Transdermal cream

Abstract

This disclosure relates to transdermal pharmaceutical compositions containing progesterone in combination with one or more solubilizing agents and penetration enhancers, wherein the pharmaceutical compositions are formulated as creams for topical administration. In some embodiments, the transdermal pharmaceutical compositions contain progesterone, a medium-chain oil, and d-limonene. In some embodiments, the transdermal pharmaceutical compositions contain progesterone, a medium-chain oil, a penetration enhancer (e.g., propylene glycol, a fatty acid ester of propylene glycol, a glycol ether), and optionally d-limonene. In certain embodiments, the pharmaceutical compositions further include estradiol. Methods for treating conditions associated with hormone deficiency in a subject are also described.

What is claimed is: 
     
         1 . A transdermal pharmaceutical composition comprising
 progesterone,   a solubilizing agent comprising a medium-chain oil, and   a penetration enhancer,   wherein the pharmaceutical composition is formulated as a cream for topical administration.   
     
     
         2 . The transdermal pharmaceutical composition of  claim 1 , wherein the penetration enhancer comprises propylene glycol monolaurate, diethylene glycol monoethyl ether, and propylene glycol. 
     
     
         3 . The transdermal pharmaceutical composition of  claim 1 , wherein the penetration enhancer further comprises d-limonene. 
     
     
         4 . The transdermal pharmaceutical composition of  claim 1 , comprising progesterone in an amount ranging from about 1.5% (w/w) to about 3.5% (w/w). 
     
     
         5 . The transdermal pharmaceutical composition of  claim 4 , comprising progesterone in an amount ranging from about 2% (w/w) to about 3% (w/w). 
     
     
         6 . The transdermal pharmaceutical composition of  claim 1 , wherein the medium-chain oil comprises medium-chain triglycerides, the medium-chain triglycerides substantially comprising caprylic triglyceride and capric triglyceride. 
     
     
         7 . The transdermal pharmaceutical composition of  claim 1 , comprising
 progesterone in an amount ranging from about 1.5% (w/w) to about 3.5% (w/w); and   the medium-chain oil in an amount ranging from about 10% (w/w) to about 30% (w/w).   
     
     
         8 . The transdermal pharmaceutical composition of  claim 7 , comprising
 progesterone in an amount ranging from about 2% (w/w) to about 3% (w/w); and   the medium-chain oil in an amount ranging from about 15% (w/w) to about 25% (w/w).   
     
     
         9 . The transdermal pharmaceutical composition of  claim 7 , comprising
 progesterone in an amount of about 2.5% (w/w); and   the medium-chain oil in an amount of about 15% (w/w).   
     
     
         10 . The transdermal pharmaceutical composition of  claim 1 , further comprising estradiol. 
     
     
         11 . The transdermal pharmaceutical composition of  claim 10 , comprising estradiol in an amount ranging from about 0.001% (w/w) to about 0.5% (w/w). 
     
     
         12 . The transdermal pharmaceutical composition of  claim 10 , comprising estradiol in an amount of about 0.005% (w/w). 
     
     
         13 . The transdermal pharmaceutical composition of  claim 10 , comprising estradiol in an amount of about 0.05% (w/w). 
     
     
         14 . A method for treating a condition associated with hormone deficiency in a subject, the method comprising administering to the subject a transdermal pharmaceutical composition according to  claim 1 .