Powdery pharmaceutical compositions for inhalation

Abstract

Powdery pharmaceutical compositions including an active ingredient and carrier particles containing only a small amount of lubricant, 0.05-0.5% by weight, are used to prepare dry powder inhalers in order to increase the fine particle dose. A process for coating the surface of the carrier particles with such little amount of lubricant is also provided. Use of limited amount of lubricant is safe and provides ordered stable mixtures without segregation of the active particles during handling and before use.

1 - 26 . (canceled)  
   
   
       27 . A powder composition comprising active ingredient particles and carrier particles, the carrier comprising one or more crystalline sugars coated with a lubricant wherein said lubricant comprises magnesium stearate in an amount between 0.1 and 0.5 percent by weight of the composition.  
   
   
       28 . A powder according to  claim 27  wherein the crystalline sugar is made of α-lactose monohydrate.  
   
   
       29 . A powder composition according to  claim 27  wherein the carrier particles have a size within the range 90 and 150 μm.  
   
   
       30 . A powder composition according to  claim 27  wherein the active ingredient particles have a particle size less than 6 μm.  
   
   
       31 . A powder composition according to  claim 27  wherein the active ingredient particles include a steroid.  
   
   
       32 . A powder composition according to  claim 31  wherein the steroid is selected from the group consisting of beclometasone dipropionate, budesonide and its epimers and flunisolide.  
   
   
       33 . A powder composition according to  claim 27  wherein the active ingredient includes a β 2 -agonist.  
   
   
       34 . A powder composition according to  claim 33 , wherein the β 2 -agonist is selected from the group consisting of salbutamol base, formoterol, salmeterol, terbutaline and the salts thereof.  
   
   
       35 . A powder composition according to  claim 27  wherein the carrier particles have a size within the range 20 and 1000 μm.  
   
   
       36 . A powder composition according to  claim 27  wherein the carrier consists of said one or more crystalline sugars coated with said lubricant.  
   
   
       37 . A powder composition according to  claim 27  wherein said lubricant consists of said magnesium stearate.  
   
   
       38 . A powder composition according to  claim 36  wherein said lubricant consists of said magnesium stearate.  
   
   
       39 . A dry powder inhaler containing the powder composition according to  claim 27  therein.  
   
   
       40 . A method of treating the lungs in a patient in need thereof comprising administering an effective amount of the powder composition according to  claim 27  to said patient.  
   
   
       41 . The method according to  claim 40 , wherein the patient is treated for asthma.