TRANSDERMAL METHODS AND SYSTEMS FOR THE DELIVERY OF ANTI-MIGRAINE COMPOUNDS
Iontophoretic patches for the delivery of anti-migraine compounds and methods of using the patches are described.
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.