使用剪切细胞方法识别药品粉末流动性分析的强大参数
Tamaki Miyazaki1, Tatsuo Koide1, Ken-Ichi Izutsu2
1Division of Drugs, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki 210-9501, Japan.
Chemical & pharmaceutical bulletin
|October 8, 2025
概括
粉末的流动性对于制药至关重要. 一个新的内在参数,临界状态线斜率 (φCSL),可靠地预测粉末在不同条件下的流动性,帮助质量控制和配方设计.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 化学工程是化学工程的重要组成部分.
背景情况:
- 粉末的流动性对于制药制造至关重要,影响强度和含量统一性.
- 剪切细胞测量为预测粉末行为提供了参数,但通常取决于巩固条件.
- 需要独立于外部因素的内在流动性参数,以更好地控制和制定质量.
研究的目的:
- 为了研究剪切细胞参数和药物粉末的巩固条件之间的关系.
- 为了确定一个强大的,内在的参数,准确地反映粉末的流动性.
- 评估颗粒大小和形状对粉末流动性参数的影响.
主要方法:
- 对具有不同颗粒大小和形状的制药粉进行了恒定体积剪切细胞测量.
- 分析了剪切细胞参数与不同巩固条件 (缩负载) 之间的关系.
- 确定并评估了临界状态线斜率 (φCSL) 作为潜在的内在流动性参数.
主要成果:
- 一个给定的粉末物质的预切点在通过原点的单一直线上对齐,不论缩负荷,颗粒大小或形状如何.
- 临界状态线斜率 (φCSL) 显示出强度和对粒子大小和形状变化的不敏感性.
- 微粉 (<10μm) 的φCSL偏差表明粒子间凝聚力的影响.
结论:
- 临界状态线斜率 (φCSL) 可以作为药品粉末的可靠内在流动性参数.
- φCSL为原材料的质量控制和高效的配方设计提供了强大的措施.
- 微粉 (<10μm) 的粒子间凝聚力变得显著,影响它们的流动性特性.
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