WO2012075209A1 - Administration de triptans par des systèmes de micro-injection - Google Patents

Administration de triptans par des systèmes de micro-injection Download PDF

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Publication number
WO2012075209A1
WO2012075209A1 PCT/US2011/062744 US2011062744W WO2012075209A1 WO 2012075209 A1 WO2012075209 A1 WO 2012075209A1 US 2011062744 W US2011062744 W US 2011062744W WO 2012075209 A1 WO2012075209 A1 WO 2012075209A1
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Prior art keywords
triptan
formulation
subject
minutes
concentration
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PCT/US2011/062744
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English (en)
Inventor
Anthony P. Deasey
Patrick Frankham
Wolfgang Renz
Thomas Lang
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Lanco Biosciences, Inc.
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Publication date
Application filed by Lanco Biosciences, Inc. filed Critical Lanco Biosciences, Inc.
Publication of WO2012075209A1 publication Critical patent/WO2012075209A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4196—1,2,4-Triazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/42—Oxazoles
    • A61K31/422—Oxazoles not condensed and containing further heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/454—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0023—Drug applicators using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/003—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a lumen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0046—Solid microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0061—Methods for using microneedles

Definitions

  • Migraine is a neurological syndrome characterized by altered bodily perceptions, severe headaches, and nausea.
  • Sumatriptan is a triptan sulfa drug containing a sulfonamide group for the treatment of migraine headaches.
  • Sumatriptan is an agonist for a vascular 5-HT
  • the vascular 5-HTi receptor subtype that sumatriptan activates is present on the human basilar artery, and in the vasculature of human aura mater and mediates vasoconstriction. This action in humans correlates with the relief of migraine headaches.
  • Sumatriptan succinate can be used for the acute treatment of migraine attacks with or without aura in adults.
  • Suppression of migraine headaches can result from sumatriptan- induced decreases in the firing of serotonergic (5-hydroxytryptaminergic, 5-HT) neurons.
  • Agonist activity at the 5- HTID receptor subtype can provide relief of acute headache.
  • An aspect of the invention provides a system comprising a microinjection device and a triptan formulation, the microinjection device comprising a microneedle array having one or more hollow tips for delivering a triptan formulation; a housing having the microneedle array and a skin-contacting face defining an opening that can be positioned at or adjacent to a target site; and a driver for moving the microneedle array toward the target site.
  • the triptan formulation has a pH between about 3.0 and 9.0.
  • the triptan formulation has a pH between about 4.0 and 8.5.
  • the triptan formulation has a pH between about 5.0 and 7.5.
  • the triptan formulation has a pH between about 5.4 and 6.0. In another embodiment, the triptan formulation comprises sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan, almotriptan, frovatriptan, avitriptan or a pharmaceutically acceptable derivative thereof. In another embodiment, the triptan formulation has a triptan concentration between about 1.0 mg in 0.1 mL and 40 mg in 0.1 mL. In another embodiment, the triptan formulation has a triptan concentration between about 5 mg in 0.1 mL and 30 mg in 0.1 mL. In another embodiment, the triptan formulation comprises a pharmaceutically acceptable excipient.
  • Another aspect of the invention provides a method for delivering a triptan to a subject, comprising providing a microinjection device comprising a microneedle array and a triptan-containing formulation; and delivering the triptan-containing formulation to the subject with the aid of the microinjection device.
  • the triptan-containing formu lation has a pH between about 3.0 and 9.0.
  • the triptan-containing formulation has a pH between about 4.0 and 8.5.
  • the triptan-containing formulation has a pH between about 5.0 and 7.5.
  • the triptan-containing formulation has a pH between about 5.4 and 6.0.
  • the triptan-containing formulation comprises sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan, almotriptan, frovatriptan, avitriptan or a pharmaceutically acceptable derivative thereof.
  • the triptan-containing formulation has a triptan concentration between about 1.0 mg in 0. 1 mL and 40 mg in 0.1 mL.
  • the triptan-containing formu lation has a triptan concentration between about 5 mg in 0.1 mL and 30 mg in 0. 1 mL.
  • the triptan-containing formulation comprises a pharmaceutically acceptable excipient.
  • Another aspect of the invention provides a method for treating migraines or migraine headaches, comprising using a microinjection device comprising a microneedle array and a triptan formulation to administer to a subject the triptan formulation.
  • the triptan formulation is administered to the subject on a daily basis.
  • the triptan formulation is administered to the subject at a dosage of between about 1 mg in 0. 1 milliliters and 40 mg in 0, 1 milliliters of the triptan formulation.
  • the triptan formulation is delivered to the subject in a length of time between about 0.1 seconds and 10 minutes.
  • the triptan formulation is delivered to the subject in a length of time between about 30 seconds and 8 minutes.
  • the triptan formulation is delivered transdermal ly. In another embod iment, the triptan formulation is delivered intradermal ly. In another embodiment, the triptan formulation has a pH between about 3.0 and 9.0. In another embodiment, the triptan formulation has a pH between about 4.0 and 8.5. In another embodiment, the triptan formulation has a pH between about 5.0 and 7.5. In another embodiment, the triptan formulation has a pH between about 5.4 and 6.0.
  • the triptan formulation comprises sumatriptan, rizatriptan, naratriptan, zo lmitriptan, eletriptan, almotriptan, frovatriptan, avitriptan or a pharmaceutically acceptable derivative thereof.
  • Another aspect of the invention provides a system comprising an application device and a triptan formulation, the application device comprising a housing having a skin-contacting face defining an opening that can be positioned at a target site, the housing having a microneedle array; and an impactor for impacting the microneedle array and accelerating the microneedle array toward the target site, the microneedle array configured to deliver the triptan formulation to the subject.
  • the impactor is configured to move along a substantially arcuate path to move the microneedle array toward the target site.
  • the triptan formulation comprises sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan, almotriptan, frovatriptan, avitriptan or a pharmaceutically acceptable derivative thereof.
  • the triptan formulation has a pH between about 3.0 and 9.0.
  • the triptan formulation has a pH between about 4.0 and 8.5.
  • the triptan formulation has a pH between about 5.0 and 7.5.
  • the triptan formulation has a pH between about 5.4 and 6.0.
  • the triptan formulation has a triptan concentration between about 1.0 mg in 0.1 mL and 40 mg in 0.1 mL.
  • the triptan formulation has a triptan concentration between about 5 mg in 0.1 mL and 30 mg in 0.1 mL.
  • the microinjection device having a triptan formulation, the microinjection device for delivering the triptan formulation to a subject.
  • the triptan formulation comprises sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan, almotriptan, frovatriptan, avitriptan or a pharmaceutically acceptable derivative thereof.
  • the triptan formulation has a pH between about 3.0 and 9.0.
  • the triptan formulation has a pH between about 4.0 and 8.5.
  • the triptan formulation has a pH between about 5.0 and 7.5.
  • the triptan formulation has a pH between about 5.4 and 6.0. In another embodiment, the triptan formulation has a pH between about 5.4 and 6.0. In another
  • the triptan formulation has a triptan concentration between about 1.0 mg in 0.1 mL and 40 mg in 0.1 mL. In another embodiment, the triptan formulation has a triptan concentration between about 5 mg in 0.1 mL and 30 mg in 0.1 mL.
  • a microinjection device for subcutaneous, transdermal or intradermal delivery of a triptan formulation, comprising a microneedle array for delivering a triptan formulation to a subject; and one or more chambers in fluid communication with the microneedle array, the one or more chambers having a triptan formulation.
  • the microneedle array comprises microneedles having hollow tips.
  • the triptan formulation comprises sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan, almotriptan, frovatriptan, avitriptan or a pharmaceutically acceptable derivative thereof.
  • the triptan formulation has a pH between about 3.0 and 9.0. In another embodiment, the triptan formulation has a pH between about 4.0 and 8.5. In another embodiment, the triptan formulation has a pH between about 5.0 and 7.5. In another
  • the triptan formulation has a pH between about 5.4 and 6.0. In another embodiment, the triptan formulation has a triptan concentration between about 1.0 mg in 0. 1 mL and 40 mg in 0.1 mL. In another embodiment, the triptan formulation has a triptan concentration between about 5 mg in 0.1 mL and 30 mg in 0.1 mL.
  • Another aspect of the invention provides a system for the administration of a triptan to a subject, comprising a triptan formulation; and a microinjection device configured to deliver the triptan formulation to the subject.
  • the triptan formulation comprises sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan, almotriptan, frovatriptan, avitriptan or a pharmaceutically acceptable derivative thereof.
  • the triptan formulation has a pH between about 3.0 and 9.0.
  • the triptan formulation has a pH between about 4.0 and 8.5.
  • the triptan formulation has a pH between about 5.0 and 7.5. In another embodiment, the triptan formulation has a pH between about 5.4 and 6.0. In another embodiment, the triptan formulation has a triptan concentration between about 1.0 mg in 0.1 mL and 40 mg in 0.1 mL. In another embodiment, the triptan formulation has a triptan concentration between about 5 mg in 0. 1 mL and 30 mg in 0. 1 mL.
  • Another aspect of the invention provides a system for applying a microneedle array to a subject's skin, comprising a triptan formulation; a housing having a skin-contacting face defining an opening that can be positioned at a target site, the housing having a microneed le array; and an impactor for impacting the microneedle array and accelerating the microneedle array toward the target site, the microneedle array configured to deliver the triptan formulation to the subject.
  • the impactor is configured to move along a substantially arcuate path to move the microneedle array toward the target site.
  • the triptan formulation is contained in the housing.
  • the triptan formulation comprises sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan, almotriptan, or a
  • the triptan formulation has a pH between about 3.0 and 9.0. In another embodiment, the triptan formu lation has a pH between about 4.0 and 8.5. In another embodiment, the triptan formulation has a pH between about 5.0 and 7.5. In another embodiment, the triptan formulation has a pH between about 5.4 and 6.0. In another embodiment, the triptan formulation has a triptan concentration between about 1.0 mg in 0.1 mL and 40 mg in 0.1 mL. In another embodiment, the triptan formu lation has a triptan concentration between about 5 mg in 0. 1 mL and 30 mg in 0.1 mL.
  • Another aspect of the invention provides a system for subcutaneous, transdermal or intradermal delivery of a triptan to a subject, comprising a triptan formulation; a microneedle array for delivering the triptan formulation to a subject; and one or more chambers in fluid communication with the microneedle array, the one or more chambers having the triptan formulation.
  • the triptan formulation comprises sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan, almotriptan, frovatriptan, avitriptan or a pharmaceutically acceptable derivative thereof.
  • the triptan formulation has a pH between about 3.0 and 9.0.
  • the triptan formulation has a pH between about 4.0 and 8.5. In another embodiment, the triptan formulation has a pH between about 5.0 and 7.5. I n another embodiment, the triptan formulation has a pH between about 5.4 and 6.0. In another embodiment, the triptan formulation has a triptan concentration between about 1.0 mg in 0. 1 mL and 40 mg in 0. 1 mL. In another embodiment, the triptan formulation has a triptan concentration between about 5 mg in 0. 1 mL and 30 mg in 0. 1 mL.
  • Another aspect of the invention provides a system for delivering a triptan formulation to a subject, comprising a triptan formulation; a microneedle array having one or more hollow tips for delivering the triptan formulation; a housing having the microneedle array and a skin- contacting face defining an opening that can be positioned at or adjacent to a target site; and a driver for moving the microneedle array toward the target site, thereby delivering the triptan formulation to the subject.
  • the triptan formulation comprises sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan, almotriptan, frovatriptan, avitriptan or a pharmaceutically acceptable derivative thereof.
  • the triptan formulation has a pH between about 3.0 and 9.0.
