Preis Maren, Öblom Heidi
Pharmaceutical Sciences Laboratory, Faculty of Science and Engineering, BioCity, Åbo Akademi University, Artillerigatan 6A, FI 20520, Turku, Finland.
AAPS PharmSciTech. 2017 Feb;18(2):303-308. doi: 10.1208/s12249-016-0704-y. Epub 2017 Jan 11.
The first medicine manufactured by three-dimensional (3D) printing was recently approved by the Food and Drug Administration (FDA). The advantages of printing as a manufacturing route enabling more flexibility regarding the dose, and enlarging individual treatment options, have been demonstrated. There is a particular need for flexible drug delivery solutions when it comes to children. Printing as a new pharmaceutical manufacturing technology brings manufacturing closer to the patient and can easily be adjusted to the required dosing scheme, offering more flexibility for treatments. Printing of medicine may therefore become the manufacturing route of choice to provide tailored and potentially on-demand treatments for patients with individual needs. This paper intends to summarize and discuss the state of the art, the crucial aspects which should be taken into account, and the still-open questions, in order to make 3D printing a suitable manufacturing route for pediatric drugs.
首款通过三维(3D)打印制造的药物最近获得了美国食品药品监督管理局(FDA)的批准。作为一种制造途径,3D打印在剂量方面具有更大的灵活性,并能增加个性化治疗选择,其优势已得到证实。在儿童用药方面,对灵活给药解决方案有着特殊需求。3D打印作为一种新的药物制造技术,使生产更贴近患者,并且可以轻松根据所需给药方案进行调整,为治疗提供了更大的灵活性。因此,药物打印可能会成为为有个性化需求的患者提供定制化且可能按需治疗的首选制造途径。本文旨在总结和讨论当前的技术水平、应考虑的关键方面以及仍未解决的问题,以便使3D打印成为适合儿科药物的制造途径。