SI2600839T1 - Farmacevtska odmerna oblika, ki obsega 6'-fluoro-(N-metil- ali N,N-dimetil-)-4-fenil-4',9'-dihidro-3'H-spiro(cikloheksan-1,1'-pirano- (3,4,b)indol)-4-amin - Google Patents

Farmacevtska odmerna oblika, ki obsega 6'-fluoro-(N-metil- ali N,N-dimetil-)-4-fenil-4',9'-dihidro-3'H-spiro(cikloheksan-1,1'-pirano- (3,4,b)indol)-4-amin Download PDF

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Publication number
SI2600839T1
SI2600839T1 SI201131434T SI201131434T SI2600839T1 SI 2600839 T1 SI2600839 T1 SI 2600839T1 SI 201131434 T SI201131434 T SI 201131434T SI 201131434 T SI201131434 T SI 201131434T SI 2600839 T1 SI2600839 T1 SI 2600839T1
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SI
Slovenia
Prior art keywords
active agent
pharmacologically active
pharmaceutical formulation
general formula
formulation according
Prior art date
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SI201131434T
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English (en)
Inventor
Marc Schiller
Nadja Gruning
Ingo Friedrich
Chris Kirby
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Gruenenthal Gmbh
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Publication date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=43481034&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=SI2600839(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Gruenenthal Gmbh filed Critical Gruenenthal Gmbh
Publication of SI2600839T1 publication Critical patent/SI2600839T1/sl

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

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

Claims (10)

  1. Farmacevtska odmema oblika, ki obsega 6’-fluoro-(N-metil- ali N,N-dimetil-)-4-fenil -4’ ,9’-dihidro-3 ’H-spiro[cikloheksan-1,1 ’-pirano-[3,4,b]indol]-4-amin Patentni zahtevki
    1. Farmacevtska odmema oblika za dajanje dvakrat dnevno, enkrat dnevno ali manj pogosto, ki vsebuje farmakološko aktivno sredstvo s splošno formulo (I)
    v kjer je R -Hali-CH3, ali njegovo fiziološko sprejemljivo sol, ki skladno s Ph. Eur. pod in vitro pogoji v 900 mL umetnega želodčnega soka pri pH 1,2 in 37 °C ± 0,5 °C po 30 minutah po metodi z napravo z veslastim mešalom s svinčnico ("sinker") pri 100 vrt/min sprosti vsaj 50 mas. % farmakološko aktivnega sredstva, na osnovi celokupne količine farmakološko aktivnega sredstva, ki je prvotno vsebovana v farmacevtski odmemi obliki; in ki obsega trden polimerni matriksni material, v katerem je farmakološko aktivno sredstvo s splošno formulo (I) dispergirano in imobilizirano v amorfnem ali pol-amorfhem stanju, in kjer je polimer izbran iz skupine, ki jo sestavljajo polivinilpirolidon, vinilpirolidon-polivinilacetatni kopolimeri in njihove kakršne koli kombinacije; in kjer je relativno masno razmerje polimera glede na farmakološko aktivno sredstvo s splošno formulo (I) vsaj 6:1.
  2. 2. Farmacevtska odmema oblika po zahtevku 1, ki nadalje obsega surfaktant.
  3. 3. Farmacevtska odmema oblika po zahtevku 2, kjer - ima surfaktant HLB vrednost vsaj 10; in/ali - je vsebnost surfaktanta vsaj 0,001 mas. %, na osnovi celokupne mase farmacevtske odmeme oblike.
  4. 4. Farmacevtska odmema oblika po zahtevku 2 ali 3, kjer je surfaktant izbran iz skupine, ki jo sestavljajo polioksietilen maščobnokislinski estri, delni maščobnokislinski estri polioksietilensorbitana in estri žveplove kisline.
  5. 5. Farmacevtska odmema oblika po katerem koli od predhodnih zahtevkov, kjer ima farmakološko aktivno sredstvo s splošno formulo (I) stereokemijo s splošno formulo (Γ)
    kjer je R definiran kot v zahtevku 1.
  6. 6. Farmacevtska odmema oblika po katerem koli od predhodnih zahtevkov, kjer je farmakološko aktivno sredstvo s splošno formulo (I) (1 r,4r)-6 ’-fluoro-N,N-dimetil-4-fenil-4 ’ ,9 ’-dihidro-3’H-spiro[cikcloheksan-1,1 ’-pirano[3,4,b]indol]-4-amin, (1 r,4r)-6 ’ -fhioro-N-metil-4-fenil-4 ’ ,9 ’ -dihidro-3 ’H-spiro[cikloheksan-1, Γ -pirano-[3,4,b]indol]-4-amin ali fiziološko sprejemljiva sol le-teh.
  7. 7. Farmacevtska odmema oblika po katerem koli od predhodnih zahtevkov, ki pod in vitro pogoji v 900 mL umetnega želodčnega soka pri pH 1,2 po 30 minutah sprosti vsaj 80 mas. % farmakološko aktivnega sredstva s splošno formulo (I), na osnovi celokupne količine farmakološko aktivnega sredstva s formulo (I), ki je prvotno vsebovana v odmemi obliki.
  8. 8. Farmacevtska odmema oblika po katerem koli od predhodnih zahtevkov, ki vsebuje farmakološko aktivno sredstvo s splošno formulo (I) v odmerku od 10 pg do 50 pg ali od 300 pg do 500 pg.
  9. 9. Farmacevtska odmema oblika po katerem koli od predhodnih zahtevkov za uporabo v zdravljenju bolečine.
  10. 10. Farmacevtska odmema oblika po zahtevku 9, kjer je bolečina izbrana izmed akutne, visceralne, nevropatske ali kronične bolečine.
SI201131434T 2010-08-04 2011-08-04 Farmacevtska odmerna oblika, ki obsega 6'-fluoro-(N-metil- ali N,N-dimetil-)-4-fenil-4',9'-dihidro-3'H-spiro(cikloheksan-1,1'-pirano- (3,4,b)indol)-4-amin SI2600839T1 (sl)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US37064310P 2010-08-04 2010-08-04
EP10008116 2010-08-04
PCT/EP2011/003909 WO2012016699A2 (en) 2010-08-04 2011-08-04 Pharmaceutical dosage form comprising 6'-fluoro-(n-methyl- or n,n-dimethyl-)-4-phenyl-4,9'-dihydro-3'h-spiro[cylohexane-1,1'-pyrano[3,4,b]indol]-4-amine
EP11746175.6A EP2600839B1 (en) 2010-08-04 2011-08-04 Pharmaceutical dosage form comprising 6'-fluoro-(n-methyl- or n,n-dimethyl-)-4-phenyl-4',9'-dihydro-3'h-spiro[cylohexane-1,1'-pyrano[3,4,b]indol]-4-amine

