Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, USA.
Department of Pharmaceutics, College of Pharmacy, University of Minnesota, Minneapolis, MN 55455, USA.
Int J Pharm. 2024 Mar 25;653:123905. doi: 10.1016/j.ijpharm.2024.123905. Epub 2024 Feb 13.
The study aims to fabricate extended release (ER) tablets using a dual-nozzle fused deposition modeling (FDM) three-dimensional (3D) printing technology based on hot melt extrusion (HME), using caffeine as the model compound. Three different ER tablets were developed, which obtained "delayed-release", "rapid-sustained release", and "release-lag-release" properties. Each type of tablet was printed with two different formulations. A novel printing method was employed in this study, which is to push the HME filament from behind with polylactic acid (PLA) to prevent sample damage by gears during the printing process. Powder X-ray diffractometry (PXRD) and differential scanning calorimetry (DSC) results showed that caffeine was predominately amorphous in the final tablets. The dissolution of 3D printed tablets was assessed using a USP-II dissolution apparatus. ER tablets containing PVA dissolved faster than those developed with Kollicoat IR. Overall, this study revealed that ER tablets were successfully manufactured through HME paired with dual-nozzle FDM 3D printing and demonstrated the power of 3D printing in developing multi-layer tablets with complex structures.
本研究旨在使用热熔挤出（HME）为基础的双喷嘴熔融沉积建模（FDM）三维（3D）打印技术来制备延长释放（ER）片剂，以咖啡因作为模型化合物。开发了三种不同的 ER 片剂，它们分别具有“延迟释放”、“快速持续释放”和“滞后释放”的性能。每种类型的片剂都采用两种不同的配方进行打印。本研究采用了一种新颖的打印方法，即用聚乳酸（PLA）从后面推动 HME 细丝，以防止在打印过程中齿轮损坏样品。粉末 X 射线衍射（PXRD）和差示扫描量热法（DSC）结果表明，最终片剂中的咖啡因主要为无定形。使用 USP-II 溶解仪评估了 3D 打印片剂的溶解情况。含有 PVA 的 ER 片剂的溶解速度快于用 Kollicoat IR 开发的片剂。总的来说，这项研究表明，通过 HME 与双喷嘴 FDM 3D 打印相结合，成功制造了 ER 片剂，并展示了 3D 打印在开发具有复杂结构的多层片剂方面的强大功能。