  • the triptan formulation has a pH between about 4.0 and 8.5.
  • the triptan formulation has a pH between about 5.0 and 7.5.
  • the triptan formulation has a pH between about 5.4 and 6.0.
  • the triptan formulation has a triptan concentration between about 1.0 mg in 0.1 mL and 40 mg in 0.1 mL.
  • the triptan formulation has a triptan concentration between about 5 mg in 0. 1 mL and 30 mg in 0.1 mL.
  • a microinjection device comprising a hollow microneedle array and a triptan formulation, the microinjection device for delivering the triptan formulation to a subject.
  • the triptan formulation comprises sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan, almotriptan, frovatriptan, avitriptan or a pharmaceutically acceptable derivative thereof.
  • the triptan formulation has a pH between about 3.0 and 9.0.
  • the triptan formulation has a pH between about 4.0 and 8.5.
  • the triptan formulation has a pH between about 5.0 and 7.5.
  • the particles are administered to a subject's skin at a high velocity.
  • the triptan formulation comprises sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan, almotriptan, frovatriptan, avitriptan or a pharmaceutically acceptable derivative thereof.
  • the triptan formulation has a pH between about 3.0 and 9.0.
  • the triptan formulation has a pH between about 4.0 and 8.5.
  • the triptan formulation has a pH between about 5.0 and 7.5.
  • the triptan formulation has a pH between about 5.4 and 6.0.
  • the triptan formulation has a triptan concentration between about 1 .0 mg in 0.1 mL and 40 mg in 0.1 mL. In another embodiment, the triptan formulation has a triptan concentration between about 5 mg in 0.1 mL and 30 mg in 0.1 mL.
  • Another aspect of the invention provides a method for subcutaneous, transdermal or intradermal delivery of a triptan formulation to a subject, comprising administering the triptan formulation to the subject by microneedle injection, hydration, ablation of the subject's skin, follicular delivery, ultrasound, iontophoresis or electroporation.
  • the triptan formulation is administered to the subject by microneedle injection.
  • the triptan formulation is administered to the subject by iontophoresis.
  • the triptan formulation comprises sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan, almotriptan, frovatriptan, avitriptan or a pharmaceutically acceptable derivative thereof.
  • the triptan formulation has a pH between about 3.0 and 9.0.
  • the triptan formulation has a pH between about 4.0 and 8.5.
  • the triptan formulation has a pH between about 5.0 and 7.5.
  • the triptan formulation has a pH between about 5.4 and 6.0.
  • the triptan formulation has a triptan concentration between about 1.0 mg in 0. 1 mL and 40 mg in 0.1 mL.
  • the triptan formulation has a triptan concentration between about 5 mg in 0.1 mL and 30 mg in 0.1 mL.
  • Another aspect of the invention provides a system for delivering a triptan formulation to a subject, comprising a triptan formulation having an excipient; and a microinjection device configured to deliver the triptan formulation to the subject.
  • a system for delivering a triptan formulation to a subject comprising a triptan formulation having an excipient; and a microinjection device configured to deliver the triptan formulation to the subject.
  • the microinjection device is configured to deliver at least about 1 mg, or 5 mg, or 10 mg, or 1 5 mg, or 20 mg of the triptan in 0.1 mL of the triptan formulation to the subject.
  • the triptan formulation comprises sumatriptan, rizatriptan, naratriptan, zo lmitriptan, eletriptan, almotriptan, frovatriptan, avitriptan or a pharmaceutically acceptable derivative thereof.
  • the triptan formulation has a pH between about 3.0 and 9.0.
  • the triptan formulation has a pH between about 4.0 and 8.5.
  • the triptan formulation has a pH between about 5.0 and 7.5.
  • the triptan formulation has a pH between about 5.4 and 6.0. In another embodiment, the triptan formulation has a triptan concentration between about 1 .0 mg in 0. 1 mL and 40 mg in 0.1 mL. In another embodiment, the triptan formulation has a triptan concentration between about 5 mg in 0.1 mL and 30 mg in 0.1 mL.
  • the excipient includes one or more of croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose and sodium bicarbonate. In another embodiment, the excipient is a pharmaceutically acceptable excipient.
  • Another aspect of the invention provides a system for the administration of a triptan to a subject, comprising a triptan formulation; and a drug delivery device configured to deliver the triptan formulation to said subject by microneedle injection, hydration, ablation of the subject's skin, follicular delivery, ultrasound, iontophoresis or electroporation.
  • a drug delivery device configured to deliver the triptan formulation to said subject by microneedle injection, hydration, ablation of the subject's skin, follicular delivery, ultrasound, iontophoresis or electroporation.
  • the triptan formulation is admin istered to the subject by microneedle injection. In another embodiment, the triptan formulation is administered to the subject by iontophoresis. In another embodiment, the triptan formulation comprises sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan, almotriptan, frovatriptan, avitriptan or a pharmaceutically acceptable derivative thereof.
  • the triptan formu lation has a pH between about 3.0 and 9.0. In another embodiment, the triptan formulation has a pH between about 4.0 and 8.5. In another embodiment, the triptan formulation has a pH between about 5.0 and 7.5. In another embodiment, the triptan formulation has a pH between about 5.4 and 6.0. In another
  • the triptan formulation has a triptan concentration between about 1 .0 mg in 0. 1 mL and 40 mg in 0.1 mL. In another embodiment, the triptan formulation has a triptan concentration between about 5 mg in 0. 1 mL and 30 mg in 0. 1 mL.
  • FIG. 1 A is a perspective view of a microinjection device having a microneed le assembly, in accordance with an embodiment of the invention
  • FIG. 1 B is a perspective side view of an array of microneedles, in accordance with an embod iment of the invention
  • FIG. 2 is a schematic cross-sectional side view of a microinjection device having an array of microneedles, in accordance with an embodiment of the invention
  • FIG. 3 is a schematic cross-sectional side view of a portion of the microinjection device of FIG. 2, in accordance with an embodiment of the invention
  • FIG. 4 is a schematic perspective side view of a microneedle device comprising a patch, in accordance with an embodiment of the invention.
  • FIG. 5A is a perspective side view of an array of microneedles, in accordance with an embodiment of the invention.
  • FIG. 5B is a cross-sectional side view of a microneedle in the array of FIG. 5A, in accordance with an embodiment of the invention;
  • FIG. 6 is a schematic side view of a microneedle application device, in accordance with an embodiment of the invention.
  • FIG. 7 is a schematic cross sectional side view of the microneedle application device of FIG. 6, in accordance with an embodiment of the invention.
  • FIG. 8 is a schematic cross sectional side view of a collar of the microneedle application device of FIGs. 6 and 7, in accordance with an embodiment of the invention.
  • FIG. 9A is a schematic perspective view of an applicator device having peelable seals, in accordance with an embodiment of the invention.
  • FIG. 9B is a schematic perspective view of the applicator of FIG. 9A with the peelable seals removed, in accordance with an embodiment of the invention.
  • FIG. 9C is a schematic cross-sectional view of the applicator of FIGs. 9A and 9B in a loaded position, in accordance with an embodiment of the invention.
  • FIG. 9D is a schematic cross-sectional view of the applicator of FIGs. 9A and 9B in a partially released position, in accordance with an embodiment of the invention.
  • FIG. 9E is a schematic cross-sectional view of the applicator of FIGs.
  • FIG. 9F is a schematic cross-sectional view of the applicator of FIGs. 9A and 9B being removed from a microneedle array that has been deployed onto a target surface, in accordance with an embodiment of the invention
  • FIG. 10 is a schematic cross-sectional side view of an applicator device, in accordance with an embodiment of the invention.
  • FIG. 1 1 is a schematic perspective view of a portion of the applicator device of FIG. 10, in accordance with an embodiment of the invention
  • FIG. 12 is a schematic perspective view of an applicator device having a patch, in accordance with an embodiment of the invention.
  • FIG. 13 is a schematic partial cross-sectional side view of a microneedle array cartridge mounted on an applicator device, in accordance with an embodiment of the invention.
  • triptan can include any triptan chemical, species or compound.
  • Triptans can include species or compounds having the sulfonamide functional group, RSO2NH2, wherein 'R' is a side group, such as an organic side group.
  • a triptan can include sumatriptan, a derivative of sumatriptan, or a variant of sumatriptan.
  • a triptan can include a triptan sulfa compound or drug, a variant of a triptan sulfa compound or drug, or a derivative of a triptan sulfa compound or drug.
  • a triptan can include sumatriptan, having the chemical formu la C14H21N3O2S and systematic name l -[3-(2-dimethylaminoethyl)- l H- indol-5-yl]-N-methyl- methanesulfonamide, a variant or derivative of sumatriptan, or a pharmaceutically acceptable variant or derivative of sumatriptan.
  • a triptan can include rizatriptan (Maxalt), naratriptan, zolmitriptan, eletriptan, almotriptan, frovatriptan, avitriptan or a combination or pharmaceutically acceptable derivative thereof.
  • a triptan or triptan-containing drug or formulation can inc lude other medically active or inactive species, compounds, or formulations.
  • transdermal and “transdermally,” as used herein, can refer to transdermal drug delivery.
  • transdermal drug delivery can include delivering a drug or formulation to a subject across the subject's skin.
  • transdermal drug delivery can include delivering a drug or formulation to a subject across the subject's skin and into a blood vessel.
  • intradermal and “intradermally,” as used herein, can refer to intradermal drug delivery.
  • intradermal drug delivery can include delivering a drug or formulation to a subject in or into the subject's skin.
  • subcutaneous injection can refer to an injection that is administered as a bolus into the subcutis, i.e., the layer of skin directly below the dermis and epidermis (collectively referred to as the cutis).
  • triptan compounds are provided that can be used to treat headaches and migraine headaches.
  • triptan compounds include triptan sulfa- containing drugs or formulations.
  • triptan compounds include sumatriptan or pharmaceutically acceptable derivatives of sumatriptan.
  • an injection solution comprising a triptan compound can be filled into primary packaging, such as an injection or microinjection apparatuses, as described below.
  • Triptan compounds and formulations of embodiments of the invention can be admin istered to one or more subjects with the aid of injection or microinjection apparatuses of embodiments of the invention.
  • a triptan compound such as a triptan sulfa-containing compound
  • a formulation that further comprises other compounds or agents, such as other pharmacological agents.
  • triptan compounds are provided that are structurally similar to serotonin (5HT), and are 5-HT (types 5-HT
  • the triptan compound is a triptan sulfa drug.
  • the triptan compound is sumatriptan or pharmaceutically acceptable derivative of sumatriptan.
  • the triptan compound is a variant or derivative of a triptan sulfa drug (or compound).
  • the triptan compound is l -[3-(2-dimethylaminoethyl)- l H-indol-5-yl]-N-methyl- methanesulfonamide, a variant, or derivative.
  • the triptan compound can activate receptor subtypes that can be present on the cranial arteries and veins of a subject. Acting as an agonist at these receptors, the triptan compound can reduce the vascular inflammation associated with headaches and migraine headaches (also "migraines" herein).
  • a triptan compound comprises the su lfonam ide functional group.
  • a triptan compound can include sumatriptan, having the formula
  • a triptan compound can include sumatriptan coordinated to one or more compounds, such as water, acids (e.g., carboxylic acids), bases, and alcohols.
