通过使用半连续迷你混合器,在商业输出中加强制药粉末混合的工艺
Maarten Jaspers1, Florian Tegel2, Timo P Roelofs1
1DFE Pharma, Klever Strasse 187, 47568 Goch, Germany.
International journal of pharmaceutics: X
|July 23, 2024
概括
使用半连续迷你混合的工艺强化增强了制药粉末加工. 这种方法可以在商业尺度上以优化的参数实现活性药物成分 (API) 和辅助剂的均混合.
科学领域:
- 制药工程 制药工程
- 化学工程是化学工程的重要组成部分.
- 过程强化 过程强化
背景情况:
- 工艺强化为制药制造提供了小型化的设备,这对于药物开发期间有限的活性药物成分 (API) 可用性至关重要.
- 目前制药粉的工艺强化应用有限,阻碍了扩大效率.
研究的目的:
- 调查半连续小型混合的应用,以加强制药粉末混合的工艺.
- 通过使用小容量混合器,在商业上相关的吞吐量上证明API和辅助剂的均混合.
主要方法:
- 使用半连续迷你混合,混合器容量小于10升.
- 优化了操作参数,包括混合速度,循环时间和混合器填充水平.
- 在一系列操作条件和辅助剂选择中评估混合物的均性.
主要成果:
- 在商业上相关的输出量下实现了活性药物成分 (API) 和辅助剂的均混合.
- 证明混合速度,循环时间和填充水平可以在不牺牲混合性能的情况下进行优化.
- 通过适当的辅助剂选择,在广泛的参数上确认可接受的混合均性.
结论:
- 半连续迷你混合是一种可行的工艺强化策略,用于制药粉末混合.
- 优化的迷你混合吞吐量符合商业连续直接压缩 (CDC) 工艺要求.
- 这种方法通过使用相同的设备,使药物产品开发向商业生产的无过渡更容易.
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