Polyamine enhanced formulations for triptan compound iontophoresis

Abstract

A patch and compositions for iontophoresis of triptan compounds are described.

1 - 28 . (canceled) 
     
     
         29 . An iontophoretic transdermal patch for the delivery of a triptan compound to a subject in need thereof, wherein the patch comprises an anode reservoir and a cathode reservoir, wherein the anode reservoir comprises a polyamine hydrogel formed from a polyamine salt of a polyacrylate copolymer and an organic acid, and a gel forming amount of water; and wherein the polyamine hydrogel further comprises:
 between about 3% and about 20% of the triptan compound in intimate mixture with the hydrogel, and   optionally one or more additives.   
     
     
         30 . The iontophoretic transdermal patch of  claim 29 , wherein the hydrogel comprises at least about 80% water and between about 3.0% and about 5.0% triptan compound. 
     
     
         31 . The iontophoretic transdermal patch of  claim 29 , wherein the hydrogel comprises between about 3% and about 10% polyamine salt. 
     
     
         32 . The iontophoretic transdermal patch of  claim 29 , wherein the hydrogel comprises between about 10% and about 18% polyamine salt. 
     
     
         33 . The iontophoretic transdermal patch of  claim 29 , wherein the polyamine salt is a salt of a methacrylate copolymer. 
     
     
         34 . The iontophoretic transdermal patch of  claim 29 , wherein the methacrylate co-polymer is an alkylated methacrylate copolymer. 
     
     
         35 . The iontophoretic transdermal patch of  claim 29 , wherein the hydrogel comprises between about 0.01% and about 1.0% antimicrobial agent. 
     
     
         36 . The iontophoretic transdermal patch of  claim 29 , wherein the organic acid comprises lauric acid, which is present in an amount between about 0.5% and about 7.0%. 
     
     
         37 . The iontophoretic transdermal patch of  claim 29 , wherein the organic acid comprises adipic acid, which is present in an amount between about 0.1% and about 2.0%. 
     
     
         38 . The iontophoretic transdermal patch of  claim 29 , wherein the triptan compound is almotriptan, frovatriptan, eletriptan, zolmitriptan, rizatriptan, sumatriptan, naratriptan, or a pharmaceutically acceptable salt thereof. 
     
     
         39 . The iontophoretic transdermal patch of  claim 29 , wherein the triptan compound is sumatriptan or a salt thereof. 
     
     
         40 . The iontophoretic transdermal patch of  claim 29 , wherein the triptan compound is sumatriptan succinate or sumatriptan hydrochloride. 
     
     
         41 . The iontophoretic transdermal patch of  claim 29 , wherein the patch is capable of administering an effective amount of the triptan compound without substantially affecting skin pH. 
     
     
         42 . The iontophoretic transdermal patch of  claim 29 , wherein the patch is capable of administering an effective amount of the triptan compound without substantially affecting skin temperature. 
     
     
         43 . The iontophoretic transdermal patch of  claim 29 , wherein the hydrogel has a pH of between about 3 and about 8. 
     
     
         44 . The iontophoretic transdermal patch of  claim 43 , wherein the hydrogel has a pH of between about 5.5 and about 7. 
     
     
         45 . The iontophoretic transdermal patch of  claim 44 , wherein the hydrogel has a pH of about 6. 
     
     
         46 . The iontophoretic transdermal patch of  claim 29 , wherein the anode reservoir further comprises a solubility enhancer, a permeation enhancer, an antimicrobial agent or any combination thereof. 
     
     
         47 . The iontophoretic transdermal patch of  claim 29 , wherein the patch comprises a battery which operates throughout use of the patch. 
     
     
         48 . The iontophoretic transdermal patch of  claim 29 , wherein the patch delivers a desired concentration of the triptan compound in less than one hour. 
     
     
         49 . The iontophoretic transdermal patch of  claim 29 , wherein the anode reservoir consists essentially of a polyamine hydrogel formed from:
 a polyamine salt of a polyacrylate copolymer and adipic acid, and   a gel forming amount of water;   wherein the polyamine hydrogel further comprises:   between about 3% and about 10% of a triptan compound in intimate mixture with the hydrogel, and   between about 0.05% and about 1.0% methyl para-hydroxy benzoate.   
     
     
         50 . The iontophoretic transdermal patch of  claim 29 , wherein the organic acid is a fatty acid, a dicarboxylic acid or a mixture thereof. 
     
     
         51 . An iontophoretic transdermal patch for the delivery of sumatriptan or a salt thereof, wherein the patch comprises an anode reservoir and a cathode reservoir, wherein the anode reservoir comprises a polyamine hydrogel formed from:
 an alkylated methacrylate copolymer,   at least about 80% water,   between about 1.0% and about 5.0% lauric acid, and   between about 0.05% and about 0.75% adipic acid; and   wherein the polyamine hydrogel further comprises:   between about 3% and about 10% sumatriptan or salt thereof in intimate mixture with the hydrogel, and   between about 0.02% and about 0.5% methyl para-hydroxy benzoate.   
     
     
         52 . The iontophoretic transdermal patch of  claim 51 , wherein sumatriptan or a salt thereof is sumatriptan succinate. 
     
     
         53 . An iontophoretic transdermal patch for the delivery of sumatriptan succinate, wherein the patch comprises an anode reservoir and a cathode reservoir, wherein the anode reservoir comprises a polyamine hydrogel formed from:
 between about 84% and about 88% water;   between about 4.0% and about 7.0% alkylated methacrylate co-polymer;   between about 1.0% and about 5.0% lauric acid; and   between about 0.05% and about 0.75% adipic acid;   wherein the polyamine hydrogel further comprises:   between about 3.0% and about 5.0% sumatriptan succinate in intimate mixture with the hydrogel, and   between about 0.05% and about 0.75% methyl para-hydroxy benzoate.