DK2600850T3 - Farmaceutisk doseringsform, der omfatter 6'-fluor-(n-methyl- eller n,n-dimethyl-)-4-phenyl-4',9'-dihydro-3'h-spiro[cyclohexan-1,1'-pyrano[3,4,b]indol]-4-amin til behandling af nociceptiv smerte - Google Patents
Farmaceutisk doseringsform, der omfatter 6'-fluor-(n-methyl- eller n,n-dimethyl-)-4-phenyl-4',9'-dihydro-3'h-spiro[cyclohexan-1,1'-pyrano[3,4,b]indol]-4-amin til behandling af nociceptiv smerte Download PDFInfo
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- DK2600850T3 DK2600850T3 DK11745929.7T DK11745929T DK2600850T3 DK 2600850 T3 DK2600850 T3 DK 2600850T3 DK 11745929 T DK11745929 T DK 11745929T DK 2600850 T3 DK2600850 T3 DK 2600850T3
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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
- A61K31/407—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 other heterocyclic ring systems, e.g. ketorolac, physostigmine
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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
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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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- 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
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
- A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
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- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
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- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
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- 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
- A61P25/04—Centrally acting analgesics, e.g. opioids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2121/00—Preparations for use in therapy
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- 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
- A61K9/08—Solutions
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- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Claims (6)
1. Farmaceutisk doseringsform, der indeholder et farmakologisk aktivt middel ifolge den almene formel (I)
hvor R er -H eller -CH3, eller et fysiologisk acceptabelt salt deraf, - som under in vhro-betingclscr ved 37 ±0,5 °C i 900 ml kunstig mavesaft ved pH 1,2 efiter 30 minutter ifolge skovlblanderfremgangsmaden med vaegtlod ved 100 omdrejninger i minuttet frigiver mindst 80 vasgt-% af det farmakologisk aktive middel ifolge den almene formel (I), baseret pa den totale masngde af det farmakologisk aktive middel ifolge den almene formel (I), som oprindelig var indeholdt i doseringsformen; - som indeholder det farmakologisk aktive middel ifolge den almene formel (I) i en dosis pa 400±150 pg, udtrykt som vasgtaskvivalentdosis baseret pa den frie base; og - hvor den farmakokinetiske parameter tmax, udtrykt som en middelvasrdi, er inden for intervallet fra 0,5 til 16 timer, til anvendelse ved behandling af nociceptiv smerte, hvor den farmaceutiske doseringsform administreres oralt en gang dagligt.
2. Farmaceutisk doseringsform til anvendelse ifolge krav 1, hvilken doseringsform indeholder det farmakologisk aktive middel i en dosis pa fra 300 pg til 500 pg, udtrykt som vaegtaekvivalentdosis baseret pa den frie base.
3. Farmaceutisk doseringsform til anvendelse ifolge et hvilket som heist af de foregaende krav, hvor det farmakologisk aktive middel ifolge den almene formel (I) har en stereokemi ifolge den almene formel (Γ) hvor R er defmeret som i krav 1.
4. Farmaceutisk doseringsform til anvendelse ifolgc et hvilket som heist af de foregaende krav, hvor det farmakologisk aktive middel ifolgc den almene formel (I) er (lr,4r)-6'-fluor-N,N-dimethyl-4-phenyl-4',9'-dihydro-3'H-spiro[cyclohexan-l,l'-pyrano[3,4,b]-indol]-4-amin, (lr,4r)-6'-fluor-N-methyl-4-phenyl-4',9'-dihydro-3'H-spiro[cyclohexan-l,l'-pyrano[3,4,b]indol]-4-amin eller et fysiologisk acceptabelt salt deraf.
5. Farmaceutisk doseringsform til anvendelse ifolge et hvilket som heist af de foregaende krav, hvor den nociceptive smerte er valgt blandt akut nociceptiv smerte og kronisk nociceptiv smerte.
6. Farmaceutisk doseringsform til anvendelse ifolge et hvilket som heist af de foregaende krav, hvor den nociceptive smerte er valgt blandt somatisk smerte og visceral smerte.
