封闭料框架的使用用于开发近红外光谱校准模型,以确定药物度
Nathaly A Movilla-Meza1, Nobel O Sierra-Vega2, Bárbara B Alvarado-Hernández1
1Department of Chemistry, University of Puerto Rico at Mayagüez, Mayagüez, PR, USA.
Pharmaceutical research
|September 12, 2023
概括
封闭的料框架显著减少了开发近红外 (NIR) 光谱校准模型的材料需求. 这种节约材料的方法可以准确地监测混合物的均性,而不会改变粉末的特性,即使是循环.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
- 工艺工程的过程工程.
背景情况:
- 近红外 (NIR) 光谱对于监测药品制造中的混合物均性至关重要.
- 开发强大的校准模型往往需要大量的材料,这对节省材料来说是一个挑战.
研究的目的:
- 评估封闭料框架作为NIR光谱校准模型开发的材料节约技术.
- 评估再循环诱导的剪切对NIR光谱和混合物特性的影响.
主要方法:
- 使用来自封闭料框架的光谱开发了NIR校准模型.
- 为了评估剪切效应,在循环之前和循环后对粉末的特性进行了表征.
- 模型预测使用通过开放料框架处理的混合物得到验证.
主要成果:
- 在封闭的料框架中的循环并没有改变混合物的物理性质.
- 校准模型实现了高预测准确度,偏差低,相对标准误差低.
- 预测性能不受剪切效应的影响,证明了模型的稳定性.
结论:
- 封闭料框架是NIR校准模型开发的有效材料节约方法.
- 它可以准确地监测混合物的均性,而不会损害粉末的完整性.
- 这种方法可以减少90%以上的材料要求.
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