Inhalable medicaments

Abstract

The present invention provides a dry powder inhaler comprising: a reservoir containing a dry powder formulation and an arrangement for delivering a metered dose of the medicament from the reservoir; a cyclone deagglomerator for breaking up agglomerates of the dry powder medicament; and a delivery passageway for directing an inhalation-induced air flow through a mouthpiece, the delivery passageway extending to the metered dose of medicament, wherein the formulation comprises an inhalable β2-agonist having a particle size distribution of d1O<1 μπι=1-3 μπι, d90=3.5-6 μm and NLT 99% 10 μm and a lactose carrier.

1 - 13 . (canceled) 
     
     
         14 . A dry powder formulation for inhalation,
 wherein active ingredients in the dry powder formulation consist of an inhalable β-agonist and inhalable budesonide; and   wherein the inhalable β-agonist is provided as a micronized powder having a particle size distribution of d10<1 μm, d50=1-3 μm, d90=3.5-6 μm and NLT 99%<10 μm measured by laser diffraction as a dry dispersion.   
     
     
         15 . The dry powder formulation of  claim 14 , wherein the β-agonist is selected from salbutamol, levosalbutamol, terbutaline, pirbuterol, procaterol, clenbuterol, metaproterenol, fenoterol, bitolterol, ritodrine, isoprenaline, formoterol, salmeterol, bambuterol, indacaterol, carmoterol, or pharmaceutically acceptable salts thereof. 
     
     
         16 . The dry powder formulation of  claim 15 , wherein the inhalable β-agonist is formoterol. 
     
     
         17 . The dry powder formulation of  claim 14 , wherein the formulation further comprises a lactose carrier. 
     
     
         18 . The dry powder formulation of  claim 14 , wherein the β-agonist has a particle size distribution of d10=0.4-0.6 μm, d50=1.5-2.5 μm and d90=3.6-5.1 μm measured by laser diffraction as a dry dispersion. 
     
     
         19 . The dry powder formulation of  claim 18 , wherein the β-agonist has a particle size distribution of d10=0.46-0.53 μm, d50=1.68-1.92 μm and d90=3.68-5.07 μm measured by laser diffraction as a dry dispersion. 
     
     
         20 . A method of treating a respiratory disease in a patient comprising administering the dry powder formulation of  claim 14  to a patient. 
     
     
         21 . The method of  claim 20 , wherein the respiratory disease is asthma or chronic obstructive pulmonary disease. 
     
     
         22 . The method of  claim 21 , wherein the asthma is mild, moderate or severe asthma classed as GINA stage 1, 2, 3 or 4. 
     
     
         23 . The dry powder formulation of  claim 16 , wherein the formoterol is formoterol fumarate. 
     
     
         24 . The dry powder formulation of  claim 14 , wherein the budesonide comprises particles less than 10 μm in size. 
     
     
         25 . The dry powder formulation of  claim 14 , wherein the budesonide comprises particles with a size distribution of d10<1 μm, d50≤5 μm and d90≤10 μm measured by laser diffraction as a dry dispersion.