Carrier-based dry powder formulation for nasal delivery of vaccines utilizing BSA as model drug

• Simple formulation of protein-carrying chitosan microparticles
• Characterization of dispersion from nasal device by laser diffraction
• Evaluation of nasal deposition utilizing a nasal cast model
• Optimization of nasal deposition by carrier-based formulation
• Best device dispersion and almost exclusive nasal deposition from mannitol carrier blend

Dry powder formulations for nasal vaccine delivery offer versatile advantages compared to liquid formulations, such as increased storage stability and simplified administration. The objective of the present study was the development of a dry powder nasal vaccine formulation making use of antigen-loaded chitosan microparticles. Special emphasis was put on the development and characterization of a formulation which can realistically be used in humans by means of a nasal dry powder sprayer. Microparticles of chitosan with bovine serum albumin as model antigen were produced by spray drying and showed a particle size of about 3 μm. In order to improve nasal deposition and dispersibility, powder blends with low separation tendency were prepared. A range of sugar alcohols (mannitol, sorbitol, maltitol) was evaluated as carriers. Among the tested carriers, blends with spray-granulated mannitol showed the most adequate deposition profile without simulated nasal inspiration and were very well dispersible by a nasal dry powder device. In conclusion, this study illustrates a simple and effective strategy for the development of a dry powder vaccine formulation for nasal administration.

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