Crystalline solvate forms of a pharmaceutical

Abstract

Described herein are solid state 17α-ethynylandrost-5-ene-3β,7β,17β-triol including amorphous and crystalline forms and specific polymorphic forms thereof, and use of solid state 17α-ethynylandrost-5-ene-3β,7β,17β-triol in treating numerous diseases and disorders, including hyperglycemic conditions, such as type 2 diabetes and metabolic syndrome, autoimmune conditions, such as rheumatoid arthritis, ulcerative colitis and type 1 diabetes, among other inflammation related conditions, and neurodegenerative conditions in subjects or human patients.

What is claimed is: 
     
         1 . A method to treat a neurodegenerative condition comprising administering to a human or mammal in need thereof an effective amount of a pharmaceutical composition comprising a solid state form of 17α-ethynylandrost-5-ene-3β,7β,17β-triol and at least one pharmaceutically acceptable excipient. 
     
     
         2 . The method of  claim 1 , wherein the neurodegenerative condition is Alzheimer's disease, Parkinson's disease or Amyotrophic Lateral Sclerosis. 
     
     
         3 . The method of  claim 1 , wherein the solid state form of 17α-ethynylandrost-5-ene-3β,7β,17β-triol is crystalline solvate 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         4 . The method of  claim 3 , wherein the crystalline solvate is crystalline methanolate 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         5 . The method of  claim 3 , wherein the crystalline solvate is crystalline ethanolate 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         6 . The method of  claim 3 , wherein the crystalline solvate is crystalline hydrate 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         7 . The method of  claim 3 , wherein the crystalline solvate is Form III 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         8 . The method of  claim 3 , wherein the crystalline solvate is Form IV 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         9 . The method of  claim 3 , wherein the crystalline solvate is Form V 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         10 . The method of  claim 1 , wherein the solid state form of 17α-ethynylandrost-5-ene-3β,7β,17β-triol is amorphous 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         11 . The method of  claim 10 , wherein the pharmaceutical composition contains less than about 3% by weight of impurities. 
     
     
         12 . A method to treat an inflammation condition comprising administering to a human or mammal in need thereof an effective amount of a formulation comprising a solid state form of 17α-ethynylandrost-5-ene-3β,7β,17β-triol and at least one pharmaceutically acceptable excipient. 
     
     
         13 . The method of  claim 12 , wherein the inflammation condition is an inflammatory bowel condition. 
     
     
         14 . The method of  claim 12 , wherein the inflammation condition is an inflammatory lung condition. 
     
     
         15 . The method of  claim 14 , wherein the inflammatory lung condition is cystic fibrosis, asthma, bronchitis or chronic obstructive pulmonary disease. 
     
     
         16 . The method of  claim 12 , wherein the solid state form of 17α-ethynylandrost-5-ene-3β,7β,17β-triol is crystalline solvate 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         17 . The method of  claim 16 , wherein the crystalline solvate is crystalline methanolate 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         18 . The method of  claim 16 , wherein the crystalline solvate is crystalline ethanolate 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         19 . The method of  claim 16 , wherein the crystalline solvate is crystalline hydrate 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         20 . The method of  claim 16 , wherein the crystalline solvate is Form III 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         21 . The method of  claim 16 , wherein the crystalline solvate is Form IV 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         22 . The method of  claim 16 , wherein the crystalline solvate is Form V 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         23 . The method of  claim 12 , wherein the solid state form of 17α-ethynylandrost-5-ene-3β,7β,17β-triol is amorphous 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         24 . The method of  claim 23 , wherein the pharmaceutical composition contains less than about 3% by weight of impurities. 
     
     
         25 . A method to treat a metabolic syndrome, impaired glucose tolerance or a hyperglycemia condition comprising administering to a human or mammal in need thereof an effective amount of a formulation comprising a solid state form of 17α-ethynylandrost-5-ene-3β,7β,17β-triol and at least one pharmaceutically acceptable excipient. 
     
     
         26 . The method of  claim 25 , wherein the hyperglycemia condition is type 1 diabetes or type 2 diabetes. 
     
     
         27 . The method of  claim 25 , wherein the solid state form of 17α-ethynylandrost-5-ene-3β,7β,17β-triol is crystalline solvate 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         28 . The method of  claim 27 , wherein the crystalline solvate is crystalline methanolate 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         29 . The method of  claim 27 , wherein the crystalline solvate is crystalline ethanolate 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         30 . The method of  claim 27 , wherein the crystalline solvate is crystalline hydrate 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         31 . The method of  claim 27 , wherein the crystalline solvate is Form III 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         32 . The method of  claim 27 , wherein the crystalline solvate is Form IV 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         33 . The method of  claim 27 , wherein the crystalline solvate is Form V 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         34 . The method of  claim 25 , wherein the solid state form of 17α-ethynylandrost-5-ene-3β,7β,17β-triol is amorphous 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         35 . The method of  claim 34 , wherein the pharmaceutical composition contains less than about 3% by weight of impurities.