US2013338122A1PendingUtilityA1

Transdermal hormone replacement therapies

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Assignee: THERAPEUTICSMD INCPriority: Jun 18, 2012Filed: Mar 15, 2013Published: Dec 19, 2013
Est. expiryJun 18, 2032(~5.9 yrs left)· nominal 20-yr term from priority
Inventors:Brian A. BernickJulia M. AmadioPeter H. R. PersicanerJanice Louise CacaceNeda Irani
A61P 5/24A61P 43/00A61P 5/30A61P 5/34A61P 15/12A61P 15/06A61P 15/00A61K 31/573A61K 9/0014A61K 47/10A61K 9/4825A61K 9/48A61K 45/06A61K 47/14A61K 31/566A61K 31/565A61K 9/1075A61K 31/57
56
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Claims

Abstract

Hormone replacement therapies are provided comprising solubilized progesterone alone and optionally with an estrogen, cyclic/sequential and continuous-combined dosing, and administered via transdermal HRT delivery systems.

Claims

exact text as granted — not AI-modified
We claim: 
     
         1 . A transdermal pharmaceutical formulation comprising solubilized progesterone. 
     
     
         2 . A transdermal pharmaceutical formulation of  claim 1 , wherein the drug load of said progesterone is selected from the group consisting of 10 mg, 12.5 mg, 20 mg, 25 mg, 30 mg, 50 mg, 75 mg, 100 mg, 125 mg, 150 mg, 175 mg, and 200 mg, per patch. 
     
     
         3 . A transdermal pharmaceutical formulation of  claim 2 , wherein the drug load of said progesterone is from about 10 mg to about 100 mg. 
     
     
         4 . A transdermal pharmaceutical formulation of  claim 3 , wherein the drug load of said progesterone is from about 20 mg to about 80 mg. 
     
     
         5 . A transdermal pharmaceutical formulation of  claim 4 , wherein the drug load of said progesterone is from about 20 mg to about 30 mg. 
     
     
         6 . A transdermal pharmaceutical formulation of  claim 2 , wherein the drug load of said progesterone is not less than about 10 mg. 
     
     
         7 . A transdermal pharmaceutical formulation of  claim 1 , wherein the daily dose of progesterone is selected from the group consisting of 10.0 mg, 12.5 mg, 20 mg, 25 mg, 30 mg, 50 mg, 75 mg, 100 mg, 125 mg, 150 mg, 175 mg and 200 mg per patch. 
     
     
         8 . A transdermal pharmaceutical formulation of  claim 7 , wherein the daily dose of progesterone is from about 10 mg to about 100 mg. 
     
     
         9 . A transdermal pharmaceutical formulation of  claim 8 , wherein the daily dose of progesterone is from about 20 mg to about 80 mg. 
     
     
         10 . A transdermal pharmaceutical formulation of  claim 9 , wherein the daily dose of progesterone is from about 20 mg to about 30 mg. 
     
     
         11 . A transdermal pharmaceutical formulation of  claim 7 , wherein the daily dose of progesterone is not less than about 10 mg. 
     
     
         12 . A transdermal pharmaceutical formulation of  claim 1 , further comprising at least one solubilized estrogen drug substance. 
     
     
         13 . A transdermal pharmaceutical formulation of  claim 12 , wherein the drug load of said estrogen drug substance is selected from 0.01 mg, 0.025 mg, 0.05 mg, 0.0625 mg, 0.1 mg, 0.125 mg, 0.25 mg, 0.375 mg, 0.50 mg, 0.625 mg, 0.75 mg, 1.00 mg, 1.125 mg, 1.25 mg, 1.375 mg, 1.50 mg, 1.625 mg, 1.75 mg and 2.00 mg. 
     
     
         14 . A transdermal pharmaceutical formulation of  claim 13 , wherein the drug load of said estrogen drug substance is from about 0.01 mg to about 1.0 mg. 
     
     
         15 . A transdermal pharmaceutical formulation of  claim 13 , wherein the drug load of said estrogen drug substance is not less than about 0.01 mg. 
     
     
         16 . A transdermal pharmaceutical formulation of  claim 13 , wherein said estrogen is estradiol. 
     
     
         17 . A transdermal pharmaceutical formulation of  claim 16 , wherein the drug load of said estradiol is from about 0.1 mg to about 1.0 mg. 
     
     
         18 . A transdermal pharmaceutical formulation of  claim 12 , wherein the daily dose of said estrogen drug substance is selected from the group consisting of 0.01 mg, 0.025 mg, 0.05 mg, 0.0625 mg, 0.1 mg, 0.125 mg, 0.25 mg, 0.375 mg, 0.50 mg, 0.625 mg, 0.75 mg, 1.00 mg, 1.125 mg, 1.25 mg, 1.375 mg, 1.50 mg, 1.625 mg, 1.75 mg and 2.00 mg. 
     
     
         19 . A transdermal pharmaceutical formulation of  claim 18 , wherein the daily dose of said estrogen drug substance is from about 0.1 mg to about 1.0 mg. 
     
     
         20 . A transdermal pharmaceutical formulation of  claim 18 , wherein the drug load of said estrogen drug substance is not less than about 0.01 mg. 
     
     
         21 . A transdermal pharmaceutical formulation of  claim 18 , wherein said estrogen is estradiol. 
     
     
         22 . A transdermal pharmaceutical formulation of  claim 21 , wherein the daily dose of said estradiol is from about 0.1 mg to about 1.0 mg. 
     
     
         23 . A method of treating at least one progesterone-deficient state in a mammal in need of treatment comprising administering an effective amount of a transdermal pharmaceutical formulation of any one of  claims 1  through  11 . 
     
     
         24 . A method of treating at least one progesterone-deficient state and at least one estrogen-deficient state in a mammal in need of treatment comprising administering an effective amount of a transdermal pharmaceutical formulation of any one of  claims 12  through  22 . 
     
     
         25 . A method of treatment of  claim 24 , wherein said progesterone and said estrogen drug substance are administered in a cyclic-sequential method. 
     
     
         26 . A method of treatment of  claim 25 , wherein said estrogen drug substance is estradiol. 
     
     
         27 . A method of treatment of  claim 24 , wherein said progesterone and said estrogen drug substance are administered in a continuous combined method. 
     
     
         28 . A method of treatment of  claim 27 , wherein said estrogen drug substance is estradiol. 
     
     
         29 . A method of treating at least one progesterone-deficient state and at least one estrogen-deficient state in a mammal in need of treatment comprising administering an effective amount of progesterone according to any one of  claims 1  through  11 , and an effective amount of at least one estrogen drug substance wherein said estrogen drug substance is administered via a method independent of the administration of progesterone in said transdermal patch. 
     
     
         30 . A method of treatment of  claim 29 , wherein said progesterone and said estrogen drug substance are administered in a cyclic-sequential method. 
     
     
         31 . A method of treatment of  claim 30 , wherein said estrogen drug substance is estradiol administered via oral administration. 
     
     
         32 . A method of treatment of  claim 29 , wherein said progesterone and said estrogen drug substance are administered in a continuous combined method. 
     
     
         33 . A method of treatment of  claim 32 , wherein said estrogen drug substance is estradiol administered via oral administration.

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