Design Space Construction of Multiple Dose-Strength Tablets Utilizing Bayesian Estimation Based on One Set of Design-of-Experiments
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- Maeda Jin
- Formulation Technology Research Laboratories, Daiichi Sankyo Co., Ltd.
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- Suzuki Tatsuya
- Formulation Technology Research Laboratories, Daiichi Sankyo Co., Ltd.
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- Takayama Kozo
- Department of Pharmaceutics, Hoshi University
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Abstract
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.
Journal
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- Chemical and Pharmaceutical Bulletin
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Chemical and Pharmaceutical Bulletin 60 (11), 1399-1408, 2012
The Pharmaceutical Society of Japan
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Details 詳細情報について
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- CRID
- 1390001204178071424
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- NII Article ID
- 130001852383
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- NII Book ID
- AA00602100
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- COI
- 1:STN:280:DC%2BC3s7gslansA%3D%3D
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- ISSN
- 13475223
- 00092363
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- NDL BIB ID
- 024032970
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- PubMed
- 23124564
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- Text Lang
- en
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- Data Source
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- JaLC
- NDL
- Crossref
- PubMed
- CiNii Articles
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- Abstract License Flag
- Disallowed