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DK2849748T3 - Farmaceutisk sammensætning omfattende (1r,4r)-6'-fluor-N,N-dimethyl-4-phenyl-4',9'-dihydro-3'H-spiro[cyklohexan-1,1'-pyran[3,4,b]indol]-4-amin og et gabapentinoid - Google Patents

Farmaceutisk sammensætning omfattende (1r,4r)-6'-fluor-N,N-dimethyl-4-phenyl-4',9'-dihydro-3'H-spiro[cyklohexan-1,1'-pyran[3,4,b]indol]-4-amin og et gabapentinoid Download PDF

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Publication number
DK2849748T3
DK2849748T3 DK13726111.1T DK13726111T DK2849748T3 DK 2849748 T3 DK2849748 T3 DK 2849748T3 DK 13726111 T DK13726111 T DK 13726111T DK 2849748 T3 DK2849748 T3 DK 2849748T3
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pharmacologically active
active ingredient
pain
pharmaceutical dosage
dosage form
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DK13726111.1T
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English (en)
Inventor
Stefanie Frosch
Klaus Linz
Thomas Christoph
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Gruenenthal Gmbh
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic 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
    • A61K31/407Heterocyclic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/06Antimigraine agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/08Antiepileptics; Anticonvulsants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/22Anxiolytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A61P29/02Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurology (AREA)
  • Pain & Pain Management (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Claims (13)

1. Farmaceutisk sammensætning til anvendelse i forebyggelse eller behandling af smerte, omfattende: a) en første farmakologisk virksom bestanddel udvalgt fra forbindelsen ifølge den kemiske formel (I) og de fysiologisk acceptable salte deraf
(I) og b) en anden farmakologisk virksom bestanddel udvalgt blandt gabapentinoider og de fysiologisk acceptable salte deraf.
2. Farmaceutisk sammensætning til anvendelse i forebyggelse eller behandling af smerte ifølge krav 1, hvor den første farmakologisk virksomme bestanddel er forbindelsen ifølge den kemiske formel (I)
(I)
3. Farmaceutisk sammensætning til anvendelse i forebyggelse eller behandling af smerte ifølge krav 1 eller 2, hvor den anden farmakologisk virksomme bestanddel er udvalgt fra gruppen bestående af pregabalin, gabapentin, vigabatrin og de fysiologisk acceptable salte deraf.
4. Farmaceutisk sammensætning til anvendelse i forebyggelse eller behandling af smerte ifølge et hvilket som helst af de foregående krav, som indeholder den første og den anden farmakologisk virksomme bestanddel i et sådant vægtforhold, at de vil udøve en synergistisk terapeutisk virkning efter indgift til en patient.
5. Farmaceutisk sammensætning til anvendelse i forebyggelse eller behandling af smerte ifølge et hvilket som helst af de foregående krav, hvor det relative vægtforhold af den første farmakologisk virksomme bestanddel og den anden farmakologisk virksomme bestanddel ligger i området fra 1:30 til 1:1000.000.
6. Farmaceutisk sammensætning til anvendelse i forebyggelse eller behandling af smerte ifølge krav 5, hvor smerten er: - perifær smerte, central smerte eller muskel-skelet-smerte; og/eller - akut, subakut eller kronisk smerte; og/eller - moderat til stærk smerte; og/elller - neuropatisk eller psykogen eller nociceptiv eller blandet smerte; og/eller - lændesmerter, visceral smerte eller hovedpine; og/eller - postoperativ (postkirurgisk) smerte, cancersmerte eller inflammationssmerte.
7. Farmaceutisk doseringsform til anvendelse i forebyggelse eller behandling af smerte omfattende den farmaceutiske sammensætning ifølge et hvilket som helst af de foregående krav.
8. Farmaceutisk doseringsform til anvendelse i forebyggelse eller behandling af smerte ifølge krav 7, som indeholder den første farmakologisk virksomme bestanddel i en dosis på 10 til 1200 pg.
9. Farmaceutisk doseringsform til anvendelse i forebyggelse eller behandling af smerte ifølge krav 7 eller 8, som indeholder den anden farmakologisk virksomme bestanddel i en dosis fra 0,05 til 5 g.
10. Farmaceutisk doseringsform til anvendelse i forebyggelse eller behandling af smerte ifølge et hvilket som helst af kravene 7 til 9, hvor dosen af den første farmakologisk virksomme bestanddel er inden for området fra 1:20 til 20:1 af mængden, som har ækvivalent virkning med dosen af den anden farmakologisk vrksomme bestanddel.
11. Farmaceutisk doseringsform til anvendelse i forebyggelse eller behandling af smerte ifølge et hvilket som helst af kravene 7 til 10, som er til oral, intravenøs, intraperitoneal, transdermal, intratekal, intramuskulær, intranasal, transmukosal, subkutan eller rektal indgift.
12. Sæt til anvendelse i forebyggelse eller behandling af smerte omfattende en første farmaceutisk doseringsform omfattende den første farmakologisk virksomme bestanddel som defineret i krav 1 eller 2, og en anden farmaceutisk doseringsform omfattende den anden farmakologisk virksomme bestanddel som defineret i krav 1 eller 3.
13. Sæt til anvendelse i forebyggelse eller behandling af smerte ifølge krav 12, hvor den første og den anden farmaceutiske doseringsform er tilpasset samtidig eller på hinanden følgende indgift, enten ad samme eller forskellige indgiftsveje.
DK13726111.1T 2012-05-18 2013-05-16 Farmaceutisk sammensætning omfattende (1r,4r)-6'-fluor-N,N-dimethyl-4-phenyl-4',9'-dihydro-3'H-spiro[cyklohexan-1,1'-pyran[3,4,b]indol]-4-amin og et gabapentinoid DK2849748T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP12003940 2012-05-18
PCT/EP2013/001465 WO2013170966A1 (en) 2012-05-18 2013-05-16 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 a gabapentinoid

