TREATMENT METHODS USING PHARMACEUTICAL SOLID STATE FORMS
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.