开源的半固体3D打印机,设计用于医院药房的口服药物生产
François Rioblanc1, Baptiste Heumel2, Daniel Alloh Nammou2
1Department of Pharmacy, Robert Debré University Hospital (AP-HP), 48 boulevard sérurier, 75019 Paris, France; Université d'Angers, CHU Angers, INSERM, CNRS, MINT, SFR ICAT, F-49000 Angers, France.
International journal of pharmaceutics
|July 27, 2025
概括
研究人员开发了一种负担得起的半固体挤出 (SSE) 3D打印机,配备了集成称重系统. 这项创新旨在提高医院药房个性化药品生产的可访问性.
科学领域:
- 制药技术 制药技术 制药技术
- 添加剂制造 添加剂制造 添加剂制造
- 药物输送系统 药物输送系统
背景情况:
- 三维 (3D) 打印,特别是半固体挤出 (SSE),对制药制造有很大的希望.
- 专用SSE3D打印机的有限可用性阻碍了其广泛采用.
- 越来越需要可定制和具有成本效益的药物生产解决方案.
研究的目的:
- 开发和验证一个可访问的,半固体挤出 (SSE) 3D打印机,配备集成的工艺称重系统.
- 为了证明打印机在准确性和可重复性生产药品印刷品方面的能力.
- 评估开发的系统在医院环境中提供个性化医疗的潜力.
主要方法:
- 开发一款新型的SSE3D打印机,配备工艺中的称重系统和本地网络功能.
- 使用瓦塞林和低乙烯基凝与 levetiracetam (LVT) 作为验证的模型材料.
- 在20分钟内将20毫升注射器的含量加热到目标温度.
- 在3D打印过程中,连续称重小打印件.
- 根据欧洲药典标准评估印刷品质量与体积的比例性,可重复性和内容统一性.
主要成果:
- 开发的SSE3D打印机在20分钟内成功加热了材料.
- 综合称重系统表现出高准确度,与外部平衡相比,偏差为0.3-0.5%.
- 瓦斯林印刷品表现出优异的质量与体积的比例 (R2 0.9954) 和在3天内重复性 (RSD 1.5%).
- 列维他拉 (LVT) 打印纸 (n=30) 符合欧洲药典内容统一性要求,平均含量为143.9毫克 (RSD 1.2%) 和接受值为5.7.
结论:
- 开发的SSE3D打印机是可定制的,价格实惠的,并配备了精确的工艺称重系统.
- 打印机的性能验证了其生产准确和可重复的药物剂量形式的潜力.
- 这项技术为医院药房内的个性化医疗民主化提供了一个有希望的途径.
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