SPRAY-FREEZE DRYING OF POLYELECTROLYTE NANOPARTICLES CONTAINING THE PROTEIN DRUG

摘要

The present invention relates to a process for spray-freeze-drying (SFD) a dispersion of polyelectrolyte complex (PEC) nanoparticles loaded with a protein drug, which yields a powdered product with adequate flowability properties that may readily be processed further into solid dosage forms such as tablets or capsules. The mean particle size of PEC nanoparticles obtained after redispersion of SFD powder or pharmaceutical compositions made from said powder in water is preserved in the nanometer range (< 1000 nm), and so is the protein biological activity.