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  1. 学術雑誌論文
  2. Chemical & pharmaceutical bulletin

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/464
622ce236-929e-43a0-9168-761125dbce4b
名前 / ファイル ライセンス アクション
ChemPharmBull_60‐11_p1399.pdf ChemPharmBull_60‐11_p1399.pdf (12.8 MB)
Item type 学術雑誌論文 / Journal Article(1)
公開日 2016-02-03
タイトル
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 en
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

en Maeda, Jin

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Suzuki, Tatsuya

× Suzuki, Tatsuya

en Suzuki, Tatsuya

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Takayama, Kozo

× Takayama, Kozo

en 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
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
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