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对于固体口服剂型的新兴3D打印技术:实时评估的过程,材料和分析工具

Nobel O Sierra-Vega¹, Muhammad Ashraf¹, Thomas O'Connor¹

¹Office of Pharmaceutical Quality Research, CDER, U.S. FDA, USA.

International journal of pharmaceutics

|March 1, 2025

概括

三维 (3D) 打印通过制造量身定制的平板电脑来提供个性化的药物输送. 确保质量需要了解关键过程参数和实时监控在制药添加剂制造.

科学领域:

制药科学制药科学
制造业制造技术制造技术

背景情况:

三维 (3D) 打印可以实现个性化药物输送和制造灵活性.
层次的材料沉积允许量身定制的固体口服剂型和修改的药物释放配置文件.
在监测和控制关键3D打印步骤时,质量保证仍然是一个挑战.

研究的目的:

审查用于固体口服剂型的3D打印技术的进展.
强调关键的工艺参数和材料属性,以优化印刷.
探索实时分析工具,用于药品添加剂制造中的质量保证.

主要方法:

对药品3D打印技术近期进展的文献综述.
对影响平板电脑性能的关键过程参数和材料属性的分析.
讨论实时分析工具和质量保证方面的考虑.

主要成果:

3D打印可以精确控制平板电脑的几何形状和药物释放.
了解材料属性和工艺参数是优化3D打印的关键.
实时监控对于确保3D打印药品质量至关重要.

结论:

3D打印对个性化制药制造具有重大潜力.
在药物产品的添加剂制造过程中,质量保证至关重要.
需要进一步研究工艺控制和材料科学,才能充分实现3D打印在制药中的潜力.

关键词:

通过3D打印打印3D打印.增材制造增材制造是一种增材制造.新兴技术新兴技术新兴技术过程分析技术过程分析技术过程参数过程参数质量属性是质量的属性.

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