Liquid inhalation formulations of dehydroepiandrosterone derivatives

Abstract

Liquid pharmaceutical compositions and kits for administration to the lungs comprise a carrier and an agent for the treatment of bronchoconstriction and asthma, wherein the agent comprises a derivative of dehydroepiandrosterone having an SO2H or SO2Na group. The liquid formulations can be administered as an aerosol.

1 . A pharmaceutical composition for administration to the lungs, comprising a carrier and an amount of an active agent effective for treatment of bronchoconstriction, lung inflammation, lung allergy, or asthma wherein the active agent comprises a compound of formula (I), or pharmaceutically or veterinarily acceptable salts thereof; 
     
       
         
         
             
             
         
       
     
     wherein the broken line represents a single or double bond; R is hydrogen; and R 1  is SO 2 OM, wherein M is H or Na;
 wherein the pharmaceutical composition comprises a liquid formulated for administration as an aerosol. 
 
   
   
       2 . The pharmaceutical composition of  claim 1  wherein the composition is prepared by combining the active agent with sterile, substantially pyrogen-free water. 
   
   
       3 . The pharmaceutical composition of  claim 2  wherein the composition is formulated for delivery with a nebulizer. 
   
   
       4 . The pharmaceutical composition of  claim 3 , wherein the composition is formulated for delivery with a nebulizer by acceleration of a compressed gas, passage through a narrow venturi orifice, or by ultrasonic agitation. 
   
   
       5 . The pharmaceutical composition of  claim 4 , wherein the composition is formulated for delivery with a nebulizer by acceleration by ultrasonic agitation. 
   
   
       6 . The pharmaceutical composition of  claim 1 , wherein the active ingredient comprises up to 40% w/w of the composition. 
   
   
       7 . The pharmaceutical composition of  claim 1 , wherein the active ingredient comprises less than 20% w/w of the composition. 
   
   
       8 . A pharmaceutical composition, comprising a carrier and an amount of an active agent effective for treatment of bronchoconstriction, lung inflammation, lung allergy, or asthma comprising dehydroepiandrosterone sulfate (DHEA-S) or pharmaceutically or veterinarily acceptable salts thereof;
 wherein the pharmaceutical composition comprises a liquid formulated for administration as an aerosol for delivery by a nebulizer wherein the composition comprises water, a preservative, a flavoring agent, and a surfactant.   
   
   
       9 . A kit comprising the formulation of  claims 1  or  8  and a delivery device. 
   
   
       10 . The kit of  claim 9  wherein the delivery device comprises a nebulizer. 
   
   
       11 . The kit of  claim 9  wherein the delivery device comprises an ultrasonic nebulizer.