JP6027549B2 - タペンタドールを含む半固形の水性医薬組成物 - Google Patents

タペンタドールを含む半固形の水性医薬組成物 Download PDF

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Publication number
JP6027549B2
JP6027549B2 JP2013555798A JP2013555798A JP6027549B2 JP 6027549 B2 JP6027549 B2 JP 6027549B2 JP 2013555798 A JP2013555798 A JP 2013555798A JP 2013555798 A JP2013555798 A JP 2013555798A JP 6027549 B2 JP6027549 B2 JP 6027549B2
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pharmaceutical composition
tapentadol
composition
composition according
weight
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JP2014506900A (ja
JP2014506900A5 (enExample
Inventor
ラインホルト・ウルリヒ
シラー・マルク
ヴュルステン・エーファ
インゲルブレヒト・サビーネ・カリーネ・カトリーン
エンブレヒツ・ローガー・カロルス・アウグスタ
ファイル・ウルリヒ
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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
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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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • 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
    • A61K47/14—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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • 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]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Emergency Medicine (AREA)
  • Dispersion Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
JP2013555798A 2011-03-04 2012-03-02 タペンタドールを含む半固形の水性医薬組成物 Expired - Fee Related JP6027549B2 (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201161449329P 2011-03-04 2011-03-04
US61/449,329 2011-03-04
EP11003603 2011-05-03
EP11003603.5 2011-05-03
PCT/EP2012/000906 WO2012119729A1 (en) 2011-03-04 2012-03-02 Semisolid aqueous pharmaceutical composition containing tapentadol

Related Child Applications (1)

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JP2016200663A Division JP6259042B2 (ja) 2011-03-04 2016-10-12 タペンタドールを含む半固形の水性医薬組成物

Publications (3)

Publication Number Publication Date
JP2014506900A JP2014506900A (ja) 2014-03-20
JP2014506900A5 JP2014506900A5 (enExample) 2016-09-01
JP6027549B2 true JP6027549B2 (ja) 2016-11-16

Family

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Application Number Title Priority Date Filing Date
JP2013555798A Expired - Fee Related JP6027549B2 (ja) 2011-03-04 2012-03-02 タペンタドールを含む半固形の水性医薬組成物
JP2016200663A Expired - Fee Related JP6259042B2 (ja) 2011-03-04 2016-10-12 タペンタドールを含む半固形の水性医薬組成物
JP2017228602A Expired - Fee Related JP6670283B2 (ja) 2011-03-04 2017-11-29 タペンタドールを含む半固形の水性医薬組成物

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JP2016200663A Expired - Fee Related JP6259042B2 (ja) 2011-03-04 2016-10-12 タペンタドールを含む半固形の水性医薬組成物
JP2017228602A Expired - Fee Related JP6670283B2 (ja) 2011-03-04 2017-11-29 タペンタドールを含む半固形の水性医薬組成物

Country Status (24)

Country Link
US (3) US9446008B2 (enExample)
EP (3) EP3766489B1 (enExample)
JP (3) JP6027549B2 (enExample)
KR (2) KR102039320B1 (enExample)
CN (1) CN103501774A (enExample)
AU (2) AU2012224954C1 (enExample)
BR (1) BR112013022556A8 (enExample)
CA (1) CA2828637C (enExample)
CY (1) CY1119725T1 (enExample)
DK (1) DK2680834T3 (enExample)
EA (2) EA033171B1 (enExample)
ES (2) ES2910085T3 (enExample)
HR (1) HRP20171836T1 (enExample)
HU (1) HUE037491T2 (enExample)
IL (2) IL227826B (enExample)
LT (1) LT2680834T (enExample)
MX (2) MX374468B (enExample)
NO (1) NO2680834T3 (enExample)
PL (1) PL2680834T3 (enExample)
PT (2) PT3766489T (enExample)
RS (1) RS56692B1 (enExample)
SI (1) SI2680834T1 (enExample)
WO (1) WO2012119729A1 (enExample)
ZA (1) ZA201306480B (enExample)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3685827A1 (en) 2011-03-04 2020-07-29 Grünenthal GmbH Aqueous pharmaceutical formulation of tapentadol for oral administration
PT3766489T (pt) 2011-05-03 2022-04-07 Gruenenthal Gmbh Composição farmacêutica aquosa semissólida contendo tapentadol
US8997860B2 (en) 2011-08-05 2015-04-07 Halliburton Energy Services, Inc. Methods for monitoring the formation and transport of a fracturing fluid using opticoanalytical devices
US9395306B2 (en) 2011-08-05 2016-07-19 Halliburton Energy Services, Inc. Methods for monitoring fluids within or produced from a subterranean formation during acidizing operations using opticoanalytical devices
US9228940B2 (en) 2012-09-14 2016-01-05 Halliburton Energy Services, Inc. Systems, methods, and apparatuses for in situ monitoring of cement fluid compositions and setting processes thereof
US8619256B1 (en) 2012-09-14 2013-12-31 Halliburton Energy Services, Inc. Systems and methods for monitoring the properties of a fluid cement composition in a flow path
US20140076550A1 (en) 2012-09-14 2014-03-20 Halliburton Energy Services, Inc. Systems and Methods for Detecting Microannulus Formation and Remediation
EP3027214A1 (en) * 2013-08-02 2016-06-08 ratiopharm GmbH Composition comprising tapentadol in a dissolved form
EP2845625A1 (en) 2013-09-04 2015-03-11 Grünenthal GmbH Tapentadol for use in the treatment of fibromyalgia and chronic fatigue syndrome
JP6923447B2 (ja) * 2015-03-27 2021-08-18 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 タペンタドールの非経口投与のための安定な製剤
EP3515412B1 (en) 2016-09-23 2025-04-23 Grünenthal GmbH Stable formulation for parenteral administration of tapentadol
WO2020020879A1 (en) * 2018-07-24 2020-01-30 Dr. August Wolff Gmbh & Co. Kg Arzneimittel Topical emulsion of an anticholinergic compound
KR102928295B1 (ko) 2018-09-07 2026-02-13 알.피.쉐러 테크놀러지즈 엘엘씨 경화 및 낮은 hlb 계면 활성제(들)의 첨가를 통한 고체 또는 반고체 지질 기반 제형 안정화
US12447119B2 (en) 2019-03-18 2025-10-21 Sunstar Americas, Inc. Oral care composition

