摘要
药物的开发和生产是一个漫长且严格的过程,技术进步与迭代相对缓慢。然而,作为一种新型增材制造技术,3D打印相比于传统制剂技术具有制造精度高、灵活性强、产品可设计和按需制造等独特优势,近年来在药物研发和生产中得到广泛关注。3D打印技术能够通过构建药物复杂的外部几何形状与内部三维结构,从而实现不同的药代动力学曲线,以满足临床需求。同时,作为智能制药的一种新手段,3D打印不仅有利于制药工艺放大,还能够与过程分析技术相结合,实时监测药物质量并同步记录相关质控数据,实现药物数字化连续生产,加速药物从研发到临床的整体开发过程。综述了近年来3D打印技术在药物剂型和药物递送系统设计中的创新应用以及3D打印药物规模化生产的主要成果,重点分析3D打印相比于传统制剂开发和生产的主要优势及其面临的挑战,并介绍相关机构的最新动态与3D打印药物的监管要求,旨在为推动3D打印技术在药物研发与生产中的应用提供思路与参考。
Drug development and manufacture is a lengthy and rigorous process,and technological advancements and iterations are relatively slow.However,as an innovative additive manufacturing technology,3D printing has unique advantages over traditional formulation technologies,including high manufacturing precision,strong flexibility,devisable products,and on-demand manufacturing.In recent years,it has gained widespread attention in drug development and manufacture.3D printing technology can achieve different pharmacokinetic profiles by constructing complex external geometries and internal three-dimensional structures of drugs,thereby meeting clinical needs.Additionally,as a new approach to intelligent pharmaceutical manufacturing,3D printing not only facilitates the scaling up of pharmaceutical process but also integrates with process analytical technologies to monitor drug quality in real time and simultaneously record relevant quality control data.This enables digital continuous manufacture of drugs,accelerating the overall development process from research to clinical application.This article summarizes the innovative applications of 3D printing technology in the design of drug dosage forms and drug delivery systems in recent years,as well as the main achievements in the large-scale manufacture of 3D-printed pharmaceutical products.It focuses on analyzing the key advantages of 3D printing over traditional formulation development and manufacture,and the challenges 3D printing faces.The article also introduces the latest developments of relevant institutions and the regulatory requirements of 3D-printed pharmaceutical products.The aim is to provide insights and references for promoting the application of 3D printing technology in pharmaceutical development and manufacture.
作者
路景驭
于雅鑫
沈中天
成森平
LU Jingyu;YU Yaxin;SHEN Zhongtian;CHENG Senping(Triastek,Inc.,Nanjing 211112,China)
出处
《药学进展》
CAS
2024年第7期506-522,共17页
Progress in Pharmaceutical Sciences
关键词
3D打印技术
口服固体制剂
热熔挤出沉积
改良型释放
药物递送系统
连续化生产
3D printing technology
oral solid dosage form
melt extrusion deposition
modified release
drug delivery system
continuous manufacturing
作者简介
通信作者:成森平,博士,研究方向:3D打印药物,数字化智能制药工艺,E-mail:scheng@triastek.com,肯塔基大学(University of Kentucky)毒理学博士,太平洋大学(University of the Pacific)兼职教授,国家重点人才计划专家,江苏省双创人才,入选2022、2023福布斯中国商界20位潜力女性榜单,2022福布斯中国科技女性50榜单、2023财富中国最具影响力的商界女性(未来榜)榜单。累计发表论文22篇,拥有专利申请180项。成森平博士拥有13年中美两国创业与企业管理经验,2010年在旧金山创立Pan-Pacific Biopharma,2015年7月创立南京三迭纪医药科技有限公司(以下简称“三迭纪”)。三迭纪是全球3D打印药物领域的引领者,也是全球新一代数字制药工艺的开创者,致力于成为全球最具影响力的智能制药企业。