  • a triptan compound can include sumatriptan succinate having the fo llowing structure:
  • a triptan compound can include rizatriptan, having the formu la
  • a triptan compound inc lude naratriptan, having the formula
  • a triptan compound can include zolm itriptan, having the formula C16H21N3O2, and the followin structure:
  • a triptan compound can include eletriptan, having the formula C22H26N2O2S, and the following structure:
  • a triptan compound can include almotriptan, having the formu la C17H25N3O2S, and the followin structure:
  • a triptan compound can include frovatriptan, having the formula C14H17N3O, and the following structure:
  • a triptan compound can include avitriptan, having the formula C22H30N6O3S, and the follo
  • a triptan-containing formulation can be configured for one or more of subcutaneous delivery, intradermal delivery and transdermal delivery to a subject (e.g., patient).
  • a triptan-containing formulation can be delivered to a subject with the aid of microinjection or microneedle devices, as described below.
  • a triptan compound can have the empirical formula C14H21 3O2S, representing a molecular weight of about 295.4 g/mol.
  • a triptan compound can be a white to off-white substance, such as a powder, that is readily soluble in water and in a saline solution.
  • a triptan formulation can have a pH between about 3.0 and 9.0, or between about 4.0 and 8.5, or between about 5.0 and 7.5, or between about 5.4 and 6.0.
  • a triptan formu lation can have a pH of about 4.0, or 4. 1 , or 4.2, or 4.3, or 4.4, or 4.5, or 4.6, or 4.7, or 4.8, or 4.9, or 5.0, or 5. 1 , or 5.2, or 5.3, or 5.4, or 5.5, or 5.6, or 5.7, or 5.8, or 5.9, or 6.0, or 6.1 , or 6.2, or 6.3, or 6.4, or 6.5.
  • a triptan and su lfa-containing formulation can have a pH between about 3.0 and 9.0, or between about 4.0 and 8.5, or between about 5.0 and 7.5, or between about 5.4 and 6.0.
  • a triptan and sulfa-containing formulation can have a pH of about 4.0, or 4.1 , or 4.2, or 4.3, or 4.4, or 4.5, or 4.6, or 4.7, or 4.8, or 4.9, or 5.0, or 5. 1 , or 5.2, or 5.3, or 5.4, or 5.5, or 5.6, or 5.7, or 5.8, or 5.9, or 6.0, or 6. 1 , or 6.2, or 6.3, or 6.4, or 6.5.
  • a sumatriptan formulation can have a pH between about 3.0 and 9.0, or between about 4.0 and 8.5, or between about 5.0 and 7.5, or between about 5.4 and 6.0.
  • a sumatriptan formulation can have a pH of about 4.0, or 4. 1 , or 4.2, or 4.3, or 4.4, or 4.5, or 4.6, or 4.7, or 4.8, or 4.9, or 5.0, or 5.1 , or 5.2, or 5.3, or 5.4, or 5.5, or 5.6, or 5.7, or 5.8, or 5.9, or 6.0, or 6. 1 , or 6.2, or 6.3, or 6.4, or 6.5.
  • a triptan formulation can have an osmolality between about 200 mOsmol and 1000 mOsmol, or between about 300 mOsmol and 800 mOsmol. In another embodiment, a triptan formulation can have an osmolality between about 300 mOsmol and 400 mOsmol, or between about 350 mOsmol and 390 mOsmol. In another embodiment, a triptan formulation can have an osmolality between about 700 mOsmol and 800 mOsmol, or between about 720 mOsmol and 750 mOsmol.
  • a triptan formulation can have an osmolality of about 370 mOsmol, or 371 mOsmol, or 372 mOsmol, or 373 mOsmol, or 374 mOsmol, or 375 mOsmol.
  • a triptan formulation can have an osmolality of about 740 mOsmol, or 74 1 mOsmol, or 742 mOsmol, or 743 mOsmol, or 744 mOsmol, or 745 mOsmol.
  • a sumatriptan formulation can have an osmolality between about 200 mOsmol and 1000 mOsmol, or between about 300 mOsmol and 800 mOsmol. In another embodiment, a sumatriptan formulation can have an osmolality between about 300 mOsmol and 400 mOsmol, or between about 350 mOsmol and 390 mOsmol. In another embodiment, a sumatriptan formulation can have an osmolality between about 700 mOsmol and 800 mOsmol, or between about 720 mOsmol and 750 mOsmol.
  • a sumatriptan formulation can have an osmolality of about 370 mOsmol, or 371 mOsmol, or 372 mOsmol, or 373 mOsmol, or 374 mOsmol, or 375 mOsmol.
  • a sumatriptan formulation can have an osmolality of about 740 mOsmol, or 741 mOsmol, or 742 mOsmol, or 743 mOsmol, or 744 mOsmol, or 745 mOsmol.
  • a triptan formulation can be lyophilized and formed into an aqueous solution suitable for subcutaneous, transdermal or intradermal injection.
  • a triptan formulation can be formulated in any of the forms known in the art for preparing oral, nasal, buccal, or rectal formulations of peptide drugs.
  • Triptan formulations can be combined or modified with various components, including, without limitation, glidants, lubricants, antioxidants, antimicrobial agents, enzyme inhibitors, stabilizers (including pH stabilizers), retarding agents, preservatives and modifiers.
  • Triptan formulations can include other pharmaceutically active or inactive ingred ients. Such ingredients can be added to provide a desirable fluid property of the formulation, such as a desirable viscosity for administering the formulation using a micro injection device.
  • a triptan formulation can include one or more excipients (inactive ingredients), such as dyes, flavors, binders, emo llients, fillers, lubricants and preservatives.
  • a triptan sulfa-containing formu lation can include one or more excipients, such as dyes, flavors, binders, emollients, fillers, lubricants and preservatives.
  • a triptan formulation can include one or more of cornstarch, lactose, lactose monohydrate, talc, magnesium stearate, sucrose, gelatin, calcium stearate, silicon dioxide, shellac and glaze.
  • a triptan sulfa-containing formulation can include one or more of cornstarch, lactose, lactose monohydrate, talc, magnesium stearate, sucrose, gelatin, calcium stearate, silicon dioxide, shellac, glaze and microcrystalline cellulose.
  • a triptan or triptan sulfa-containing formulation can include one or more excipients selected from lactose, lactose monohydrate, dextrose, sucrose, sorbitol, mannitol, glycine, aspartame, starches, gum acacia, calcium phosphate, alginates, tragacanth, gelatin, calcium silicate, microcrystalline cellulose, polyvinylpyrrolidone, cellulose, sterile water, syrup and methyl cellulose.
  • excipients selected from lactose, lactose monohydrate, dextrose, sucrose, sorbitol, mannitol, glycine, aspartame, starches, gum acacia, calcium phosphate, alginates, tragacanth, gelatin, calcium silicate, microcrystalline cellulose, polyvinylpyrrolidone, cellulose, sterile water, syrup and methyl cellulose.
  • a triptan or triptan sulfa-containing formu lation can also include one or more of lubricating agents (such as talc); magnesium stearate; mineral o il; wetting agents; emulsifying and suspending agents; preserving agents, such as methyl and
  • a triptan or sumatriptan formulation can include one or more of croscarmellose sodium; hypromellose; lactose; magnesium stearate; microcrystalline cellulose; triacetin; and titanium dioxide, iron oxide yellow (2.5-mg tablet only).
  • a triptan or sumatriptan formulation can include one or more of anhydrous lactose, cellulose (or microcrystalline cellulose), sodium starch glycolate, magnesium stearate, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol, and ferric oxide.
  • a triptan or sumatriptan formulation can include one or more of microcrystalline cellulose NF, lactose NF, croscarmellose sodium NF, magnesium stearate NF, titanium dioxide USP, hypromellose and triacetin USP.
  • a triptan or sumatriptan formulation can include one or more of mannitol, cellulose, povidone, sodium starch glycolate, sodium stearyl fumarate, titanium dioxide, hypromellose, polyethylene glycol, propylene glycol and iron oxide.
  • a triptan or sumatriptan formulation can include one or more of lactose NF, microcrystalline cellulose NF, colloidal silicon dioxide NF, sodium starch glycolate NF, magnesium stearate NF, hydroxypropylmethylcellulose USP, polyethylene glycol 3000 USP, triacetin USP, and titanium dioxide USP.
  • a triptan formulation can include one or more inactive ingredients (or excipients) selected from water, monobasic potassium phosphate, anhydrous d ibasic sod ium phosphate, sulfuric acid and sodium hydroxide.
  • a sumatriptan formulation can include one or more inactive ingredients (or excipients) selected from water, monobasic potassium phosphate, anhydrous dibasic sodium phosphate, sulfuric acid and sod ium hydroxide.
  • a triptan formulation can include, in addition to triptan, one or more of croscarmellose sodium, dibasic calcium phosphate, magnesium stearate,
  • a sumatriptan formulation can include, in addition to sumatriptan or a derivative of sumatriptan, one or more of croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose and sodium bicarbonate.
  • Triptan formulations of embodiments of the invention can be combined or modified with other triptan formulations and methods for forming triptan formulations, such as, for example, compounds, formulations and/or methods provided by U.S. Patent Publication No. 2007/01 66336 to
  • injection systems are provided for the delivery triptan compounds of embodiments of the invention.
  • injection systems include microinjection systems.
  • Microinjection systems of embodiments of the invention can be configured for subcutaneous, transdermal or intradermal drug delivery.
  • Microinjection systems of embodiments of the invention can provide for improved delivery efficiency and absorption times in relation to traditional syringes.
  • Microinjection systems of embodiments of the invention can include one or more microneedles configured to deliver triptan drug formulations, such as, for example, a formulation comprising sumatriptan or a pharmaceutically acceptable derivative of sumatriptan.
  • a microinjection system can include a solid microneedle system having one or more solid microneedles, wherein at least a portion of the one or more solid microneedles are coated with a triptan drug formulation, such as sumatriptan.
  • a microinjection system can include a hollow microneedle system having one or more hollow microneedles. The one or more hollow microneedles can include fluid passages for directing a formulation having a triptan drug formulation from a reservoir to a subject.
  • solid microneedle systems having one or more microneedles (or microneedle assemblies).
  • the solid microneedle systems can be configured for the delivery of triptan drug formulations, up to and including about 1 mg, or 2 mg, or 3 mg, or 4 mg, or 5 mg, or 6 mg, or 7 mg, or 8 mg, or 9 mg, or 10 mg, or 1 1 mg, or 12 mg, or 13 mg, or 14 mg, or 15 mg, or 16 mg, or 17 mg, or 1 8 mg, or 19 mg, or 20 mg of a triptan drug formulation.
  • the solid microneedle systems can be configured for the delivery of sumatriptan drug formulations, up to and including about 1 mg, or 2 mg, or 3 mg, or 4 mg, or 5 mg, or 6 mg, or 7 mg, or 8 mg, or 9 mg, or 10 mg, or 1 1 mg, or 12 mg, or 13 mg, or 14 mg, or 15 mg, or 16 mg, or 1 7 mg, or 18 mg, or 19 mg, or 20 mg of a sumatriptan drug formulation.
  • solid microneedle systems can include between about 300 and 1500 solid microneedles. Each microneedle can have a height between about 250 and 700 ⁇ tall. In another embodiment, each microneedle can be coated with a triptan-containing drug or vaccine, such as a drug formulation comprising sumatriptan. In an embodiment, the tip of each microneedle can be coated with a triptan drug formulation.
  • a solid microneedle system can be integrated into a user-wearable device. Upon application, the microneedles penetrate stratum corneum for delivery of the triptan drug formulation.
  • the microneedles can remain in the skin for a desirable or predetermined period of time, such as a length of time selected to permit the delivery of the triptan-containing drug to a subject. Such time can be between about 30 seconds and 10 minutes.
  • Triptan drug formulations can be kept in a dry state, which can enhance stability, allowing for room temperature storage of the formulations.
  • Solid microneedle system can be configured for single or multiple uses.
