Near Infrared and Frequency Modulated Spectroscopy as Non-Invasive Methods for Moisture Assessment of Freeze-Dried Biologics
| Autor: | Richard P. Affleck, Nikoletta Adler, Katie M. Lowerre, Dikshitkumar Khamar, Mark X. Yang, Sean Cullen, Timothy R. McCoy |
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| Rok vydání: | 2021 |
| Předmět: |
Biological Products
Sucrose Spectroscopy Near-Infrared Chromatography Materials science Moisture Process analytical technology Non invasive Near-infrared spectroscopy Water Pharmaceutical Science Residual moisture 02 engineering and technology 021001 nanoscience & nanotechnology 030226 pharmacology & pharmacy 03 medical and health sciences Freeze-drying Freeze Drying 0302 clinical medicine Approximation error 0210 nano-technology Spectroscopy |
| Zdroj: | Journal of Pharmaceutical Sciences. 110:3395-3402 |
| ISSN: | 0022-3549 |
| DOI: | 10.1016/j.xphs.2021.06.016 |
| Popis: | Near-infrared (NIR) and frequency modulated spectroscopy (FMS) were employed, for non-invasive moisture determination of a lyophilized biologic drug product (DP). Development of NIR and FMS provides a rapid non-invasive means of residual moisture measurement, and would be beneficial compared with traditional time consuming, product destructive methods such as Karl Fischer (KF). A model therapeutic enzyme in a sucrose-based formulation was employed for proof of concept studies, and NIR and FMS methods were compared side by side for residual moisture analysis. Moisture models were created using lyophilized vials and comparisons were made between the methods using different moisture preparation approaches:1) direct water droplet addition to the vial headspace, 2) use of elevated temperature (80°C), and 3) using various levels of moisture in stoppers generated during the washing and drying procedures, then lyophilizing using the stoppers and placing the sealed vials on stability. The results for direct water addition gave an average percent error for residual moisture of 5.7% for NIR and 9.4% for FMS when compared to KF. The elevated temperature method resulted in an average percent error for residual moisture of 54% for NIR and 43% for FMS compared to KF. The stopper moisture stability study, for FMS, provided an average percent error for residual moisture of 31% compared to KF. The error was greater for the elevated temperature and stopper methods, due to the low moisture values, which resulted in greater error. At this lower range of moisture ( |
| Databáze: | OpenAIRE |
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