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SI2849748T1 - Farmacevtski sestavek, ki obsega (1r,4r)-6'-fluoro-N,N-dimetil-4-fenil- 4',9'-dihidro-3'H-spiro(cikloheksan-1,1'-pirano(3,4,b)indol)-4-amin in gabapentinoid - Google Patents

Farmacevtski sestavek, ki obsega (1r,4r)-6'-fluoro-N,N-dimetil-4-fenil- 4',9'-dihidro-3'H-spiro(cikloheksan-1,1'-pirano(3,4,b)indol)-4-amin in gabapentinoid Download PDF

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Publication number
SI2849748T1
SI2849748T1 SI201330920T SI201330920T SI2849748T1 SI 2849748 T1 SI2849748 T1 SI 2849748T1 SI 201330920 T SI201330920 T SI 201330920T SI 201330920 T SI201330920 T SI 201330920T SI 2849748 T1 SI2849748 T1 SI 2849748T1
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SI
Slovenia
Prior art keywords
pain
active ingredient
prevention
treatment
pharmacologically active
Prior art date
Application number
SI201330920T
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English (en)
Inventor
Stefanie Frosch
Klaus Linz
Thomas Christoph
Original Assignee
Gruenenthal Gmbh
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Filing date
Publication date
Application filed by Gruenenthal Gmbh filed Critical Gruenenthal Gmbh
Publication of SI2849748T1 publication Critical patent/SI2849748T1/sl

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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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular 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
    • 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
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/08—Antiepileptics; Anticonvulsants
    • 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
    • A61P25/22—Anxiolytics
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A61P29/02—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
    • 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

Landscapes

  • 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)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Pain & Pain Management (AREA)
  • Neurosurgery (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. EP 2849748 BI Farmacevtski sestavek, ki obsega (lr,4r)-6’-fluoro-N,N-dimetil-4-fenil-4’,9,-dihidro-3’H-spiro[cikloheksan-l,r-pirano[3,4,b]indol]-4-amin in gabapentinoid Patentni zahtevki
    1. Farmacevtski sestavek za uporabo pri preprečevanju ali zdravljenju bolečine, obsegajoč: (a) prvo farmakološko aktivno sestavino, izbrano izmed spojine s kemijsko formulo (I) in fiziološko sprejemljivih soli le-te
    (I) in (b) drugo farmakološko aktivno sestavino, izbrano izmed gabapentinoidov in fiziološko sprejemljivih soli le-teh.
  2. 2. Farmacevtski sestavek za uporabo pri preprečevanju ali zdravljenju bolečine po zahtevku 1, kjer je prva farmakološko aktivna sestavina spojina s kemijsko formulo (I):
    (I)
  3. 3. Farmacevtski sestavek za uporabo pri preprečevanju ali zdravljenju bolečine po zahtevku 1 ali 2, kjer je druga farmakološko aktivna sestavina izbrana iz skupine, ki jo sestavljajo pregabalin, gabapentin, vigabatrin in fiziološko sprejemljive soli le-teh.
  4. 4. Farmacevtski sestavek za uporabo pri preprečevanju ali zdravljenju bolečine po katerem koli od prejšnjih zahtevkov, ki vsebuje prvo in drugo farmakološko aktivno sestavino v takem masnem razmerju, da bosta imeli sinergističen terapevtski učinek po dajanju pacientu.
  5. 5. Farmacevtski sestavek za uporabo pri preprečevanju ali zdravljenju bolečine po katerem koli od prejšnjih zahtevkov, kjer je relativno masno razmerje prve farmakološko aktivne sestavine proti drugi farmakološko aktivni sestavini v območju od 1 : 30 do 1 : 1 000 000.
  6. 6. Farmacevtski sestavek za uporabo pri preprečevanju ali zdravljenju bolečine po zahtevku 5, kjer je bolečina: - periferna, centralna ali mišičnoskeletna bolečina; in/ali - akutna, subakutna ali kronična bolečina; in/ali - zmerna do huda bolečina; in/ali - nevropatska ali psihogena ali nociceptivna ali mešana bolečina; in/ali - bolečina v križu, visceralna bolečina ali glavobol; in/ali - pooperacijska (pokirurška) bolečina, bolečina zaradi raka ali vnetna bolečina.
  7. 7. Farmacevtska odmema oblika za uporabo pri preprečevanju ali zdravljenju bolečine, obsegajoča farmacevtski sestavek po katerem koli od prejšnjih zahtevkov.
  8. 8. Farmacevtska odmema oblika za uporabo pri preprečevanju ali zdravljenju bolečine po zahtevku 7, ki vsebuje prvo farmakološko aktivno sestavino v odmerku 10-1 200 μ§·
  9. 9. Farmacevtska odmema oblika za uporabo pri preprečevanju ali zdravljenju bolečine po zahtevku 7 ali 8, ki vsebuje drugo farmakološko aktivno sestavino v odmerku 0,05-5 g.
  10. 10. Farmacevtska odmema oblika za uporabo pri preprečevanju ali zdravljenju bolečine po katerem koli od zahtevkov 7-9, kjer je odmerek prve farmakološko aktivne sestavine v območju od 1 : 20 do 20 : 1 količine, ki je enako učinkovita kot odmerek druge farmakološko aktivne sestavine.
  11. 11. Farmacevtska odmema oblika za uporabo pri preprečevanju ali zdravljenju bolečine po katerem koli od zahtevkov 7-10, ki je za peroralno, intravenozno, intraperitonealno, transdermalno, intratekalno, intramuskulamo, intranazalno, transmukozno, subkutano ali rektalno dajanje.
  12. 12. Komplet za uporabo pri preprečevanju ali zdravljenju bolečine, ki obsega prvo farmacevtsko odmemo obliko, ki obsega prvo farmakološko aktivno sestavino, kot je definirana v zahtevku 1 ali 2, in drugo farmacevtsko odmemo obliko, ki obsega drugo farmakološko aktivno sestavino, kot je definirana v zahtevku 1 ali 3.
  13. 13. Komplet za uporabo pri preprečevanju ali zdravljenju bolečine po zahtevku 12, kjer sta prva in druga farmacevtska odmema oblika prilagojeni za sočasno ali zaporedno dajanje, bodisi na enak ali drugačen način dajanja.
SI201330920T 2012-05-18 2013-05-16 Farmacevtski sestavek, ki obsega (1r,4r)-6'-fluoro-N,N-dimetil-4-fenil- 4',9'-dihidro-3'H-spiro(cikloheksan-1,1'-pirano(3,4,b)indol)-4-amin in gabapentinoid SI2849748T1 (sl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP12003940 2012-05-18
EP13726111.1A EP2849748B1 (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
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
SI2849748T1 true SI2849748T1 (sl) 2018-02-28