Applications Claiming Priority (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US37064310P | 2010-08-04 | 2010-08-04 | |
US37064810P | 2010-08-04 | 2010-08-04 | |
US37063410P | 2010-08-04 | 2010-08-04 | |
EP10008117 | 2010-08-04 | ||
EP10008115 | 2010-08-04 | ||
EP10008116 | 2010-08-04 | ||
PCT/EP2011/003907 WO2012016697A2 (en) | 2010-08-04 | 2011-08-04 | Pharmaceutical dosage form comprising 6'-fluoro-(n-methyl- or n,n-dimethyl-)-4-phenyl-4',9'-dihydro-3'h-spiro[cyclohexane-1,1'-pyrano[3,4,b]indol]-4-amine for the treatment of nociceptive pain |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2600850T3 true DK2600850T3 (da) | 2018-12-03 |
Family
ID=45556332
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK11746174.9T DK2600851T3 (da) | 2010-08-04 | 2011-08-04 | Farmaceutisk doseringsform, der omfatter 6'-fluor-(n-methyl- eller n,n-dimethyl-)-4-phenyl-4',9'-dihydro-3'h-spiro[cyclohexan-1,1'-pyrano[3,4,b]indol]-4-amin til behandling af neuropatiske smerter |
DK11745929.7T DK2600850T3 (da) | 2010-08-04 | 2011-08-04 | Farmaceutisk doseringsform, der omfatter 6'-fluor-(n-methyl- eller n,n-dimethyl-)-4-phenyl-4',9'-dihydro-3'h-spiro[cyclohexan-1,1'-pyrano[3,4,b]indol]-4-amin til behandling af nociceptiv smerte |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK11746174.9T DK2600851T3 (da) | 2010-08-04 | 2011-08-04 | Farmaceutisk doseringsform, der omfatter 6'-fluor-(n-methyl- eller n,n-dimethyl-)-4-phenyl-4',9'-dihydro-3'h-spiro[cyclohexan-1,1'-pyrano[3,4,b]indol]-4-amin til behandling af neuropatiske smerter |
Country Status (28)
Country | Link |
---|---|
US (3) | US20120034297A1 (da) |
EP (3) | EP3459533A1 (da) |
JP (2) | JP5792298B2 (da) |
KR (2) | KR20130097173A (da) |
CN (2) | CN103260610A (da) |
AU (2) | AU2011287955B2 (da) |
BR (2) | BR112013003677A2 (da) |
CA (2) | CA2805523C (da) |
CL (2) | CL2013000218A1 (da) |
CO (2) | CO6670579A2 (da) |
DK (2) | DK2600851T3 (da) |
EC (2) | ECSP13012423A (da) |
ES (1) | ES2675316T3 (da) |
HR (2) | HRP20180904T1 (da) |
HU (1) | HUE039328T2 (da) |
IL (2) | IL224154B (da) |
LT (2) | LT2600850T (da) |
MX (2) | MX354686B (da) |
NZ (2) | NZ605887A (da) |
PE (2) | PE20131084A1 (da) |
PL (2) | PL2600850T3 (da) |
PT (1) | PT2600851T (da) |
RS (2) | RS57344B1 (da) |
RU (2) | RU2631481C2 (da) |
SI (2) | SI2600850T1 (da) |
TR (1) | TR201808244T4 (da) |
WO (2) | WO2012016698A2 (da) |
ZA (1) | ZA201300655B (da) |
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DK2600851T3 (da) | 2010-08-04 | 2018-06-25 | Gruenenthal Gmbh | Farmaceutisk doseringsform, der omfatter 6'-fluor-(n-methyl- eller n,n-dimethyl-)-4-phenyl-4',9'-dihydro-3'h-spiro[cyclohexan-1,1'-pyrano[3,4,b]indol]-4-amin til behandling af neuropatiske smerter |
US8614245B2 (en) | 2011-07-08 | 2013-12-24 | Gruenenthal Gmbh | Crystalline (1r,4r)-6′-fluoro-N,N-dimethyl-4-phenyl-4′,9′-dihydro-3′H-spiro[cyclohexane-1,1′-pyrano[3,4,b]indol]-4-amine |
DK3235821T3 (da) * | 2011-07-08 | 2020-04-20 | Gruenenthal Gmbh | Krystallinsk (1r,4r)-6'-fluor-n,n-dimethyl-4-phenyl-4',9'-dihydro-3'h-spiro[cyclohexan-1,1'-pyran¬[3,4,b]indol]-4-amin |
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US20130310435A1 (en) * | 2012-05-18 | 2013-11-21 | Gruenenthal Gmbh | Pharmaceutical Composition Comprising (1r,4r)-6'-fluoro-N, N-dimethyl-4-phenyl-4,9' -dihydro-3'H-spiro[cyclohexane-1,1' -pyrano[3,4,b]indol]-4-amine and Paracetamol or Propacetamol |
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DK2248519T3 (da) * | 2006-10-02 | 2018-01-02 | Applied Pharma Res | Ikke-mucoadhæsive filmdoseringsformer |
ES2371230T3 (es) | 2008-03-27 | 2011-12-28 | Grünenthal GmbH | Derivados de ciclohexano espirocíclicos sustituidos. |
CN100560061C (zh) | 2008-06-20 | 2009-11-18 | 海南锦瑞制药股份有限公司 | 一种氯诺昔康冻干粉针剂及其制备方法 |
DK2600851T3 (da) | 2010-08-04 | 2018-06-25 | Gruenenthal Gmbh | Farmaceutisk doseringsform, der omfatter 6'-fluor-(n-methyl- eller n,n-dimethyl-)-4-phenyl-4',9'-dihydro-3'h-spiro[cyclohexan-1,1'-pyrano[3,4,b]indol]-4-amin til behandling af neuropatiske smerter |
HUE028436T2 (hu) | 2010-08-04 | 2016-12-28 | Gruenenthal Gmbh | Gyógyszerészeti adagolási forma, amely tartalmaz-6'-fluor-(N-metil- vagy N,N-dimetil)-4-fenil-4',9'-dihidro-3'H-spiro[ciklohexán-1,1'-pirano[3,4B]indol]-4-amint |
SI2600838T1 (sl) | 2010-08-04 | 2015-12-31 | Gruenenthal Gmbh | Farmacevtska odmerna oblika, ki obsega 6'-fluoro-(N-metil- ali N,N-dimetil-)-4-fenil-4',9'-dihidro-3'H-spiro(cikloheksan-1,1'-pirano (3,4,b)indol)-4-amin |
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