US2007031344A1PendingUtilityA1

Aerosolized anti-infectives, anti-inflammatories, and decongestants for the treatment of sinusitis

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Individually held — no corporate assignee on recordPriority: Jul 6, 1999Filed: Sep 14, 2006Published: Feb 8, 2007
Est. expiryJul 6, 2019(expired)· nominal 20-yr term from priority
Inventors:Robert Scott OsbakkenMary HaleFrederick LeivoJames Munk
A61P 31/04A61P 31/00A61K 9/0078A61P 11/02A61K 9/0043A61K 31/573A61M 11/06
53
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Claims

Abstract

Pharmaceutical compositions are described that contain one agent for treatment of sinusitis and a surfactant. The compositions are prepared to have a surface tension that renders the composition effective for treatment of sinusitis.

Claims

exact text as granted — not AI-modified
1 . An aerosolized pharmaceutical composition, comprising: aerosolized particles of the composition, which contains an anti-inflammatory for treating chronic sinusitis, and a surfactant, wherein: 
 the aerosolized composition is formulated for nasal administration as an aqueous composition;    the aerosolized composition as formulated comprises from about 0.01% (w/v) to 0.03% (w/v) surfactant;    the aerosolized composition as formulated has a surface tension of about 10 to about 70 dynes/cm, wherein the surface tension is effective for retention, deposition and penetration of the composition in the nasal sinuses;    and wherein at least about 80% of the aerosolized particles of the pharmaceutical composition have a mass median aerodynamic diameter (MMAD) in the size range of about 0.5 μm to about 5.0 μm in diameter, whereby the aerosolized pharmaceutical composition is effective for treatment of chronic sinusitis.    
   
   
       2 . The composition of  claim 1 , wherein the composition has a surface tension of about 30 to about 50 dynes/cm  
   
   
       3 . The composition of  claim 1 , wherein the anti-inflammatory agent comprises a glucocorticoid, disodium cromoglycate, nedcromil sodium or a combination thereof.  
   
   
       4 . The compositions of clam  3 , wherein the anti-inflammatory agent is a glucocorticoid.  
   
   
       5 . The composition of  claim 1 , wherein the composition is formulated for administration via a nebulizer.  
   
   
       6 . The composition of  claim 1 , wherein at least about 80% of the particles have a mass median aerodynamic diameter (MMAD) in the size range of about 1.0 μm to about 4.0 μm in diameter.  
   
   
       7 . The composition of  claim 1 , wherein at least about 80% of the particles have a mass median aerodynamic diameter (MMAD) in the size range of about 2.0 μm to about 3.5 μm in diameter.  
   
   
       8 . The composition of  claim 1 , wherein less than about 20% of the total particles have a mass median aerodynamic diameter (MMAD) of greater than 5 μm.  
   
   
       9 . The composition of  claim 1 , wherein the composition has an osmolality of about 150 mOsm/kg to about 880 mOsm/kg.  
   
   
       10 . The composition of  claim 1 , wherein the composition has an osmolality of about 400 mOsm/kg to about 700 mOsm/kg.  
   
   
       11 . The composition of  claim 1 , wherein the composition has an osmolality of about 500 mOsm/kg to about 600 mOsm/kg.  
   
   
       12 . The composition of  claim 1 , wherein the composition has a NaCl equivalency of about 0.9% to about 3.0% NaCl.  
   
   
       13 . The composition of  claim 1 , wherein the composition has a NaCl equivalency of about 1.1% NaCl to about 1.8% NaCl.  
   
   
       14 . The composition of  claim 1 , wherein the composition has a NaCl equivalency of about 1.3% NaCl to about 1.7% NaCl.  
   
   
       15 . The composition of  claim 1 , wherein the composition has a pH of about 3.0 to about 8.5.  
   
   
       16 . The composition of  claim 1 , wherein the composition comprises from about 0.015% (w/v) to 0.025% (w/v) surfactant.  
   
   
       17 . The composition of  claim 1 , wherein the composition comprises about 0.02% (w/v) surfactant.  
   
   
       18 . The composition of  claim 1 , wherein the surfactant comprises polyethylene glycol 400, sodium lauryl sulfate, sorbitan esters, polysorbates, benzalkonium chloride or a combination thereof.  
   
   
       19 . The composition of  claim 18 , wherein the surfactant comprises polysorbate.  
   
   
       20 . The composition of  claim 1 , wherein the surfactant has a hydrophile-lipophile-balance (HLB) of between about 1.8 to about 8.6.  
   
   
       21 . The composition of  claim 1 , wherein the surfactant has a hydrophile-lipophile-balance (HLB) of between about 9.6 to about 16.7.  
   
   
       22 . The composition of  claim 1 , wherein the composition is formulated for single dosage administration.

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