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材料节约方法预测在加工压缩条件下基于来自压缩模拟和晶体结构分析的机械和分子性质来预测平板电脑的封装

Pratap Basim^1,2,3, Harsh S Shah^1,4, Robert Sedlock^2,5

¹Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Division of Pharmaceutical Sciences, Long Island University, 75 DeKalb Avenue, Brooklyn, New York, 11201, USA.

AAPS PharmSciTech

|October 10, 2024

概括

压缩模拟模型通过分析压缩下的机械特性和分子行为,准确地预测了乙氨基 (APAP) 和布洛芬 (IBU) 的药片封闭风险. 这种节约材料的方法可以识别值压缩压力 (TCP),以防止封闭.

科学领域:

制药科学制药科学
材料科学材料科学材料科学
化学工程是化学工程的重要组成部分.

背景情况:

药片封装是一个关键的制造缺陷,影响药品质量.
评估上限风险的传统方法是材料密集型和耗时的.
预测建模为流程优化提供了一个潜在的节约材料的替代方案.

研究的目的:

评估基于压缩模拟的机械模型的有效性,以预测平板电脑的封装.
建立材料节约方法来确定乙氨基 (APAP) 和布洛芬 (IBU) 的值压缩压力 (TCP).
通过分子模拟和X射线粉末衍射 (XRPD) 验证预测模型.

主要方法:

使用主要成分分析 (PCA) 和主要成分回归 (PCR) 测量和分析了APAP和IBU配方的机械性能.
基于压缩压力 (CP) 的PCR模型预测了上限得分 (CS).
纳入XRPD数据的分子模型计算了滑行平面属性,以预测TCP并验证机械模型预测.

主要成果:

APAP的配方显示了CS和CP之间的二次关系,TCP在200-300MPa之间.
IBU配方显示了CS和CP之间的线性关系,TCP在100-200MPa之间.
机械和分子模型准确地预测了TCP值 (APAP为245MPa,IBU为175MPa),与观察到的封闭行为保持一致.

结论:

基于压缩模拟的机械模型是有效,快速和准确的工具,用于预测平板电脑限制风险.
这些模型作为一种有价值的材料节约方法,用于制药工艺开发和优化.
了解压缩压力,材料特性和分子行为之间的关系是防止平板电脑封装缺陷的关键.

关键词:

压缩模拟和仿真模拟和仿真.机械性质机械性质多变量分析多变量分析.平板电脑封装的盖子

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