在完全集成的连续粉末到颗粒线中,基于拉曼的在线无水含量定量

IF 5.2 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Petra Záhonyi, Dániel Fekete, Erzsébet Moharos, Zsombor Kristóf Nagy, Edina Szabó
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引用次数: 0

摘要

本研究是基于一个完全集成的连续双螺杆湿造粒生产线,从粉料到干燥颗粒。它的关键步骤之一是连续干燥,这可以影响晶体的形式,从而影响颗粒的质量。因此,本研究的主要目的是开发一种拉曼光谱方法,用于在不同干燥温度下在线实时监测连续过程中的晶型转变。葡萄糖被用作模型材料,因为它作为一种活性药物成分和赋形剂具有很高的工业相关性。对颗粒结晶形态的实时监测表明,在较高温度(100℃和120℃)下干燥会导致初始α-d-葡萄糖一水合物的部分脱水。拉曼光谱结合多变量数据分析证明适合实时定量无水含量,均方根误差为3.3% w/w。结果通过各种常规的离线分析技术进行了验证,进一步证实了模型和检测到的无水含量的可靠性。这项工作显示了拉曼光谱在完全集成的连续粉末到颗粒线中在线和实时无水含量监测的高预测性能,增强了对工艺的理解,并确保了高和一致的产品质量。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

In-line Raman-based quantification of the anhydrous content in a fully integrated continuous powder-to-granule line

In-line Raman-based quantification of the anhydrous content in a fully integrated continuous powder-to-granule line
This research is based on a fully integrated continuous twin-screw wet granulation line from powder feeding to dried granules. One of its crucial steps is continuous drying, which can influence the crystal form and thus, the quality of the granules. Therefore, the main objective of this research was to develop a Raman spectroscopic method for monitoring the crystal form transition in-line and real-time during the continuous process while applying different drying temperatures. Dextrose was used as a model material due to its high industrial relevance as an active pharmaceutical ingredient and excipient. The real-time monitoring of the granules’ crystal form demonstrated that drying at higher temperatures (100 °C and 120 °C) resulted in partial dehydration of the initial α-d-glucose monohydrate. Raman spectroscopy combined with multivariate data analysis proved suitable for real-time quantification of anhydrous content with a root mean square error of 3.3 % w/w. The results were validated by various conventional, off-line analytical techniques, which further confirmed the reliability of the model and the detected anhydrous content. This work shows the high predictive performance of Raman spectroscopy for in-line and real-time anhydrous content monitoring in a fully integrated continuous powder-to-granule line, enhancing process understanding and ensuring high and consistent product quality.
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来源期刊
CiteScore
10.70
自引率
8.60%
发文量
951
审稿时长
72 days
期刊介绍: The International Journal of Pharmaceutics is the third most cited journal in the "Pharmacy & Pharmacology" category out of 366 journals, being the true home for pharmaceutical scientists concerned with the physical, chemical and biological properties of devices and delivery systems for drugs, vaccines and biologicals, including their design, manufacture and evaluation. This includes evaluation of the properties of drugs, excipients such as surfactants and polymers and novel materials. The journal has special sections on pharmaceutical nanotechnology and personalized medicines, and publishes research papers, reviews, commentaries and letters to the editor as well as special issues.
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