Abstract
The manufacturing and performance of caffeine powders having a form of chimeral agglomerates designed for nasal insufflation are described in this paper. Agglomerates containing caffeine were prepared in a rotating cylindrical container by tumbling primary microparticles prepared by spray drying drug and excipient solutions. Production yield, agglomerate morphology and size, insufflation performance and caffeine dissolution rate were the determined characteristics. Agglomerate formation and behavior during insufflation were favorably influenced by the presence of lecithin in the microparticle formulation. Insufflation through three different devices showed that the agglomerate structure enabled the complete emission of the dose. The agglomerates were broken into fragments of a size appropriate for nasal deposition. Finally, the agglomeration process did not reduce the dissolution rate of caffeine.
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