Details for Patent: 9,238,072

Title:	Controlled release delivery system for nasal applications and method of treatment
Abstract:	This invention relates to a gel formulation for nasal administration of a controlled release formulation of hormones to the systemic circulation and/or to the brain. The special lipophilic or partly lipophilic system of the invention leads to higher bioavailability of the active ingredient caused by sustained serum levels in plasma but also leads to a more favorable serum level profile. The special lipophilic or partly lipophilic system also allows for the modulation of brain functioning. The invention also relates to the nasal administration of steroid hormones for treatment of female sexual dysfunction (FSD) or female arousal disorder.
Inventor(s):	Mattern; Claudia (Emmetten, CH)
Assignee:	MATTERN PHARMA AG (Vaduz, LI)
Filing Date:	Jul 02, 2014
Application Number:	14/322,319
Claims:	1. A method of making a testosterone formulation comprising forming a mixture comprising (a) testosterone, (b) at least one lipophilic or partly lipophilic carrier in an amount of from about 60% to about 98% by weight of the testosterone formulation, (c) at least one compound or a mixture of compounds having surface tension decreasing activity in a total amount of from about 1% to about 20% by weight of the formulation; and (d) a viscosity-regulating agent in an amount of from about 0.5% to about 10% by weight of the formulation. 2. The method of claim 1, comprising (a) mixing the at least one lipophilic or partly lipophilic carrier and the at least one compound having surface tension decreasing activity; (b) dispersing the testosterone in the mixture; and then (c) adjusting the viscosity by adding at least one viscosity-regulating agent. 3. The method of claim 1, wherein the testosterone is present in the testosterone formulation in an amount of from about 0.2% to about 6% by weight of the testosterone formulation. 4. The method of claim 1, wherein the testosterone is present in the testosterone formulation in an amount of from about 0.2% to about 4% by weight of the testosterone formulation. 5. The method of claim 1, wherein the at least one lipophilic or partly lipophilic carrier is present in the testosterone formulation in an amount of from about 85% to about 95% by weight of the formulation. 6. The method of claim 5, wherein the lipophilic carrier comprises castor oil. 7. The method of claim 1, wherein the at least one compound or mixture of compounds having surface tension decreasing activity is present in the testosterone formulation in an amount of from about 1% to about 5% by weight of the formulation. 8. The method of claim 7, wherein the at least one compound or mixture of compounds having surface tension decreasing activity comprises an oleoyl macrogolglyceride. 9. The method of claim 1, wherein the viscosity regulating agent is present in an amount of from about 1% to about 4% by weight of the formulation. 10. The method of claim 1, wherein the viscosity regulating agent comprises colloidal silicon dioxide. 11. The method of claim 1, wherein the testosterone formulation comprises: (a) testosterone; (b) castor oil in an amount of from about 60% to about 98% by weight of the formulation; (c) an oleoyl macrogolglyercide or a mixture of macrogolglycerides in an amount of from about 1% to about 20% by weight of the formulation; and (d) colloidal silicon dioxide in an amount of from about 0.5% to about 10% by weight of the formulation. 12. The method of claim 11, wherein the testosterone formulation comprises the testosterone in an amount of from about 0.2% to about 6% by weight of the formulation. 13. The method of claim 1, wherein the testosterone formulation comprises: (a) testosterone in an amount of from about 0.2% to about 6% by weight of the formulation; (b) castor oil in an amount of from about 75% to about 95% by weight of the formulation; (c) an oleoyl macrogolglyercide or a mixture of oleoyl macrogolglycerides in an amount of from about 1% to about 5% by weight of the formulation; and (d) colloidal silicon dioxide in an amount of from about 0.5% to about 7% by weight of the formulation.