HRP20171922T1 - 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 duloksetin - 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 duloksetin Download PDF

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Publication number
HRP20171922T1
HRP20171922T1 HRP20171922TT HRP20171922T HRP20171922T1 HR P20171922 T1 HRP20171922 T1 HR P20171922T1 HR P20171922T T HRP20171922T T HR P20171922TT HR P20171922 T HRP20171922 T HR P20171922T HR P20171922 T1 HRP20171922 T1 HR P20171922T1
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Croatia
Prior art keywords
pharmacologically active
pain
active ingredient
dosage form
pharmaceutical
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HRP20171922TT
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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 HRP20171922T1 publication Critical patent/HRP20171922T1/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
    • A61K31/33Heterocyclic compounds
    • A61K31/38Heterocyclic compounds having sulfur as a ring hetero atom
    • A61K31/381Heterocyclic compounds having sulfur as a ring hetero atom having five-membered rings
    • 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
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/53751,4-Oxazines, e.g. morpholine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61P25/08Antiepileptics; 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
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants
    • 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
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (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)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)

Claims (10)

1. Farmaceutski pripravak naznačen time da sadrži: a) prvi farmakološki aktivni sastojak, koji je izabran od spoja prema kemijskoj formuli (I) i njegove fiziološki prihvatljive soli [image] i b) drugi farmakološki aktivni sastojak koji je odabran iz skupine koja sadrži duloksetin i njegove fiziološki prihvatljive soli.
2. Farmaceutski pripravak prema zahtjevu 1, naznačen time da je prvi farmakološki aktivni sastojak spoj prema kemijskoj formuli (I) [image]
3. Farmaceutski pripravak prema bilo kojem od prethodnih zahtjeva, naznačen time da sadrži prvi i drugi farmakološki aktivni sastojak u takvom masenom omjeru da će oni nakon davanja pacijentu imati sinergističko terapeutsko djelovanje.
4. Farmaceutski pripravak 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 : 1 do 1 : 1,000,000.
5. Farmaceutski pripravak prema bilo kojem od prethodnih zahtjeva naznačen time da je za uporabu za sprječavanje ili liječenje boli.
6. Farmaceutski pripravak prema zahtjevu5, 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 naznačen time da sadrži farmaceutski pripravak prema bilo kojem od prethodnih zahtjeva.
8. Farmaceutski oblik doziranja prema zahtjevu 7, naznačen time da sadrži prvi farmakološki aktivni sastojak u dozi od 10 do 1,200 µg.
9. Farmaceutski oblik doziranja prema zahtjevu 7 ili 8, naznačen time da sadrži drugi farmakološki aktivni sastojak u dozi od 1 mg do 1,000 mg.
10. Komplet naznačen time da sadrži prvi farmaceutski oblik doziranja koji obuhvaća 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 zahtjevu 1.
HRP20171922TT 2012-05-18 2017-12-12 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 duloksetin HRP20171922T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP12003937 2012-05-18
EP13723003.3A EP2849744B1 (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 duloxetine
PCT/EP2013/001464 WO2013170965A1 (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 antidepressants

Publications (1)

Publication Number Publication Date
HRP20171922T1 true HRP20171922T1 (hr) 2018-02-09

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HRP20171922TT HRP20171922T1 (hr) 2012-05-18 2017-12-12 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 duloksetin

Country Status (23)

Country Link
US (2) US20130310385A1 (hr)
EP (1) EP2849744B1 (hr)
JP (1) JP6116672B2 (hr)
CN (1) CN104271131A (hr)
AU (1) AU2013262071B2 (hr)
BR (1) BR112014028562A2 (hr)
CA (1) CA2873634A1 (hr)
CY (1) CY1119825T1 (hr)
DK (1) DK2849744T3 (hr)
EA (1) EA027268B1 (hr)
ES (1) ES2660461T3 (hr)
HK (1) HK1204944A1 (hr)
HR (1) HRP20171922T1 (hr)
HU (1) HUE037746T2 (hr)
IL (1) IL235657B (hr)
LT (1) LT2849744T (hr)
MX (1) MX354684B (hr)
NO (1) NO2849744T3 (hr)
PL (1) PL2849744T3 (hr)
PT (1) PT2849744T (hr)
RS (1) RS56856B1 (hr)
SI (1) SI2849744T1 (hr)
WO (1) WO2013170965A1 (hr)

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US20170065560A1 (en) 2017-03-09
EA027268B1 (ru) 2017-07-31
CA2873634A1 (en) 2013-11-21
HK1204944A1 (en) 2015-12-11
EP2849744A1 (en) 2015-03-25
US20130310385A1 (en) 2013-11-21
LT2849744T (lt) 2018-02-26
MX354684B (es) 2018-03-15
AU2013262071B2 (en) 2018-01-18
WO2013170965A1 (en) 2013-11-21
DK2849744T3 (en) 2018-01-22
SI2849744T1 (en) 2018-01-31
AU2013262071A1 (en) 2015-01-22
CY1119825T1 (el) 2018-06-27
PT2849744T (pt) 2018-02-28
PL2849744T3 (pl) 2018-06-29
JP6116672B2 (ja) 2017-04-19
IL235657B (en) 2018-08-30
NO2849744T3 (hr) 2018-04-21
RS56856B1 (sr) 2018-04-30
MX2014012859A (es) 2015-01-19
US10328055B2 (en) 2019-06-25
HUE037746T2 (hu) 2018-09-28
IL235657A0 (en) 2015-01-29
EP2849744B1 (en) 2017-11-22
JP2015520154A (ja) 2015-07-16
ES2660461T3 (es) 2018-03-22
CN104271131A (zh) 2015-01-07
EA201401269A1 (ru) 2016-05-31
BR112014028562A2 (pt) 2017-06-27

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