Abstract:
:Product temperature (Tb) 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 Tb 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 (Cr) was estimated via the water sublimation test. The use of Cr value made it possible to obtain the time course of Tb 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.
journal_name
J Pharm Scijournal_title
Journal of pharmaceutical sciencesauthors
Kawasaki H,Shimanouchi T,Sawada H,Hosomi H,Hamabe Y,Kimura Ydoi
10.1016/j.xphs.2019.02.015subject
Has Abstractpub_date
2019-07-01 00:00:00pages
2305-2314issue
7eissn
0022-3549issn
1520-6017pii
S0022-3549(19)30131-5journal_volume
108pub_type
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