Family Cites Families (32)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4775678A (en) * 1984-10-01 1988-10-04 Schering Corporation Clotrimazole cream
DE4426245A1 (de) 1994-07-23 1996-02-22 Gruenenthal Gmbh 1-Phenyl-3-dimethylamino-propanverbindungen mit pharmakologischer Wirkung
US6183758B1 (en) * 1998-01-29 2001-02-06 Highland Laboratories, Inc. Phytochemicals, nutrients & medication absorption &/or treatment
US6399087B1 (en) 2000-12-20 2002-06-04 Amphastar Pharmaceuticals, Inc. Propofol formulation with enhanced microbial inhibition
US20050176790A1 (en) * 2001-02-28 2005-08-11 Johannes Bartholomaus Pharmaceutical salts
DE10109763A1 (de) 2001-02-28 2002-09-05 Gruenenthal Gmbh Pharmazeutische Salze
PE20030527A1 (es) 2001-10-24 2003-07-26 Gruenenthal Chemie Formulacion farmaceutica con liberacion retardada que contiene 3-(3-dimetilamino-1-etil-2-metil-propil) fenol o una sal farmaceuticamente aceptable del mismo y tabletas para administracion oral que la contienen
PT1485078E (pt) 2002-03-15 2013-01-14 Cypress Bioscience Inc Milnacipran para o tratamento do síndrome do intestino irritável
US20030191187A1 (en) 2002-04-01 2003-10-09 Lee Fang Yu Injectable pharmaceutical composition containing a non-steroidal anti-inflammatory drug and method for preparing the same
MXPA05002728A (es) 2002-09-13 2005-07-25 Cydex Inc Capsulas que contienen composiciones de relleno acuoso estabilizadas con ciclodextrina derivada.
US20040180915A1 (en) 2003-03-14 2004-09-16 Xanodyne Pharmacal, Inc. Methadone-containing compositions for parenteral administration and method of use thereof
WO2005112926A1 (en) 2004-05-17 2005-12-01 Pharmacofore, Inc. Compositions and methods for treating or preventing pain
ES2291780T3 (es) 2004-06-28 2008-03-01 Grunenthal Gmbh Formas cristalinas del clorhidrato de (-)-(1r,2r)-3-(3-dimetilamino-1-etil-2-metilpropil)fenol.
AR053304A1 (es) 2004-07-01 2007-05-02 Gruenenthal Gmbh Formas farmaceuticas orales protegidas frente al abuso con liberacion controlada de (1r,2r)-3-(3 dimetilamino-1-etil-2metil-propil)fenol y procedimiento para su produccion.
CA2606947A1 (en) 2005-04-28 2006-11-02 Theraquest Biosciences Llc Methods and compositions for treating pain
TWI329334B (en) 2005-12-02 2010-08-21 Chung Shan Inst Of Science Manufacture method of electromagnetic interference layer for the plasma display panel
US20080039405A1 (en) * 2006-04-25 2008-02-14 Croda, Inc. Modification of percutaneous absorption of topically active materials
CN102675136B (zh) 2006-04-28 2016-01-20 格吕伦塔尔有限公司 包含3-(3-二甲基氨基-1-乙基-2-甲基-丙基)-苯酚和nsaid的药物组合物
CN101431990B (zh) 2006-04-28 2011-08-03 格吕伦塔尔有限公司 包含3-（3-二甲基氨基-1-乙基-2-甲基-丙基）-酚和对乙酰氨基酚的药物结合
SI2046726T1 (sl) 2006-07-24 2010-05-31 Janssen Pharmaceutica Nv Priprava R R metoksifenil N N trimetilpentanamina
DE102007012165A1 (de) 2007-03-12 2008-09-18 Grünenthal GmbH Verwendung von 1-Phenyl-3-dimethylamino-propanverbindungen zur Therapie des Neuropathieschmerzes
EP1985292A1 (en) 2007-04-23 2008-10-29 Grünenthal GmbH Titration of tapentadol
MX2010005680A (es) 2007-11-23 2010-12-21 Protect Pharmaceutical Corp Composiciones de tapentadol.
TWI454288B (zh) 2008-01-25 2014-10-01 Gruenenthal Chemie 藥物劑型
SI2352494T1 (sl) 2008-10-30 2019-12-31 Gruenenthal Gmbh Nove in potentne dozirne oblike tapentadola
WO2010100477A2 (en) 2009-03-03 2010-09-10 Shire Llc Amino acid and peptide carbamate prodrugs of tapentadol and uses thereof
US20100272815A1 (en) 2009-04-28 2010-10-28 Actavis Group Ptc Ehf Amorphous form of tapentadol hydrochloride
WO2011083304A1 (en) * 2010-01-05 2011-07-14 Shire Llc Prodrugs of opioids and uses thereof
CA2794734C (en) * 2010-03-30 2017-12-12 Phosphagenics Limited Transdermal delivery patch
GB201006200D0 (en) 2010-04-14 2010-06-02 Ayanda As Composition
US20120270848A1 (en) * 2010-10-22 2012-10-25 Galleon Pharmaceuticals, Inc. Novel Compositions and Therapeutic Methods Using Same
PT3766489T (pt) * 2011-05-03 2022-04-07 Gruenenthal Gmbh Composição farmacêutica aquosa semissólida contendo tapentadol

