Formulation factors affecting foam properties during vacuum foam-drying.

Area of Science:

• Biotechnology
• Pharmaceutical Sciences
• Materials Science

Background:

• Protein stability during drying is crucial for drug formulation.
• Vacuum foam-drying is a promising technique for preserving protein structure and function.
• Understanding formulation impacts is key to optimizing this process.

Purpose of the Study:

• To investigate formulation parameter effects on vacuum foam-drying of proteins.
• To assess the influence of matrix formers and surfactants on foam structure and protein stability.
• To evaluate the physical properties and protein drug stability during and after drying.

Main Methods:

• Utilized recombinant human bile salt-stimulated lipase as a model protein drug.
• Employed sucrose and trehalose as matrix formers, assessing physical properties (residual water, glass transition temperature, crystalline state).
• Investigated surfactant head group impact on foamability and surface coverage, keeping alkyl chain length constant.

Main Results:

• Achieved a dry, solid foam with high foam overrun (up to 2600%) using the model protein.
• Estimated foam wall thickness between 20-50 µm.
• Observed distinct differences between sucrose and trehalose as matrix formers.
• Confirmed no loss of lipase activity post-drying and rehydration, even with surface coverage.

Conclusions:

• Formulation parameters significantly influence vacuum foam-drying outcomes for proteins.
• Disaccharides are effective matrix formers for stabilizing protein drugs during foam-drying.
• The developed vacuum foam-drying method preserves protein activity, showing potential for pharmaceutical applications.