Development of a Mini-Freeze Dryer for Material-Sparing Laboratory Processing with Representative Product Temperature History

作者：Obeidat Wasfy M^*; Sahni Ekneet; Kessler William; Pikal Michael

来源：AAPS PharmSciTech, 2018, 19(2): 599-609.

DOI：10.1208/s12249-017-0871-5

• mini-freeze dryer
• heat transfer coefficients
• sucrose
• mannitol
• LyoStar

The goal of the work described in this publication was to evaluate a new, small, material-sparing freeze dryer, denoted as the "mini-freeze dryer or mini-FD", capable of reproducing the product temperature history of larger freeze dryers, thereby facilitating scale-up. The mini-FD wall temperatures can be controlled to mimic loading procedures and dryer process characteristics of larger dryers. The mini-FD is equipped with a tunable diode laser absorption spectroscopy (TDLAS) water vapor mass flow monitor and with other advanced process analytical technology (PAT) sensors. Drying experiments were performed to demonstrate scalability to larger freeze dryers, including the determination of vial heat transfer coefficients, K (v) . Product temperature histories during K (v) runs were evaluated and compared with those obtained with a commercial laboratory-scale freeze dryer (LyoStar II) for sucrose and mannitol product formulations. When the mini-FD wall temperature was set at the LyoStar II band temperature (- 20A degrees C) to mimic lab dryer edge vials, edge vial drying in the mini-FD possessed an average K (v) within 5% of those obtained during drying in the LyoStar II. When the wall temperature of the mini-FD was set equal to the central vial product temperature, edge vials behaved as center vials, possessing a K (v) value within 5% of those measured in the LyoStar II. During both K (v) runs and complete product freeze drying runs, the temperature-time profiles for the average edge vials and central vial in the mini-FD agreed well with the average edge and average central vials of the LyoStar II.

• 出版日期2018-2