一个评估六种技术,以测量由滚筒紧缩生产的带的多孔性
Yiwang Guo1, Lizbeth Martinez2, Arnesh Palanisamy2
1Department of pharmaceutics, College of pharmacy, University of Minnesota, 308 Harvard St. S.E. Minneapolis, MN 55455, USA.
International journal of pharmaceutics
|October 23, 2024
概括
六种孔隙度测量技术进行了对比,用于滚筒紧缩. 激光三角测试显示微晶纤维素带的精度和可重复性很好,有助于过程优化.
科学领域:
- 制药工程 制药工程
- 材料科学 材料科学 材料科学
- 过程分析技术 过程分析技术
背景情况:
- 丝带的多孔性是滚筒紧缩的关键质量属性.
- 准确的孔径测量对于过程控制和优化至关重要.
- 有各种各样的技术存在,但它们适用于带孔隙性评估的适用性各不相同.
研究的目的:
- 为了比较六种不同的孔径测量技术的准确性和适用性.
- 评估微晶纤维素 (MCC) 紧材料和通过滚筒紧生产的带的方法.
- 提供关于选择适当方法监测带孔性的指导.
主要方法:
- 评估了六种技术:口径,X射线微观图 (μCT),近红外光谱 (NIR),激光三角测量 (激光),入孔测量 (MIP) 和GeoPyc.
- 测量是在不同压力 (8-130MPa) 压缩的矩形MCC丝带上和来自滚筒压缩机的MCC丝带上进行的.
- 样品的多孔度范围为0.09 - 0.52.
主要成果:
- 激光三角测量证明了对肋带测量的良好准确性和可重复性.
- 在较低的多孔度 (<0.2) 中,μCT的准确性更高,而在较高的多孔度 (>0.4) 中,MIP的精度更高.
- 对于线内监测,NIR是快速的,但对样品表面特征敏感;校准器不适用于带.
结论:
- 没有任何一种方法是普遍优越的;选择取决于孔隙范围和应用 (线上与线下).
- 激光三角测量是一种有前途的技术,用于准确和可重复的带孔隙度评估.
- 了解方法的局限性有助于选择最好的方法来开发滚筒压缩工艺.
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