HRP20151289T1 - Farmaceutski oblik doziranja koji sadrži 6'-fluoro-(n-metil- ili n,n-dimetil)-4-fenil-4',9'-dihidro-3'h-spiro[cikloheksan-1,1'-pirano[3,4,b]indol]-4-amin - Google Patents

Farmaceutski oblik doziranja koji sadrži 6'-fluoro-(n-metil- ili 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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HRP20151289T1
HRP20151289T1 HRP20151289TT HRP20151289T HRP20151289T1 HR P20151289 T1 HRP20151289 T1 HR P20151289T1 HR P20151289T T HRP20151289T T HR P20151289TT HR P20151289 T HRP20151289 T HR P20151289T HR P20151289 T1 HRP20151289 T1 HR P20151289T1
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dosage form
pharmaceutical dosage
use according
general formula
active substance
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HRP20151289TT
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Nadja Grüning
Marc Schiller
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Grünenthal GmbH
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Publication of HRP20151289T1 publication Critical patent/HRP20151289T1/hr

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    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Dispersion Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Rheumatology (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)

Claims (12)

1. Farmaceutski oblik doziranja naznačen time da je za upotrebu za liječenje bola, te sadrži farmakološki aktivnu tvar u skladu s općom formulom (I) [image] pri čemu R je -H ili -CH3, ili njegovu fiziološki prihvatljivu sol i samo emulgirajuću formulaciju; pri čemu se farmaceutski oblik doziranja daje dva puta dnevno, jednom dnevno ili rjeđe.
2. Farmaceutski oblik doziranja za upotrebu prema zahtjevu 1, naznačen time da je farmakološki aktivna tvar u skladu s općom formulom (I) molekularno dispergirana.
3. Farmaceutski oblik doziranja za upotrebu prema zahtjevu 1 ili 2, koji sadrži tekuću jezgru enkapsuliranu s krutim materijalom, naznačen time da je farmakološki aktivna tvar u skladu s općom formulom (I) dispergirana u tekućoj jezgri.
4. Farmaceutski oblik doziranja za upotrebu prema bilo kojem od prethodnih zahtjeva, naznačen time da samo emulgirajuća formulacija daje (mikro)emulzije s prosječnom veličinom kapljice manjom od ili jednakom 10 mikrometara u prisutnosti vodenog medija.
5. Farmaceutski oblik doziranja za upotrebu prema bilo kojem od prethodnih zahtjeva, naznačen time da sadrži surfaktant koji ima HLB vrijednost od najmanje 10.
6. Farmaceutski oblik doziranja za upotrebu prema bilo kojem od prethodnih zahtjeva, naznačen time da sadrži surfaktant u količini od najmanje 0.001 tež. %, na temelju ukupne težine farmaceutskog oblika doziranja.
7. Farmaceutski oblik doziranja za upotrebu prema bilo kojem od prethodnih zahtjeva, naznačen time da sadrži surfaktant odabran iz skupine koja se sastoji od estera masnih kiselina polioksietilena, djelomičnih estera masnih kiselina polioksietilensorbitana, te estera sumporne kiseline
8. Farmaceutski oblik doziranja za upotrebu prema bilo kojem od prethodnih zahtjeva, naznačen time da farmakološki aktivna tvar u skladu s općom formulom (I) ima stereokemijsku konfiguraciju u skladu s općom formulom (I') [image] pri čemu je R definiran kao u zahtjevu 1.
9. Farmaceutski oblik doziranja za upotrebu prema bilo kojem od prethodnih zahtjeva, naznačen time da farmakološki aktivna tvar u skladu s općom formulom (I) je (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, (1r,4r)-6'-fluoro-N-metil-4-fenil-4',9'-dihidro-3'H-spiro[cikloheksan-1,1'-pirano[3,4,b]indol]-4-amin, ili njegova fiziološki prihvatljiva sol.
10. Farmaceutski oblik doziranja za upotrebu prema bilo kojem od prethodnih zahtjeva, naznačen time da oslobađa pod in vitro uvjetima u 900 mL umjetnog želučanog soka uz pH 1.2 nakon 30 minuta najmanje 80 tež.% farmakološki aktivne tvari prema općoj formuli (I), na temelju ukupne količine farmakološki aktivne tvari prema općoj formuli (I) koja je izvorno sadržana u obliku doziranja.
11. Farmaceutski oblik doziranja za upotrebu prema bilo kojem od prethodnih zahtjeva, naznačen time da sadrži farmakološki aktivnu tvar u skladu s općom formulom (I) u dozi od 10 µg do 50 µg ili od 300 µg do 500 µg.
12. Farmaceutski oblik doziranja za upotrebu prema bilo kojem od prethodnih zahtjeva, naznačen time da je bol izabrana od akutne, visceralne, neuropatske ili kronične boli.
HRP20151289TT 2010-08-04 2015-11-27 Farmaceutski oblik doziranja koji sadrži 6'-fluoro-(n-metil- ili n,n-dimetil)-4-fenil-4',9'-dihidro-3'h-spiro[cikloheksan-1,1'-pirano[3,4,b]indol]-4-amin HRP20151289T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US37063410P 2010-08-04 2010-08-04
EP10008115 2010-08-04
EP11746176.4A EP2600838B1 (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[cyclohexane-1,1'-pyrano[3,4,b]indol]-4-amine
PCT/EP2011/003918 WO2012016703A2 (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[cyclohexane-1,1'-pyrano[3,4,b]indol]-4-amine

