Kimmel Vincent, Gräfe Lorena, Grieser Luca, Lips Alexey, Hennig Robert, Winck Judith, Thommes Markus
Laboratory of Solids Process Engineering, Department of Biochemical and Chemical Engineering, Technical University Dortmund, Emil-Figge-Str. 68, 44227 Dortmund, Germany.
Drug Delivery Innovation Center, INVITE GmbH, Chempark Building W32, Otto-Bayer-Str. 32, 51061 Cologne, Germany.
Pharmaceutics. 2025 Mar 9;17(3):353. doi: 10.3390/pharmaceutics17030353.
Hot-melt extrusion has been established as a formulation strategy for various pharmaceutical applications. However, tailoring the screw configuration is a major challenge where 1D modeling is utilized. This usually requires specific screw parameters, which are rarely noted in the literature, especially when dealing with shear-thinning formulations. Therefore, a custom-made test rig was used to assess the behavior of various conveying and kneading elements using Newtonian silicon oil and shear-thinning silicon rubber. The pressure and the power were measured as a function of volume flow. A model was proposed characterizing the screw element behavior by six individual parameters A1, A2, A3, B1, B2, B3. The experimental results regarding the behavior with respect to Newtonian fluids were in good agreement with the literature and were modeled in accordance with the Pawlowski approach. In terms of shear-thinning fluids, the influence of screw speed on pressure and power was quantified. An evaluation framework was proposed to assess this effect using two additional parameters. Based on a high number of repetitive measurements, a confidence interval for the individual screw parameters was determined that is suitable to highlight the differences between element types. Finally, geometrical screw parameters for Newtonian and shear-thinning flow were assessed and modeled, with three conveying and three kneading elements characterized.
热熔挤出已被确立为一种适用于各种药物应用的制剂策略。然而,在使用一维建模时,调整螺杆配置是一项重大挑战。这通常需要特定的螺杆参数,而这些参数在文献中很少被提及,尤其是在处理剪切变稀制剂时。因此,使用了一个定制的试验台,用牛顿硅油和剪切变稀硅橡胶来评估各种输送和捏合元件的性能。测量了压力和功率随体积流量的变化。提出了一个用六个独立参数A1、A2、A3、B1、B2、B3来表征螺杆元件性能的模型。关于牛顿流体性能的实验结果与文献吻合良好,并根据帕夫洛夫斯基方法进行了建模。对于剪切变稀流体,量化了螺杆转速对压力和功率的影响。提出了一个评估框架,用另外两个参数来评估这种影响。基于大量重复测量,确定了各个螺杆参数的置信区间,该区间适合突出不同元件类型之间的差异。最后,评估并建模了牛顿流体和剪切变稀流体的螺杆几何参数,对三个输送元件和三个捏合元件进行了表征。