通过FDM3D打印推进个性化医疗:具有可定制药物释放特征的烯酸片和在模拟中
Haya Khader Ahmad Yasin1,2,3, Moawia M Al-Tabakha2,3, Siok Yee Chan1
1School of Pharmaceutical Sciences, Universiti Sains Malaysia, Pulau Pinang 11800, Malaysia.
Pharmaceutics
|November 27, 2025
概括
融合沉积建模 (FDM) 3D打印通过为即时释放和持续释放的口服剂型创建强大的氨酸纤维来实现个性化医疗. 这项技术为医疗点制造提供了一个可行的平台,具有量身定制的药物输送配置文件.
科学领域:
- 制药技术 制药技术 制药技术
- 通过3D打印打印3D打印.
- 药物输送系统 药物输送系统
背景情况:
- 融合沉积建模 (FDM) 三维 (3D) 打印是个性化口服剂型的新兴技术.
- 开发具有稳定性和一致性属性的强大的药物载入纤维对药品中FDM3D打印的成功至关重要.
- 本研究重点是用于即时释放 (IR) 和持续释放 (SR) 应用的烯酸加载纤维.
研究的目的:
- 开发和描述使用热挤出 (HME) 带有烯的纤维.
- 通过FDM3D打印制造IR和SR烯片.
- 评估3D打印片的质量,药物释放和药理动力学特征.
主要方法:
- 使用Kollicoat® IR或propyl甲基纤维素 (HPMC) 与酸盐和酸 (SLS) 制备了烯酸丝.
- 使用包括SEM,ATR-FTIR,XRD,DSC,TGA和USP测试在内的技术来表征线材和3D打印平板电脑.
- 溶解研究和GastroPlus®模拟进行了 in vitro-in silico相关性 (IVIVC).
主要成果:
- 基于Kolicoat®红外线的丝 (F6) 显示出对红外线平板电脑的优越打印能力,而基于HPMC的丝 (F13) 则是SR平板电脑的最佳选择.
- 根据希古奇和科尔斯迈耶-佩帕斯动力学,IR片在30分钟内实现了>80%的烯释放,SR片的释放时间延长至12小时.
- 所有的质量属性都符合USP的限制,而GastroPlus®的模拟支持IVIVC.
结论:
- 建立了一个集成的工作流程,用于使用单个FDM3D打印平台生产IR和SR烯片.
- 这项研究证明了FDM3D打印在护理点,个性化医疗和量身定制药物释放方面的可行性.
- 这种方法为制造定制口服剂型提供了一个强大的战略.
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