DK2120875T3 - Fremgangsmåde til terapeutisk administration af dhe med henblik på at muliggøre hurtig lindring af migræne samtidig med minimering af bivirkningsprofilen - Google Patents
Fremgangsmåde til terapeutisk administration af dhe med henblik på at muliggøre hurtig lindring af migræne samtidig med minimering af bivirkningsprofilen Download PDFInfo
- Publication number
- DK2120875T3 DK2120875T3 DK08725456.1T DK08725456T DK2120875T3 DK 2120875 T3 DK2120875 T3 DK 2120875T3 DK 08725456 T DK08725456 T DK 08725456T DK 2120875 T3 DK2120875 T3 DK 2120875T3
- Authority
- DK
- Denmark
- Prior art keywords
- dhe
- dihydroergotamine
- administration
- migraine
- cmax
- Prior art date
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Classifications
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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
- A61K31/495—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
- A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
-
- 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
- A61K31/095—Sulfur, selenium, or tellurium compounds, e.g. thiols
- A61K31/10—Sulfides; Sulfoxides; Sulfones
-
- 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/48—Ergoline derivatives, e.g. lysergic acid, ergotamine
-
- 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
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
-
- 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
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/06—Antimigraine agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Pulmonology (AREA)
- Otolaryngology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Pain & Pain Management (AREA)
- Biomedical Technology (AREA)
- Rheumatology (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Dispersion Chemistry (AREA)
Claims (11)
1. Forbindelse, der er dihydroergotamin eller et salt, et hydrat, en polymorf eller et ionpar deraf til anvendelse ved en fremgangsmåde til behandling af migræne hos et menneskeindivid; hvor behandlingen omfatter afgivelse via lungeinhalation ved hjælp af en indretning, som omfatter en tørpulverinhalator, forstøver, fordamper, tryksat inhalator til afmålte doser eller åndedrætsaktiveret tryksat inhalator til afmålte doser, af en samlet dosis af dihydroergotamin eller et salt, et hydrat, en polymorf eller et ionpar deraf på fra 0,1 til 10 mg pr. migræneanfald; og hvor dosen er i en fast eller flydende formulering eller aerosolformulering, der er tilpasset til administration ved hjælp af indretningen med henblik på at administrere dihydroergotaminet eller et salt, et hydrat, en polymorf eller et ionpar deraf ved en sådan hastighed, at topplasmakoncentrationen (Cmax) af dihydroergotamin er mindre end 15.000 pg/ml, og tiden til Cmax (T max) af dihydroergotamin er mindre end 20 minutter efter administration.
2. Forbindelse ifølge krav 1 til anvendelse ifølge krav 1, hvorTmax af dihydroergotamin er inden for 15 minutter efter administration.
3. Forbindelse ifølge krav 1 til anvendelse ifølge krav 1, hvor den samlede dosis ligger i intervallet fra 0,5 mg til 5,0 mg.
4. Forbindelse ifølge krav 1 til anvendelse ifølge krav 1, hvor dihydroergotaminet, saltet, hydratet, polymorfen eller ionparret deraf administreres i en enhedsdosis på mindre end 3,0 mg.
5. Forbindelse ifølge krav 1 til anvendelse ifølge krav 1, hvor den samlede dosis ligger i intervallet fra 1,0 mg til 2,0 mg.
6. Forbindelse ifølge krav 1 til anvendelse ifølge krav 1, hvor indretningen er en inhalatorindretning, som omfatter én eller flere enhedsdoser af en formulering af dihydroergotamin eller et salt, et hydrat, en polymorf eller et ionpar deraf, hvor hver enhedsdosis administreres ved en sådan hastighed, at Cmax er mindre end 10.000 pg/ml, og Tmax er mindre end 20 minutter efter administration.
7. Forbindelse ifølge krav 1 til anvendelse ifølge krav 1, hvilken forbindelse omfatter dihydroergotaminmesylat.
8. Forbindelse ifølge krav 1 til anvendelse ifølge krav 1, hvor fremgangsmåden omfatter administration af forbindelsen ved hjælp af en indretning, som omfatter en åndedrætsaktiveret tryksat inhalator til afmålte doser.
