Suspension formulations

Abstract

The present invention relates to suspension formulations, especially those for delivering a pharmaceutically active agent in aerosol form using a spray or aerosol device, such as a pressurised metered dose inhaler (pMDI). The formulations may be for pulmonary, nasal, buccal or topical administration, but are preferably for pulmonary inhalation.

1 - 21 . (canceled) 
     
     
         22 . A suspension formulation comprising:
 particles comprising formoterol;   a propellant; and   an additive material.   
     
     
         23 . The suspension formulation according to  claim 22 , wherein the suspension formulation comprises a second pharmaceutically active agent. 
     
     
         24 . The suspension formulation according to  claim 23 , wherein the second pharmaceutically active agent is glycopyrrolate. 
     
     
         25 . The suspension formulation according to  claim 22 , wherein the propellant comprises HFA 227, HFA 134a, or a combination thereof. 
     
     
         26 . The suspension formulation according to  claim 22 , wherein the propellant is HFA 134a. 
     
     
         27 . The suspension formulation according to  claim 22 , wherein the additive material is a phospholipid. 
     
     
         28 . The suspension formulation according to  claim 22 , wherein the additive material is lecithin. 
     
     
         29 . The suspension formulation according to  claim 22 , wherein the additive material promotes formulation stability and controls agglomeration of the particles. 
     
     
         30 . The suspension formulation according to  claim 22 , wherein the suspension comprises spray dried materials. 
     
     
         31 . The suspension formulation according to  claim 30 , wherein the spray dried materials comprise formoterol and the additive material. 
     
     
         32 . The suspension formulation according to  claim 31 , wherein the additive material is a phospholipid. 
     
     
         33 . The suspension formulation according to  claim 22 , wherein the particles comprise the additive material and at least 90% of the particles have a Mass Median Aerodynamic Diameter (MMAD) of no more than about 10 μm. 
     
     
         34 . The suspension formulation according to  claim 22 , wherein at least 90% of the particles have a Mass Median Aerodynamic Diameter (MMAD) of from about 1 μm to about 5 μm. 
     
     
         35 . A metered dose inhaler comprising the suspension formulation according to  claim 22 . 
     
     
         36 . The suspension formulation according to  claim 22 , wherein the propellant is HFA 134a, the additive is a phospholipid, and the suspension formulation comprises spray dried materials. 
     
     
         37 . The suspension formulation according to  claim 36 , wherein the spray dried materials comprise formoterol and the phospholipid. 
     
     
         38 . The suspension formulation according to  claim 22 , wherein the propellant is HFA 134a, the additive material is a phospholipid, and the suspension formulation further comprises glycopyrrolate. 
     
     
         39 . The suspension formulation according to  claim 38 , wherein the suspension formulation comprises spray dried materials comprising formoterol and a phospholipid.