Irma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, Texas A&M University, College Station, Texas, 77843, USA.
Department of Mechanical Engineering, Texas A&M University, College Station, Texas, 77843, USA.
AAPS J. 2018 Sep 12;20(6):101. doi: 10.1208/s12248-018-0225-6.
Three-dimensional (3D) printing was discovered in the 1980s, and many industries have embraced it, but the pharmaceutical industry is slow or reluctant to adopt it. Spiritam® is the first and only 3D-printed drug product approved by FDA in 2015. Since then, the FDA has not approved any 3D-printed drug product due to technical and regulatory issues. The 3D printing process cannot compete with well-established and understood conventional processes for making solid dosage forms. However, pharmaceutical companies can utilize it where mass production is not required; rather, consistency, precision, and accuracy in quality are paramount. There are many 3D printing technologies available, and not all of them are amenable to pharmaceutical manufacturing. Each 3D technology has certain prerequisites in terms of material that it can handle. Some of the pertinent technical and regulatory issues are as follows: Current Good Manufacturing Practice, in-process tests and process control, and cleaning validation. Other promising area of 3D printing use is printing medications for patients with special needs in a hospital and/or pharmacy setting with minimum regulatory oversight. This technology provides a novel opportunity for in-hospital compounding of necessary medicines to support patient-specific medications. However, aspects of the manufacturing challenges and quality control considerations associated with the varying formulation and processing methods need to be fully understood before 3D printing can emerge as a therapeutic tool. With these points in mind, this review paper focuses on 3D technologies amenable for pharmaceutical manufacturing, excipient requirement, process understanding, and technical and regulatory challenges.
三维（3D）打印技术于 20 世纪 80 年代问世，许多行业都已采用该技术，但制药行业对其采用速度缓慢或持抵触态度。Spiritam®是 2015 年 FDA 批准的首款也是唯一一款 3D 打印药物产品。此后，由于技术和监管问题，FDA 尚未批准任何 3D 打印药物产品。3D 打印工艺无法与成熟且已被广泛理解的传统固体制剂生产工艺相竞争。然而，制药公司可以在不需要大规模生产的情况下使用它，而是在质量方面需要保持一致性、精确性和准确性。目前有许多 3D 打印技术，但并非所有技术都适用于制药生产。每种 3D 技术在其能够处理的材料方面都有一定的先决条件。一些相关的技术和监管问题如下：现行良好生产规范、过程检验和过程控制以及清洁验证。3D 打印技术的另一个有前途的应用领域是在医院和/或药房环境中为有特殊需求的患者打印药物，只需进行最低限度的监管。这项技术为在医院内对必要药物进行个性化调配提供了新的机会，以支持患者特定的药物治疗。然而，在 3D 打印能够成为一种治疗工具之前，需要充分了解与不同配方和加工方法相关的制造挑战和质量控制考虑因素。基于这些观点，本文重点介绍了适用于制药生产的 3D 技术、赋形剂要求、工艺理解以及技术和监管挑战。