  • a microinjection device having one or more hollow microneedles is provided.
  • the one or more hollow microneedles can be configured to deliver triptans of embodiments of the invention.
  • microinjection devices can include a plurality of hollow microneedles.
  • a hollow microneedle system can be configured for the delivery of a triptan drug formulation in liquid form, from about 0.01 mL up to and including about 3 mL of a triptan drug formulation, such as at least about 0.01 , 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1 , 0.1 1 , 0.12, 0.13, 0.14, 0.15, 0.16, 0.1 7, 0.
  • a hollow microneedle system can be configured for the delivery of a triptan drug formulation in liquid form, from 0.01 ml to 6 mL, or 0.01 mL to 3 mL, or 0.02 mL to 2 mL of a triptan drug formulation.
  • hollow microneedle systems can include about 18 hollow microneedles per cm 2 . Each microneedle can have a height of about 900 ⁇ .
  • a hollow microneedle system can be integrated into user-wearable device. Upon application, the microneedles penetrate the skin. Small channels in each microneedle allow for the flow of a fluid having a triptan drug formulation from the device into the skin.
  • the delivery time can be between about 0.1 seconds and 2 hours, or between about 10 seconds and 1 hour, or between about 30 seconds and 40 minutes, or between about 1 minute and 30 minutes.
  • the infusion time can be dependent on the viscosity and volume of the triptan- containing fluid.
  • a microinjection device having one or more hollow microneedles is provided.
  • the one or more hollow microneedles can be configured to deliver sumatriptan.
  • microinjection devices can include a plurality of hollow microneedles.
  • a hollow microneedle system can be configured for the delivery of a sumatriptan drug formulation in liquid form, from about 0.01 mL up to and including about 3 mL of a sumatriptan drug formulation, such as at least about 0.01 , 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.1 1 , 0.12, 0.13, 0.14, 0.15, 0.16, 0.17, 0.18, 0.19, 0.20, 0.21 , 0.22, 0.23, 0.24, 0.25, 0.26, 0.27, 0.28, 0.29, 0.30, 0.31 , 0.32, 0.33, 0.34, 0.35, 0.36, 0.37, 0.38, 0.39, 0.40, 0.41, 0.42, 0.43, 0.44, 0.45, 0.46, 0.47, 0.48, 0.49, 0.50, 0.51 , 0.52, 0.53, 0.54, 0.55, 0.56, 0.57, 0.58, 0.59, 0.60, 0.61 , 0.
  • a hollow microneedle system can be configured for the delivery of a sumatriptan-containing drug formulation in liquid form, from 0.01 ml to 6 mL, or 0.01 mL to 3 mL, or 0.02 mL to 2 mL of a sumatriptan- containing drug formulation.
  • hollow microneedle systems can include about 18 hollow microneedles per cm 2 . Each microneedle can have a height of about 900 ⁇ .
  • a hollow microneedle system can be integrated into user-wearable device. Upon application, the microneedles penetrate the skin. Small channels in each microneed le allow for the flow of a fluid having a sumatriptan-containing drug formulation from the device into the skin.
  • the delivery time can be between about 0. 1 seconds and 2 hours, or between about 10 seconds and 1 hour, or between about 30 seconds and 40 minutes, or between about 1 minute and 30 minutes.
  • the infusion time can be dependent on the viscosity and volume of the sumatriptan-containing fluid.
  • a microinjection device comprises a plurality of hollow microneedles configured to deliver a triptan formulation to a subject.
  • each microneedle is formed of a polymeric material.
  • each microneedle is formed of a metallic material, such as an elemental metal or a metal alloy.
  • each microneedle is formed of a semiconductor material.
  • each microneedle is formed of an insulating material.
  • each microneedle is formed of one or more of a metallic material, a semiconductor material and an insulating material.
  • a system for subcutaneous, transdermal or intradermal delivery of a triptan to a subject comprises a triptan formu lation; a microneedle array for delivering the triptan formulation to a subject; and one or more chambers in fluid communication with the microneedle array, the one or more chambers configured to hold the triptan formulation.
  • the system can be configured to deliver to a subject a formulation comprising sumatriptan or derivatives of sumatriptan.
  • FIG. 1 A illustrates a microinjection device configured to deliver triptans, in accordance with an embodiment of the invention.
  • the micro injection device includes a handle portion configured to permit a user to hold or grip the microinjection device.
  • FIG. 1 B illustrates an array of microneedles mountable to the microinjection device of FIG. 1 A, in accordance with an embodiment of the invention.
  • the microneedles can penetrate the skin of a subject with minimal discomfort. Small channels in each microneedle can allow for fluid flow from the device into the subject's skin.
  • FIG. 2 illustrates a microinjection device having an array of m icroneed les (also "microneedle array application device” herein), in accordance with an embod iment of the invention.
  • the application device includes a patch 20, microneedle array 22, collar 34, actuator 36, piston 42, driver 44, holding tabs 50 and distance sensors 60.
  • the actuator 36 of the device has not been engaged.
  • the driver 44 has stored energy and the piston 42 is not in contact with the patch 20, which is retained within the collar 34 of the application device.
  • the application device has distance sensors 60 that sense distances "B" and "C” between the sensor and a skin surface 38.
  • a user can bring the applicator in proximity to the skin surface 38 so that the distances "B” and “C” 40 can be adjusted so that a distance, "x,” between the end of the collar 34 and the skin surface 38 can be as desired.
  • the application device can be triggered.
  • FIG. 3 illustrates a portion of the application device of FIG. 2, in accordance with an embodiment of the invention.
  • the application device is in the second released or triggered position, where the actuator 36 has been engaged, allowing the driver 44 to move the piston 42 towards the patch 20, thereby removing the patch from the hold ing tabs 50, propelling the patch 20 beyond an open distal end 48 of the collar 34 and pressing the microneedle array 22 and a skin facing adhesive 24 against the skin 38.
  • the piston 42 can then be removed from contact with the patch 20, thereby leaving the patch 20 in place on the skin 38.
  • the piston 42 can propel the patch 20 and array 22 from the application device and the patch 20 and array 22 can travel part of the distance in air (not shown) before impacting with the skin surface 38.
  • FIG. 4 illustrates a microneedle device comprising a patch 20 in the form of a combination of an array 22, pressure sensitive adhesive 24 and backing 26, in accordance with an embodiment of the invention.
  • a portion of the array 22 is illustrated with microneedles 10 protruding from a microneedle substrate surface 14.
  • the microneedles 10 can be arranged in any desired pattern or distributed over the microneedle substrate surface 14 randomly.
  • the microneedles 10 are configured for delivering a triptan-containing formulation, such as a sumatriptan-containing formulation, to a subject.
  • the microneedles 1 0 are arranged in uniformly spaced rows.
  • arrays of the present invention have a skin-facing surface area of more than about 0.1 cm 2 and less than about 20 cm 2 , or more than about 0.5 cm 2 and less than about 5 cm 2 .
  • a portion of the substrate surface 1 6 of the patch 20 is non-patterned.
  • the non-patterned surface has an area of more than about 1 percent and less than about 75 percent of the total area of the device surface that faces a skin surface of a subject.
  • the non-patterned surface can have an area of more than about 0.10 square inch (0.65 cm 2 ) to less than about 1 square inch (6.5 cm 2 ).
  • the microneedles can be disposed over substantially the entire surface area of the array 22.
  • microneedle devices useful in various embodiments of the invention can comprise any of a variety of configurations, such as the structures and configuration disclosed in U.S. Patent Publication No. 2003/0045837 to Delmore et al., U.S. Patent Publication No.
  • a microinjection device having an array of microneedles, wherein the microneedles in the array include tapered structures that include at least one channel formed in the outside surface of each microneedle.
  • the microneedles can include bases that are elongated in one direction.
  • the channels in microneedles with elongated bases can extend from one of the ends of the elongated bases towards the tips of the
  • microneedles The channels formed along the sides of the microneedles can optionally be terminated short of the tips of the microneedles.
  • the microneedle arrays can also include conduit structures formed on the surface of the substrate on which the microneedle array is located. The channels in the microneedles can be in fluid communication with the conduit structures.
  • each of the microneedles can include a truncated tapered shape and a controlled aspect ratio.
  • microneedles can include bladelike microprotrusions for piercing the skin.
  • microneedles can include a hollow central channel.
  • each of the microneedles can be hollow and include at least one longitudinal blade at the top surface of tip of a microneedle.
  • FIG. 5A an array of microneedles is shown, in accordance with an embodiment of the invention.
  • FIG. 5B shows a cross-section of a microneedle in the array, in accordance with an embodiment of the invention.
  • the microneedles can be formed of a polymeric material, such as a medical-grade polymeric material. They can be configured to overcome the barrier properties of the stratum corneum to deliver to a subject triptans of embodiments of the invention, such as sumatriptan.
  • microneedles can be modeled as mini hypodermic needles, each having a height between about 100 ⁇ and 1000 ⁇ , or between about 300 ⁇ and 950 ⁇ , or between about 500 ⁇ and 900 ⁇ .
  • the array can include 18 microneedles in an array area of about I cm 2 .
  • Each microneedle can include a fluid passage for delivering triptans, each fluid passage running the length of a microneedle.
  • Each microneedle can include a tip portion configured to pierce a subject's skin.
  • FIG. 6 illustrates a microneedle application device 30 and a skin surface 32, in accordance with an embodiment of the invention.
  • the microneedle device 30 can be used to deliver triptan compounds of embodiments of the invention, such as sumatriptan.
  • the microneedle device 30 can be used to deliver a sumatriptan-containing formulation.
  • the microneedle device 30 can be used to deliver a sumatriptan-containing formulation, which can include other active or inactive ingredients (see above).
  • the microneedle application device 30 can be used to deploy patches that include a microneedle array to a surface, such as to the skin surface 32.
  • the device 30 includes a housing 34 with a gripping portion 36, a trigger 38 and a collar 40.
  • the collar 40 defines an outward-facing contact portion 42.
  • the collar 40 is detachable from the housing 34, and can be disposable or reusable.
  • the collar 40 is a unitary member of generally cylindrical shape, and contact portion 42 is generally annular in shape.
  • the collar 40 can have nearly any shape and configuration.
  • the collar 40 can have a rectangular, triangular, oval, or other shape or combination of shapes.
  • the contact portion 42 will typically have a shape corresponding to the shape of the collar 40.
  • the collar 40 need not be unitary, and can be configured to form a number of discrete feet or supports that collectively define the contact portion 42.
  • FIG. 7 is a cross sectional side view of the microneedle application device 30 of FIG. 6, in accordance with an embodiment of the invention.
  • the device 30 includes a microneedle array patch 52; the device 30 is positioned against the skin surface 32.
  • the device 30 includes a support member or actuator.
  • the support member or actuator can be a piston 44 having a pad 46 and a shaft 48.
  • any type of mechanical, electromechanical, pneumatic, or other type of support member or actuator can be used.
  • a driver 50 capable of storing energy engages the shaft 48 of the piston 44, and can accelerate the piston 44 to a desired velocity.
  • the driver 50 can be in the form of a mechanical spring (e.g., a coil spring, leaf spring, etc.), compressed resilient member (e.g., rubber, etc.), compressed fluids (e.g., air, liquids, etc.), piezoelectric structure, electromagnetic structure, etc.
  • the collar 40 can hold a patch 52, carrying a microneedle array, prior to patch application.
  • the microneedle application device 30 can be positioned with the collar 40 near a desired application site.
  • the contact portion 42 of the collar 40 is placed in contact with the skin surface ' 32, and the contact portion 42 defines a target patch application site 54 on the skin surface 32.
