ES2553742T3 - Forma de dosificación farmacéutica que comprende 6'-fluor-(N-metil- o N,N-dimetil)-4-fenil-4',9'-dihidro-3'H-espiro[ciclohexano-1,1'-pirano[3,4,b]indol]-4-amina - Google Patents

Forma de dosificación farmacéutica que comprende 6'-fluor-(N-metil- o N,N-dimetil)-4-fenil-4',9'-dihidro-3'H-espiro[ciclohexano-1,1'-pirano[3,4,b]indol]-4-amina Download PDF

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Publication number
ES2553742T3
ES2553742T3 ES11746176.4T ES11746176T ES2553742T3 ES 2553742 T3 ES2553742 T3 ES 2553742T3 ES 11746176 T ES11746176 T ES 11746176T ES 2553742 T3 ES2553742 T3 ES 2553742T3
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Spain
Prior art keywords
dosage form
pharmaceutical dosage
fluor
pyran
spiro
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ES11746176.4T
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English (en)
Inventor
Nadja Grüning
Marc Schiller
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Gruenenthal GmbH
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Gruenenthal GmbH
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Application filed by Gruenenthal GmbH filed Critical Gruenenthal GmbH
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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)

Abstract

Forma de dosificación farmacéutica para su uso en el tratamiento del dolor que contiene un agente farmacológicamente activo de acuerdo con la fórmula general (I)**Fórmula** donde R es -H o -CH3, o una sal fisiológicamente aceptable del mismo, y una formulación autoemulsionante; administrándose la forma de dosificación farmacéutica dos veces al día, una vez al día o con menos frecuencia.

Description

imagen1

Claims (1)

  1. imagen1
ES11746176.4T 2010-08-04 2011-08-04 Forma de dosificación farmacéutica que comprende 6'-fluor-(N-metil- o N,N-dimetil)-4-fenil-4',9'-dihidro-3'H-espiro[ciclohexano-1,1'-pirano[3,4,b]indol]-4-amina Active ES2553742T3 (es)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US37063410P 2010-08-04 2010-08-04
US370634P 2010-08-04
EP10008115 2010-08-04
EP10008115 2010-08-04
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
ES2553742T3 true ES2553742T3 (es) 2015-12-11

Family

ID=43446583

Family Applications (1)

Application Number Title Priority Date Filing Date
ES11746176.4T Active ES2553742T3 (es) 2010-08-04 2011-08-04 Forma de dosificación farmacéutica que comprende 6'-fluor-(N-metil- o N,N-dimetil)-4-fenil-4',9'-dihidro-3'H-espiro[ciclohexano-1,1'-pirano[3,4,b]indol]-4-amina

Country Status (28)

Country Link
EP (1) EP2600838B1 (es)
JP (1) JP5792301B2 (es)
KR (1) KR101788535B1 (es)
CN (1) CN103153282B (es)
AR (1) AR082559A1 (es)
AU (1) AU2011287873B2 (es)
BR (1) BR112013004055A2 (es)
CA (1) CA2802767C (es)
CL (1) CL2012003584A1 (es)
CO (1) CO6640316A2 (es)
DK (1) DK2600838T3 (es)
EC (1) ECSP13012421A (es)
ES (1) ES2553742T3 (es)
HK (1) HK1183610A1 (es)
HR (1) HRP20151289T1 (es)
HU (1) HUE025322T2 (es)
IL (1) IL223881A (es)
MX (1) MX2013000980A (es)
NZ (1) NZ604662A (es)
PE (1) PE20131108A1 (es)
PL (1) PL2600838T3 (es)
PT (1) PT2600838E (es)
RS (1) RS54438B1 (es)
RU (1) RU2589830C2 (es)
SI (1) SI2600838T1 (es)
TW (1) TWI522360B (es)
WO (1) WO2012016703A2 (es)
ZA (1) ZA201209501B (es)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP5792299B2 (ja) 2010-08-04 2015-10-07 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 神経因性疼痛の治療のための６’−フルオロ−（Ｎ−メチル−又は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−アミンを含む医薬剤形
CN106432256B (zh) * 2011-12-12 2019-08-09 格吕伦塔尔有限公司 盐酸盐的固体形式
TWI567078B (zh) * 2011-12-12 2017-01-21 歌林達有限公司 （１ｒ，４ｒ）－６’－氟－（Ｎ，Ｎ－二甲基）－４－苯基－４’，９’－二氫－３’Ｈ－螺－［環己烷－１，１’－吡喃並－［３，４，b］吲哚］－４－胺及硫酸之固體形式
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
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
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
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
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
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
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
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
JP6673924B2 (ja) 2015-01-23 2020-03-25 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 肝機能障害および／または腎機能障害を有する対象における疼痛を治療するためのセブラノパドール
US20180021304A1 (en) 2015-02-02 2018-01-25 Ratiopharm Gmbh Composition comprising cebranopadol in a dissolved form
MX2018010367A (es) 2016-02-29 2018-12-10 Guenenthal Gmbh Titulacion 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
WO2024129782A1 (en) 2022-12-12 2024-06-20 Park Therapeutics, Inc. Regimens and compositions useful for alleviating pain

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003500368A (ja) * 1999-05-24 2003-01-07 ソーナス ファーマシューティカルス，インコーポレイテッド 溶解度が不十分な薬剤のためのエマルジョンビヒクル
KR100441167B1 (ko) * 2001-12-27 2004-07-21 씨제이 주식회사 마이크로에멀젼 예비 농축액 조성물
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
JP2009514890A (ja) * 2005-11-07 2009-04-09 マーティ・ファーマシューティカルズ・インク テトラヒドロカンナビノールの改良された送達
DE102006046745A1 (de) 2006-09-29 2008-04-03 Grünenthal GmbH Gemischte ORL1/µ-Agonisten zur Behandlung von Schmerz

Also Published As

Publication number Publication date
KR101788535B1 (ko) 2017-10-20
EP2600838A2 (en) 2013-06-12
CN103153282B (zh) 2015-08-19
RU2589830C2 (ru) 2016-07-10
ZA201209501B (en) 2013-08-28
AU2011287873A1 (en) 2013-01-24
NZ604662A (en) 2014-08-29
AU2011287873B2 (en) 2014-09-25
DK2600838T3 (en) 2015-10-05
IL223881A (en) 2017-01-31
WO2012016703A3 (en) 2012-08-16
MX2013000980A (es) 2013-02-15
BR112013004055A2 (pt) 2018-04-24
HK1183610A1 (en) 2014-01-03
EP2600838B1 (en) 2015-09-16
KR20130095270A (ko) 2013-08-27
TWI522360B (zh) 2016-02-21
AR082559A1 (es) 2012-12-19
PT2600838E (pt) 2015-11-17
CA2802767C (en) 2019-08-13
SI2600838T1 (sl) 2015-12-31
RS54438B1 (en) 2016-06-30
JP5792301B2 (ja) 2015-10-07
HUE025322T2 (en) 2016-02-29
PE20131108A1 (es) 2013-10-17
JP2013532699A (ja) 2013-08-19
HRP20151289T1 (hr) 2016-01-01
CN103153282A (zh) 2013-06-12
PL2600838T3 (pl) 2016-02-29
CA2802767A1 (en) 2011-12-09
CL2012003584A1 (es) 2013-02-01
WO2012016703A2 (en) 2012-02-09
RU2013109136A (ru) 2014-09-10
ECSP13012421A (es) 2013-03-28
TW201209059A (en) 2012-03-01
CO6640316A2 (es) 2013-03-22

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