基于3D打印的自动化非无菌组合技术,用于卫生系统药房环境中的小儿皮质类固醇剂量表格
M Brooke Bernhardt1, Farnaz Shokraneh2,3, Ludmila Hrizanovska2
1Department of Pharmacy and Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, TN 38105, USA.
Pharmaceutics
|June 27, 2025
概括
自动化3D打印提高了组合非无菌儿科药物的精度. 这项技术提高了个性化药物配方的准确性和效率,使药房工作流程现代化.
科学领域:
- 制药技术 制药技术 制药技术
- 药物输送系统 药物输送系统
- 儿科药房 儿科药房
背景情况:
- 非无菌的制药化合物主要是手工制造,缺乏创新.
- 自动化复合平台提供了提高精度和效率的潜力.
研究的目的:
- 实施和评估一个基于3D打印的自动化组合平台,用于儿科皮质类固醇配方.
- 评估平台在创建具有个性化优势的多样化剂型方面的多功能性.
主要方法:
- 使用半固体挤出 (SSE) 3D 打印工作流程制备了个性化的皮剂型 (凝片,三叶片,ODF).
- 使用自动剂量,注射器加热和API辅助剂混合.
- 评估了质量和含量统一性的药典标准.
主要成果:
- 所有复合配方都符合药典统一性标准.
- 观察到ODFs和troches的药物释放速度快 (在5分钟内超过75%);凝片的释放速度较慢.
- 通过在工艺过程中的同质性测试证实了API分布的一致性.
结论:
- 自动化复合技术可用于整合到药房工作流程中.
- 这项技术提高了准确性,减少了变化,并简化了定制儿科药物的生产.
- 自动化有可能使非无菌化合物现代化,并支持个性化治疗.
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