Publications (1)

Publication Number Publication Date
DK2849748T3 true DK2849748T3 (da) 2017-12-04

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DK13726111.1T DK2849748T3 (da) 2012-05-18 2013-05-16 Farmaceutisk sammensætning omfattende (1r,4r)-6'-fluor-N,N-dimethyl-4-phenyl-4',9'-dihydro-3'H-spiro[cyklohexan-1,1'-pyran[3,4,b]indol]-4-amin og et gabapentinoid

Country Status (22)

Country Link
US (2) US9320725B2 (da)
EP (1) EP2849748B1 (da)
JP (1) JP6116673B2 (da)
CN (1) CN104284658A (da)
AU (1) AU2013262072B2 (da)
BR (1) BR112014028574A2 (da)
CA (1) CA2873624A1 (da)
CY (1) CY1119777T1 (da)
DK (1) DK2849748T3 (da)
EA (1) EA029766B1 (da)
ES (1) ES2658218T3 (da)
HR (1) HRP20171708T1 (da)
HU (1) HUE034659T2 (da)
IL (1) IL235658A (da)
LT (1) LT2849748T (da)
MX (1) MX356245B (da)
NO (1) NO2849748T3 (da)
PL (1) PL2849748T3 (da)
PT (1) PT2849748T (da)
RS (1) RS56799B1 (da)
SI (1) SI2849748T1 (da)
WO (1) WO2013170966A1 (da)

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Also Published As

Publication number Publication date
US20160193183A1 (en) 2016-07-07
IL235658A (en) 2017-07-31
ES2658218T3 (es) 2018-03-08
MX356245B (es) 2018-05-21
AU2013262072B2 (en) 2018-01-18
US20130310434A1 (en) 2013-11-21
EP2849748B1 (en) 2017-11-01
US9320725B2 (en) 2016-04-26
HUE034659T2 (en) 2018-02-28
MX2014012764A (es) 2014-11-21
WO2013170966A1 (en) 2013-11-21
NO2849748T3 (da) 2018-03-31
SI2849748T1 (en) 2018-02-28
CA2873624A1 (en) 2013-11-21
US9629825B2 (en) 2017-04-25
AU2013262072A1 (en) 2015-01-22
EP2849748A1 (en) 2015-03-25
EA201401268A1 (ru) 2015-06-30
PT2849748T (pt) 2018-02-07
CN104284658A (zh) 2015-01-14
PL2849748T3 (pl) 2018-03-30
BR112014028574A2 (pt) 2017-06-27
RS56799B1 (sr) 2018-04-30
IL235658A0 (en) 2015-01-29
EA029766B1 (ru) 2018-05-31
JP2015516446A (ja) 2015-06-11
HK1204943A1 (en) 2015-12-11
JP6116673B2 (ja) 2017-04-19
HRP20171708T1 (hr) 2017-12-29
LT2849748T (lt) 2018-01-25
CY1119777T1 (el) 2018-06-27

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