Process Understanding in Freeze-Drying Cycle Development: Applications for Through-Vial Impedance Spectroscopy (TVIS) in Mini-pilot Studies

作者：Smith Geoff^*; Arshad Muhammad Sohail; Polygalov Eugene; Ermolina Irina; McCoy Timothy R; Matejtschuk Paul

来源：Journal of Pharmaceutical Innovation, 2017, 12(1): 26-40.

DOI：10.1007/s12247-016-9266-5

• Freeze drying
• In-line process control
• PAT
• QbD
• Critical process parameters

Here, we present a new approach for process understanding in freeze-drying cycle development, which uses a through-vial impedance measurement.
The technique has been used to characterise a broad range of features of the process, including, ice onset times, the completion of ice solidification, the glass transition and the structural relaxation of the amorphous solid, a surrogate for primary drying rate and the primary drying end point.
The on-going development of this technology may see the application with microtitre plate technologies for formulation screening (microscale down) and for scale-up into production by using a non-contact probes for monitoring problematic regions within the dryer.

• 出版日期2017-3
• 单位中国食品药品检定研究院