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Temperature Measurement by Sublimation Rate as a Process Analytical Technology Tool in Lyophilization
Hidenori Kawasaki1, Toshinori Shimanouchi2, Hiroyuki Sawada3
1Graduate School of Environmental and Life Science, Okayama University, 3-1-1, Tsuhima-naka, Kitaku, Okayama, Japan; Formulation R&D Center, CMC R&D Division, Shionogi & Co., Ltd., 1-3, Kuise, Amagasaki, Hyogo, Japan.
Journal of Pharmaceutical Sciences
|March 3, 2019
Summary
A new temperature measurement by sublimation rate (TMbySR) system accurately monitors product temperature during lyophilization. This method effectively determines primary drying endpoints, offering a promising tool for laboratory-scale freeze-drying processes.
Area of Science:
- Pharmaceutical Sciences
- Chemical Engineering
- Materials Science
Background:
- Product temperature and drying time are critical parameters in lyophilization, particularly during primary drying.
- Accurate monitoring of product temperature and precise determination of the primary drying endpoint are essential for successful lyophilization.
- Conventional sensors for monitoring lyophilization can be invasive or provide limited real-time data.
Purpose of the Study:
- To develop and validate a novel temperature measurement by sublimation rate (TMbySR) system for monitoring product temperature during primary drying in lyophilization.
- To assess the capability of the TMbySR system in determining the endpoint of primary drying.
- To evaluate the scalability and reliability of the TMbySR system in laboratory-scale lyophilization.
Main Methods:
- Estimated the water vapor transfer resistance coefficient (Cr) through the sublimation test.
- Utilized the Cr value to calculate the time course of product temperature (Tb) from chamber and condenser pressure measurements.
- Applied the TMbySR system to lyophilize a Flomoxef sodium bulk solution and compared results with conventional sensors.
Main Results:
- The TMbySR system successfully monitored product temperature and determined the primary drying endpoint for Flomoxef sodium lyophilization.
- Results obtained using TMbySR were comparable to those from conventional sensors.
- The system's performance was consistent across different laboratory-scale lyophilization batch sizes (220, 440, and 660 vials), independent of loading amount.
Conclusions:
- The TMbySR system is a viable and promising tool for real-time product temperature monitoring during lyophilization.
- This method provides accurate determination of the primary drying endpoint.
- The TMbySR system demonstrates scalability and reliability for laboratory applications in freeze-drying processes.
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