US2005152849A1PendingUtilityA1

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

61
Assignee: VECTURA LTDPriority: Jul 24, 1995Filed: Feb 9, 2005Published: Jul 14, 2005
Est. expiryJul 24, 2015(expired)· nominal 20-yr term from priority
Inventors:John Staniforth
A61K 9/145A61K 9/0075
61
PatentIndex Score
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Claims

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.

Claims

exact text as granted — not AI-modified
1 . A powder for use in a dry powder inhaler, the powder comprising additive material and particles comprising active material, the additive material comprising an anti-adherent material and forming at least a partial covering on the surfaces of particles comprising active material so that cohesion and adhesion of the powder is reduced; wherein the powder includes at least 60% by weight of active material based on the weight of the powder.  
     
     
         2 . A powder according to  claim 1 , wherein the reduction in powder cohesion and adhesion improves the respirable fraction of the powder.  
     
     
         3 . A powder according to  claim 1 , wherein the powder comprises agglomerates of particles, the agglomerates having a size of at least 45 μm, and wherein the agglomerates break up upon actuation of the inhaler so that particles comprising active material are of a size suitable for delivery to the lower lung.  
     
     
         4 . A powder according to  claim 1 , wherein the powder comprises at least 0.1% by weight of additive material based on the weight of the powder.  
     
     
         5 . A powder according to  claim 1 , wherein the the powder comprises not more than 10% by weight of additive material based on the weight of the powder.  
     
     
         6 . A powder according to  claim 5 , wherein the powder comprises not more than 8% by weight of additive material based on the weight of the powder.  
     
     
         7 . 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.  
     
     
         8 . A powder according to  claim 1 , wherein at least 95% by weight of the particles comprising active material have a particle size less than 10 μm.  
     
     
         9 . A powder according to  claim 7 , wherein at least 95% by weight of the particles comprising active material have a particle size between about 0.1 μm and 5 μm.  
     
     
         10 . A powder according to  claim 1  wherein at least 90% by weight of the particles of the powder have a particle size of less than 63 μm.  
     
     
         11 . A powder according to  claim 1 , wherein the powder includes less than 20% by weight of constituents other than the active material and the anti-adherent material.  
     
     
         12 . A powder according to  claim 1 , wherein the additive material includes one or more compounds selected from the group consisting of amino acids and derivatives thereof, peptides and polypeptides having a molecular weight of between about 0.25 to 1000 kDa, and derivatives thereof.  
     
     
         13 . A powder according to  claim 12 , wherein the additive material is selected from the group consisting of leucine, isoleucine, lysine, valine, methionine, cysteine, pheylalanine and derivatives thereof.  
     
     
         14 . A powder according to  claim 1 , wherein the additive material includes one or more water soluble compounds.  
     
     
         15 . A powder according  claim 14 , wherein the additive material is lecithin.  
     
     
         16 . A powder according to  claim 1 , wherein the additive material includes dipolar ions.  
     
     
         17 . A powder according to  claim 16 , wherein the additive material includes zwitterions.  
     
     
         18 . A powder according  claim 1 , wherein the additive material includes a glidant material.  
     
     
         19 . A powder according to  claim 1 , wherein the active material includes one or more materials selected from the group consisting of peptides and polypeptides β 2- agonists, steroids, cromones, leukotriene receptor antagonists, and carbohydrates.  
     
     
         20 . A powder according to  claim 1 , wherein the additive material is in the form of particles.  
     
     
         21 . A dry powder inhaler including a powder according to  claim 1 .  
     
     
         22 . A method of forming a powder according to  claim 1 , wherein the active material and additive material are co-spray dried.  
     
     
         23 . A method according to  claim 22 , wherein the additive material is selected from the group consisting of leucine, a derivative of leucine and lecithin.  
     
     
         24 . A method according to  claim 23 , wherein the active material is heparin.  
     
     
         25 . A method according to  claim 1 , wherein the active material and additive material are co-micronised.  
     
     
         26 . A method according to  claim 25 , wherein the additive material is selected from the group consisting of leucine, a derivative of leucine and lecithin.  
     
     
         27 . A method according to  claim 26 , wherein the active material is heparin.  
     
     
         28 - 36 . (canceled)

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