Scientific papers
Roller compaction and dry granulation are well-established unit operations within the pharmaceutical industry. The ribbon solid fraction, considered a critical quality attribute directly influencing final product quality and performance, is currently under investigation for novel measurement methods. The development and assessment of innovative approaches for measuring the ribbon solid fraction are crucial for at-, on-, or in-line process monitoring. This is essential to overcome the limitations of end product testing and pave the way for continuous manufacturing.
In this study, a novel analytical device utilizing laser triangulation was explored for its potential as an at-line process analytical technology tool during a roller compaction process. The laser triangulation device was compared with X-ray micro-computed tomography and powder-based volume displacement measurement techniques using various statistical evaluation methods. Emphasis was placed on accuracy, precision, and total measurement time. The results confirmed the laser triangulation device's high accuracy and precision, along with the shortest total measurement time compared to other methods. This study supports the adoption of the laser triangulation device as a novel at-line process analytical technology tool in roller compaction processes.
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