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使用真空鼓使用纯 API 填充的自动化过程开发.

Isabel Gallego1, Thomas Brinz2, Martin Sommerfeld3

  • 1Syntegon Technology GmbH, Stuttgarter Str. 130, 71332 Waiblingen, Germany; Multiphase Flow Systems (MPS), Institute Process Engineering, Otto-von-Guericke-University, Universitätsplatz 2, 39106 Magdeburg, Germany.

International journal of pharmaceutics
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概括

自动化过程开发 (APD) 优化了使用真空鼓填充器的纯活性药物成分 (API) 填充. 粉末制备参数,特别是3线机,显著提高了囊填充精度和减少了变化.

关键词:
自动化过程开发过程的开发.囊的填充方式设计实验的设计.帕拉西他摩尔是一种可怕的药物.纯粹的API 纯粹的API真空鼓是一个真空鼓.

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科学领域:

  • 制药制造业 制药制造业 制药制造业
  • 工艺工程是过程工程.
  • 药物开发 药物开发

背景情况:

  • 纯活性药物成分 (API) 的剂量对于药物开发的效率至关重要,减少了消耗和开发时间.
  • 真空鼓填充器是微量注射的精确仪器,通常用于干粉吸入 (DPI),但它们适用于纯 API 填充需要研究.
  • 自动化过程开发 (APD) 将实验设计 (DoE) 与自动执行相结合,以实现高效的过程优化.

研究的目的:

  • 评估真空鼓填充器对于纯API囊填充的适用性.
  • 用APD方法分析各种工艺参数对填充重量和相对标准偏差 (RSD) 的影响.
  • 确定优化纯API填充流程的关键参数.

主要方法:

  • 使用真空鼓填充系统研究了纯的API填充.
  • 采用自动化过程开发 (APD) 方法,整合实验设计 (DoE).
  • 测试了两种形式的青:粉末和微缩,评估填充重量和RSD.

主要成果:

  • 与室内粉末制备相关的工艺参数,而不是真空或压力,对填充精度的影响最大.
  • 三线机始终改善了填充重量,并减少了粉末和微缩青的RSD.
  • APD成功地确定了最小化RSD的参数,强调了需要量身定制的优化.

结论:

  • 在优化真空鼓填充纯API时,APD方法是有效的.
  • 粉末制备参数,特别是使用3线机,对于实现精确和一致的囊填充至关重要.
  • 需要进一步的研究,以优化微化青的粉末制备,以实现一致的填充.