Treatment methods using pharmaceutical solid state forms

Abstract

The invention provides and describes solid state 17α-ethynyl-androst-5-ene-3β,7β,17β-triol including amorphous and crystalline forms and specific polymorphic forms thereof. Anhydrates and solvates of 17α-ethynyl-androst-5-ene-3β,7β,17β-triol include Form I anhydrate and Form IV and Form V solvates. The invention further relates to solid and suspension formulations containing 17α-ethynyl-androst-5-ene-3β,7β,17β-triol in a described solid state form and use of the formulations to treat hyperglycemic conditions, such as type 2 diabetes and metabolic syndrome, and autoimmune conditions, such as rheumatoid arthritis, ulcerative colitis and type 1 diabetes, among other inflammation related conditions in subjects or human patients. The invention also relates to methods to make liquid formulations from solid state forms of 17α-ethynyl-androst-5-ene-3β,7β,17β-triol and uses of such formulations in treating the described conditions.

1 . A method to treat an inflammation condition or a metabolic disorder in a subject comprising administering to the subject an effective amount of crystalline 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         2 . The method of  claim 1  wherein the crystalline 17α-ethynylandrost-5-ene-3β,7β,17β-triol is Form I 17α-ethynylandrost-5-ene-3β,7β,17β-triol. 
     
     
         3 . The method of  claim 2  wherein the metabolic disorder is type 2 diabetes, hyperglycemia, obesity or hypercholesterolemia. 
     
     
         4 . The method of  claim 2  wherein the inflammation condition is a disease or condition associated with neuroinflammation. 
     
     
         5 . The method of  claim 4  wherein the disease or condition associated with neuroinflammation is Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis and age-related macular degeneration. 
     
     
         6 . The method of  claim 2  wherein the inflammation condition is associated with ischemia, hemorrhage or a trauma. 
     
     
         7 . The method of  claim 6  wherein the inflammation condition associated with ischemia, hemorrhage or a trauma is a myocardial infarction or a stroke. 
     
     
         8 . The method of  claim 2  wherein the inflammation condition is an autoimmune disease. 
     
     
         9 . The method of  claim 8  wherein the autoimmune disease is type 1 diabetes, multiple sclerosis or rheumatoid arthritis. 
     
     
         10 . The method of  claim 2  wherein the inflammation condition is an inflammatory bowel disease. 
     
     
         11 . The method of  claim 10  wherein the inflammatory bowel disease is ulcerative colitis or Crohn's disease.