Solid inhalation formulations of dehydroepiandrosterone derivatives

Abstract

Solid 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 solid 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 respirable dry solid particles formulated for administration as an aerosol. 
 
   
   
       2 . The pharmaceutical composition of  claim 1  wherein particles are prepared by grinding the active agent and passing composition through a filter screen. 
   
   
       3 . The pharmaceutical composition of  claim 2  wherein the particles are micronized. 
   
   
       4 . The pharmaceutical composition of  claim 2  wherein the filter screen is a 400 mesh screen. 
   
   
       5 . The pharmaceutical composition of  claim 1  further comprising a dispersant which serves to facilitate the formation of the aerosol. 
   
   
       6 . The pharmaceutical composition of  claim 5  wherein the dispersant is lactose. 
   
   
       7 . The pharmaceutical composition of  claim 1  wherein the active compound and the lactose are present at a ratio by weight of about 1 to 1. 
   
   
       8 . The pharmaceutical composition of  claim 1  further comprising a surfactant. 
   
   
       9 . A kit comprising the formulation of  claims 1  and a delivery device. 
   
   
       10 . The kit of  claim 9  wherein the delivery device comprises a metered dose inhaler or an insufflator.