Publications (1)

Publication Number Publication Date
HRP20151289T1 true HRP20151289T1 (hr) 2016-01-01

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ID=43446583

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Application Number Title Priority Date Filing Date
HRP20151289TT HRP20151289T1 (hr) 2010-08-04 2015-11-27 Farmaceutski oblik doziranja koji sadrži 6'-fluoro-(n-metil- ili 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) EP2600838B1 (hr)
JP (1) JP5792301B2 (hr)
KR (1) KR101788535B1 (hr)
CN (1) CN103153282B (hr)
AR (1) AR082559A1 (hr)
AU (1) AU2011287873B2 (hr)
BR (1) BR112013004055A2 (hr)
CA (1) CA2802767C (hr)
CL (1) CL2012003584A1 (hr)
CO (1) CO6640316A2 (hr)
DK (1) DK2600838T3 (hr)
EC (1) ECSP13012421A (hr)
ES (1) ES2553742T3 (hr)
HK (1) HK1183610A1 (hr)
HR (1) HRP20151289T1 (hr)
HU (1) HUE025322T2 (hr)
IL (1) IL223881A (hr)
MX (1) MX2013000980A (hr)
NZ (1) NZ604662A (hr)
PE (1) PE20131108A1 (hr)
PL (1) PL2600838T3 (hr)
PT (1) PT2600838E (hr)
RS (1) RS54438B1 (hr)
RU (1) RU2589830C2 (hr)
SI (1) SI2600838T1 (hr)
TW (1) TWI522360B (hr)
WO (1) WO2012016703A2 (hr)
ZA (1) ZA201209501B (hr)

