开发一个3D打印的多个单元粒子系统 (MUPS) 含有metoprolol糖酸盐
Lee Roy Oldfield1, Björn Fischer1, Tobias Auel1
1Heinrich Heine University Düsseldorf, Faculty of Mathematics and Natural Sciences, Institute of Pharmaceutics and Biopharmaceutics, Universitätsstraße 1, 40225 Düsseldorf, Germany.
概括
这项研究开发了3D打印的多个单元颗粒系统 (MUPS) 片,含有metoprolol succinate,证明了个性化药物递送的可行性. 然而,活性药物成分 (API) 的热降解需要进一步优化.
科学领域:
- 制药技术 制药技术 制药技术
- 3D打印应用 3D打印应用
- 药物输送系统 药物输送系统
背景情况:
- 3D打印为个性化药物和复杂的剂量形式提供了潜力.
- 多重单元粒子系统 (MUPS) 提供可控药物释放的优势.
研究的目的:
- 开发和表征双挤出3D打印的含有metoprolol糖酸盐的MUPS片.
- 评估将药物载荷颗粒集成到可分解的药片外中的可行性.
- 评估3D打印对药物稳定性和释放概况的影响.
主要方法:
- 使用药品级的Eudragit® RL PO和Kollicoat® IR.进行化丝制造.
- 通过SEM,X射线微计算机断层扫描和数字显微镜进行形态和结构分析.
- 测试质量均性,分解,API状态 (XRPD),降解 (HPLC) 和体外溶解.
主要成果:
- 均的粒子几何和分布得到证实;平板电脑达到Ph. 欧元. 欧元. 在欧元. 质量统一标准. 质量统一标准.
- 在15分钟内完全分解药片外;在无形状态下发现API.
- 观察到显著的API热降解 (97.8%至65.9%);印刷层与药物含量之间建立了线性相关性.
- 试管溶解显示在105-150分钟之间80%的API释放.
结论:
- 双挤出3D打印是可行的生产API-MUPS平板电脑用药品等级的材料.
- 像API热不稳定性和粒子聚合等关键缺陷需要配方和过程优化.
- 这项技术显示了个性化药物输送的前景,使剂量个性化成为可能.
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