3D打印技术在药物制剂中的应用和挑战

Applications and Challenges of 3D Printing Technique in Manufacturing Pharmaceutical Preparations

美国食品药品监督管理局于2015年7月批准了全球第1个3D打印药品,标志着药品生产领域的新篇章。3D打印是一种通过数字模型层层叠加,逐层打印所需产品的工艺。作为一种新型技术平台,3D打印在产品设计复杂度、产品个性化和按需制造方面具有极大的优势。总结了常用3D打印技术及其在药物制剂领域的应用,强调了3D打印与传统制造工艺相比具有的巨大优势,但也提出了该技术存在的问题和监管方面的挑战。整体而言,3D打印技术在药物制剂领域发展潜力巨大,将为医药发展带来新的机遇和希望。

The US Food and Drug Administration(FDA) approved the world’s first 3 D-printed drug product in July 2015, marking a new chapter of pharmaceutical manufacturing. 3 D printing is a process of layer-by-layer printing of designed product with materials being added layer by layer based on a digital model. As a new technology platform, 3 D printing has competitive advantages in complex product design, product personalization, and on-demand manufacturing. This review summarizes the commonly-used 3 D printing technology and its application in the field of pharmaceutical preparations, emphasizes the great advantages of 3 D printing compared with traditional manufacturing processes, and also raises the limitations and regulatory challenges of this technology. Overall, 3 D printing technology has great potential in the field of pharmaceutical preparations and will bring new opportunities and hopes for the development of medicine.