DRY POWDER FORMULATION COMPRISING AN ANTICHOLINERGIC, A CORTICOSTEROID AND A BETA-ADRENERGIC FOR ADMINISTRATION BY INHALATION

摘要

Dry powder formulations for inhalation comprising a combination of an anticholinergic, a long-acting beta2-adrenoceptor agonist, and a corticosteroid are useful for the prevention and/or treatment of inflammatory and/or obstructive airways diseases.

主权项

1. A dry powder formulation for use in a dry powder inhaler (DPI), comprising:
(a) a fraction of fine particles, consisting of a mixture, prepared by co-mixing in a high-energy apparatus for a period of less than 20 minutes, of 90 to 99.5 percent by weight of micronized particles of a physiologically acceptable excipient and 0.5 to 10 percent by weight of magnesium stearate, wherein at least 90% of all said particles have a volume diameter lower than 15 microns and the volume median diameter of said particles is from 3 to 7 microns; (b) a fraction of coarse particles consisting of a physiologically acceptable excipient having a mass median diameter equal to or higher than 100 microns, wherein the ratio between said fine particles (a) and said coarse particles (b) is from 1:99 to 30:70 percent by weight; and (c) micronized particles of an anticholinergic, an inhaled corticosteroid (ICS), and a long-acting β2-agonist (LABA) as active ingredients.