DHEA composition and method

Abstract

Disclosed are improved pharmaceutical formulations comprising dehydroepiandrosterone (DHEA), enriched in selected polymorphic forms, for therapeutic applications. In one embodiment, the formulation comprises, in solid form, DHEA, at least 85% of which is present as a single polymorph selected from the form I polymorph or the form II polymorph, and at least one pharmaceutical excipient. Methods for making and using such compositions are also disclosed.

1 - 10 . (canceled)  
   
   
       11 . In a method for administering dehydroepiandrosterone (DHEA) to obtain an ameliorative result, the improvement comprising administering a pharmaceutically acceptable amount of DHEA, wherein at least 85% of the DHEA is present as the form I polymorph.  
   
   
       12 . The method of  claim 11 , wherein, at least 90% of the DHEA is present as the form I polymorph.  
   
   
       13 . The method of  claim 11 , wherein, at least 95% of the DHEA is present as the form I polymorph.  
   
   
       14 . The method of  claim 11 , wherein, at least 99% of the DHEA is present as the form I polymorph.  
   
   
       15 . The method of  claim 11 , wherein, said ameliorative result is treatment of systemic lupus erythematosus.  
   
   
       16 . The method of  claim 11 , wherein, said ameliorative result is prevention or reduction of loss of bone density.  
   
   
       17 . The method of  claim 11  wherein, said ameliorative result is treatment of chronic fatigue syndrome or fibromyalgia.  
   
   
       18 . A pharmaceutical formulation comprising dehydroepiandrosterone (DHEA), at least 85% of which is present as the form II polymorph, and at least one pharmaceutical excipient.  
   
   
       19 - 21 . (canceled)  
   
   
       22 . A method for preparing a solid DHEA formulation, said method comprising: 
 mixing at least one solid pharmaceutical excipient with dehydroepiandrosterone (DHEA), at least 85% of which is present as the form II polymorph.    
   
   
       23 - 27 . (canceled)  
   
   
       28 . In a method for administering dehydroepiandrosterone (DHEA) to obtain an ameliorative result, the improvement comprising administering a pharmaceutically acceptable amount of DHEA, wherein at least 85% of the DHEA is present as the form II polymorph.  
   
   
       29 - 34 . (canceled)  
   
   
       35 . A method for controlling the bioavailability of a DHEA formulation, the method comprising: 
 administering to a subject a DHEA formulation comprising DHEA and a pharmaceutical excipient, wherein said DHEA in said formulation consists of a preselected, known ratio of DHEA polymorphs.