US 11,793,819 B2
Natural combination hormone replacement formulations and therapies
Brian A. Bernick, Boca Raton, FL (US); Janice Louise Cacace, Miami, FL (US); Peter H. R. Persicaner, Boca Raton, FL (US); Neda Irani, Palm Beach Gardens, FL (US); Julia M. Amadio, Boca Raton, FL (US); and Frederick D. Sancilio, Stuart, FL (US)
Assigned to TherapeuticsMD, Inc., Boca Raton, FL (US)
Filed by TherapeuticsMD, Inc., Boca Raton, FL (US)
Filed on Aug. 16, 2018, as Appl. No. 16/104,101.
Application 14/830,398 is a division of application No. 14/476,040, filed on Sep. 3, 2014, granted, now 9,114,146, issued on Aug. 25, 2015.
Application 14/099,545 is a division of application No. 13/684,002, filed on Nov. 21, 2012, granted, now 8,633,178, issued on Jan. 21, 2014.
Application 16/104,101 is a continuation of application No. 14/830,398, filed on Aug. 19, 2015, abandoned.
Application 14/476,040 is a continuation of application No. 14/099,545, filed on Dec. 6, 2013, granted, now 8,846,648, issued on Sep. 30, 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.
Claims priority of provisional application 61/563,408, filed on Nov. 23, 2011.
Prior Publication US 2019/0046542 A1, Feb. 14, 2019
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/565 (2006.01); A61K 31/57 (2006.01); A61K 9/48 (2006.01); A61K 47/14 (2017.01); A61K 9/02 (2006.01); A61P 15/00 (2006.01); A61K 47/10 (2017.01); A61K 9/107 (2006.01); A61K 9/16 (2006.01); A61K 9/70 (2006.01)
CPC A61K 31/57 (2013.01) [A61K 9/1075 (2013.01); A61K 9/16 (2013.01); A61K 9/48 (2013.01); A61K 9/4825 (2013.01); A61K 9/4858 (2013.01); A61K 9/7023 (2013.01); A61K 31/565 (2013.01); A61K 47/10 (2013.01); A61K 47/14 (2013.01)] 20 Claims
 
1. A method of treating a menopause symptom in a woman with a uterus comprising: administering an effective amount of a pharmaceutical composition, the pharmaceutical composition comprising:
a solubilizing agent comprising:
mono- and diglycerides of capric and caprylic acid; and
at least one of lauroyl macrogol-32 glycerides EP, lauroyl polyoxyl-32 glycerides NF, or lauroyl polyoxylglycerides;
progesterone, wherein the progesterone is micronized and partially solubilized; and
estradiol, the estradiol being at least about 90% solubilized in the solubilizing agent;
wherein the estradiol and the progesterone are present in the solubilizing agent, and the micronized progesterone is uniformly dispersed.