Department of Pharmaceutical Technology and Biopharmaceutics, University of Bonn, Gerhard-Domagk-Straße 3, 53121 Bonn, Germany.
Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397 Biberach an der Riß, Germany.
Int J Pharm. 2021 Dec 15;610:121241. doi: 10.1016/j.ijpharm.2021.121241. Epub 2021 Nov 6.
Roller compaction and dry granulation represent well-established unit operations in the pharmaceutical industry. The ribbon solid fraction is classified as a critical quality attribute, that directly impacts final product quality and performance. The development and evaluation of novel methods measuring ribbon solid fraction represent a subject of current research, since novel analyses strategies need to be established for at-, on-, or in-line process monitoring to overcome limitations of end product testing and to set the course for continuous manufacturing. In this study, a novel analytical device, using the principle of laser triangulation, was investigated to asses its potential being used as at-line process analytical technology tool during a roller compaction process. To this end, the laser triangulation device was compared with X-ray micro-computed tomography and powder based volume displacement measurement techniques using different statistical evaluation methods. Special focus was given to accuracy, precision, and total measurement time. The laser triangulation device was confirmed as highly accurate and precise, enabling the shortest total measurement time compared to the other methods. The findings of this study support the idea of implementing the laser triangulation device as a novel at-line process analytical technology tool into a roller compaction process.
辊压和干法造粒是制药行业中成熟的单元操作。带状固体部分被归类为关键质量属性，直接影响最终产品的质量和性能。因此，开发和评估新型测量带状固体部分的方法是当前研究的主题，因为需要为在线、过程中或过程内的工艺监测建立新的分析策略，以克服最终产品测试的局限性，并为连续制造设定方向。在这项研究中，使用激光三角测量原理的新型分析装置被研究，以评估其作为在线工艺分析技术工具在辊压过程中的潜在用途。为此，使用不同的统计评估方法，将激光三角测量装置与 X 射线微计算机断层扫描和基于粉末的体积位移测量技术进行了比较。特别关注准确性、精密度和总测量时间。激光三角测量装置被证实具有很高的准确性和精密度，与其他方法相比，能够实现最短的总测量时间。这项研究的结果支持将激光三角测量装置作为一种新型的在线工艺分析技术工具，应用于辊压工艺的想法。
