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在连续制造混合过程中监测混合统一性,用于低剂量配方,使用流采样仪和近红外光谱学

Raúl S Rangel-Gil¹, Juan M Nasrala-Álvarez¹, Rodolfo J Romañach²

¹Department of Chemical Engineering, University of Puerto Rico at Mayaguez, Puerto Rico 00681, United States.

International journal of pharmaceutics

|July 17, 2024

概括

本研究展示了一种流采样仪和近红外 (NIR) 光谱仪,用于实时监测连续制造中的混合物均性. 开发的校准模型准确预测API度,确保口服固体剂型的质量一致.

科学领域:

制药制造业制药制造业制药制造业
过程分析技术 (PAT) 是一种分析技术.
化学工程是化学工程的重要组成部分.

背景情况:

连续制造为口服固体剂型提供了优势,包括通过PAT降低成本和实时控制过程.
实施PAT工具,如流采样和NIR光谱,对于监测连续工艺中的混合均性至关重要.

研究的目的:

开发近红外 (NIR) 校准模型,用于使用流采样器在连续制造过程中监测混合物均性.
评估流采样器和NIR系统的性能和可靠性,以实时确定API度.

主要方法:

用于粉末混合物的料和连续混合器 (2.5-7.5%重/重布洛芬) 的表征.
从流动的粉末中获取NIR光谱数据,使用流量采样器进行混合后的采集.
开发和评估用于API度预测的部分最小平方回归 (PLS-R) 模型.

主要成果:

一个PLS-R模型实现了0.39% w/w的预测误差 (RMSEP) 和0.05% w/w的偏差.
连续混合过程和NIR模型显示,独立运行的日复一日变化很低.
变形图分析表明,与流采样器的采样过程相关的差异很小.

结论:

流采样器与NIR探头相结合,是连续制造中实时API度确定的一个有希望的工具.
这种方法可以有效地监测混合物的一致性,有助于稳健和可控的制药生产.

关键词:

混合的统一性是混合的统一性.化学测量化学测量化学测量连续制造连续制造制造在NIR光谱学中使用NIR光谱.这就是PATAT PATAT.流采样器流采样器

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UV–Vis Spectrometers

UV–Vis Spectrometers

The absorbance of UV and visible (UV–visible) radiations is measured using a UV–visible spectrophotometer. Deuterium lamps, which emit UV radiation, and tungsten lamps, which produce radiation in the visible region, are used as light sources in UV–visible spectrophotometers. A monochromator or prism is used for diffraction grating, i.e., to split the incoming radiation into different wavelengths. A system of slits is used to focus the desired wavelength on the sample cell.