Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 2, 2100, Copenhagen, Denmark.
Mille International ApS, Hellerup, Denmark.
AAPS PharmSciTech. 2022 Jul 14;23(6):196. doi: 10.1208/s12249-022-02321-w.
Binder jetting (BJ) three-dimensional (3D) printing is becoming an established additive manufacturing technology for manufacturing of solid products for oral drug delivery. Similar to traditional solutions based on compaction of powder mixture, successful processing of BJ products requires control of bulk powder properties. In contrast to traditional compaction-based process, BJ 3D printing allows for flexible modifications on microstructure, material composition and dose in the printed pharmaceutical products. Currently, systematic strategies for selecting excipients and optimizing the printing process have not been fully established. To address this challenge, a summary of the published work and selected patent literature around BJ 3D printing to fabricate pharmaceutical solid products for oral administration purposes is presented. First, an overview of characteristics of printed products as a part of the product design and a description of the commonly used excipients and active pharmaceutical ingredients is given. The critical powder and ink properties, as well as physical geometries and inner structures of a final product, are discussed in term of the mechanisms that determine the formation of a printed solid product and finally the quality of this product. This review is also summarizing the technical features of printers, printheads, and the critical considerations for post-processing procedures. BJ 3D printing is one of the most promising additive manufacturing technologies for mass customization of pharmaceutical products.
粉末黏结喷射(Binder Jetting,BJ)3D 打印技术正在成为一种成熟的增材制造技术,可用于制造口服药物输送的固体产品。类似于基于粉末混合物压实的传统方法,BJ 产品的成功加工需要控制散装粉末特性。与传统的基于压实的工艺不同,BJ 3D 打印允许在打印药物产品中灵活地修改微观结构、材料组成和剂量。目前,尚未完全建立用于选择赋形剂和优化打印工艺的系统策略。为了应对这一挑战,本文总结了已发表的关于 BJ 3D 打印用于制造口服给药固体药物产品的工作和部分专利文献。首先,概述了打印产品作为产品设计一部分的特性,并描述了常用的赋形剂和活性药物成分。讨论了关键的粉末和墨水特性以及最终产品的物理几何形状和内部结构,这些特性与决定打印固体产品形成和最终产品质量的机制有关。本文还总结了打印机、喷头的技术特点以及后处理程序的关键注意事项。BJ 3D 打印是最有前途的药物产品大规模定制的增材制造技术之一。