Smith G (2022) Oxford Global Formulation & Delivery May 5_6 with notes.pptx (112.39 MB)
Download fileSmith, G. (2022) Freeze-drying for the stabilization of drug products: Recent developments in process analytical technologies. Podium presentation at Oxford Global Formulation and Delivery UK. London 5-6 May
Cite as
Smith, G. (2022) Freeze-drying for the stabilization of drug products: Recent developments in process analytical technologies. Podium presentation at Oxford Global Formulation and Delivery UK. London 5-6 May 2022
Topics covered by this talk:
- Why freeze-dry?
- Process analytical technologies for freeze-drying (single vial and batch techniques)
- Introduction to through-via impedance spectroscopy (TVIS)
- Case study : Primary drying end point
- Separation between sublimation (primary drying) and diffusive desorption (secondary drying)
- The impact of phase states (crystalline vs amorphous) on the end point profile
Conclusion: Existing, vapour and temperature sensing PATs cannot differentiate between source of water vapour (ice or adsorbed water).TVIS provides identification of true sublimation (primary drying) end point