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3D 打印药物的转化:从炒作到现实世界的临床应用。

Translating 3D printed pharmaceuticals: From hype to real-world clinical applications.

机构信息

Department of Pharmacology, Pharmacy and Pharmaceutical Technology, Paraquasil Group, Faculty of Pharmacy, and Health Research Institute of Santiago de Compostela (IDIS), University of Santiago de Compostela (USC), Santiago de Compostela 15782, Spain.

Department of Pharmaceutics, UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK.

出版信息

Adv Drug Deliv Rev. 2021 Jul;174:553-575. doi: 10.1016/j.addr.2021.05.003. Epub 2021 May 20.

Abstract

Three-dimensional (3D) printing is a revolutionary technology that is disrupting pharmaceutical development by enabling the production of personalised printlets (3D printed drug products) on demand. By creating small batches of dose flexible medicines, this versatile technology offers significant advantages for clinical practice and drug development, namely the ability to personalise medicines to individual patient needs, as well as expedite drug development timelines within preclinical studies through to first-in-human (FIH) and Phase I/II clinical trials. Despite the widely demonstrated benefits of 3D printing pharmaceuticals, the clinical potential of the technology is yet to be realised. In this timely review, we provide an overview of the latest cutting-edge investigations in 3D printing pharmaceuticals in the pre-clinical and clinical arena and offer a forward-looking approach towards strategies to further aid the translation of 3D printing into the clinic.

摘要

三维(3D)打印是一项颠覆性技术,它通过按需生产个性化的打印片(3D 打印药物产品),正在改变药物开发领域。通过制造小批量的剂量灵活的药物,这项多功能技术为临床实践和药物开发带来了显著的优势,即能够根据个体患者的需求对药物进行个性化定制,同时还能通过临床前研究、首次人体(FIH)和 I/II 期临床试验加快药物开发的时间线。尽管 3D 打印药物已被广泛证明具有优势,但该技术的临床潜力尚未得到充分发挥。在本次及时的综述中,我们概述了 3D 打印药物在临床前和临床领域的最新前沿研究,并对进一步帮助 3D 打印技术转化为临床应用的策略提出了前瞻性的方法。

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