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filingDate 2014-07-10-04:00^^<http://www.w3.org/2001/XMLSchema#date>
grantDate 2021-10-20-04:00^^<http://www.w3.org/2001/XMLSchema#date>
inventor http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_993ecd84009a982adc1e94cd010f7bf9
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publicationDate 2021-10-20-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber ES-2867552-T3
titleOfInvention Dry powder formulation comprising an anticholinergic, a corticosteroid and a beta adrenergic for administration by inhalation
abstract A dry powder formulation for use in a dry powder inhaler (DPI) to be administered by inhalation, said formulation comprising: a) a fine particle fraction consisting of a mixture of 90 to 99.5 weight percent of particles micronized of a physiologically acceptable excipient and 0.5 to 10 percent by weight of magnesium stearate, in which at least 90% of all said particles have a volume diameter less than 15 microns, and the average diameter of the volume of the mentioned particles is between 3 and 7 microns, and no more than 10% of the mentioned particles have a diameter less than 1.8 microns; b) a fraction of coarse particles consisting of a physiologically acceptable excipient having a mean mass diameter equal to or greater than 100 microns, in which the ratio between the fine particles mentioned a) and the coarse particles b) is from 1 : 99 and 30:70 percent by weight; c) micronized particles of glycopyrronium bromide, beclomethasone dipropionate and formoterol fumarate dihydrate as active ingredients; wherein at least 90% of the micronized particles of each active ingredient have a volume diameter equal to or less than 6 microns, and the formulation delivers a therapeutically effective dose of the three active ingredients comprised between 100 and 500 microg; wherein said formulation can be obtained by a process comprising the steps of i) co-mixing in a high energy apparatus for a period of less than 30 minutes the excipient and magnesium stearate particles; and ii) mixing the fine particle fraction a), the lactose coarse particle fraction b) and all micronized active ingredients; and therefore, after administration from the inhaler, the formulation delivers a fraction of active particles equal to or greater than 30% having a particle size equal to or less than 2.0 microns.
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