Department of Pharmacy, University of Copenhagen, Universitetsparken 2, 2100 Copenhagen, Denmark.
Department of Pharmacy, University of Copenhagen, Universitetsparken 2, 2100 Copenhagen, Denmark.
J Pharm Sci. 2024 Sep;113(9):2957-2966. doi: 10.1016/j.xphs.2024.05.032. Epub 2024 Jun 8.
Semisolid extrusion (SSE) 3D printing (3DP) technology is emerging due to its simplicity and potential for on-site manufacturing of personalized drug products with tailored functionality (dose, release profile), as well as recognizability (size, shape, color). However, even a minor change in the composition of the ink (the feedstock material) and the printing process parameters can largely influence the outcome of printing. This paper summarizes the recent SSE 3DP studies, where the important factors affecting the quality of the printed drug products are discussed. Further challenges are showcased by introducing a case study focusing on the design of oral theophylline immediate-release drug products. The identified crucial factors, such as the printing hardware and connected software, printing parameters, and composition of the ink are discussed. Especially, the rheological properties of the ink during the printing process, together with solidification, mechanical properties, and morphology studies of already printed products are deliberated to gain more understanding of the printability of drug products by SSE. This work aims to provide an overview of design aspects related to SSE-based fabrication of personalized drug products.
半固态挤出（SSE）3D 打印（3DP）技术因其简单性以及能够现场制造具有定制功能（剂量、释放曲线）和可识别性（大小、形状、颜色）的个性化药物产品而崭露头角。然而，即使油墨（原料材料）组成和打印工艺参数发生微小变化，也会在很大程度上影响打印效果。本文总结了最近的 SSE 3DP 研究，讨论了影响打印药物产品质量的重要因素。通过引入一个专注于设计茶碱即时释放口服药物产品的案例研究，展示了进一步的挑战。讨论了已确定的关键因素，如打印硬件和相关软件、打印参数以及油墨的组成。特别是，讨论了油墨在打印过程中的流变性能以及已经打印产品的固化、机械性能和形态研究，以更深入地了解 SSE 对药物产品可打印性的影响。这项工作旨在提供与基于 SSE 的个性化药物产品制造相关的设计方面的概述。
