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3D 屏幕打印 - 一种用于药物剂型大规模制造的创新技术。

3D screen printing - An innovative technology for large-scale manufacturing of pharmaceutical dosage forms.

机构信息

Laxxon Medical GmbH, Hans-Knöll-Str. 6, 07745 Jena, Germany.

Pharmaceutical Technology and Biopharmacy, Institute of Pharmacy, Friedrich Schiller University Jena, Lessingstr. 8, 07743 Jena, Germany.

出版信息

Int J Pharm. 2021 Jan 5;592:120096. doi: 10.1016/j.ijpharm.2020.120096. Epub 2020 Nov 18.

DOI:10.1016/j.ijpharm.2020.120096
PMID:33217548
Abstract

Three-dimensional (3D) screen printing was used to fabricate oral dosage forms of different geometry and size. The paste required as starting material for the 3D screen printing process was designed for delayed release and contained the model drug paracetamol (acetaminophen). A prototype screen printing unit was used to fabricate different tablets in a single production process. The resulting tablets were produced with three different sizes and designed geometries (disk, donut, cuboid, oval and grid). Investigation of size and mass of the individual tablets demonstrated high uniformity within the various groups of tablets. Further characterization of their physical properties, such as breaking force and friability, yielded results comparing favorably to conventionally produced tablets. Finally, drug release tests in artificial gastric media showed paracetamol release to depend on the surface-area-to-volume ratio. In conclusion, the study shows the potential of 3D screen printing to fabricate more complex oral dosage forms in the setting of mass production with high reproducibility.

摘要

三维(3D)丝网印刷被用于制造不同几何形状和尺寸的口服剂型。作为 3D 丝网印刷工艺起始材料的膏体被设计用于延迟释放,并包含模型药物扑热息痛(对乙酰氨基酚)。使用原型丝网印刷单元在单个生产过程中制造不同的片剂。所得到的片剂采用三种不同的尺寸和设计的几何形状(圆盘、甜甜圈、长方体、椭圆形和网格)制造。对各个片剂的尺寸和质量的研究表明,在各种片剂组内具有高度的均匀性。对其物理性质(如抗破碎力和脆性)的进一步表征,得到的结果与常规生产的片剂相比具有优势。最后,在人工胃液介质中的药物释放测试表明,扑热息痛的释放取决于表面积与体积比。总之,该研究表明 3D 丝网印刷在大规模生产中制造更复杂的口服剂型具有很大的潜力,且具有高度的重现性。

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