  • a user can apply force to the microneedle application device 30 at the gripping portion 36 of the housing 34. At least a portion of that force can be transmitted through the collar 40 to the skin 32. That force can be referred to as a "pushdown force".
  • a "dome” 56 is generally created at the target site 54, as the skin 32 responds to the pushdown force. This "dome” has parameters of height and firmness.
  • Both of these parameters of the dome can be dependent upon the force applied to the applicator during microneedle application device 30 positioning.
  • the depth of penetration of a microneed le array is related to the application site, i.e., soft and fatty areas of a body versus firm muscular areas of the body. Skin characteristics can vary from one individual to another, and particular characteristics of skin can vary across subjects (e.g., patients) and across selected application sites on individual subjects. Such variations can affect characteristics of the dome 56.
  • a "pushback force" is exerted by the skin 32 in response to the pushdown force. The pushback force is generally directed in a direction directly opposed to the direction of the pushdown force, although specific relationships can be complex and wil l vary depending on the particular application site.
  • a force sensor can be coupled to the piston 44 at either end or anywhere along the length of piston 44, for example, at location 58A, 58B and/or 58C (jointly referred to as sensor 58).
  • the sensor 58 can be capable of sensing applied mechanical forces, such as pushback force at the piston 44.
  • the sensor 58 can be a strain gauge, variable capacitance sensor, or variable resistance sensor.
  • the sensor 58 can comprise a variable resistance member having a semi-conducting polymer disposed between conductive layers or grids, where the resistance of the variable resistance member varies according to applied force.
  • variable resistance member can be further configured in a voltage divider, which converts the resistance of the member into a voltage signal output that can be measured to detect force applied to the sensor 58.
  • a voltage divider which converts the resistance of the member into a voltage signal output that can be measured to detect force applied to the sensor 58.
  • An example of such a variable resistance member is disclosed in U.S. Patent No. 5,209,967, which is herein incorporated by reference in its entirety.
  • Other examples of aspects of such a variable resistance member are d isclosed in U.S. Patent Nos. 5,904,978 and 5,573,626, which are entirely incorporated herein by reference.
  • the piston 44 is moveable between a stored position and an extended position. In the stored position, energy is stored in the driver 50, and an actuator 38 secures the piston 44 in its stored position.
  • the actuator 38 allows an operator to trigger the release of energy stored in the driver 50 to accelerate the piston 44 through the collar 40 and toward the patch 52.
  • the microneedle application device 30 can be used to deliver the microneedle array patch 52 to the skin surface 32, in order to pierce the stratum corneum at the target application site 54 on a subject's skin.
  • the patch application device can be used to deliver a triptan formulation through the skin in a variation on transdermal delivery, or to the skin for intradermal or topical treatment, such as, e.g., vaccination.
  • the patch application device can be used to deliver a sumatriptan formulation through the skin in a variation on transdermal delivery, or to the skin for intradermal or topical treatment, such as, e.g., vaccination.
  • the microneedle array patch 52 can be used to pierce the stratum corneum before or after a pharmacological agent is applied to the skin surface in a separate step, thus being used as a pre- or post-treatment step.
  • FIG. 8 shows an enlarged cross sectional view of the collar 40 of the microneedle application device 30 of FIGs. 6 and 7, positioned against the skin surface 32, in accordance with an embodiment of the invention.
  • the collar 40 includes obstructions 70 on an interior portion thereof.
  • the obstructions 70 can be configured to retain patches, such as the patch 52.
  • Patch 52 can include a backing 72, an adhesive 74 (e.g., a pressure sensitive adhesive), and a microneedle array 76.
  • a desired patch application path 78 is defined through the collar 40.
  • the path 78 is substantially perpendicular to a plane in which the microneedle array 76 is retained by the obstructions 70 within the collar 40, and is generally perpendicular to the target application site 54.
  • the patch 52 is moved along the patch application path 78.
  • This patch movement can be accomplished by mechanically pushing the patch 52 with the piston 44.
  • the microneedle application device 30 can use other means for moving the patch 52.
  • the patch 52 can be moved pneumatically, without contacting a piston.
  • FIG. 9A is a perspective view of an applicator device 120 having a housing 1 22 that includes a base 124 and an upper cover structure 126, in accordance with an embodiment of the invention.
  • the device is elongate in shape and has a first, tapered end 127 and a second end 129.
  • the second end 129 has a top and bottom sealed by a top peelable seal 13 1 having a tab 1 33 and a bottom peelable seal 132 having a tab 135 (only tab 135 is visible in FIG. 9A).
  • FIG. 9B shows the applicator device after the peelable seals 13 1 , 132 have been removed.
  • a trigger 137 is integrally formed in the top surface of the housing 122.
  • the trigger is connected to the top surface of the housing at a single attachment point 139, thus allowing the trigger to be deflected downward by thumb or finger pressure (see FIG. 9D).
  • FIG. 9C is a cross-sectional view of the device of FIGs. 9A, showing a patch 1 72 mounted on an impactor 170, in accordance with an embodiment of the invention.
  • the impactor 170 is integrally formed with a drive member 166 having a length extend ing from a fixed end 167 attached to the housing 122 to a movable end 169.
  • the drive member 166 is bendable along its length.
  • a holding mechanism in the form of a latch uses a hook 125 attached to the housing 122. The hook 125 engages with a slot 171 in the movable end 169 of the drive member 166 to hold the movable end 169 of the drive member 166 away from the skin-contacting face 124 of the housing 122.
  • the drive member can be any elongate, bendable member, such as, for example, a leaf spring.
  • a target surface such as a skin surface (not shown).
  • FIG. 9E shows the drive member 166 fully deployed, having propelled the patch 172 past the skin- contacting face 124 so that the patch is pressed against the skin surface (not shown).
  • FIG. 9F shows the device 120 being removed from the skin surface 181 , leaving a patch 1 72 with a microneedle array 174 in place on the skin surface 181.
  • the impactor 1 70 is shown as a curled end of a leaf spring, as this allows for a convenient means for providing a holding mechanism (via the slot 171 in the movable end 169 of the leaf spring) while also providing a separate patch contacting and holding surface.
  • any variety of suitable shapes can be used for the movable end 169 of the drive member 166, including a flat leaf spring having no curled end.
  • FIG. 10 illustrates an applicator device 20 having a housing 22 that includes a base 24 and an upper cover structure 26, in accordance with an embodiment of the invention.
  • the applicator device 20 is configured to deliver a triptan formulation to a subject.
  • the applicator device 20 is configured to deliver a sumatriptan-containing formulation to a subject.
  • the base 24 can be rectangular in shape, and include a recess 28 located on a bottom face 30 thereof.
  • a generally circular opening 32 is defined in the recess 28 of the base 24.
  • a raised portion 34 is formed on an upper face 36 of the base 24 for holding a patch accelerating or patch applicator assembly 38.
  • a mounting structure or retaining portion of the applicator device 20 is formed by a pair of retainers 40, also referred to as a first retainer and a second retainer, connected to the base 24 (only one retainer 40 is visible in FIG. 10).
  • the retainer members 40 are generally elongate and each have a substantially flat upper surface 42 that is generally parallel to and facing a bottom portion 44 of the recess 28, and is spaced from the bottom face 30 (i.e., the skin-contacting face) of the base 24.
  • the pair of retainer members 40 are located on opposite sides of the opening 32 and are connected to the base 24 at one side of the recess 28.
  • the retainer members 40 define an opening 46 at one end for accepting patches between the retainer members 40 and the bottom portion 44 of the recess 28.
  • the upper surfaces 42 of the retainer members 40 can be non-stick or release surfaces.
  • a non-stick or release surface can be achieved, for example, by a non-stick or release coating applied to the upper surfaces 42.
  • the non-stick or release coating can be selected according to the desired use of the applicator device 20.
  • a release coating such as a low surface energy silicone, fluoropolymer, or fluoro-silicone release coating, can be selected based upon the adhesives used with patches applied using the patch application device 20.
  • a blade or other cutting means can be provided as part of the mounting structure, for separating portions of items from patches mounted on the applicator.
  • the upper cover structure 26 is connected to the base 24 at or near a perimeter of the base 24.
  • the upper cover structure 26 is shaped to fit on the base 24, and defines a volume, which is selected to provide space for the patch accelerating assembly 38.
  • the housing 22 can also provide space for storing patches (e.g., a roll of patches) for eventual deployment by the applicator device 20.
  • a slot 48 is defined in a side portion of the upper cover structure 26. In the illustrated embodiment of FIG. 1 0, the slot 48 is arcuate in shape and generally resembles a half circle, with the open portion of the half circle facing the base 24 of the housing 22.
  • Both the base 24 and the upper cover structure 26 can be formed of a polymeric material.
  • FIG. 1 1 is a perspective view of a portion of the applicator device 20 of FIG. 10 with the upper cover portion 26 omitted to show interior portions of the device 20.
  • the patch acceleration assembly 38 includes a frame member 60, an impactor 62, a handle 64, a bracket 66, and a torsion spring 68.
  • the torsion spring 68 serves as a drive member to bias the impactor relative to the housing.
  • the bracket 66 is mounted to the raised portion 34 of the base 24 of the housing 22 and pivotally retains the frame member 60. In some instances the bracket 66 can be directly affixed to the base 24, for example, if the base has sufficient thickness to allow for placement of the torsion spring 68.
  • the frame member 60 can be a wire formed as a rectangular loop.
  • the impactor 62 is attached to the frame member 60 opposite the bracket 66, and is the portion of the patch acceleration assembly 38 that interfaces with a patch to move it (i.e., to accelerate it), that is, it is the patch contacting portion of the device.
  • the impactor 62 has a patch contacting surface 70 that is configured according to characteristics of a desired application, for instance, based upon the shape of a patch to be applied. In the embodiment shown in FIG. 10, the patch contacting surface 70 is configured so that it is general ly parallel to and aligned with the frame member 60. Furthermore, it will be general ly aligned with the bottom face 30 of the device 20 when fully deployed.
  • the patch contacting surface 70 can be configured so that it is at another angle with respect to the frame member 60, and with respect to the bottom face 30 of the device 20 when fully deployed. Other such angles are possible.
  • the patch contacting surface 70 can be aligned so as to form an angle of between 4 and 15 degrees with the plane of the frame member.
  • the angle of the patch contacting surface 70 can be selected so that it is aligned with the back of the a patch resting on retaining members 40 when the patch contacting surface 70 contacts the patch.
  • the impactor 62 can be formed of a polymer material.
  • the handle 64 extends from the impactor 62, and can be integrally formed with the impactor 62.
  • FIG. 10 represents one configuration for manipulating the patch acceleration assembly 38.
  • a slot can be provided on the upper cover portion 26, thereby allowing the handle 64 or any other suitable actuation protrusion to protrude through the upper cover portion 26.
  • the method for manipulating the patch acceleration assembly 38 need not be by means of a direct mechanical connection.
  • various linkages or gears can be provided such that a button or knob on the exterior of the housing 22 can be pressed or turned to manipulate the patch acceleration assembly 38.
  • the patch acceleration assembly 38 can be moved by a motor or solenoid that is electrically controlled by a button or knob on the exterior of the housing 22.
  • the torsion spring 68 biases the frame 60 of the patch acceleration assembly 38 relative to the base 24 of the housing 22.
  • the torsion spring 68 can be a conventional coiled spring steel torsion spring.
  • the torsion spring 68 biases the frame 60, and therefore also the impactor 62, toward the opening 32 in the base 24 of the housing 22.
  • the impactor In a substantially de-energized state, the impactor is at rest and positioned near the opening 32 in the base 24 of the housing 22.
  • an operator can store potential energy in the torsion spring 68.
