Heinrich Heine University Duesseldorf, Institute of Pharmaceutics and Biopharmaceutics, Universitaetsstrasse 1, 40225 Duesseldorf, Germany.
Heinrich Heine University Duesseldorf, Institute of Pharmaceutics and Biopharmaceutics, Universitaetsstrasse 1, 40225 Duesseldorf, Germany.
J Pharm Sci. 2024 Apr;113(4):1020-1028. doi: 10.1016/j.xphs.2023.10.013. Epub 2023 Oct 13.
Process Analytical Technology (PAT) plays a crucial role in the design of today's manufacturing lines as continuous manufacturing becomes more important. Until now PAT tools to measure the ribbon solid fraction (SF) in-line are not commonly used in roll compaction. The aim of this study was therefore to establish a new approach as PAT for in-line ribbon solid fraction determination. Different placebo formulations with different binders and one formulation containing active pharmaceutical ingredient were investigated using in-line laser triangulation measurement to detect the ribbon thickness after compaction. With this the ribbon elastic recovery was determined in-line (ER) while the ribbons are attached to the roll surface. It was found that the ratio (ER) between the total elastic recovery and ER is formulation specific and not influenced by any process parameters. This enables ER as prediction tool for SF, if the solid fraction at gap (SF) width is known. SF was determined with ribbon mass flow measurement or based on the Midoux model, a simplified Johanson model, gaining two prediction models for SF. Both models showed good agreement of the predicted SF and the measured one.
过程分析技术（PAT）在当今的制造生产线设计中起着至关重要的作用，因为连续制造变得越来越重要。到目前为止，用于测量压辊制粒过程中带状固体分数（SF）的在线 PAT 工具并不常用。因此，本研究旨在建立一种新的在线带状固体分数测定的 PAT 方法。使用在线激光三角测量法研究了不同的含不同粘合剂的安慰剂配方和一种含活性药物成分的配方，以检测压辊后带状物的厚度。由此可以在线（ER）测定压辊制粒过程中带状物的弹性恢复（ER），此时带状物附着在压辊表面。结果发现，总弹性恢复与 ER 的比值（ER）是配方特定的，不受任何工艺参数的影响。如果已知间隙（SF）宽度处的固体分数（SF），则 ER 可以作为 SF 的预测工具。SF 通过带状物质量流量测量或基于简化的 Johanson 模型 Midoux 模型来确定，得出了两个 SF 的预测模型。两个模型都显示出了预测 SF 和测量 SF 之间的良好一致性。
