NON-IRRITATING TESTOSTERONE EMULSIONS
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.
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).