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Design Space Construction of Multiple Dose-Strength Tablets Utilizing Bayesian Estimation Based on One Set of Design-of-Experiments
https://stella.repo.nii.ac.jp/records/464
https://stella.repo.nii.ac.jp/records/464622ce236-929e-43a0-9168-761125dbce4b
名前 / ファイル | ライセンス | アクション |
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ChemPharmBull_60‐11_p1399.pdf (12.8 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 | ||||||
言語 | en | |||||
タイトル | Design Space Construction of Multiple Dose-Strength Tablets Utilizing Bayesian Estimation Based on One Set of Design-of-Experiments | |||||
言語 | ||||||
言語 | eng | |||||
キーワード | ||||||
言語 | en | |||||
主題Scheme | Other | |||||
主題 | quality by design | |||||
キーワード | ||||||
言語 | en | |||||
主題Scheme | Other | |||||
主題 | design of experiments | |||||
キーワード | ||||||
言語 | en | |||||
主題Scheme | Other | |||||
主題 | multivariate regression | |||||
キーワード | ||||||
言語 | en | |||||
主題Scheme | Other | |||||
主題 | modeling | |||||
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 |
Maeda, Jin
× Maeda, Jin× Suzuki, Tatsuya× Takayama, Kozo |
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抄録 | ||||||
内容記述タイプ | Abstract | |||||
内容記述 | Design spaces for multiple dose strengths of tablets were constructed using a Bayesian estimation method with one set of design of experiments (DoE) of only the highest dose-strength tablet. The lubricant blending process for theophylline tablets with dose strengths of 100, 50, and 25 mg is used as a model manufacturing process in order to construct design spaces. The DoE was conducted using various Froude numbers (X1) and blending times (X2) for theophylline 100-mg tablet. The response surfaces, design space, and their reliability of the compression rate of the powder mixture (Y1), tablet hardness (Y2), and dissolution rate (Y3) of the 100-mg tablet were calculated using multivariate spline interpolation, a bootstrap resampling technique, and self-organizing map clustering. Three experiments under an optimal condition and two experiments under other conditions were performed using 50- and 25-mg tablets, respectively. The response surfaces of the highest-strength tablet were corrected to those of the lower-strength tablets by Bayesian estimation using the manufacturing data of the lower-strength tablets. Experiments under three additional sets of conditions of lower-strength tablets showed that the corrected design space made it possible to predict the quality of lower-strength tablets more precisely than the design space of the highest-strength tablet. This approach is useful for constructing design spaces of tablets with multiple strengths. | |||||
書誌情報 |
Chemical and Pharmaceutical Bulletin 巻 60, 号 11, p. 1399-1408, 発行日 2012 |
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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 | 130001852383 | |||||
DOI | ||||||
関連タイプ | isIdenticalTo | |||||
識別子タイプ | DOI | |||||
関連識別子 | info:10.1248/cpb.c12-00491 | |||||
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 |