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PROCÉDÉ DE PRÉPARATION D'UNE FORMULATION DE POUDRE SÈCHE COMPRENANT UN ANTICHOLINERGIQUE, UN CORTICOSTÉROÏDE ET UN BÊTA-ADRÉNERGIQUE
专利权人:
Chiesi Farmaceutici S.p.A.
发明人:
申请号:
EP18725151.7
公开号:
EP3621589A1
申请日:
2018.05.09
申请国别(地区):
EP
年份:
2020
代理人:
摘要:
The invention relates to a process for preparing a powder formulation for inhalation for use in a dry powder inhaler, said powder formulation comprising: (A) a carrier, comprising : (a) a fraction of coarse particles of a physiologically acceptable carrier having a particle size of at least 60 micron; and optionally (b) a fraction of fine particles comprising a physiologically acceptable excipient, wherein at least 90% of all said fine particles has a volume diameter lower than 15 micron, (B) micronized particles of glycopyrronium bromide, an inhaled corticosteroid (ICS), and optionally a long-acting O2 -agonist (LABA), as active ingredients, wherein said process comprises: (i) preparing by co-milling microparticles consisting of glycopyrronium bromide and a first part of the ICS in a ratio ranging from 80:20 to 70:30 by weight, wherein the volume diameter of said microparticles is not higher than 15 micron; (ii) mixing the carrier, the remaining part of said ICS, and optionally the long-acting O2 -agonist, to obtain a first mixture; and (iii) adding the co-milled microparticles obtained in step (i) to the first mixture obtained in step (ii), to obtain a second, final, mixture.
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