Also Published As

Publication number Publication date
EA201600442A1 (ru) 2017-02-28
CA2828637C (en) 2019-06-11
KR101911362B1 (ko) 2018-10-25
IL227826A0 (en) 2013-09-30
BR112013022556A2 (pt) 2016-12-06
US9446008B2 (en) 2016-09-20
EP3766489B1 (en) 2022-03-16
JP2014506900A (ja) 2014-03-20
MX2013010100A (es) 2013-10-01
US20160346229A1 (en) 2016-12-01
MX374468B (es) 2025-03-06
AU2012224954A1 (en) 2013-09-19
CA2828637A1 (en) 2012-09-13
IL258357A (en) 2018-05-31
JP2018065839A (ja) 2018-04-26
AU2017200040A1 (en) 2017-02-02
CN103501774A (zh) 2014-01-08
EA025194B1 (ru) 2016-11-30
WO2012119729A1 (en) 2012-09-13
RS56692B1 (sr) 2018-03-30
EP3766489A1 (en) 2021-01-20
KR102039320B1 (ko) 2019-11-01
EP3290029A1 (en) 2018-03-07
EP3290029B1 (en) 2020-09-02
ES2910085T3 (es) 2022-05-11
JP6670283B2 (ja) 2020-03-18
EP2680834A1 (en) 2014-01-08
PT3766489T (pt) 2022-04-07
PL2680834T3 (pl) 2018-03-30
PT2680834T (pt) 2018-01-25
ES2654407T3 (es) 2018-02-13
BR112013022556A8 (pt) 2018-01-16
EA033171B1 (ru) 2019-09-30
AU2012224954B2 (en) 2016-10-20
AU2017200040B2 (en) 2018-09-06
CY1119725T1 (el) 2018-06-27
JP2017039756A (ja) 2017-02-23
MX344473B (es) 2016-12-16
HUE037491T2 (hu) 2018-09-28
EA201300988A1 (ru) 2014-06-30
HRP20171836T1 (hr) 2017-12-29
SI2680834T1 (en) 2018-01-31
KR20180116463A (ko) 2018-10-24
US20120225950A1 (en) 2012-09-06
ZA201306480B (en) 2014-05-28
US20180133174A1 (en) 2018-05-17
AU2012224954C1 (en) 2017-04-06
JP6259042B2 (ja) 2018-01-10
LT2680834T (lt) 2018-01-10
KR20140013020A (ko) 2014-02-04
EP2680834B1 (en) 2017-10-18
IL227826B (en) 2018-04-30
NO2680834T3 (enExample) 2018-03-17
DK2680834T3 (en) 2017-12-04

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