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Related Experiment Video

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Formulations for Freeze-drying of Bacteria and Their Influence on Cell Survival

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Humidity induced collapse in freeze dried cakes: A direct visualization study using DVS.

Arnold Duralliu¹, Paul Matejtschuk², Daryl R Williams¹

¹Surfaces and Particle Engineering Laboratory, Department of Chemical Engineering, Imperial College London, SW7 2AZ, United Kingdom.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V

|February 7, 2018

Summary

Maintaining low moisture content is crucial for freeze-dried (FD) product stability. This study identifies critical humidity points for collapse and phase transitions, enabling improved formulation and storage of FD cakes.

Keywords:

Collapse Dynamic vapor sorption Freeze-drying Moisture Sorption Visualization

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Published on: July 5, 2017

Area of Science:

Pharmaceutical Sciences
Materials Science
Physical Chemistry

Background:

Low moisture content is vital for long-term stability in freeze-dried (FD) cakes.
Higher moisture levels can cause cake collapse, degradation, and loss of biological potency.

Purpose of the Study:

To determine the onset humidity points for collapse (RHcp), crystallization (RHc), and glass transition (RHg) in FD cakes.
To investigate moisture sorption behavior and its relation to morphological phase transitions.
To create stability maps for FD formulations as a function of relative humidity (%RH) and temperature.

Main Methods:

Utilized Dynamic Vapour Sorption (DVS) instrument with gravimetric data and video imaging.
Determined RHcp, RHc, and RHg at various temperatures (10, 25, and 40°C).
Analyzed three formulations: sucrose, trehalose, and an influenza antigen formulation with sucrose.

Main Results:

Established critical humidity and temperature thresholds for collapse and phase transitions for tested formulations.
Provided direct visualization of collapse behavior, enabling standardization of FD cake analysis.
Developed stability maps correlating %RH, temperature, and formulation type.

Conclusions:

The developed methods allow for routine and standardized determination of FD cake collapse behavior.
Stability maps facilitate the formulation of FD products with enhanced stability and storage performance.
Understanding moisture sorption is key to preventing degradation and maintaining potency in freeze-dried products.