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使用太赫兹时域光谱对硝苯地平加速结晶过程进行自动化原位监测。

Automated in-situ monitoring of accelerated crystallization processes of nifedipine using terahertz time-domain spectroscopy.

作者信息

Heidrich Lara, Wiener Julian, Castro-Camus Enrique, Koch Martin, Ornik Jan

机构信息

Department of Physics and Material Sciences Center, Philipps-Universität Marburg, Renthof 5, 35032, Marburg, Germany.

Centro de Investigaciones en Optica A.C, Loma del Bosque 115, Lomas del Campestre, Leon, Guanajuato, 37150, Mexico.

出版信息

Sci Rep. 2024 Dec 2;14(1):29928. doi: 10.1038/s41598-024-81316-y.

DOI:10.1038/s41598-024-81316-y
PMID:39622901
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11611916/
Abstract

We developed and tested an automated measurement platform which can fit multiple samples for their investigation in transmission mode using terahertz time-domain spectroscopy. The temperature inside the platform can be varied to simulate different storage conditions of the samples, in our case, pharmaceuticals. As a proof-of-concept, the setup was successfully tested to monitor the crystallization process of amorphous nifedipine, as a model drug, at 24 °C, 30 °C and 35 °C for over 144 h. To the best of our knowledge, this is the first study to follow the crystallization of nifedipine with quasi-continuous measurements over a time frame of several days. The influence of the storage temperature on the crystallization rate was monitored including the appearance of polymorphic intermediate states of nifedipine throughout the process. The platform developed in combination with terahertz time-domain spectroscopy is a helpful tool for deepening the understanding of the crystallization behavior of amorphous and polymorphic materials and can be, for example, of great importance for the development of novel amorphous pharmaceutical formulations.

摘要

我们开发并测试了一个自动化测量平台，该平台能够容纳多个样品，以便使用太赫兹时域光谱在透射模式下对其进行研究。平台内部的温度可以变化，以模拟样品（在我们的研究中为药品）的不同储存条件。作为概念验证，该装置成功地用于监测作为模型药物的无定形硝苯地平在24°C、30°C和35°C下超过144小时的结晶过程。据我们所知，这是第一项在数天的时间范围内通过准连续测量跟踪硝苯地平结晶过程的研究。监测了储存温度对结晶速率的影响，包括整个过程中硝苯地平多晶型中间态的出现。结合太赫兹时域光谱开发的该平台是加深对无定形和多晶型材料结晶行为理解的有用工具，例如，对于新型无定形药物制剂的开发可能具有重要意义。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2a77/11611916/660cebcad6cf/41598_2024_81316_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2a77/11611916/82832ed2f289/41598_2024_81316_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2a77/11611916/8c57296634db/41598_2024_81316_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2a77/11611916/160fbd4b4d21/41598_2024_81316_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2a77/11611916/4604dc28c325/41598_2024_81316_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2a77/11611916/41b57893776c/41598_2024_81316_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2a77/11611916/660cebcad6cf/41598_2024_81316_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2a77/11611916/82832ed2f289/41598_2024_81316_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2a77/11611916/8c57296634db/41598_2024_81316_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2a77/11611916/160fbd4b4d21/41598_2024_81316_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2a77/11611916/4604dc28c325/41598_2024_81316_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2a77/11611916/41b57893776c/41598_2024_81316_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2a77/11611916/660cebcad6cf/41598_2024_81316_Fig6_HTML.jpg

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3
Real-time in situ X-ray micro-computed tomography study of the effect of impurities on the crystallization of amorphous nifedipine.
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J Pharm Biomed Anal. 2023 Mar 20;226:115248. doi: 10.1016/j.jpba.2023.115248. Epub 2023 Jan 12.
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Cryst Growth Des. 2022 Jun 1;22(6):3961-3972. doi: 10.1021/acs.cgd.2c00352. Epub 2022 May 20.
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Detecting Crystallinity Using Terahertz Spectroscopy in 3D Printed Amorphous Solid Dispersions.利用太赫兹光谱技术在 3D 打印无定形固体分散体中检测结晶度。
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