9. Forbindelse ifølge krav 1 til anvendelse ifølge krav 1, hvor fremgangsmåden omfatter administration af forbindelsen ved hjælp afen indretning, som omfatter en tørpulverinhalator.
10. Forbindelse ifølge krav 1 til anvendelse ifølge krav 1, hvor formuleringen administreres til individet ved hjælp afen åndedrætsaktiveret inhalator til afmålte doser, hvor dihydroergotaminet eller et salt, et hydrat, en polymorf eller et ionpar deraf administreres ved en sådan hastighed, at topplasmakoncentrationen af dihydroergotamin (Cmax) er mindre end 10.000 pg/ml koncentration, og tiden (T max ) efter administration, når topplasmakoncentrationen opnås, er mindre end 20 minutter efter administration, og hvor formuleringen administreres uden administration af et antiemetikum.
11. Anvendelse af en forbindelse, der er dihydroergotamin eller et salt, et hydrat, en polymorf eller et ionpar deraf ved fremstilling af et medikament til behandling af migræne hos et menneskeindivid; hvor behandlingen omfatter afgivelse via lungeinhalation ved hjælp afen indretning, som omfatter en tørpulverinhalator, forstøver, fordamper, tryksat inhalator til afmålte doser eller åndedrætsaktiveret tryksat inhalator til afmålte doser, af en samlet dosis af dihydroergotamin eller et salt, hydrat, polymorf eller ionpar deraf på fra 0,1 til 10 mg pr. migræneanfald; og hvor dosen er i en fast eller flydende formulering eller aerosolformulering, der er tilpasset til administration ved hjælp af indretningen med henblik på at afgive dihydroergotamin eller et salt, hydrat, polymorf eller ionpar deraf ved en sådan hastighed, at topplasmakoncentrationen (Cmax) af dihydroergotamin er mindre end 15.000 pg/ml, og tiden til Cmax (Tmax) af dihydroergotamin er mindre end 20 minutter efter administration.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US90085007P | 2007-02-11 | 2007-02-11 | |
| PCT/US2008/001829 WO2008097664A1 (en) | 2007-02-11 | 2008-02-11 | Method of therapeutic administration of dhe to enable rapid relief of migraine while minimizing side effect profile |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2120875T3 true DK2120875T3 (da) | 2018-10-22 |
Family
ID=39400937
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK11191794.4T DK2425820T3 (da) | 2007-02-11 | 2008-02-11 | Fremgangsmåde til terapeutisk administration af dhe for at muliggøre hurtig lindring af migræne, mens bivirkningsprofilen minimeres |
| DK08725456.1T DK2120875T3 (da) | 2007-02-11 | 2008-02-11 | Fremgangsmåde til terapeutisk administration af dhe med henblik på at muliggøre hurtig lindring af migræne samtidig med minimering af bivirkningsprofilen |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK11191794.4T DK2425820T3 (da) | 2007-02-11 | 2008-02-11 | Fremgangsmåde til terapeutisk administration af dhe for at muliggøre hurtig lindring af migræne, mens bivirkningsprofilen minimeres |
Country Status (19)
| Country | Link |
|---|---|
| US (10) | US8148377B2 (da) |
| EP (3) | EP2120875B1 (da) |
| JP (4) | JP5825757B2 (da) |
| KR (3) | KR20160106200A (da) |
| CN (2) | CN101677954A (da) |
| AU (3) | AU2008214205B2 (da) |
| CA (1) | CA2677838C (da) |
| CY (1) | CY1116546T1 (da) |
| DK (2) | DK2425820T3 (da) |
| ES (2) | ES2538082T3 (da) |
| HK (1) | HK1204918A1 (da) |
| HU (1) | HUE026884T2 (da) |
| IL (1) | IL200333A (da) |
| MX (1) | MX2009008582A (da) |
| PL (1) | PL2425820T3 (da) |
| PT (1) | PT2425820E (da) |
| SI (1) | SI2425820T1 (da) |
| WO (1) | WO2008097664A1 (da) |
| ZA (1) | ZA200905628B (da) |
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