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PROCESS FOR PREPARING A POWDER FORMULATION FOR INHALATION FOR USE IN A DRY POWDER INHALER
专利权人:
CHIESI FARMACEUTICI S.P.A.
发明人:
ALESSANDRO CAVECCHI,CRISTIANA MERUSI,FAUSTO PIVETTI,FRANCESCA SCHIARETTI
申请号:
BR112019023378
公开号:
BR112019023378A2
申请日:
2018.05.09
申请国别(地区):
BR
年份:
2020
代理人:
摘要:
the present invention relates to a process for preparing a powder formulation for inhalation for use in a dry powder inhaler, said powder comprising: (a) a carrier comprising: (a) 80 to 95 percent by weight, based on in the total weight of said carrier, of coarse particles of a physiologically acceptable excipient having an average particle size of at least 175 microns; and (b) 19.6 to 4.9 percent by weight, based on the total weight of said carrier, of micronized particles of a physiologically acceptable excipient, and (c) 0.1 to 0.4 percent by weight, based on the total weight of said carrier, of a fatty acid salt; and (b) micronized particles of glycopyrronium bromide, a long-acting o2 agonist (lab) and an inhaled corticosteroid (ics), as active ingredients, said process comprising: (i) preparation by co-grinding of microparticles consisting of glycopyrronium and a first part of an ics in a proportion ranging from 80:20 to 70:30 by weight, where the volumetric diameter of said microparticles is not more than 15 microns; (ii) mixing of the coarse particles of a physiologically acceptable excipient, the salt of a fatty acid, a first part of said micronized particles of a physiologically acceptable excipient, the micronized particles of said lab, the co-crushed microparticles obtained in step (i), and the remaining parts of said ics in a container of a stirrer at a rotation speed of not less than 16 rpm for a time of not less than 60 minutes, to obtain a first mixture; and (iii) adding the remaining part of the micronized particles of a physiologically acceptable excipient to said mixture to obtain a second mixture, and mixing said second mixture at a speed of rotation of not less than 16 rpm for a time of at least 120 minutes to get a formulation.a presente invenção se refere a um processo para preparar uma formulação em pó para inalação para uso em um inalador de pó seco, o referido pó compreendendo: (a) um carreador compreendendo: (a) 80 a 95 por cento por peso,
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