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PE20131096A1 (es) 2010-08-04 2013-10-10 Gruenenthal Chemie Forma de dosificacion farmaceutica que comprende 6'-fluoro-(n-metil-o n,n-dimetil)-4-fenil-4',9-dihidro-3'h-espiro[ciclohxan-1,1'-pirano[3,4,b]indol]-4-amina para el tratamiento de dolor neuropatico
DK2797924T3 (en) * 2011-12-12 2016-08-01 Gruenenthal Gmbh Solid forms of (1 R, 4 R) -6 & apos; fluoro- (N, N-dimethyl) -4-phenyl-4 ', 9'-dihydro-3'H-spiro [cyclohexane-1,1'-pyran [3,4-b] indole] -4-amine and sulfuric acid
JP6276702B2 (ja) * 2011-12-12 2018-02-07 グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング （１ｒ，４ｒ）−６’−フルオロ−Ｎ，Ｎ−ジメチル−４−フェニル−４’，９’−ジヒドロ−３’Ｈ−スピロ−［シクロヘキサン−１，１’−ピラノ［３，４，ｂ］インドール］−４−アミン塩酸塩の固体形態
US20130310435A1 (en) 2012-05-18 2013-11-21 Gruenenthal Gmbh 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
US9345689B2 (en) * 2012-05-18 2016-05-24 Gruenenthal Gmbh 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 an anticonvulsant
US9320725B2 (en) * 2012-05-18 2016-04-26 Gruenenthal Gmbh 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
US9308196B2 (en) * 2012-05-18 2016-04-12 Gruenenthal Gmbh Pharmaceutical composition comprising (1 r,4r) -6'-fluoro-N ,N-dimethyl-4-phenyl-4',9'-d ihydro-3'H-spiro[cyclohexane-1,1'-pyrano-[3,4,b]indol]-4-amine and an oxicam
US8912226B2 (en) * 2012-05-18 2014-12-16 Gruenenthal Gmbh 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 NSAR
US20130310385A1 (en) 2012-05-18 2013-11-21 Gruenenthal Gmbh 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
US9855286B2 (en) * 2012-05-18 2018-01-02 Gruenenthal Gmbh Pharmaceutical composition comprising (1r,4r)-6′-fluoro-N,N-di methyl-4-phenyl-4′,9′-dihydro-3′H-spiro[cyclohexane-1,1′-pyrano-[3,4,b]indol]-4-amine and a salicylic acid component
US9320729B2 (en) * 2012-05-18 2016-04-26 Gruenenthal Gmbh Pharmaceutical composition comprising (1r,4r)-6′-flouro-N,N-dimethyl-4-phenyl-4′,9′-dihydro-3′H-spiro[cyclohexane-1,1′-pyrano-[3,4,b]indol]-4-amine and a propionic acid derivative
TW201642853A (zh) 2015-01-23 2016-12-16 歌林達有限公司 用於治療肝功能之損傷及／或腎功能之損傷個體疼痛之西博帕多（Ｃｅｂｒａｎｏｐａｄｏｌ）
US20180021304A1 (en) 2015-02-02 2018-01-25 Ratiopharm Gmbh Composition comprising cebranopadol in a dissolved form
BR112018017167A2 (pt) 2016-02-29 2019-01-02 Gruenenthal Gmbh titulação de cebranopadol
EP3613747A1 (en) * 2018-08-24 2020-02-26 Grünenthal GmbH Crystalline forms of trans-6'-fluoro-n-methyl-4-phenyl-4',9'-dihydro-3'h-spiro[cyclohexane-1,1'-pyrano[3,4-b]indol]-4-amine
RU2765946C1 (ru) * 2021-03-11 2022-02-07 Графт Полимер Айпи Лимитед Система доставки сверхнасыщаемых самонаноэмульгирующихся лекарственных средств (SNEDDS) для слаборастворимых в воде фармацевтических композиций и способ ее приготовления

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AU2011287873B2 (en) 2014-09-25
ZA201209501B (en) 2013-08-28
AU2011287873A1 (en) 2013-01-24
ECSP13012421A (es) 2013-03-28
CN103153282A (zh) 2013-06-12
TW201209059A (en) 2012-03-01
PL2600838T3 (pl) 2016-02-29
KR101788535B1 (ko) 2017-10-20
JP2013532699A (ja) 2013-08-19
RU2013109136A (ru) 2014-09-10
HUE025322T2 (en) 2016-02-29
CN103153282B (zh) 2015-08-19
MX2013000980A (es) 2013-02-15
ES2553742T3 (es) 2015-12-11
PE20131108A1 (es) 2013-10-17
EP2600838A2 (en) 2013-06-12
EP2600838B1 (en) 2015-09-16
CO6640316A2 (es) 2013-03-22
TWI522360B (zh) 2016-02-21
WO2012016703A2 (en) 2012-02-09
SI2600838T1 (sl) 2015-12-31
CA2802767A1 (en) 2011-12-09
BR112013004055A2 (pt) 2018-04-24
KR20130095270A (ko) 2013-08-27
HK1183610A1 (en) 2014-01-03
JP5792301B2 (ja) 2015-10-07
PT2600838E (pt) 2015-11-17
IL223881A (en) 2017-01-31
RS54438B1 (en) 2016-06-30
CL2012003584A1 (es) 2013-02-01
CA2802767C (en) 2019-08-13
NZ604662A (en) 2014-08-29
WO2012016703A3 (en) 2012-08-16
RU2589830C2 (ru) 2016-07-10
DK2600838T3 (en) 2015-10-05
AR082559A1 (es) 2012-12-19

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