US 11,865,179 B2
Progesterone formulations having a desirable PK profile
Janice Cacace, St. Petersburg, FL (US); Peter H. R. Persicaner, Boca Raton, FL (US); Thorsteinn Thorsteinsson, West Palm Beach, FL (US); Frederick Sancilio, Palm Beach Gardens, FL (US); Julia Amadio, Boca Raton, FL (US); Brian Bernick, Boca Raton, FL (US); and Neda Irani, Palm Beach Gardens, FL (US)
Assigned to TherapeuticsMD, Inc., Boca Raton, FL (US)
Filed by TherapeuticsMD, Inc., Boca Raton, FL (US)
Filed on Jun. 15, 2021, as Appl. No. 17/348,140.
Application 17/348,140 is a continuation of application No. 16/578,148, filed on Sep. 20, 2019, granted, now 11,033,626.
Application 16/578,148 is a continuation of application No. 15/454,898, filed on Mar. 9, 2017, granted, now 10,471,148, issued on Nov. 12, 2019.
Application 15/454,898 is a continuation of application No. 14/671,655, filed on Mar. 27, 2015, abandoned.
Application 14/671,655 is a continuation in part of application No. 14/125,547, granted, now 10,052,386, issued on Aug. 21, 2018, previously published as PCT/US2013/046442, filed on Jun. 18, 2013.
Application 14/671,655 is a continuation in part of application No. 13/843,428, filed on Mar. 15, 2013, granted, now 9,301,920, issued on Apr. 5, 2016.
Application PCT/US2013/046442 is a continuation of application No. 13/843,362, filed on Mar. 15, 2013, abandoned.
Application 13/843,362 is a continuation of application No. PCT/US2013/023309, filed on Jan. 25, 2013.
Application PCT/US2013/023309 is a continuation of application No. 13/684,002, filed on Nov. 21, 2012, granted, now 8,633,178, issued on Jan. 21, 2014.
Claims priority of provisional application 61/972,068, filed on Mar. 28, 2014.
Claims priority of provisional application 61/662,265, filed on Jun. 20, 2012.
Claims priority of provisional application 61/661,302, filed on Jun. 18, 2012.
Prior Publication US 2022/0040307 A1, Feb. 10, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 47/14 (2017.01); A61K 31/57 (2006.01); A61K 9/48 (2006.01)
CPC A61K 47/14 (2013.01) [A61K 9/4825 (2013.01); A61K 9/4858 (2013.01); A61K 31/57 (2013.01)] 14 Claims
OG exemplary drawing
 
1. A pharmaceutical composition for orally administering progesterone to a subject in need thereof, the composition comprising:
progesterone;
a solubilizing agent; and
a nonionic surfactant;
wherein the solubilizing agent comprises predominantly C6-C12 fatty acid tri-esters of glycerol;
wherein the progesterone is present from about 20 to about 50 weight percent of the composition; and
wherein the nonionic surfactant is lauroyl polyoxyl-32 glycerides.