Transdermal Methods And Systems For The Delivery Of Rizatriptan
OwnerAngel S. ANGELOV, David B. LEBOinventors
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Abstract
Iontophoretic patches for the delivery of rizatriptan and methods of using the patches are described.
Claims27
A method for treating a subject for a rizatriptan responsive state, comprising transdermally administering to the subject an effective amount of rizatriptan or a salt thereof in less than 45 minutes using an integrated iontophoretic patch, wherein the rizatriptan or salt thereof is formulated in a flowable hydrogel and wherein said patch uses a current density selected such that said current does not substantially irritate said subject's skin.
The method according to any one of the preceding claims, wherein the patch provides rizatriptan at an iontophoretic flux rate of about 22.9 mcg/cm2/min or greater across the subject's skin.
The method according to any one of the preceding claims, wherein the patch provides rizatriptan at an iontophoretic flux rate of about 28.5 mcg/cm2/min or greater across the subject's skin.
The method according to any of the preceding claims, wherein said patch uses an average current density of 0.20 mA/cm2 or less for a significant portion of delivery time of the rizatriptan or salt thereof.
The method according to any of the preceding claims, wherein said patch uses an average current density of 0.15 mA/cm2 or less for a significant portion of delivery time of the rizatriptan or salt thereof.
The method according to any of the preceding claims, wherein said patch uses an average current density of 0.10 mA/cm2 or less for a significant portion of delivery time of the rizatriptan or salt thereof.
The method according to any of the preceding claims, wherein said patch uses an average current density of 0.05 mA/cm2 or less for a significant portion of delivery time of the rizatriptan or salt thereof.
The method according to any of the preceding claims, wherein the patch provides an uninterrupted two-stage patterned delivery sequence wherein current densities average between about 0.05 and about 0.40 mA/cm2 during a significant portion of a first stage followed by a second stage delivery wherein current densities average between about 0.01 and about 0.40 mA/cm2 during a significant portion of the second stage, to provide a waveform delivery pattern in which a therapeutically effective dosage level is reached in a subject in less than about one hour and a maintenance level is continued for one or more hours.
The method according to any one of the preceding claims, wherein usage of the patch to deliver a steady state concentration of said rizatriptan results in a mean skin erythema score of 1.00 or less immediately after patch removal.
The method according to any one of the preceding claims, wherein usage of the patch to deliver a steady state concentration of said rizatriptan results in a mean skin erythema score of 0.50 or less immediately after patch removal.
The method according to any one of the preceding claims, wherein usage of the patch to deliver a steady state concentration of said rizatriptan results in a mean skin erythema score of zero immediately after patch removal.
The method according to any one of the preceding claims, wherein said hydrogel comprises a flux enhancer.
An integrated iontophoretic transdermal patch for the delivery of rizatriptan or a salt thereof to a subject in need thereof, comprising
- a controller to deliver at least a portion of said rizatriptan or salt thereof to the subject by driving an electrotransport current through an animal body surface using a controllable power supply;
- an electrode which does not form an insoluble salt of the rizatriptan or salt thereof;
- and
- a composition comprising rizatriptan or a salt thereof formulated in a flowable hydrogel;
- wherein the patch delivers an effective amount of rizatriptan or a salt thereof to the subject in less than 45 minutes.
Dependencies are inferred from the claim text.