@article{oai:stella.repo.nii.ac.jp:00000464,
 author = {Maeda, Jin and Suzuki, Tatsuya and Takayama, Kozo},
 issue = {11},
 journal = {Chemical and Pharmaceutical Bulletin},
 month = {},
 note = {application/pdf, 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.},
 pages = {1399--1408},
 title = {Design Space Construction of Multiple Dose-Strength Tablets Utilizing Bayesian Estimation Based on One Set of Design-of-Experiments},
 volume = {60},
 year = {2012}
}