  • Energy stored in the torsion spring 68 can be used to accelerate the impactor 62 toward a patch and also to accelerate a patch that has contacted the impactor 62.
  • the amount of energy stored in the torsion spring 68 will vary depending on the amount of displacement of the impactor 62 away from the opening 32 and along the arcuate path.
  • the appropriate torsion spring constant will depend upon a number of parameters, including the mass of the patch acceleration assembly, the mass of the patch, the arc length through which the patch acceleration assembly travels, and the desired speed of the patch on impact with a surface.
  • the torsion spring constant can be more than about 0.5 Newton* mm/degree, or more than about 2.0 Newton*mm/degree.
  • the torsion spring constant can be less than about 5.0 Newton* mm/degree, or less than about 4.0 Newton*mm/degree.
  • the impactor 62 can be held at various points along the arcuate path either manually or, in some embodiments, with ho ld ing means (not shown) that engage and temporarily secure the handle 64 along the slot 48 in the upper cover structure 26 of the housing 22.
  • demarcations or other indicators can be provided for indicating the levels of force associated with particular degrees of displacement of the impactor 62 along the arcuate path.
  • the range of angular travel of the patch acceleration assembly will often be less than about 170 degrees and sometimes less than about 1 1 0 degrees.
  • the range of angu lar travel of the patch acceleration assembly will often be more than about 10 degrees and sometimes more than about 60 degrees.
  • the mass of the patch acceleration assembly will often be more than about 1 gram and sometimes more than about 5 grams.
  • the mass of the patch acceleration assembly wil l often be less than about 100 grams and sometimes less than about 30 grams.
  • FIG. 12 is a perspective view of a patch 72 (e.g., a patch 72 carrying a microneedle array 74) mounted on the applicator device 20, in accordance with an embodiment of the invention.
  • the applicator device 20, including the patch 72 is configured to deliver a triptan formulation to a subject.
  • applicator device 20 is configured to deliver a sumatriptan-containing formulation to a subject.
  • the patch 72 is disposed between the retainer members 40 and the bottom portion 44 of the recess 28 in the base 24 of the housing 22.
  • the microneedle array 74 faces away from the opening 32 in the base 24 of the housing 22.
  • the patch 72 which can have adhesive surrounding the microneed le array 74 on the surface facing away from the patch application device 20, contacts the upper surfaces 42 of the retainer members 40, but is generally not adhered firmly to the retainer members 40 due to the release character of the upper surfaces 42.
  • microneedle array carried on the patch 72 is generally aligned relative to the open ing 32 in the base 24 of the housing 22 (the opening 32 is not visible in FIG. 12).
  • the retainer members 40 have cutaway portions 76 that provide an enlarged, partially circular open region that is generally aligned with the opening 32 on the bottom portion 44 of the recess 28 of the base 24 of the housing 22.
  • the wider, open region defined by the cutaway portions 76 facilitates patch application by reducing the amount of deflection of the patch 72 required during deployment to move the patch 72 from a mounted position on the applicator device 20 to a target location.
  • Such cutaway portions 76 can be omitted if, for example, the patch has a generally rectangular shape.
  • FIG. 13 is a partial cross-sectional view of a microneedle array cartridge 80, having a patch 72 and a cover 82, mounted on an applicator device 20.
  • the applicator device 20 is similar to the applicator device of FIG. 12.
  • the microneed le array cartridge 80 includes a microneedle array 74.
  • the microneedle array 74 is configured to deliver triptan formulations to a subject.
  • Mounting the patch 72 on the applicator device 20 includes the following steps. The cartridge 80 is partially slid onto the retainer members 40. Then the cartridge 80 is slid further along the retainer members 40, simultaneously separating the cover 82 from the patch 72, until the patch 72 is fully mounted on the applicator device 20 (e.g., such that the microneedle array 74 is aligned with the opening 32 defined in the bottom portion 44 of the recess 28). The cover 82 is removed from (i.e., separated from) the patch 72 to uncover and expose the microneedle array 74 prior to microneedle deployment.
  • Microinjection methods, devices and systems of embodiments of the invention can be combined or modified with other injection or microinjection methods, devices and systems, including methods, devices and systems for manufacturing micro injection devices and components (such as, e.g., microneedles).
  • micro injection devices and components such as, e.g., microneedles.
  • the microneedle devices provided herein can be combined or modified with devices, apparatuses, systems and methods (including methods of manufacturing) described in U.S. Patent Publication Nos.
  • microneedle (or microinjection) devices provided herein can be combined or modified with devices, apparatuses, systems and methods (such as methods of manufacturing) described in U.S. Patent Publication No. 2004/0249339, U.S. Patent Publication No.
  • microinjection devices are used to deliver triptan formulations to subjects.
  • Microinjection devices for delivering triptan formulations can be selected from any micro injection or microneedle devices provided herein.
  • a microinjection device having one or more microneedles is used to deliver a triptan formu lation to a subject.
  • a microinjection device having a plural ity o f microneedles can be used to deliver a sumatriptan formulation (or a sumatriptan-containing formulation) to a subject.
  • the sumatriptan-containing formulation is delivered to a subject subcutaneously.
  • the sumatriptan-containing formulation is delivered to a subject in a transdermal fashion.
  • the sumatriptan-containing formulation is delivered to a subject in an intradermal fashion.
  • a micro injection device having a triptan formulation can be used to treat headaches.
  • a microinjection device having a triptan formulation can be used to treat migraines.
  • a microinjection device having a sumatriptan formulation can be used to treat headaches.
  • a microinjection device having a triptan formulation can be used to treat headaches.
  • microinjection device having a sumatriptan formulation can be used to treat migraines.
  • a triptan is administered to a subject by subcutaneous, transdermal or intradermal administration.
  • subcutaneous, transdermal or intradermal administration is by drug vehicle interaction.
  • subcutaneous, transdermal or intradermal administration is by the use of ion pairs or coacervates.
  • subcutaneous, transdermal or intradermal administration is by vesicles and particles.
  • subcutaneous, transdermal or intradermal administration is by liposomes and analogues.
  • subcutaneous, transdermal or intradermal administration is with the use of high velocity particles.
  • subcutaneous, transdermal or intradermal administration is by removing, bypassing or modifying the stratum corneum.
  • subcutaneous, transdermal or intradermal administration is by hydration.
  • subcutaneous, transdermal or intradermal administration is with the use of chemical enhances.
  • subcutaneous, transdermal or intradermal administration is by microneed le injection.
  • subcutaneous, transdermal or intradermal admin istration is by ablation.
  • subcutaneous, transdermal or intradermal administration is by follicular delivery.
  • subcutaneous, transdermal or intradermal administration is by electrically assisted methods.
  • subcutaneous, transdermal or intradermal administration is by ultrasound.
  • subcutaneous, transdermal or intradermal administration is by iontophoresis.
  • subcutaneous, transdermal or intradermal admin istration is by electroporation.
  • a triptan is admin istered subcutaneously, transdermally or intradermaliy with the aid of iontophoresis, which can involve non-invasively propelling high concentrations of a charged substance, such as a triptan formulation, subcutaneously, transdermally or intradermaliy by a repulsive electromotive force using a small electrical charge applied to an iontophoretic chamber containing a similarly charged active agent, such as a triptan, and its vehicle.
  • sumatriptan is administered subcutaneously, transdermally or intradermaliy with the aid of iontophoresis.
  • a device having one or more chambers filled with a solution containing a triptan is provided.
  • the triptan can be provided in the one or more chambers with a solvent to aid in (or facilitate) delivery.
  • the device can include one or both of a positively charged chamber for repelling a positively charged chemical and a negatively charged chamber for repell ing a negatively charged chemical into the skin of a subject.
  • a triptan is admin istered subcutaneously, transdermally or intradermaliy with the aid of ultrasound or ultrasonic energy (also "ultrasound" herein).
  • sumatriptan is administered subcutaneously, transdermal ly or intradermaliy with the aid of ultrasound.
  • the application of ultrasound to the skin can increase the permeability of skin to a triptan, which can enable the delivery of a triptan, such as sumatriptan, through the skin.
  • a triptan is administered subcutaneously, transdermally or intradermally with the aid of electroporation.
  • sumatriptan is administered subcutaneously, transdermally or intradermally with the aid of electroporation.
  • a device is provided for applying an electric field to an area of a subject's body in which transdermal administration of a triptan is desired, such as, for example, a portion of a subject's arm. The application of the electric field can facilitate the transdermal delivery of the triptan, such as sumatriptan, to the subject.
  • a triptan is administered subcutaneously, transdermally or intradermally by microneedle injection.
  • sumatriptan is administered subcutaneously, transdermally or intradermally by microneed le injection.
  • M icroneedle injection can include use of a microneedle device, such as a microneed le device of various embodiments of the invention.
  • a first user employs a microinjection device having a triptan formulation to deliver the triptan formulation to a subject.
  • the first user is a doctor or healthcare professional and the subject is a patient.
  • the first user is a caregiver and the second user is a subject under the caregiver's care.
  • the first user is a friend or relative of the subject.
  • a subject employs a microinjection device having a triptan formulation to self-administer the triptan formulation.
  • a subject employs a microinjection device having a sumatriptan formulation to self-ad minister the sumatriptan formulation.
  • the term "user,” as used herein, can refer to an ind ividual using a microinjection device to administer a triptan formulation to another individual, such as a subject, or to an individual using the microinjection device to admin ister the triptan formulation to her or himself.
  • the term "subject,” as used herein, can refer to an individual under treatment by another individual, such as a healthcare provider (e.g., physician, physician's assistant, nurse) or a care provider, or to an individual admin istering the triptan formulation to himself or herself (i.e., self administration).
  • a "subject” includes asymptomatic ind ividuals and symptomatic individuals, such as a patient.
  • a triptan formulation (or triptan-containing formu lation) can have a triptan concentration (mg triptan / mL formulation) of about 1 mg/0. 1 mL, or 2 mg 0. 1 mL, or 3 mg 0.1 mL, or 4 mg/0.1 mL, or 5 mg/0.1 mL, or 6 mg/0.1 mL, or 7 mg/0.1 mL, or 8 mg/0. 1 mL, or 9 mg/0.1 mL, or 10 mg/0.1 mL, or 1 1 mg/0.1 mL, or 12 mg/0.1 mL, or 13 mg/0.
  • a triptan concentration (mg triptan / mL formulation) of about 1 mg/0. 1 mL, or 2 mg 0. 1 mL, or 3 mg 0.1 mL, or 4 mg/0.1 mL, or 5 mg/0.1 mL, or 6 mg/0.1 mL, or 7 mg/0.1 mL, or 8 mg/0. 1
  • a triptan formulation can have a triptan concentration between about 1 mg/0.1 mL and 40 mg/0.1 mL, or between about 5 mg/0.1 mL and 30 mg/0.1 mL, or between about 15 mg/0.1 mL and 25 mg 0.1 mL.
  • a sumatriptan formulation (or sumatriptan-containing formulation) can have a sumatriptan concentration (mg sumatriptan / mL formulation) of about 1 mg/0.1 mL, or 2 mg/0.1 mL, or 3 mg/0.1 mL, or 4 mg/0.1 mL, or 5 mg/0.1 mL, or 6 mg/0.1 mL, or 7 mg/0.1 mL, or 8 mg/0.1 mL, or 9 mg/0.1 mL, or 10 mg/0.1 mL, or 1 1 mg/0.1 mL, or 12 mg/0.1 mL, or 13 mg/0.1 mL, or 14 mg/0.1 mL, or 15 mg/0.1 mL, or 16 mg/0.1 mL, or 1 7 mg/0.1 mL, or 18 mg/0.1 mL, or 19 mg/0.1 mL, or 20 mg/0.1 mL, or 21 mg/0.1 mL, or 22 mg/0.1 mL, or 23
  • a sumatriptan formulation can have a sumatriptan concentration between about 1 mg/0.1 mL and 40 mg/0.1 mL, or between about 5 mg/0.1 mL and 30 mg/0.1 mL, or between about 15 mg/0.1 mL and 25 mg/0.1 mL.
