Ketamine transdermal delivery system

Abstract

The present invention is directed to a transdermal delivery device comprising ketamine and formulations thereof. The present invention is also directed to a transdermal delivery device comprising ketamine for the treatment of major depressive disorder (MDD) and/or pain. The present invention is further directed to a transdermal delivery device comprising ketamine and abuse deterrent agents.

1 - 5 . (canceled) 
     
     
         6 . A method of treating major depressive disorders comprising administration of a transdermal delivery device comprising ketamine, wherein the transdermal delivery device provides a ketamine permeation rate of about 0.1-30 mg/day/cm2 of ketamine for about 8 hours to about 168 hours. 
     
     
         7 . (canceled) 
     
     
         8 . A method of treating pain comprising administration of a transdermal delivery device comprising ketamine, wherein the transdermal delivery device provides a ketamine permeation rate of about 0.1-30 mg/day/cm2 of ketamine for about 8 hours to about 168 hours. 
     
     
         9 . (canceled) 
     
     
         10 . The method of  claim 6 , wherein the transdermal delivery device provides about 0.1-30 mg/day/cm 2  of ketamine for about 7 days. 
     
     
         11 . The method of  claim 6 , wherein the transdermal delivery device provides about 0.1-30 mg/day/cm 2  of ketamine for about 1 day. 
     
     
         12 . The method of  claim 6 , wherein the transdermal delivery device provides about 0.1-30 mg/day/cm 2  of ketamine for about 3.5 days. 
     
     
         13 . The method of  claim 6 , wherein the transdermal delivery device provides about 0.5-5 mg/day/cm 2  of ketamine for about 7 days. 
     
     
         14 . The method of  claim 6 , wherein the transdermal delivery device provides about 0.5-5 mg/day/cm 2  of ketamine for about 1 day. 
     
     
         15 . The method of  claim 6 , wherein the transdermal delivery device provides about 0.5-5 mg/day/cm 2  of ketamine for about 3.5 days. 
     
     
         16 . The method of  claim 6 , wherein the transdermal delivery device is about 10-300 cm 2 . 
     
     
         17 . The method of  claim 6 , wherein the transdermal delivery device is about 100-300 cm 2 . 
     
     
         18 . The method of  claim 6 , wherein the transdermal delivery device is about 10-100 cm 2 . 
     
     
         19 . The method of  claim 6 , wherein administering the transdermal delivery device provides reduced C max  compared to immediate release administration of ketamine. 
     
     
         20 . The method of  claim 6 , wherein administering the transdermal delivery device provides ketamine plasma concentrations from about 0.4-4000 ng/ml for about 8-168 hours. 
     
     
         21 . The method of  claim 6 , wherein administering the transdermal delivery device provides ketamine plasma concentrations from about 10-200 ng/ml for treatment of major depressive disorders. 
     
     
         22 . The method of  claim 6 , wherein administering the transdermal delivery device provides ketamine plasma concentrations below 100 ng/ml for about 8 hours to about 7 days, and which reduces the adverse side effect of ketamine when compared with plasma concentrations from immediate release ketamine formulations. 
     
     
         23 . The method of  claim 8 , wherein administering the transdermal delivery device provides ketamine plasma concentrations from about 50-1000 ng/ml for treatment of pain. 
     
     
         24 . The method of  claim 6 , wherein administering the transdermal delivery device provides reduced plasma fluctuations over time when compared with plasma concentrations from immediate release ketamine formulations. 
     
     
         25 . The method of  claim 6 , wherein administering the transdermal delivery device provides:
 (a) reduced C max  fluctuations,   (b) reduced plasma concentration fluctuations, and   (c) reduced adverse side effects,   
       when compared with ketamine plasma concentrations from immediate release formulations. 
     
     
         26 . The method of  claim 6 , wherein administering the transdermal delivery device provides a C max  no greater than about 30% of the C max  from a dose equivalent immediate release ketamine formulation. 
     
     
         27 . The method of  claim 6 , wherein the ketamine is the R-enantiomer. 
     
     
         28 . The method of  claim 6 , wherein the ketamine is the S-enantiomer. 
     
     
         29 . A transdermal delivery device comprising ketamine, which is a drug-in-adhesive patch comprising a backing layer, an adhesive-drug layer, and a release liner, wherein the adhesive-drug layer comprises ketamine of 10-25% by weight and a pressure sensitive adhesive, wherein ketamine is the only active ingredient in the transdermal delivery device.