Creaton of tablet database and visulalization of its internal structure

平板电脑数据库的创建及其内部结构可视化

• 批准号: 23590053
• 负责人: TAKAYAMA Kozo
• 金额: $ 3万
• 依托单位: Hoshi University
• 依托单位国家: 日本
• 项目类别: Grant-in-Aid for Scientific Research (C)
• 财政年份: 2011
• 资助国家: 日本
• 起止时间: 2011 至 2013
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-23590053/
• 关键词: 錠剤データベース; ニューラルネットワーク; 自己組織化マップ; 主薬物性; 品質特性; 破壊強度; 崩壊時間; 比表面積; サポートベクターマシン; 製剤特性; 溶出率; 硬度; 溶出時間; 拡張シンプレックス

A tablet database was created in order for designing tablet formulations based on the quality by design concept. The contribution of active ingredients (APIs) to tablet properties such as tensile strength and disintegration time was clarified. Before investigating effects of APIs, the tablet base formulation (placebo tablet) was optimized according to an expanded simplex search. The optimal placebo tablet showed sufficient hardness and rapid disintegration. Model tablets were prepared by incorporating each of 14 kinds of active ingredients into the optimal placebo tablet, and then examined the tablet properties, including tensile strength and disintegration time. Based on the experimental data, an ensemble artificial neural network incorporating general regression analysis was conducted. A reliable model of the correlation between the physicochemical properties of the active ingredients and the tablet properties was thus constructed.

建立片剂数据库，以设计理念为依据进行片剂质量设计。阐明了活性成分对片剂抗拉强度和崩解时间等性能的影响。在研究原料药的效果之前，根据扩展单纯形搜索对片剂基础配方（安慰剂片）进行优化。优选的安慰剂片硬度足够，崩解迅速。将14种有效成分分别掺入最佳安慰剂片剂中制备模型片，考察片剂的抗张强度、崩解时间等性能。在实验数据的基础上，建立了综合广义回归分析的集成人工神经网络。建立了有效成分的理化性质与片剂性质之间的可靠关系模型。

项目成果

Novel statistical approach in pharmaceutical formulation development

药物制剂开发中的新型统计方法

• 发表时间: 2010
• 作者: H. Arai;T. Suzuki;C. Kaseda;K. Takayama;H.Arai;K.Takayama;高山幸三
• 通讯作者: 高山幸三

Novel method to construct large-scale design space in lublication process ultilizing Bayesian estimation based on a small-scale design-of-experiment and small sets of large-scale manufacturing data

基于小规模实验设计和小规模大规模制造数据集，利用贝叶斯估计构建润滑过程大规模设计空间的新方法

• DOI: 10.3109/03639045.2011.653790
• 发表时间: 2012
• 期刊: Drug Dev. Ind. Pharm.
• 作者: J. Maeda;T. Suzuki;K. Takayama
• 通讯作者: K. Takayama

Latent structure analysis of the process variables and pharmaceutical responses of an orally disintegrating tablet

口腔崩解片的工艺变量和药物反应的潜在结构分析

• 发表时间: 2012
• 期刊: Chem. Pharm. Bull
• 作者: Y. Hayashi;E. Oshima;J. Maeda;Y. Onuki;Y. Obata;K. Takayama
• 通讯作者: K. Takayama

Reliability evalua- tion of the desing space of the granulation process of mefenamic acid tablets using a bootstrap resampling technique

使用 Bootstrap 重采样技术评价甲芬那酸片制粒工艺设计空间的可靠性

• 发表时间: 2011
• 期刊: Chem. Pharm. Bull
• 作者: Arai;T. Suzuki;S. Yada;C. Kaseda;Y. Onuki;K. Takayama
• 通讯作者: K. Takayama

イブプロフェン固体分散体製剤の調製と評価

布洛芬固体分散体制剂的制备及评价

• 发表时间: 2013
• 作者: Saburo Neya;Masaaki Suzuki;and Tyuji Hoshino;乙黒沙織,林祥弘,大貫義則,小幡誉子,高山幸三
• 通讯作者: 乙黒沙織,林祥弘,大貫義則,小幡誉子,高山幸三