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通过真空压缩成型加速3D打印药物开发.

Anna Kirstine Jørgensen1, Ye Chan Oh1, Hanxiang Li1

  • 1Department of Pharmaceutics, UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK.

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概括
此摘要是机器生成的。

真空压缩成型 (VCM) 允许小规模生产精确的3D打印药物纤维和个性化口服药片的非破坏性剂量验证. 这种方法可以加速开发可持续的,针对患者量身定制的药物.

关键词:
化学测量用于药物定量化.基于挤出的3D打印技术化丝制造 添加剂制造 加工制造制药化沉积模型的建模.过程分析技术和质量控制.可持续的个性化成型印刷品真空压缩成型真空压缩成型

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科学领域:

  • 制药技术 制药技术 制药技术
  • 材料科学 材料科学 材料科学
  • 药物输送系统 药物输送系统

背景情况:

  • 三维打印 (3DP) 提供了个性化药物治疗的可能性,但在生产一致的药物加载细丝 (药物墨水) 用于化沉积建模 (FDM) 方面存在挑战.
  • 对于3DP片的非破坏性质量控制,需要校准模型,这种校准模型可能受到不同药物度的配方可加工性问题所阻碍.

研究的目的:

  • 引入真空压缩成型 (VCM) 作为小规模制药油墨生产和3DP个性化口服片中的非破坏性剂量验证的新方法.
  • 在近红外 (NIR) 光谱分析中证明VCM生产的圆柱形物体作为3DP平板电脑的替代品的实用性.

主要方法:

  • 用真空压缩成型 (VCM) 来创建尺寸精确的药品墨水用于3DP.
  • 含有不同剂量的他莫西芬的药片使用FDM3D打印.
  • 使用VCM样本校准的近红外 (NIR) 光谱法用于3DP片中的非破坏性剂量确定.

主要成果:

  • 达到了准确的3D打印塔莫西芬片 (10,20,30毫克),在药典限制内保持一致的质量和药物含量.
  • 药物释放概况在不同尺寸的片中是一致的.
  • 与VCM替代品校准的NIR模型准确地预测了3DP片中的他莫西芬剂量,显示出极好的线性 (R2 = 0.997) 和稳定性 (R2cv = 0.996).

结论:

  • VCM是一种生产精确药品墨水的可行方法,也是3DP中开发非破坏性NIR质量控制方法的有效替代品.
  • 协同使用VCM和FDM打印加速了个性化口服药物的开发,提高了材料的可持续性.