Department of Pharmaceutics and Drug Delivery, The University of Mississippi, MS 38677, USA.
Analytical Development, Biogen, Cambridge, MA, USA.
Int J Pharm. 2020 Oct 15;588:119760. doi: 10.1016/j.ijpharm.2020.119760. Epub 2020 Aug 12.
Lack of a conventional quantitative characterization method for filament printability has been recognized as a critical barrier to fused deposition modeling (FDM) 3D printing application. In this study, a small molecule drug, indomethacin, was utilized as a model compound. Polymers with various solubility were mixed with model drug and extruded into filaments using hot melt extrusion method. Thirty-two filaments with or without indomethacin were evaluated by texture analyzer to study the correlation between mechanical properties and the printability. Three different texture analysis methods were utilized and compared, and a parameter "toughness" calculated by stiffness test was identified to quantitatively describe the printability of filaments in the FDM 3D printer. The toughness threshold value of printable filament was defined as a process window of certain FDM printing. This study provides a quantitative way to evaluate and predict filament printability, and it has great potential to be applied to FDM filament development and quality control in the pharmaceutical industry.
缺乏对纤维打印性能的常规定量描述方法，被认为是熔融沉积建模（FDM）3D 打印应用的一个关键障碍。在本研究中，采用一种小分子药物吲哚美辛作为模型化合物。将具有不同溶解度的聚合物与模型药物混合，并使用热熔挤出法将其挤出成纤维。通过纹理分析仪评估了 32 根带有或不带有吲哚美辛的纤维，以研究机械性能与可打印性之间的相关性。利用了三种不同的纹理分析方法进行比较，并确定了由刚性测试计算得出的参数“韧性”来定量描述纤维在 FDM 3D 打印机中的可打印性。可打印纤维的韧性阈值被定义为一定 FDM 打印的工艺窗口。本研究提供了一种定量评估和预测纤维可打印性的方法，有望在制药行业的 FDM 纤维开发和质量控制中得到应用。
