発行日 2013 |
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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 | |||||||||||||||||||
| 書誌レコードID | ||||||||||||||||||||
| 収録物識別子タイプ | NCID | |||||||||||||||||||
| 収録物識別子 | AA00602100 | |||||||||||||||||||
| 論文ID（NAID） | ||||||||||||||||||||
| 関連タイプ | isIdenticalTo | |||||||||||||||||||
| 識別子タイプ | NAID | |||||||||||||||||||
| 関連識別子 | 130003360719 | |||||||||||||||||||
| DOI | ||||||||||||||||||||
| 関連タイプ | isIdenticalTo | |||||||||||||||||||
| 識別子タイプ | DOI | |||||||||||||||||||
| 関連識別子 | info:10.1248/cpb.c12-00743 | |||||||||||||||||||
| 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 | |||||||||||||||||||
