Patent ID: 8778402
Filing Date: 2014-07-15
Classification: A61K,A61M,A61P,Y10S

Abstract:
1. A dry powder formulation for use in a dry powder inhaler, comprising: (a) a fraction of fine particles made of a mixture comprising 90 to 99.5 percent by weight of particles of a physiologically acceptable excipient and 0.5 to 10 percent by weight of magnesium stearate, said mixture having a mass median diameter lower than 20 microns; (b) a fraction of coarse particles comprising a physiologically acceptable excipient having a mass median diameter equal to or higher than 100 microns, wherein the weight ratio between said fine particles and said coarse particles is 1:99 to 30:70 percent by weight; and (c1) formoterol fumarate dihydrate in the form of micronized particles; (c2) beclometasone dipropionate (BDP) in the form of micronized particles; wherein: (i) no more than 10% of said BDP particles (c2) have a volume diameter lower than 0.6 microns; (ii) no more than 50% of said BDP particles (c2) have a volume diameter of 1.5 microns to 2.0 microns; and (iii) at least 90% of said BDP particles (c2) have a volume diameter lower than 4.7 microns, wherein said BDP particles (c2) are further characterized by a specific surface area of 5.5 to 7.0 m