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publicationDate 2022-04-20-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber EP-3984527-A1
titleOfInvention Nano-in-micro encapsulated sirna dry powder, method for producing the same and use of a powder formulation as a pharmaceutical dosage form, in particular for pulmonary delivery
abstract Method for producing high yield nano-in-micro (NIM) encapsulated bioactive siRNA dry powder comprising the steps of:- providing an aqueous suspension comprising polyplexes, in particular polyelectrolyte complexes, formed from at least a polyamine, and/or polyamide and/or polyester and siRNA, wherein the polyplexes are provided with and/or encapsulated into water soluble excipients, in particular highly purified water and/or sugar alcohol and/or sugar;- spray drying the aqueous suspension using a spray drying apparatus, preferably a Büchi B-290, by feeding the aqueous suspension to a spray drying atomizing nozzle and subjecting the atomized droplets to a heated gas stream of a carrier gas, preferably dried and cleaned air, in particular through a multicomponent atomizing nozzle for the suspension and an atomizing gas;- collecting a spray dried powder in an accumulation means of the spray drying apparatuscharacterized in thatthe temperature in the vicinity of an outlet opening of the spray drying apparatus, in particular an outlet opening connecting a spray drying chamber with the accumulation means, during feeding of the aqueous suspension to the nozzle is controlled by temperature controlling means to be limited to an upper threshold temperature which is equal to or below a melting temperature of the respective naked siRNA.
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