  • formulation volumes when used in association with doses (mg), are used to illustrate concentrations and may not necessarily be the volumes of formulations delivered to subjects.
  • a microinjection device is loaded with about 2 mL of a triptan formulation having a triptan concentration of about 20.1 mg in 0.1 mL.
  • the triptan formulation can include an excipient.
  • a microinjection device such as any device provided herein, is used to deliver a triptan to a subject from once a day to once a month.
  • a microinjection device such as any device provided herein, is used to deliver a triptan to a subject once a day, once every two days, once every three days, once every four days, once every five days, once every six days, once a week, once every two weeks, once every three weeks, once a month, once every two months, once every three months, once every four months, once every five months, once every six months, once a year, or more.
  • a microinjection device such as any device provided herein, is used to deliver a triptan to a subject from once a day to once every other day.
  • a microinjection device such as any device provided herein, is used to deliver a triptan to a subject once a day, or twice a day, or three times per day, or four times per day, or five times per day, or six times per day, or seven times per day, or eight times per day, or nine times per day, or ten times per day, or eleven times per day, or twelve times per day, or thirteen times per day, or fourteen times per day, or fifteen times per day, or sixteen times per day, or seventeen times per day, or eighteen times per day, or nineteen times per day, or twenty times per day, or twenty one times per day, or twenty two times per day, or twenty three times per day, or twenty four times per day.
  • a microinjection device such as any device provided herein, is used to deliver sumatriptan to a subject from once a day to once a month.
  • a microinjection device such as any device provided herein, is used to deliver sumatriptan (or a sumatriptan formulation) to a subject once a day, once every two days, once every three days, once every four days, once every five days, once every six days, once a week, once every two weeks, once every three weeks, once a month, once every two months, once every three months, once every four months, once every five months, once every six months, once a year, or more.
  • a microinjection device such as any device provided herein, is used to deliver sumatriptan to a subject from once a day to once every other day.
  • a microinjection device such as any device provided herein, is used to deliver sumatriptan to a subject once a day, or twice a day, or three times per day, or four times per day, or five times per day, or six times per day, or seven times per day, or eight times per day, or nine times per day, or ten times per day, or eleven times per day, or twelve times per day, or thirteen times per day, or fourteen times per day, or fifteen times per day, or sixteen times per day, or seventeen times per day, or eighteen times per day, or nineteen times per day, or twenty times per day, or twenty one times per day, or twenty two times per day, or twenty three times per day, or twenty four times per day.
  • a microinjection device is used to deliver a triptan (or a triptan formulation) to a subject at a dose of about 1 mg, or 2 mg, or 3 mg, or 4 mg, or 5 mg, or 6 mg, or 7 mg, or 8 mg, or 9 mg, or 10 mg, or 1 1 mg, or 12 mg, or 13 mg, or 14 mg, or 1 5 mg, or 16 mg, or 17 mg, or 18 mg, or 19 mg, or 20 mg.
  • a microinjection device is used to deliver sumatriptan or a sumatriptan formulation to a subject at a dose of about 1 mg, or 2 mg, or 3 mg, or 4 mg, or 5 mg, or 6 mg, or 7 mg, or 8 mg, or 9 mg, or 10 mg, or 1 1 mg, or 12 mg, or 13 mg, or 14 mg, or 15 mg, or 16 mg, or 17 mg, or 1 8 mg, or 19 mg, or 20 mg.
  • a microinjection device is used to deliver a triptan or a triptan formulation to a subject at a regimen (volume) of at least about 0.1 mL, or 0.2 mL, or 0.3 mL, or 0.4 mL, or 0.5 mL, or 0.6 mL, or 0.7 mL, or 0.8 mL, or 0.9 mL, or 1 .0 mL, or 1.1 mL, or 1 .2 mL, or 1.3 mL, or 1.4 mL, or 1.5 mL, or 1.6 mL, or 1.7 mL, or 1.8 mL, or 1.9 mL, or 2.0 mL, 3.0 mL, 4.0 mL, 5.0 mL, 10.0 mL, or more.
  • a microinjection device is used to deliver sumatriptan or a sumatriptan formulation to a subject at a regimen (volume) of at least about 0.1 mL, or 0.2 mL, or 0.3 mL, or 0.4 mL, or 0.5 mL, or 0.6 mL, or 0.7 mL, or 0.8 mL, or 0.9 mL, or 1.0 mL, or 1.1 mL, or 1.2 mL, or 1.3 mL, or 1.4 mL, or 1.5 mL, or 1.6 mL, or 1 .7 mL, or 1.8 mL, or 1.9 mL, or 2.0 mL, 3.0 mL, 4.0 mL, 5.0 mL, 10.0 mL, or more.
  • a microinjection device is used to deliver a triptan to a subject once a day at a dosage (or dose) of about 1 milligram (“mg") or less, or 2 mg or less, or 3 mg or less, or 4 mg or less, or 5 mg or less, or 6 mg or less, or 7 mg or less, or 8 mg or less, or 9 mg or less, or 10 mg or less, or 1 1 mg or less, or 12 mg or less, or 13 mg or less, or 14 mg or less, or 1 5 mg or less, or 16 mg or less, or 17 mg or less, or 18 mg or less, or 19 mg or less, or 20 mg or less, or 21 mg or less, or 22 mg or less, or 23 mg or less, or 24 mg or less, or 25 mg or less, or 30 mg or less, or 40 mg or less, or 50 mg or less.
  • a microinjection device is used to deliver a triptan to a subject once a day at a dosage of about 20 mg in a 1
  • a microinjection device is used to deliver a triptan to a subject at a dose of about 1 mg day, or 2 mg/day, or 3 mg/day, or 4 mg/day, or 5 mg/day, or 6 mg/day, or 7 mg day, or 8 mg/day, or 9 mg/day, or 10 mg/day, or 1 1 mg/day, or 12 mg day, or 13 mg/day, or 14 mg/day, or 15 mg/day, or 16 mg/day, or 17 mg/day, or 18 mg/day, or 19 mg/day, or 20 mg/day, or 21 mg/day, or 22 mg/day, or 23 mg/day, or 24 mg/day, or 25 mg/day, or 26 mg/day, or 27 mg/day, or 28 mg/day, or 29 mg/day, or 30 mg/day, or 31 mg/day, or 32 mg/day, or 33 mg/day, or 34 mg/day, or 35 mg/day, or 36 mg/day, or 37 mg/day, or 38 mg
  • a microinjection device is used to deliver sumatriptan to a subject once a day at a dosage of about 1 milligram (“mg") or less, or 2 mg or less, or 3 mg or less, or 4 mg or less, or 5 mg or less, or 6 mg or less, or 7 mg or less, or 8 mg or less, or 9 mg or less, or 10 mg or less, or 1 1 mg or less, or 12 mg or less, or 13 mg or less, or 14 mg or less, or 15 mg or less, or 16 mg or less, or 17 mg or less, or 18 mg or less, or 19 mg or less, or 20 mg or less, or 21 mg or less, or 22 mg or less, or 23 mg or less, or 24 mg or less, or 25 mg or less, or 30 mg or less, or 40 mg or less, or 50 mg or less.
  • mg milligram
  • a microinjection device is used to deliver sumatriptan to a subject once a day at a dosage of about 20 mg in a I mL formulation having sumatriptan.
  • a microinjection device is used to deliver sumatriptan to a subject at a dose of about 1 mg/day, or 2 mg/day, or 3 mg/day, or 4 mg/day, or 5 mg/day, or 6 mg/day, or 7 mg day, or 8 mg/day, or 9 mg/day, or 10 mg day, or 1 1 mg/day, or 12 mg/day, or 13 mg/day, or 14 mg/day, or 15 mg/day, or 16 mg/day, or 1 7 mg/day, or 1 8 mg/day, or 1 9 mg/day, or 20 mg/day, or 21 mg/day, or 22 mg/day, or 23 mg/day, or 24 mg/day, or 25 mg/day, or 26 mg/day, or 27 mg/day, or 28 mg/day, or 29 mg
  • the length of time in which a given dosage of a triptan is delivered to a subject using a microinjection device is dependent on various fluid and delivery properties, such as the volume of a triptan formulation, the viscosity of the formulation, the flow rate of the formulation from the microinjection device, the d iameter of any flu id channels in any microneedles included in the microinjection device, and the pressure drop across fluid channels in any hollow microneedles included in the micro injection device.
  • a microinjection device can be used to deliver a triptan formulation to a subject in a time period between about 0.1 seconds and 60 minutes, or between about 30 seconds and 30 minutes, or between about 1 minute and 7 minutes, or between about 2 minutes and 6 minutes, or between about 3 minutes and 5 minutes.
  • a microinjection device can be used to deliver a triptan formulation to a subject in a time period up to an including 1 minute, or 2 minutes, or 3 minutes, or 4 minutes, or 5 minutes, or 6 minutes, or 7 minutes, or 8 minutes, or 9 minutes, or 10 minutes, or 30 minutes, or 1 hour, or 2 hours, or 3 hours, or 4 hours, or 5 hours, or 6 hours, or 7 hours, or 8 hours, or 9 hours, or 10 hours, or 1 5 hours, or 20 hours, or 24 hours.
  • the length of time in which a given dosage of a triptan (e.g., sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan, almotriptan, frovatriptan, avitriptan or a pharmaceutically acceptable derivative thereof) is delivered to a subject using a triptan (e.g., sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan, almotriptan, frovatriptan, avitriptan or a pharmaceutically acceptable derivative thereof) is delivered to a subject using a triptan (e.g., sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan, almotriptan, frovatriptan, avitriptan or a pharmaceutically acceptable derivative thereof) is delivered to a subject using a triptan (e.g., sum
  • a microinjection device is dependent on various fluid and delivery properties, such as the volume of a sumatriptan-containing formulation, the viscosity of the formu lation, the flow rate of the formulation from the microinjection device, the diameter of any flu id channels in any microneedles included in the microinjection device, and the pressure drop across fluid channels in any microneedles included in the microinjection device.
  • a microinjection device can be used to deliver a triptan (e.g., sumatriptan) formulation to a subject in a time period between about 0.1 seconds and 60 minutes, or between about 30 seconds and 30 minutes, or between about 1 minute and 7 minutes, or between about 2 minutes and 6 minutes, or between about 3 minutes and 5 minutes.
  • a microinjection device can be used to deliver a triptan (e.g., sumatriptan) formulation to a subject in a time period up to an including 1 minute, or 2 minutes, or 3 minutes, or 4 minutes, or 5 minutes, or 6 minutes, or 7 minutes, or 8 minutes, or 9 minutes, or 10 minutes, or 30 minutes, or 1 hour, or 2 hours, or 3 hours, or 4 hours, or 5 hours, or 6 hours, or 7 hours, or 8 hours, or 9 hours, or 10 hours, or 1 5 hours, or 20 hours, or 24 hours.
