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SI2849740T1 - 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 paracetamol ali propacetamol - 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 paracetamol ali propacetamol Download PDF

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Publication number
SI2849740T1
SI2849740T1 SI201330870T SI201330870T SI2849740T1 SI 2849740 T1 SI2849740 T1 SI 2849740T1 SI 201330870 T SI201330870 T SI 201330870T SI 201330870 T SI201330870 T SI 201330870T SI 2849740 T1 SI2849740 T1 SI 2849740T1
Authority
SI
Slovenia
Prior art keywords
active ingredient
pharmacologically active
pain
pharmaceutical composition
pharmaceutical
Prior art date
Application number
SI201330870T
Other languages
English (en)
Inventor
Stefanie Frosch
Klaus Linz
Klaus Schiene
Original Assignee
Gruenenthal Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Gruenenthal Gmbh filed Critical Gruenenthal Gmbh
Publication of SI2849740T1 publication Critical patent/SI2849740T1/sl

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/223Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of alpha-aminoacids
    • 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
    • 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
    • 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

Landscapes

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

Claims (13)

  1. EP 2849740 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 paracetamol ali propacetamol Patentni zahtevki
    1. Farmacevtski sestavek, ki obsega: (a) prvo farmakološko aktivno sestavino, izbrano izmed spojine s splošno formulo (I) in fiziološko sprejemljivih soli le-te
    (I) in (b) drugo farmakološko aktivno sestavino, izbrano izmed paracetamola ali propacetamola.
  2. 2. Farmacevtski sestavek po zahtevku 1, kjer je prva farmakološko aktivna sestavina kemična spojina s formulo (I):
    (I) v obliki hidrokloridne, hemicitratne ali maleatne soli.
  3. 3. Farmacevtski sestavek po zahtevku 1 ali 2, kjer je druga farmakološko aktivna sestavina paracetamol.
  4. 4. Farmacevtski sestavek 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.
  5. 5. Farmacevtski sestavek po katerem koli od prejšnjih zahtevkov za uporabo pri preprečevanju ali zdravljenju bolečine.
  6. 6. Farmacevtski sestavek 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, ki obsega farmacevtski sestavek po katerem koli od prejšnjih zahtevkov.
  8. 8. Farmacevtska odmema oblika po zahtevku 7, ki vsebuje prvo farmakološko aktivno sestavino v odmerku 10-1200 pg.
  9. 9. Farmacevtska odmema oblika po zahtevku 7 ali 8, ki vsebuje drugo farmakološko aktivno sestavino v odmerku 100-8 000 mg.
  10. 10. Farmacevtska odmema oblika 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 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, 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 drago farmakološko aktivno sestavino, kot je definirana v zahtevku 1 ali 3.
  13. 13. Komplet po zahtevku 12, kjer sta prva in druga farmacevtska odmema oblika prilagojeni za sočasno ali zaporedno dajanje, bodisi na enak ali drugačen način dajanja.
SI201330870T 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 paracetamol ali propacetamol SI2849740T1 (sl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP12003897 2012-05-18
PCT/EP2013/001468 WO2013170969A1 (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 paracetamol or propacetamol
EP13723674.1A EP2849740B1 (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 paracetamol or propacetamol

Publications (1)

Publication Number Publication Date
SI2849740T1 true SI2849740T1 (sl) 2018-01-31

Family

ID=48468208

Family Applications (1)

Application Number Title Priority Date Filing Date
SI201330870T SI2849740T1 (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 paracetamol ali propacetamol

Country Status (22)

Country Link
US (3) US20130310435A1 (sl)
EP (1) EP2849740B1 (sl)
JP (1) JP6116676B2 (sl)
CN (2) CN104302282A (sl)
AU (1) AU2013262075B2 (sl)
BR (1) BR112014028561A2 (sl)
CA (1) CA2873644A1 (sl)
CY (1) CY1119610T1 (sl)
DK (1) DK2849740T3 (sl)
EA (1) EA026949B1 (sl)
ES (1) ES2650441T3 (sl)
HR (1) HRP20171438T1 (sl)
HU (1) HUE034676T2 (sl)
IL (1) IL235651B (sl)
LT (1) LT2849740T (sl)
MX (1) MX352596B (sl)
NO (1) NO2849740T3 (sl)
PL (1) PL2849740T3 (sl)
PT (1) PT2849740T (sl)
RS (1) RS56617B1 (sl)
SI (1) SI2849740T1 (sl)
WO (1) WO2013170969A1 (sl)

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US10022353B2 (en) 2015-01-23 2018-07-17 Grünenthal GmbH Cebranopadol for treating pain in subjects with impaired hepatic and/or impaired renal function
JP7373904B2 (ja) 2016-02-29 2023-11-06 パーク・セラピューティクス・インコーポレイテッド セブラノパドールの滴定

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Also Published As

Publication number Publication date
ES2650441T3 (es) 2018-01-18
JP2015516449A (ja) 2015-06-11
JP6116676B2 (ja) 2017-04-19
HRP20171438T1 (hr) 2017-11-03
HUE034676T2 (hu) 2018-02-28
CN108524498A (zh) 2018-09-14
MX2014012723A (es) 2015-01-15
EP2849740B1 (en) 2017-09-13
CA2873644A1 (en) 2013-11-21
WO2013170969A1 (en) 2013-11-21
LT2849740T (lt) 2017-12-27
CN104302282A (zh) 2015-01-21
CY1119610T1 (el) 2018-04-04
US11311504B2 (en) 2022-04-26
AU2013262075B2 (en) 2017-10-26
MX352596B (es) 2017-11-30
IL235651A0 (en) 2015-01-29
IL235651B (en) 2018-08-30
US20130310435A1 (en) 2013-11-21
US20180092867A1 (en) 2018-04-05
EP2849740A1 (en) 2015-03-25
BR112014028561A2 (pt) 2017-07-25
HK1204940A1 (en) 2015-12-11
PT2849740T (pt) 2017-12-13
NO2849740T3 (sl) 2018-02-10
US20190350884A1 (en) 2019-11-21
EA026949B1 (ru) 2017-06-30
AU2013262075A1 (en) 2015-01-22
EA201401272A1 (ru) 2015-05-29
PL2849740T3 (pl) 2018-03-30
DK2849740T3 (da) 2017-11-20
RS56617B1 (sr) 2018-02-28

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