Innovative Applications and Prospects of 3D Printing Technology in Drug Development and Manufacture

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.