HRP20171708T1 - FARMACEUTSKI PRIPRAVAK KOJI SADRŽI (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 I GABAPENTINOID - Google Patents

FARMACEUTSKI PRIPRAVAK KOJI SADRŽI (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 I GABAPENTINOID Download PDF

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Publication number
HRP20171708T1
HRP20171708T1 HRP20171708TT HRP20171708T HRP20171708T1 HR P20171708 T1 HRP20171708 T1 HR P20171708T1 HR P20171708T T HRP20171708T T HR P20171708TT HR P20171708 T HRP20171708 T HR P20171708T HR P20171708 T1 HRP20171708 T1 HR P20171708T1
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Croatia
Prior art keywords
pain
pharmacologically active
active ingredient
dosage form
pharmaceutical preparation
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HRP20171708TT
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English (en)
Inventor
Stefanie Frosch
Klaus Linz
Thomas Christoph
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Grünenthal GmbH
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Publication of HRP20171708T1 publication Critical patent/HRP20171708T1/hr

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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
    • A61K31/185Acids; 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
    • 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
    • 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)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (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)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)

Claims (13)

1. Farmaceutski pripravak naznačen time da je za uporabu za sprječavanje ili liječenje boli koji sadrži: a) prvi farmakološki aktivni sastojak izabran od spoja prema kemijskoj formuli (I) i njihove fiziološki prihvatljive soli [image] i b) drugi farmakološki aktivni sastojak izabran od gabapentinoida i njihovih fiziološki prihvatljivih soli.
2. Farmaceutski pripravak za uporabu za sprječavanje ili liječenje boli prema zahtjevu 1, naznačen time da je prvi farmakološki aktivni sastojak spoj prema kemijskoj formuli (I) [image]
3. Farmaceutski pripravak za uporabu za sprječavanje ili liječenje boli prema zahtjevu 1 ili 2, naznačen time da je drugi farmakološki aktivni sastojak odabran iz skupine koja sadrži pregabalin, gabapentin, vigabatrin i njihove fiziološki prihvatljive soli.
4. Farmaceutski pripravak za uporabu za sprječavanje ili liječenje boli prema bilo kojem od prethodnih zahtjeva, naznačen time da sadrži prvi i drugi farmakološki aktivni sastojak u takvom masenom omjeru da će nakon davanja pacijentu imati sinergističko terapeutsko djelovanje.
5. Farmaceutski pripravak za uporabu za sprječavanje ili liječenje boli prema bilo kojem od prethodnih zahtjeva, naznačen time da je relativni omjer mase prvog farmakološki aktivnog sastojka prema drugom farmakološki aktivnom sastojku unutar raspona od 1:30 do 1 : 1,000,000.
6. Farmaceutski pripravak za uporabu za sprječavanje ili liječenje boli prema zahtjevu 5, naznačen time da bol je: - periferna, središnja ili mišićna skeletna bol; i/ili - akutna, subakutna ili kronična bol; i/ili - umjerena do jaka bol; i/ili - neuropatska ili psihogena ili nociceptivna ili miješana bol; i/ili - bol u donjem dijelu leđa, visceralna bol ili glavobolja; i/ili - postoperativna (post-kirurška) bol, rak ili upalna bol
7. Farmaceutski oblik doziranja za uporabu za sprječavanje ili liječenje boli naznačen time da sadrži farmaceutski pripravak prema bilo kojem od prethodnih zahtjeva.
8. Farmaceutski oblik doziranja za uporabu za sprječavanje ili liječenje boli prema zahtjevu 7, naznačen time da sadrži prvi farmakološki aktivni sastojak u dozi od 10 do 1,200 µg.
9. Farmaceutski oblik doziranja za uporabu za sprječavanje ili liječenje boli prema zahtjevu 7 ili 8, naznačen time da sadrži drugi farmakološki aktivni sastojak u dozi od 0.05 do 5 g.
10. Farmaceutski oblik doziranja za uporabu za sprječavanje ili liječenje boli prema bilo kojem od zahtjeva 7 do 9, naznačen time da je doziranje prvog farmakološki aktivnog sastojka u rasponu od 1:20 do 20:1 količine koja je ekvivalentno djelotvorna doziranju drugog farmakološki aktivnog sastojka.
11. Farmaceutski oblik doziranja za uporabu za sprječavanje ili liječenje boli prema bilo kojem od zahtjeva 7 do 10, naznačen time da je za oralnu, intravensku, intraperitonealnu, transdermalnu, intratekalnu, intramuskularnu, intranazalnu, transmukoznu, potkožnu ili rektalnu primjenu.
12. Komplet za uporabu za sprječavanje ili liječenje boli koji sadrži prvi farmaceutski oblik doziranja koji sadrži prvi farmakološki aktivni sastojak kako je definiran u zahtjevu 1 ili 2, te drugi farmaceutski oblik doziranja koji sadrži drugi farmakološki aktivni sastojak kako je definiran u patentnom zahtjevu 1 ili 3.
13. Komplet za uporabu za sprječavanje ili liječenje boli prema zahtjevu 12, naznačen time da su prvi i drugi farmaceutski oblik doziranja prilagođeni za istovremenu ili uzastopnu primjenu, bilo istim ili različitim putem primjene.
HRP20171708TT 2012-05-18 2013-05-16 FARMACEUTSKI PRIPRAVAK KOJI SADRŽI (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 I GABAPENTINOID HRP20171708T1 (hr)

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)

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HRP20171708T1 true HRP20171708T1 (hr) 2017-12-29

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HRP20171708TT HRP20171708T1 (hr) 2012-05-18 2013-05-16 FARMACEUTSKI PRIPRAVAK KOJI SADRŽI (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 I GABAPENTINOID

Country Status (22)

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

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Also Published As

Publication number Publication date
MX356245B (es) 2018-05-21
EA029766B1 (ru) 2018-05-31
EP2849748B1 (en) 2017-11-01
HUE034659T2 (en) 2018-02-28
HK1204943A1 (en) 2015-12-11
JP6116673B2 (ja) 2017-04-19
ES2658218T3 (es) 2018-03-08
US9320725B2 (en) 2016-04-26
EA201401268A1 (ru) 2015-06-30
RS56799B1 (sr) 2018-04-30
SI2849748T1 (en) 2018-02-28
CN104284658A (zh) 2015-01-14
WO2013170966A1 (en) 2013-11-21
PT2849748T (pt) 2018-02-07
US9629825B2 (en) 2017-04-25
CY1119777T1 (el) 2018-06-27
MX2014012764A (es) 2014-11-21
DK2849748T3 (en) 2017-12-04
IL235658A0 (en) 2015-01-29
BR112014028574A2 (pt) 2017-06-27
CA2873624A1 (en) 2013-11-21
AU2013262072A1 (en) 2015-01-22
AU2013262072B2 (en) 2018-01-18
LT2849748T (lt) 2018-01-25
US20130310434A1 (en) 2013-11-21
PL2849748T3 (pl) 2018-03-30
NO2849748T3 (hr) 2018-03-31
US20160193183A1 (en) 2016-07-07
EP2849748A1 (en) 2015-03-25
IL235658A (en) 2017-07-31
JP2015516446A (ja) 2015-06-11

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