Powders comprising anti-adherent materials for use in dry powder inhalers

Abstract

A powder for use in a dry powder inhaler comprises active material and additive material. The additive material comprises an anti-adherent material and the powder includes at least 60% by weight of active material. The inclusion of the additive material in the powder has been found to give an increased respirable fraction of the active material.

1 . A powder for use in a dry powder inhaler, the powder comprising active material and additive material, the additive material comprising an anti-adherent material and the powder including at least 60% by weight of active material based on the weight of the powder.  
     
     
         2 . A powder according to  claim 1 , wherein the powder comprises at least 80% by weight of active material based on the weight of the powder.  
     
     
         3 . A powder according to  claim 1  or  claim 2 , wherein at least 90% by weight of the particles of the powder have a particle size less than 63 μm.  
     
     
         4 . A powder according to  claim 3 , wherein at least 90% by weight of the particles of the powder have a particle size less than 10 μm.  
     
     
         5 . A powder according to any preceding claim, wherein the additive material includes one or more compounds selected from amino acids and derivatives thereof, and peptides and polypeptides having a molecular weight of between about 0.25 to 1000 kDa, and derivatives thereof.  
     
     
         6 . A powder according to  claim 5 , wherein the additive material includes leucine.  
     
     
         7 . A powder according to any preceding claim, wherein the additive material includes one or more water soluble compounds.  
     
     
         8 . A powder according to any preceding claim, wherein the additive material includes dipolar ions.  
     
     
         9 . A powder according to  claim 8 , wherein the additive material includes zwitterions.  
     
     
         10 . A powder according to any preceding claim wherein the additive material includes a glidant material.  
     
     
         11 . A powder according to any preceding claim, wherein the active material includes a β 2 -agonist.  
     
     
         12 . A powder according to any preceding claim, wherein the powder comprises particles of active material and particles of additive material.  
     
     
         13 . A powder according to  claim 12 , wherein at least 90% by weight of the additive particles have a particle size less than 63 μm.  
     
     
         14 . A powder according to  claim 13 , wherein at least 90% by weight of the additive particles have a particle size less than 10 μm.  
     
     
         15 . A powder according to any of  claims 1  to  14 , wherein the additive material forms at least a partial coating on the surfaces of particles of the active material.  
     
     
         16 . A powder according to any preceding claim, wherein the powder comprises at least 0.1% by weight of additive material based on the weight of the powder.  
     
     
         17 . A powder according to any preceding claim, wherein the powder comprises not more than 10% by weight of additive material based on the weight of the powder.  
     
     
         18 . A powder according to any preceding claim, wherein the powder comprises not more than 5% by weight of additive material based on the weight of the powder.  
     
     
         19 . A powder according to any preceding claim, wherein at least 95% by weight of the active particles have a particle size less than 10 μm.  
     
     
         20 . A powder according to  claim 19 , wherein at least 95% by weight of the active particles have a particle size between about 0.1 μm and 5 μm.  
     
     
         21 . A powder according to any preceding claim, wherein the powder includes less than 20% by weight of constituents other than the active material and the anti-adherent material.  
     
     
         22 . A powder for use in a dry powder inhaler the powder comprising active particles and additive material, at least 90% by weight of the powder particles having a particle size of less than 63 μm, the powder including at least 60% by weight of active particles based on the weight of the powder.  
     
     
         23 . A powder according to  claim 22 , wherein at least 90% by weight of the powder particles have a particle size of less than 30 μm.  
     
     
         24 . A powder according to  claim 22  or  claim 23 , wherein the powder includes at least 80% by weight of active particles based on the weight of the powder.  
     
     
         25 . A powder according to any of  claims 22  to  24 , wherein the powder includes not more than 5% by weight of additive material based on the weight of the powder.  
     
     
         26 . A powder according to any of  claims 22  to  25 , wherein the additive material is in the form of particles.  
     
     
         27 . A powder for use in a dry powder inhaler, the powder comprising active particles and additive material, the additive material forming at least a partial coating on the surfaces of the particles of active material, the powder including at least 60% by weight of active material based on the weight of the powder, at least 90% by weight of the particles of the powder having a particle size less than 63 μm.  
     
     
         28 . A powder according to  claim 27 , wherein the powder includes at least 80% by weight of active material based on the weight of the powder.  
     
     
         29 . A powder for use in a dry powder inhaler the powder being substantially as herein described.  
     
     
         30 . A dry powder inhaler including a powder according to any of  claims 1  to  29 .  
     
     
         31 . A dry powder inhaler containing powder substantially as herein described having reference to FIG. 1.  
     
     
         32 . A dry powder inhaler according to  claim 30  or  claim 31 , wherein the inhaler may be activated to dispense a dose of less than lomg of the powder.  
     
     
         33 . A dry powder inhaler according to  claim 32 , wherein the dose contains not more than 1 mg of the powder.  
     
     
         34 . A dose of powder, the dose containing not more than 5 mg of powder according to any of  claims 1  to  29 .  
     
     
         35 . A dose of powder according to  claim 34 , the dose containing not more than 1 mg of powder according to any of  claims 1  to  29 .  
     
     
         36 . Use of an anti-adherent material in a powder for use in a dry powder inhaler, for improving the flow characteristics of the powder, the powder comprising at least 60% by weight of active material based on the weight of the powder.