Non-irritating testosterone emulsions

Abstract

Disclosed herein are emulsions comprising testosterone or related androgens, castor oil, cyclodextrin, Pemulen TR-2, Polyoxyl 40, and other ingredients. The compositions are useful for treating keratoconjunctivitis sicca and meibomian gland disease.

What is claimed is: 
     
         1 . A method of treating meibomian gland disease, the method comprising topical ocular administration of a composition, the composition comprising:
 Testosterone at a concentration between about 0.01% (w/w) and about 5.0% (w/w);   Castor oil at a concentration between about 0.10% (w/w) and about 5% (w/w);   a cyclodextrin at a concentration between about 0.25% (w/w) and about 10% (w/w);   a C10-30 alkyl acrylate crosspolymer at a concentration between about 0.01% (w/w) and about 5% (w/w);   Polyoxyl 40 stereate at a concentration between about 0.01% (w/w) and about 5% (w/w).   
     
     
         2 . The method of  claim 1 , wherein the testosterone is present in the composition at a concentration of between about 0.01% (w/w) and about 1% (w/w). 
     
     
         3 . The method of  claim 2 , wherein the testosterone is present in the composition at a concentration of between about 0.01% (w/w) and about 0.5% (w/w). 
     
     
         4 . The method of  claim 3 , wherein the testosterone is present in the composition at a concentration of about 0.03% (w/w) , about 0.1% (w/w), or about 0.3% (w/w). 
     
     
         5 . The method of  claim 4 , wherein the castor oil is present in the composition at a concentration of between about 0.10% (w/w) and about 5% (w/w). 
     
     
         6 . The method of  claim 5 , wherein the castor oil is present in the composition at a concentration of between about 0.10% (w/w) and about 1% (w/w). 
     
     
         7 . The method of  claim 6 , wherein the castor oil is present in the composition at a concentration of between about 0.10% (w/w) and about 0.5% (w/w). 
     
     
         8 . The method of  claim 7 , wherein the castor oil is present in the composition at a concentration of about 0.25% (w/w). 
     
     
         9 . The method of  claim 8 , wherein the cyclodextrin is sulfobutyl ether-β-cyclodextrin present in the composition at a concentration of between about 0.25% (w/w) and about 5% (w/w). 
     
     
         10 . The method of  claim 9 , wherein the sulfobutyl ether-β-cyclodextrin is present in the composition at a concentration of between about 0.25% (w/w) and about 5% (w/w). 
     
     
         11 . The method of  claim 10 , wherein the sulfobutyl ether-β-cyclodextrin is present in the composition at a concentration of about 0.36% (w/w), 1.25% (w/w), or about 3.75% (w/w). 
     
     
         12 . The method of  claim 11 , wherein the C10-30 alkyl acrylate crosspolymer is present in the composition at a concentration of between about 0.01% (w/w) and about 1% (w/w). 
     
     
         13 . The method of  claim 12 , wherein the C10-30 alkyl acrylate crosspolymer is present in the composition at a concentration of about 0.1% (w/w). 
     
     
         14 . The method of  claim 13 , wherein the Polyoxyl 40 stearate is present in the composition at a concentration of between about 0.01% (w/w) and about 2% (w/w). 
     
     
         15 . The method of  claim 14 , wherein the Polyoxyl 40 stearate is present in the composition at a concentration of between about 0.01% (w/w) and about 1% (w/w). 
     
     
         16 . The method of  claim 15 , wherein the Polyoxyl 40 stearate is present in the composition at a concentration of about 0.25% (w/w). 
     
     
         17 . The method of  claim 16 , wherein the composition further comprises Polysorbate 80 at a concentration of between about 0.01% (w/w) and about 5% (w/w). 
     
     
         18 . The method of  claim 17 , wherein the Polysorbate 80 is present in the composition at a concentration of between about 0.01% (w/w) and about 1% (w/w). 
     
     
         19 . The method of  claim 18 , wherein the Polysorbate 80 is present in the composition at a concentration of about 0.25% (w/w).