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使用密度变化来监测与铁酸混合的特拉赫兹时域光谱法

Moritz Anuschek¹, Thea Nilsson², Anne Linnet Skelbæk-Lorenzen²

¹Department of Pharmacy University of Copenhagen Copenhagen Denmark; Novo Nordisk A/S ET Oral Product Development Måløv Denmark.

International journal of pharmaceutics

|February 2, 2025

概括

太赫兹时域光谱 (THz-TDS) 非侵入性地监测酸 (MgSt) 混合物中剪切诱导的密度. 这项技术通过评估制药配方中的总剪切暴露来改善平板电脑抗拉强度的预测.

科学领域:

制药科学制药科学
材料科学材料科学材料科学
频谱学是一种光谱学.

背景情况:

石酸 (MgSt) 是一种常见的滑剂,在固体口服剂型中,对于药片喷射至关重要.
MgSt度和剪切暴露显著影响平板电脑的性能,可能导致过度滑.
在加工过程中监测混合物变化对于稳定的药片质量至关重要.

研究的目的:

研究太赫兹时域光谱 (THz-TDS) 的应用,用于监测微晶纤维素和MgSt混合物的剪切诱导密度.
评估THz-TDS对不同的MgSt度 (0.3-1.0%) 和混合时间的敏感性.
将THz-TDS混合监测集成到一个统一的模型中,用于预测平板电脑的抗拉强度.

主要方法:

微晶纤维素的粉末混合物具有不同的MgSt度,在扩散混合机中经过不同的混合时间 (5-20分钟).
在传输模式下,THz-TDS测量直接通过混合容器进行.
分析了特拉赫兹频率的折射率,以量化混合物密度.

主要成果:

THz-TDS成功地解决了混合物密度,将折射率变化与增加的混合时间和剪切暴露相关联.
THz-TDS混合密度测量作为总剪切暴露的可靠替代品.
将THz-TDS混合数据集成到预测拉伸强度的模型中,可以将根平均平方误差降低40%以上.

结论:

THz-TDS是一种有前途的非侵入性工艺分析技术 (PAT),用于监测滑粉末混合物的剪切效应.
这种方法可以更好地控制混合物特性,并提高最终平板质量的预测,特别是拉力强度.
该研究证明了THz-TDS在制药制造中的实时过程监测和质量控制方面的实用性.

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