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SI201330920T SI2849748T1 (sl) 2012-05-18 2013-05-16 Farmacevtski sestavek, ki obsega (1r,4r)-6'-fluoro-N,N-dimetil-4-fenil- 4',9'-dihidro-3'H-spiro(cikloheksan-1,1'-pirano(3,4,b)indol)-4-amin in gabapentinoid

Country Status (22)

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

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Also Published As

Publication number Publication date
US20130310434A1 (en) 2013-11-21
CN104284658A (zh) 2015-01-14
AU2013262072B2 (en) 2018-01-18
HRP20171708T1 (hr) 2017-12-29
DK2849748T3 (en) 2017-12-04
PL2849748T3 (pl) 2018-03-30
US20160193183A1 (en) 2016-07-07
CA2873624A1 (en) 2013-11-21
US9320725B2 (en) 2016-04-26
AU2013262072A1 (en) 2015-01-22
JP6116673B2 (ja) 2017-04-19
LT2849748T (lt) 2018-01-25
ES2658218T3 (es) 2018-03-08
PT2849748T (pt) 2018-02-07
US9629825B2 (en) 2017-04-25
EA029766B1 (ru) 2018-05-31
WO2013170966A1 (en) 2013-11-21
HK1204943A1 (en) 2015-12-11
MX2014012764A (es) 2014-11-21
IL235658A0 (en) 2015-01-29
EP2849748B1 (en) 2017-11-01
MX356245B (es) 2018-05-21
HUE034659T2 (en) 2018-02-28
CY1119777T1 (el) 2018-06-27
BR112014028574A2 (pt) 2017-06-27
RS56799B1 (sr) 2018-04-30
NO2849748T3 (sl) 2018-03-31
JP2015516446A (ja) 2015-06-11
EA201401268A1 (ru) 2015-06-30
EP2849748A1 (en) 2015-03-25
IL235658A (en) 2017-07-31

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