Sierra-Vega Nobel O, Ashraf Muhammad, O'Connor Thomas, Kopcha Michael, Prima Mathew Di, Coburn James, Zidan Ahmed
Office of Pharmaceutical Quality Research, CDER, U.S. FDA, USA.
Office of Pharmaceutical Quality, CDER, U.S. FDA, USA.
Int J Pharm. 2025 Mar 30;673:125415. doi: 10.1016/j.ijpharm.2025.125415. Epub 2025 Feb 27.
Three-dimensional (3D) printing is an emerging technology with the potential to increase manufacturing flexibility and enable personalized drug delivery. 3D printing may form tablets using digitally controlled layer-by-layer material deposition, permitting the tailoring of solid oral dosage geometry and facile modifications of drug release profiles without requiring extensive alterations to the pharmaceutical formulation and process. The challenge to assure the quality of drugs still lies in monitoring and controlling critical steps in the 3D printing process. Optimizing an 3D printing process requires a comprehensive understanding of the critical process parameters, material attributes and their impact on the performance of 3D-printed tablets. This review focuses on recent advances in 3D printing technologies for solid oral dosage forms, emphasizing critical process parameters and material attributes that may be considered for optimizing printing processes and enhancing the quality of printed tablets. Additionally, this review explores real-time analytical tools and the crucial considerations for ensuring the performance of building materials, printing processes, and manufactured solid drug products. This review contributes to the ongoing discourse on harnessing the potential of 3D printing in the pharmaceutical field while emphasizing the imperative need for quality assurance throughout additive manufacturing processes.
三维（3D）打印是一项新兴技术，具有提高制造灵活性和实现个性化药物递送的潜力。3D打印可通过数控逐层材料沉积来成型片剂，从而能够定制固体口服剂型的几何形状，并轻松改变药物释放曲线，而无需对药物制剂和工艺进行大规模改动。确保药物质量的挑战仍在于监测和控制3D打印过程中的关键步骤。优化3D打印过程需要全面了解关键工艺参数、材料属性及其对3D打印片剂性能的影响。本综述重点关注固体口服剂型3D打印技术的最新进展，强调可用于优化打印过程和提高打印片剂质量的关键工艺参数和材料属性。此外，本综述还探讨了实时分析工具以及确保建筑材料、打印过程和制成的固体药品性能的关键考虑因素。本综述有助于推动关于在制药领域利用3D打印潜力的持续讨论，同时强调在整个增材制造过程中进行质量保证的迫切需求。
