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UV-VIS 光谱作为测量压缩物料密度的潜在过程分析技术(PAT):CIELAB 颜色空间的评估。

UV-VIS spectra as potential process analytical technology (PAT) for measuring the density of compressed materials: Evaluation of the CIELAB color space.

机构信息

Department of Pharmaceutical Technology and Biopharmaceutics, University of Bonn, Gerhard-Domagk-Straße 3, 53121 Bonn, Germany.

ColVisTec AG, Max-Planck-Str. 3, 12489 Berlin - Adlershof, Germany.

出版信息

Int J Pharm. 2021 Jun 15;603:120668. doi: 10.1016/j.ijpharm.2021.120668. Epub 2021 May 1.

Abstract

Measurement methods for determining the density of compressed materials, being a critical quality attribute, provide an important parameter for successful processing. In this study, a novel approach was developed for determining the density of compacts using ultraviolet-visible spectrophotometry. The assumption within this context was that a change in density affects the corresponding color information of the compact. From the obtained spectra of the visible range, the color information of the compact was calculated which turned out to be directly proportional to the density of the compact. In comparison, the obtained spectra were analyzed using partial least square regression. The results of this study showed that both methods could be used predicting the density of a compact from the corresponding visible spectrum at identical accuracy. In contrast to the partial least square regression, the correlation of the color information as a direct output parameter of the spectrophotometer with the density required no excessive data pre-processing. Subsequently, the easier and faster data processing of the color information over the partial least square regression, conceives using this novel approach as potential process analytical technology tool for implementation into a compression process e.g., tableting or roller compaction.

摘要

用于测定压缩材料密度的测量方法是一个关键的质量属性,为成功的加工提供了一个重要的参数。在这项研究中,开发了一种使用紫外可见分光光度法测定压块密度的新方法。在这种情况下的假设是,密度的变化会影响压块的相应颜色信息。从获得的可见光谱中,计算了压块的颜色信息,结果表明它与压块的密度成正比。相比之下,使用偏最小二乘回归分析了获得的光谱。这项研究的结果表明,这两种方法都可以在相同的精度下,从相应的可见光谱预测压块的密度。与偏最小二乘回归相比,颜色信息作为分光光度计的直接输出参数与密度的相关性不需要过多的数据预处理。随后,颜色信息比偏最小二乘回归更容易和更快地进行数据处理,因此可以考虑将这种新方法作为潜在的过程分析技术工具,应用于压缩过程,例如片剂或滚压。

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