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用于固体制剂制造中辊压过程控制的过程分析技术工具。

Process analytical technology tools for process control of roller compaction in solid pharmaceuticals manufacturing.

机构信息

Krka, d.d. Novo mesto, 8501 Novo mesto, Slovenia.

University of Ljubljana, Faculty of Pharmacy, 1000 LjubljanaSlovenia.

出版信息

Acta Pharm. 2020 Dec 1;70(4):443-463. doi: 10.2478/acph-2020-0038.

Abstract

This article presents an overview of using process analytical technology in monitoring the roller compaction process. In the past two decades, near-infrared spectroscopy, near-infrared spectroscopy coupled with chemical imaging, microwave resonance technology, thermal effusivity and various particle imaging techniques have been used for developing at-, off-, on- and in-line models for predicting critical quality attributes of ribbons and subsequent granules and tablets. The common goal of all these methods is improved process understanding and process control, and thus improved production of high-quality products. This article reviews the work of several researchers in this field, comparing and critically evaluating their achievements.

摘要

本文概述了在监测辊压过程中使用过程分析技术。在过去的二十年中,近红外光谱、近红外光谱与化学成像结合、微波共振技术、热扩散率以及各种粒子成像技术已被用于开发用于预测条带和后续颗粒和片剂的关键质量属性的在线、离线、在位和在线模型。所有这些方法的共同目标都是提高工艺理解和过程控制水平,从而提高高质量产品的生产效率。本文综述了该领域几位研究人员的工作,比较和批判性地评估了他们的成果。

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