使用水友聚合物进行个性化卡巴马西平片的三维打印:研究溶解动力学与打印参数之间的相关性
Lianghao Huang1, Xingyue Zhang2, Qichen Huang1
1Key Laboratory of Marine Drugs, Ministry of Education, School of Medicine and Pharmacy, Ocean University of China, Qingdao 266003, China.
Polymers
|August 14, 2025
概括
3D打印通过制造可控释放药片,使个性化医疗成为可能. 打印速度显著影响药物释放,允许通过优化结沉积建模 (FDM) 参数来定制溶解配置.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 生物医学工程 生物医学工程
背景情况:
- 精准医学旨在个性化药物治疗方案,以获得最佳的疗效和最小的副作用.
- 增材制造 (AM) 或3D打印为精确的药物输送提供了可定制的解决方案.
- 了解3D打印参数对于优化可控释放药物概况至关重要.
研究的目的:
- 建立3D打印可控释放片的制造工艺,使用化沉积建模 (FDM) 和热挤出 (HME).
- 调查打印参数对用HPMC-AS/HPC-EF配制的卡巴马西平 (CBZ) 片体体外药物输送性能的影响.
主要方法:
- 使用热重力测量分析 (TGA) 评估CBZ与辅助剂的热兼容性.
- 通过差分扫描热量计 (DSC),极化光显微镜 (PLM) 和粉末X射线衍射 (PXRD) 验证无形固体分散 (ASD) 的形成.
- 采用了15组的全因数设计来研究风扇速度,平台温度和打印速度对平板电脑性能的影响,并使用响应表面建模 (RSM) 进行分析.
主要成果:
- 确认了CBZ与HPMC-AS/HPC-EF的热兼容性和稳定的ASD形成.
- 确定打印速度是影响药物释放的主要参数,高速度加速,低速度延长释放.
- 开发了具有高可预测性 (R2值分别为0.9936和0.9019) 的溶解动力学 (t50%和Q4h) 的预测性RSM模型.
结论:
- 证明了聚合物复合物AM的适应性,用于定制药物释放特征.
- 展示了平衡机械完整性,释放动力学和制造可扩展性的能力.
- 推进了用于制药应用的多功能3D打印药物输送设备的开发.
相关概念视频
01:28Factors Influencing Drug Absorption: Pharmaceutical Parameters
192
Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
192
01:21Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism
403
Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
403