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利用拉曼光谱和太赫兹脉冲成像预测缓释制剂的溶解时间和包衣厚度。

Prediction of dissolution time and coating thickness of sustained release formulations using Raman spectroscopy and terahertz pulsed imaging.

机构信息

Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University, Duesseldorf, Germany.

出版信息

Eur J Pharm Biopharm. 2012 Apr;80(3):690-7. doi: 10.1016/j.ejpb.2011.12.003. Epub 2012 Jan 5.

DOI:10.1016/j.ejpb.2011.12.003
PMID:22245221
Abstract

Raman spectroscopy was implemented successfully as a non-invasive and rapid process analytical technology (PAT) tool for in-line quantitative monitoring of functional coating. Coating experiments were performed at which diprophylline tablets were coated with a sustained release formulation based on Kollicoat SR 30 D. Using PLS a multivariate model was constructed by correlating Raman spectral data with the mean dissolution time as determined by dissolution testing and the coating thickness as measured by terahertz pulsed imaging. By performing in-line measurements it was possible to monitor the progress of the coating process and to detect the end point of the process, where the acquired coating amount was achieved for the desired MDT or coating thickness.

摘要

拉曼光谱成功地实现为一种非侵入式和快速的过程分析技术(PAT)工具,用于对功能性包衣进行在线定量监测。在包衣实验中,二羟丙茶碱片剂用基于 Kollicoat SR 30 D 的缓释制剂进行包衣。使用 PLS 通过将拉曼光谱数据与通过溶解测试确定的平均溶解时间和通过太赫兹脉冲成像测量的涂层厚度相关联,构建了一个多元模型。通过进行在线测量,可以监测包衣过程的进展并检测过程的终点,在该终点处达到了所需的 MDT 或涂层厚度的所获得的涂层量。

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