三种不同的干涂设备的比较,以提高精细的API散装性能:设备强度和处理参数的影响
Siddharth Tripathi1, Anna Owasit1, Elzar Adham1
1New Jersey Center for Engineered Particulates, New Jersey Institute of Technology, Newark, NJ 07102, USA.
International journal of pharmaceutics
|August 31, 2025
概括
用二氧化干涂层有效地降低了粉末凝聚力. 高强度振动混合器 (HIVM) 通过确保更好的散,提供了比V混合器或复合剂更好的效果,尤其对于凝聚性粉末.
科学领域:
- 制药工程
- 材料科学
- 粉末技术
背景情况:
- 粉末凝聚力对制药制造过程产生重大影响.
- 用二氧化干涂层是一种提高粉末流动性的方法.
- 需要对不同加工强度进行评估.
研究的目的:
- 评估低强度和中强度粉末混合剂 (V-blender,comil) 对凝聚性活性药物 (API) 的干涂层的有效性.
- 将这些设备与高强度振动混合器 (HIVM) 进行比较,以提高流量性能.
- 扩展粒子接触模型以考虑低强度混合器中的二氧化聚合物.
主要方法:
- 使用V-blender,comil和HIVM对三种凝聚性API涂上两种类型 (A200,R972P).
- 使用流量函数系数 (FFC) 和条件散装密度 (CBD) 评估粉末的流动性.
- 扫描电子显微镜 (SEM) 用于评估API表面上的散和聚合.
主要成果:
- 在V-blender中,FFC和CBD的改善很小,通过SEM观察到显著的聚物.
- 虽然Comil的效果有所改善,但仍有一些聚物.
- 在FFC和CBD中,HIVM由于 dispersion优越而取得了最实质性的增强.
结论:
- 由于过度的聚,V混合器不适合干涂.
- 具有更细的幕的COMIL为改善粉末流动性提供了可行的连续制造选项.
- 即使在较低的强度下,HIVM也可以达到与其他设备相比较的性能,作为潜在的查工具.
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