Publications (1)

Publication Number Publication Date
SI2600839T1 true SI2600839T1 (sl) 2018-04-30

Family

ID=43481034

Family Applications (1)

Application Number Title Priority Date Filing Date
SI201131434T SI2600839T1 (sl) 2010-08-04 2011-08-04 Farmacevtska odmerna oblika, ki obsega 6'-fluoro-(N-metil- ali N,N-dimetil-)-4-fenil-4',9'-dihidro-3'H-spiro(cikloheksan-1,1'-pirano- (3,4,b)indol)-4-amin

Country Status (28)

Country Link
EP (1) EP2600839B1 (sl)
JP (1) JP5792300B2 (sl)
KR (1) KR101828768B1 (sl)
CN (1) CN103179953A (sl)
AR (1) AR082560A1 (sl)
AU (1) AU2011287956B2 (sl)
BR (1) BR112013002714A2 (sl)
CA (1) CA2804878C (sl)
CL (1) CL2012003582A1 (sl)
CO (1) CO6640315A2 (sl)
CY (1) CY1119887T1 (sl)
DK (1) DK2600839T3 (sl)
EC (1) ECSP13012419A (sl)
ES (1) ES2665344T3 (sl)
HR (1) HRP20180143T1 (sl)
HU (1) HUE035543T2 (sl)
IL (1) IL223880A (sl)
LT (1) LT2600839T (sl)
MX (1) MX345068B (sl)
NZ (1) NZ604735A (sl)
PE (1) PE20131107A1 (sl)
PL (1) PL2600839T3 (sl)
PT (1) PT2600839T (sl)
RS (1) RS57027B1 (sl)
RU (1) RU2582390C2 (sl)
SI (1) SI2600839T1 (sl)
WO (1) WO2012016699A2 (sl)
ZA (1) ZA201300038B (sl)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2016208779B2 (en) 2015-01-23 2020-11-12 Grunenthal Gmbh Cebranopadol for treating pain in subjects with impaired hepatic and/or impaired renal function
MX2018010367A (es) 2016-02-29 2018-12-10 Guenenthal Gmbh Titulacion de cebranopadol.

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AR038681A1 (es) * 2002-02-14 2005-01-26 Solvay Pharm Bv Formulacion oral de solucion solida de una sustancia activa pobremente soluble en agua
DE10252667A1 (de) 2002-11-11 2004-05-27 Grünenthal GmbH Spirocyclische Cyclohexan-Derivate
DE102005005446A1 (de) * 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
US20070048228A1 (en) * 2003-08-06 2007-03-01 Elisabeth Arkenau-Maric Abuse-proofed dosage form
DE102006046745A1 (de) * 2006-09-29 2008-04-03 Grünenthal GmbH Gemischte ORL1/µ-Agonisten zur Behandlung von Schmerz
DE102007009235A1 (de) * 2007-02-22 2008-09-18 Grünenthal GmbH Spirocyclische Cyclohexan-Derivate

Also Published As

Publication number Publication date
ZA201300038B (en) 2013-09-25
MX345068B (es) 2017-01-16
PL2600839T3 (pl) 2018-07-31
RS57027B1 (sr) 2018-05-31
EP2600839A2 (en) 2013-06-12
JP5792300B2 (ja) 2015-10-07
AU2011287956A8 (en) 2014-09-25
KR101828768B1 (ko) 2018-02-13
NZ604735A (en) 2014-08-29
DK2600839T3 (da) 2018-01-29
KR20130135238A (ko) 2013-12-10
CO6640315A2 (es) 2013-03-22
PE20131107A1 (es) 2013-10-17
RU2013109134A (ru) 2014-09-10
AR082560A1 (es) 2012-12-19
CA2804878C (en) 2019-01-08
WO2012016699A8 (en) 2013-02-07
CY1119887T1 (el) 2018-06-27
PT2600839T (pt) 2018-04-17
CL2012003582A1 (es) 2013-06-07
BR112013002714A2 (pt) 2017-05-30
MX2013001114A (es) 2013-03-12
EP2600839B1 (en) 2018-01-10
WO2012016699A2 (en) 2012-02-09
HRP20180143T1 (hr) 2018-02-23
IL223880A (en) 2017-01-31
ECSP13012419A (es) 2013-03-28
RU2582390C2 (ru) 2016-04-27
CN103179953A (zh) 2013-06-26
JP2013532698A (ja) 2013-08-19
AU2011287956A1 (en) 2013-01-10
CA2804878A1 (en) 2012-02-09
HUE035543T2 (en) 2018-05-28
LT2600839T (lt) 2018-03-26
ES2665344T3 (es) 2018-04-25
AU2011287956B2 (en) 2015-01-22
WO2012016699A3 (en) 2012-08-16

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