POLYAMINE ENHANCED FORMULATIONS FOR TRIPTAN COMPOUND IONTOPHORESIS
A patch and compositions for iontophoresis of triptan compounds are described.
1 - 29 . (canceled)
30 . An iontophoretic transdermal patch for the delivery of a triptan compound, 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;
wherein the polyamine hydrogel further comprises:
about 3% to about 20% of the triptan compound in intimate mixture with the hydrogel, and
optionally one or more additives.
31 . The iontophoretic transdermal patch of claim 30 , wherein the hydrogel comprises at least about 80% water and about 3.0% to about 5.0% triptan compound.
32 . The iontophoretic transdermal patch of claim 30 , wherein the hydrogel comprises between about 3% and about 10% polyamine salt.
33 . The iontophoretic transdermal patch of claim 30 , wherein the hydrogel comprises between about 10% and about 18% polyamine salt.
34 . The iontophoretic transdermal patch of claim 30 , wherein the polyamine salt is a salt of a methacrylate copolymer.
35 . The iontophoretic transdermal patch of claim 30 , wherein the methacrylate co-polymer is an alkylated methacrylate copolymer.
36 . The iontophoretic transdermal patch of claim 30 , wherein the hydrogel comprises about 0.01% to about 1.0% antimicrobial agent.
37 . The iontophoretic transdermal patch of claim 30 , wherein the organic acid comprises lauric acid, which is present in an amount between about 0.5% and about 7.0%.
38 . The iontophoretic transdermal patch of claim 30 , wherein the organic acid comprises adipic acid, which is present in an amount between about 0.1% and about 2.0%.
39 . The iontophoretic transdermal patch of claim 30 , wherein the triptan compound is almotriptan, frovatriptan, eletriptan, zolmitriptan, rizatriptan, sumatriptan, naratriptan, or a pharmaceutically acceptable salt thereof.
40 . The iontophoretic transdermal patch of claim 30 , wherein the triptan compound is sumatriptan or a salt thereof.
41 . The iontophoretic transdermal patch of claim 30 , wherein the triptan compound is sumatriptan succinate or sumatriptan hydrochloride.
42 . The iontophoretic transdermal patch of claim 30 , wherein the patch is capable of administering an effective amount of the triptan compound without substantially affecting skin pH.
43 . The iontophoretic transdermal patch of claim 30 , wherein the patch is capable of administering an effective amount of the triptan compound without substantially affecting skin temperature.
44 . The iontophoretic transdermal patch of claim 30 , wherein the hydrogel has a pH of about 3 to about 8.
45 . The iontophoretic transdermal patch of claim 44 , wherein the hydrogel has a pH of about 5.5 to about 7.
46 . The iontophoretic transdermal patch of claim 45 , wherein the hydrogel has a pH of about 6.
47 . The iontophoretic transdermal patch of claim 30 , wherein the anode reservoir further comprises a solubility enhancer, a permeation enhancer, an antimicrobial agent or any combination thereof.
48 . The iontophoretic transdermal patch of claim 30 , wherein the patch comprises a battery which operates throughout use of the patch.
49 . The iontophoretic transdermal patch of claim 30 , wherein the patch delivers a desired concentration of the triptan compound in less than one hour.
50 . The iontophoretic transdermal patch of claim 30 , 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 0.75% methyl para-hydroxy benzoate.
51 . The iontophoretic transdermal patch of claim 30 , wherein the organic acid is a fatty acid, a dicarboxylic acid or a mixture thereof.
52 . 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.
53 . The method of claim 52 , wherein sumatriptan or a salt thereof is sumatriptan succinate.
54 . 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:
approximately 84% to about 88% water;
approximately 4.0% to about 7.0% alkylated methacrylate co-polymer;
approximately 1.0% to about 5.0% lauric acid; and
approximately 0.05% to about 0.75% adipic acid;
wherein the polyamine hydrogel further comprises:
approximately 3.0% to about 5.0% sumatriptan succinate in intimate mixture with the hydrogel, and
approximately 0.05% to about 0.75% methyl para-hydroxy benzoate.