| US 11,813,354 B1 | ||
| Trans-mucosal delivery system for testosterone | ||
| Alvin Kershman, Chesterfield, MO (US); and Jeff L Shear, Bonita Springs, FL (US) | ||
| Assigned to Shear Kershman Laboratories, Inc, Chesterfield, MO (US) | ||
| Filed by Alvin Kershman, Chesterfield, MO (US); and Jeff L Shear, Bonita Springs, FL (US) | ||
| Filed on Jan. 10, 2020, as Appl. No. 16/740,007. | ||
| Claims priority of provisional application 62/791,346, filed on Jan. 11, 2019. | ||
| Int. Cl. A61K 47/26 (2006.01); A61K 9/00 (2006.01); A61K 9/107 (2006.01); A61K 31/568 (2006.01); A61K 47/14 (2017.01); A61K 47/44 (2017.01); A61K 47/12 (2006.01); A61K 47/10 (2017.01) | ||
| CPC A61K 9/0053 (2013.01) [A61K 9/107 (2013.01); A61K 31/568 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01); A61K 47/14 (2013.01); A61K 47/26 (2013.01); A61K 47/44 (2013.01)] | 15 Claims |
|
1. A transmucosal testosterone release composition, comprising a combination of:
A) an aqueous phase comprising an aqueous solution or suspension containing at least one humectant;
wherein the at least one humectant is present in the aqueous phase in the range of from about 50 to 99 wt. %, and
B) an oil phase comprising oil soluble testosterone, at least one non-water soluble surfactant, and optionally at least one oil, wherein the at least one surfactant is present in the oil phase in the range of from about 1 to 99.999 wt.%;
wherein a weight ratio of the aqueous phase to the oil phase is about 3:1 to 49:1;
wherein the non-water soluble surfactant is present in the composition in an amount in the range of from about 1 to 15 wt. %;
wherein the humectant is present in the composition in an amount in the range from about 50 wt. % to about 90 wt. %;
wherein the oil soluble testosterone is present in the composition in an amount in the range from about 0.001 to 25.00 wt.%
wherein the non-water soluble surfactant has an HLB of less than 4;
wherein the non-water soluble surfactant is selected from the group consisting of acetylated monoglycerides, glycerol dioleate, sorbitan tristearate, glycerol monooleate, propylene glycol monoglyceride, propylene glycol diglyceride and combinations thereof;
wherein the testosterone is the native form of testosterone;
wherein the aqueous phase is encapsulated by the oil phase; and
wherein the composition is a lotion that is viscous, pourable, non-water dispersible, hydrophobic and has extended release properties of 12 hours or more elevated blood serum testosterone levels over baseline blood serum testosterone levels.
|