Abstract
The tert-butanol (TBA)-water system is studied in relation to increasing the efficiency of obtaining pharmaceutical powders by freeze-drying. Trehalose was used as a model target product. We report the X-ray diffraction and thermal analysis data which add surprising new information to the phase diagram of this previously repeatedly studied system. The freezing protocol has a strong impact on the specific surface area of the trehalose freeze-dried cakes and on the primary drying time. This is related to a discrepancy between the kinetic and thermodynamic stabilities of several TBA hydrates: di-hydrate (H1), heptahydrate (H2), and decahydrate (H3).
Original language | English |
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Pages (from-to) | 4262-4265 |
Number of pages | 4 |
Journal | Chemical Communications |
Volume | 55 |
Issue number | 29 |
DOIs | |
Publication status | Published - 17 Apr 2019 |
Keywords
- Drug Stability
- Freeze Drying
- Kinetics
- Powders
- Thermodynamics
- tert-Butyl Alcohol/chemistry
- COSOLVENT SYSTEMS
- DESIGN
- BUTYL ALCOHOL
- ICE NUCLEATION
- LYOPHILIZATION
- QUALITY ATTRIBUTES
- PROCESS PERFORMANCE
- PHASE-DIAGRAM