  • a triptan e.g., sumatriptan
  • a microinjection device such as any device provided herein, can be used to deliver a triptan (e.g., sumatriptan) to a subject at a dosage of about 1 mg, or 2 mg, or 3 mg, or 4 mg, or 5 mg, or 6 mg, or 7 mg, or 8 mg, or 9 mg, or 1 0 mg, or 1 1 mg, or 12 mg, or 13 mg, or 14 mg, or 1 5 mg, or 16 mg, or 1 7 mg, or 1 8 mg, or 19 mg, or 20 mg, or 21 mg, or 22 mg, or 23 mg, or 24 mg, or 25 mg, or 26 mg, or 27 mg, or 28 mg, or 29 mg, or 30 mg, or 3 1 mg, or 32 mg, or 33 mg, or 34 mg, or 35 mg, or 36 mg, or 37 mg, or 38 mg, or 39 mg, or 40 mg.
  • a triptan e.g., sumatriptan
  • a microinjection device such as any device provided herein, can be used to deliver a triptan at least every 1 hour, or 2 hours, or 3 hours, or 4 hours, or 5 hours, or 6 hours, or 7 hours, or 8 hours, or 9 hours, or 1 0 hours, or 1 1 hours, or 12 hours, or once a day.
  • a microinjection device such as any device provided herein, can be used to deliver a triptan over a time period of about 0.1 seconds to 60 minutes, or about 1 second to 30 minutes, or about 5 seconds to 5 minutes, or about 10 seconds to 1 minute, or about 1 5 to 45 seconds.
  • a triptan can be delivered to a subject over a period of 1 minute or less, or 2 minutes or less, or 3 minutes or less, or 4 minutes or less, or 5 minutes or less, or 6 minutes or less, or 7 minutes or less, or 8 minutes or less, or 9 minutes or less, or 10 minutes or less, or 30 minutes or less, or 1 hour or less, or 2 hours or less, or 3 hours or less, or 4 hours or less, or 5 hours or less, or 6 hours or less, or 7 hours or less, or 8 hours or less, or 9 hours or less, or 10 hours or less, or 1 1 hours or less, or 12 hours or less, or 13 hours or less, or 14 hours or less, or 15 hours or less, or 16 hours or less, or 1 7 hours or less, or 1 8 hours or less, or 19 hours or less, or 20 hours or less, or 21 hours or less, or 22 hours or less, or 23 hours or less, or 24 hours or less.
  • a microinjection device such as any device provided herein, can be used to deliver a triptan to a subject at a dosage of about 20 mg in a 1 ttiL formu lation once a day over a period less than about 1 hour, or less than about 30 minutes, or less than about 10 minutes, or less than about 1 minute.
  • a microinjection device such as any device provided herein, can be used to deliver a triptan to a subject in a time period of about 30 seconds, or 1 minute, or 1.5 minutes, or 2 minutes, or 2.5 minutes, or 3 minutes, or 3.5 minutes, or 4 minutes, or 4.5 minutes, or 5 minutes, or 5.5 minutes, or 6 minutes, or 7.5 minutes, or 8 minutes, or 8.5 minutes, or 9 minutes, or 9.5 minutes, or 1 0 minutes, or 1 0.5 minutes, or 1 1 minutes, or 1 1.5 minutes, or 1 2 minutes, or 12.5 minutes, or 1 3 minutes, or 1 3.5 minutes, or 14 minutes, or 14..5 minutes, or 15 minutes, or 15. ,5 minutes, or 16 minutes, or 16.
  • a microinjection device such as any device provided herein, can be used to deliver sumatriptan to a subject at a dosage of about 1 mg, or 2 mg, or 3 mg, or 4 mg, or 5 mg, or 6 mg, or 7 mg, or 8 mg, or 9 mg, or 10 mg, or 1 1 mg, or 12 mg, or 13 mg, or 14 mg, or 15 mg, or 16 mg, or 17 mg, or 18 mg, or 19 mg, or 20 mg, or 21 mg, or 22 mg, or 23 mg, or 24 mg, or 25 mg, or 26 mg, or 27 mg, or 28 mg, or 29 mg, or 30 mg, or 31 mg, or 32 mg, or 33 mg, or 34 mg, or 35 mg, or 36 mg, or 37 mg, or 38 mg, or 39 mg, or 40 mg.
  • a microinjection device such as any device provided herein, can be used to deliver sumatriptan to a subject at least every 1 hour, or 2 hours, or 3 hours, or 4 hours, or 5 hours, or 6 hours, or 7 hours, or 8 hours, or 9 hours, or 10 hours, or 1 1 hours, or 12 hours, or once a day.
  • a microinjection device such as any device provided herein, can be used to deliver sumatriptan to a subject over a time period of about 0. 1 seconds to 60 minutes, or about 1 second to 30 minutes, or about 5 seconds to 5 minutes, or about 10 seconds to 1 minute, or about 15 to 45 seconds.
  • sumatriptan can be delivered to a subject over a period of 1 minute or less, or 2 minutes or less, or 3 minutes or less, or 4 minutes or less, or 5 minutes or less, or 6 minutes or less, or 7 minutes or less, or 8 minutes or less, or 9 minutes or less, or 10 minutes or less, or 30 minutes or less, or 1 hour or less, or 2 hours or less, or 3 hours or less, or 4 hours or less, or 5 hours or less, or 6 hours or less, or 7 hours or less, or 8 hours or less, or 9 hours or less, or 10 hours or less, or 1 1 hours or less, or 12 hours or less, or 13 hours or less, or 14 hours or less, or 15 hours or less, or 1 6 hours or less, or 1 7 hours or less, or 1 8 hours or less, or 19 hours or less, or 20 hours or less, or 21 hours or less, or 22 hours or less, or 23 hours or less, or 24 hours or less.
  • a micro injection device such as any device provided herein, can be used to deliver sumatriptan to a subject at a dosage of about 20 mg in a 1 mL formulation once a day over a period less than about 1 hour, or less than about 30 minutes, or less than about 10 minutes, or less than about 1 minute.
  • a microinjection device such as any device provided herein, can be used to deliver sumatriptan to a subject in a time period of about 30 seconds, or 1 minute, or 1 .5 minutes, or 2 minutes, or 2.5 minutes, or 3 minutes, or 3.5 minutes, or 4 minutes, or 4.5 minutes, or 5 minutes, or 5.5 minutes, or 6 minutes, or 7.5 minutes, or 8 minutes, or 8.5 minutes, or 9 minutes, or 9.5 minutes, or 1 0 minutes, or 10.5 minutes, or 1 1 minutes, or 1 1.5 minutes, or 1 2 minutes, or 12.5 minutes, or 1 3 minutes, or 13.5 minutes, or 14 minutes, or 14.5 minutes, or 1 5 minutes, or 1 5.5 minutes, or 1 6 minutes, or 16.5 minutes, or 1 7 minutes, or 1 7.5 minutes, or 1 8 minutes, or 1 8.5 minutes, or 1 9 minutes, or 19.5 minutes, or 20 minutes, or 20.5 minutes, or 21 minutes, or 21 .5 minutes, or 22 minutes, or 22.5 minutes, or 23 minutes, or 23.5
  • the equivalent of 20 mg of sumatriptan is delivered to a subject once a day.
  • 20 mg of sumatriptan is delivered to a subject once a day and over a time period up to and including 1 minute, or 2 minutes, or 3 minutes, or 4 minutes, or 5 minutes, or 6 minutes, or 7 minutes, or 8 minutes, or 9 minutes, or 10 minutes, or 20 minutes, or 30 minutes, or 40 minutes, or 50 minutes, or 1 hour, or 2 hours, or 3 hours, or 4 hours, or 5 hours, or 6 hours, or 7 hours, or 8 hours, or 9 hours, or 1 0 hours, or 1 1 hours, or 12 hours, or 13 hours, or 14 hours, or 1 5 hours, or 16 hours, or 1 7 hours, or 1 8 hours, or 19 hours, or 20 hours, or 21 hours, or 22 hours, or 23 hours, or 24 hours.
  • a micro injection device such as any device provided herein, is loaded with a sumatriptan formulation having a concentration of about 1 mg/0.1 mL, or 5 mg/0. 1 mL, or 10 mg/0.1 mL, or 1 5 mg/0.1 mL, or 20 mg/0.1 mL.
  • the microinjection device can be used to deliver sumatriptan to a subject over a predetermined time period, such as a time period up to and including 1 minute, or 2 minutes, or 3 minutes, or 4 minutes, or 5 minutes, or 6 minutes, or 7 minutes, or 8 minutes, or 9 minutes, or 10 minutes, or 20 minutes, or 30 minutes, or 40 minutes, or 50 minutes, or 1 hour, or 2 hours, or 3 hours, or 4 hours, or 5 hours, or 6 hours, or 7 hours, or 8 hours, or 9 hours, or 10 hours, or 1 1 hours, or 1 2 hours, or 13 hours, or 14 hours, or 15 hours, or 16 hours, or 1 7 hours, or 1 8 hours, or 19 hours, or 20 hours, or 21 hours, or 22 hours, or 23 hours, or 24 hours.
  • a subject can apply a microinjection device having a sumatriptan formulation with a sumatriptan concentration of about 20 mg 1 mL to the subject's arm for delivery of sumatriptan on a daily basis.
  • a microinjection device having a deliverable triptan formulation having a deliverable triptan formulation.
  • a triptan or sumatriptan formulation can be delivered by subcutaneous, transdermal or intradermal injection.
  • a user can place the device adjacent another user's skin or adjacent the user's skin, if self administration is desired, to deliver the triptan formulation.
  • the user employs the microinjection device to deliver the triptan formulation to another user or the user (self administration). The user then removes the microinjection device from the skin.
  • the microinjection device is a single use device and is be disposed of after it is used.
  • the microinjection device can be used for a future administration of the triptan formulation, such as with a replaceable cartridge or with additional doses provided in the original cartridge having the triptan formulation.

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Abstract

La présente invention concerne des dispositifs et des systèmes de micro-injection pour administrer des formulations de triptans à des sujets par administration sous-cutanée, transdermique ou intradermique. Les formulations de triptan peuvent comprendre des formulations de médicament triptan sulfamidé. Dans certains cas, les formulations de triptan comprennent des formulations de sumatriptan.
PCT/US2011/062744 2010-12-02 2011-11-30 Administration de triptans par des systèmes de micro-injection WO2012075209A1 (fr)

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WO2017143345A1 (fr) * 2016-02-19 2017-08-24 Zp Opco, Inc. Procédé pour obtenir rapidement des concentrations thérapeutiques de triptans pour le traitement de migraines
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WO2020264026A1 (fr) * 2019-06-28 2020-12-30 Passport Technologies, Inc. Système de distribution de micro-porosités de triptan
US11660265B2 (en) 2018-06-28 2023-05-30 Emergex USA Corporation Method of rapidly achieving therapeutic concentrations of triptans for treatment of migraines and cluster headaches
US11660264B2 (en) 2017-08-23 2023-05-30 Emergex USA Corporation Method of rapidly achieving therapeutic concentrations of triptans for treatment of migraines and cluster headaches
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WO2006055802A1 (fr) * 2004-11-18 2006-05-26 3M Innovative Properties Company Attache et applicateur pour jeu de micro-aiguilles
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CN108430581A (zh) * 2015-10-28 2018-08-21 雷迪博士实验室有限公司 用于利扎曲普坦的药物组合物
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CN110177534A (zh) * 2016-09-05 2019-08-27 海因派克兹有限公司 冲击波产生装置和系统
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US11660265B2 (en) 2018-06-28 2023-05-30 Emergex USA Corporation Method of rapidly achieving therapeutic concentrations of triptans for treatment of migraines and cluster headaches
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WO2020264026A1 (fr) * 2019-06-28 2020-12-30 Passport Technologies, Inc. Système de distribution de micro-porosités de triptan
WO2023228043A1 (fr) 2022-05-24 2023-11-30 Global Medical Institute Sa Méthode d'adaptation d'un appareil à micro-aiguille pour des interventions de neuropathie intracutanées

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