Temperature Measurement by Sublimation Rate as a Process Analytical Technology Tool in Lyophilization

Hidenori Kawasaki, Toshinori Shimanouchi, Hiroyuki Sawada, Hiroshi Hosomi, Yuta Hamabe, Yukitaka Kimura

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Product temperature (T b ) and drying time constitute critical material attributes and process parameters in the lyophilization process and especially during the primary drying stage. In the study, we performed a temperature measurement by the sublimation rate (TMbySR) to monitor the T b value and determine the end point of primary drying. First, the water vapor transfer resistance coefficient through the main pipe from the chamber to the condenser (C r ) was estimated via the water sublimation test. The use of C r value made it possible to obtain the time course of T b from the measurement of pressure at the drying chamber and at the condenser. Second, a Flomoxef sodium bulk solution was lyophilized by using the TMbySR system. The outcome was satisfactory when compared with that obtained via conventional sensors. The same was applicable for the determination of the end point of primary drying. A laboratory-scale application of the TMbySR system was evidenced via the experiment using 220-, 440-, and 660-vial scales of lyophilization. The outcome was not dependent on the loading amount. Thus, the results confirmed that the TMbySR system is a promising tool in laboratory scale.

Original languageEnglish
JournalJournal of Pharmaceutical Sciences
DOIs
Publication statusPublished - Jan 1 2019

Keywords

  • diffusion
  • drying
  • freeze-drying
  • lyophilization
  • process analytical technology (PAT)

ASJC Scopus subject areas

  • Pharmaceutical Science

Fingerprint Dive into the research topics of 'Temperature Measurement by Sublimation Rate as a Process Analytical Technology Tool in Lyophilization'. Together they form a unique fingerprint.

  • Cite this