Transdermal methods and systems for the delivery of anti-migraine compounds

Abstract

Iontophoretic patches for the delivery of anti-migraine compounds and methods of using the patches are described.

What is claimed is: 
     
         1 - 148 . (canceled) 
     
     
         149 . A method for delivery of an active serotonin agonist in the form of a triptan compound for treating a triptan compound responsive state in a human, the method comprising:
 administering to a human in need thereof an active serotonin agonist in the form of a triptan compound using an integrated iontophoretic transdermal patch, wherein the triptan compound is delivered in a delivery sequence that includes:
 an initial first stage delivery during which current densities average between about 0.05 and about 0.20 mA/cm 2  during a significant portion of the initial first stage delivery such that an effective plasma concentration of greater than 10 ng/mL of the triptan compound is provided to the subject in less than one hour; and 
 a second stage delivery during which current densities average between about 0.01 and about 0.2 mA/cm 2  during a significant portion of said second stage delivery such that the effective plasma concentration level of the triptan compound is maintained for one or more hours. 
   
     
     
         150 . The method of  claim 149 , wherein said triptan compound is selected from sumatriptan, and salts thereof. 
     
     
         151 . The method of  claim 149 , wherein the plasma concentration level of the triptan compound is maintained at about 10 ng/mL or greater. 
     
     
         152 . The method of  claim 151 , wherein the average current density is about 0.1 mA/cm 2  during a significant portion of the initial first stage delivery. 
     
     
         153 . The method of  claim 152 , wherein the average current density is about 0.05 mA/cm 2  during a significant portion of the second stage delivery. 
     
     
         154 . The method of  claim 149 , wherein the plasma concentration level of the triptan compound is maintained for about four hours or greater. 
     
     
         155 . The method of  claim 154 , wherein the plasma concentration level of the triptan compound is maintained for about six hours or greater. 
     
     
         156 . The method of  claim 155 , wherein the plasma concentration level of the triptan compound is maintained for at least seven hours. 
     
     
         157 . The method of  claim 149 , wherein said current densities are selected such that said current densities do not substantially irritate said human's skin. 
     
     
         158 . The method of  claim 149 , wherein the current densities are selected such that usage of the patch does not result in a skin erythema score of greater than 2.00 immediately after patch removal. 
     
     
         159 . The method of  claim 149 , wherein the current densities are selected such that usage of the patch does not result in a skin erythema score of greater than 1.00 immediately after patch removal. 
     
     
         160 . The method of  claim 149 , wherein the human is treated without substantial side effects. 
     
     
         161 . The method of  claim 149 , wherein the iontophoretic patch comprises an electrode that does not react to form an insoluble salt of the triptan compound. 
     
     
         162 . The method of  claim 149 , wherein the iontophoretic patch includes an electrode comprising zinc or a zinc coating. 
     
     
         163 . The method of  claim 149 , wherein the triptan is formulated in a flowable hydrogel. 
     
     
         164 . The method of  claim 149 , wherein a plasma concentration of greater than 10 ng/mL of the triptan compound is provided to the subject during the initial first stage delivery.