DK2680833T3 - Parenteral indgivelse af tapentadol - Google Patents
Parenteral indgivelse af tapentadol Download PDFInfo
- Publication number
- DK2680833T3 DK2680833T3 DK12709792.1T DK12709792T DK2680833T3 DK 2680833 T3 DK2680833 T3 DK 2680833T3 DK 12709792 T DK12709792 T DK 12709792T DK 2680833 T3 DK2680833 T3 DK 2680833T3
- Authority
- DK
- Denmark
- Prior art keywords
- tapentadol
- composition
- administration
- still
- pain
- Prior art date
Links
Classifications
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- 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
-
- 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
- A61K9/08—Solutions
-
- 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
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P23/00—Anaesthetics
-
- 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
-
- 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]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Dermatology (AREA)
- Emergency Medicine (AREA)
- Engineering & Computer Science (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biomedical Technology (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Anesthesiology (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (15)
1. Vandig farmaceutisk sammensætning tilpasset til parenteral indgivelse af ta-pentadol eller et fysiologisk acceptabelt salt deraf, der har en pH-værdi på mindst 5,4.
2. Sammensætning ifølge krav 1, som er tilpasset til lokal og/eller systemisk indgivelse.
3. Sammensætning ifølge krav 1 eller 2, som er tilpasset til indgivelse ved injektion eller infusion.
4. Sammensætning ifølge et hvilket som helst af de foregående krav, hvor koncentrationen af tapentadol er under 50 mg/mL, baseret på det samlede volumen af sammensætningen.
5. Sammensætning ifølge et hvilket som helst af de foregående krav, som yderligere indeholder en puffer.
6. Sammensætning ifølge et hvilket som helst af de foregående krav, som ikke indeholder noget konserveringsmiddel.
7. Sammensætning ifølge et hvilket som helst af de foregående krav, som har en osmolaritet på mindst 0,25 osmol/L.
8. Sammensætning ifølge et hvilket som helst af de foregående krav, som er tilpasset til indgivelse i kombination med et anæstetisk middel.
9. Farmaceutisk doseringsform omfattende den farmaceutiske sammensætning ifølge et hvilket som helst af de foregående krav.
10. Doseringsform ifølge krav 9, som er tilpasset til indgivelse til pædiatri.
11. Doseringsform ifølge krav 9 eller 10, som er en depotformulering.
12. Sammensætning ifølge et hvilket som helst af krav 1 til 8 eller doseringsformen ifølge et hvilket som helst af krav 9 til 11, til anvendelse i behandling af smerte.
13. Sammensætning ifølge krav 12, hvor smerten er valgt fra gruppen bestående af diabetisk neuropatisk smerte, cancersmerte, perioperativ og/eller postoperativ smerte.
14. Sammensætning ifølge krav 12 eller 13, hvor indgivelse foregår intramusku-lært, intravenøst, subkutant, epiduralt, intratekalt, intraspinalt og/eller intracerebroventri-kulært.
15. Sammensætning ifølge et hvilket som helst af krav 12 til 14, hvor doseringen af tapentadol til indgivelse er reguleret af patienten.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201161449317P | 2011-03-04 | 2011-03-04 | |
EP11003602 | 2011-05-03 | ||
PCT/EP2012/000905 WO2012119728A1 (en) | 2011-03-04 | 2012-03-02 | Parenteral administration of tapentadol |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2680833T3 true DK2680833T3 (da) | 2016-05-23 |
Family
ID=44653043
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK12709792.1T DK2680833T3 (da) | 2011-03-04 | 2012-03-02 | Parenteral indgivelse af tapentadol |
Country Status (23)
Country | Link |
---|---|
US (3) | US20120225951A1 (da) |
EP (2) | EP3025710A1 (da) |
JP (4) | JP2014510067A (da) |
KR (2) | KR101970468B1 (da) |
CN (2) | CN107088226A (da) |
AU (2) | AU2012224953C1 (da) |
BR (1) | BR112013022213A2 (da) |
CA (1) | CA2828635C (da) |
CY (1) | CY1117426T1 (da) |
DK (1) | DK2680833T3 (da) |
EA (2) | EA028149B1 (da) |
ES (1) | ES2573414T3 (da) |
HK (1) | HK1194964A1 (da) |
HR (1) | HRP20160400T1 (da) |
HU (1) | HUE027514T2 (da) |
IL (1) | IL227825A (da) |
MX (1) | MX348831B (da) |
PL (1) | PL2680833T3 (da) |
PT (1) | PT2680833E (da) |
RS (1) | RS54711B1 (da) |
SI (1) | SI2680833T1 (da) |
WO (1) | WO2012119728A1 (da) |
ZA (1) | ZA201306479B (da) |
Families Citing this family (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU2011267474B2 (en) | 2010-06-15 | 2016-05-26 | Grünenthal GmbH | Pharmaceutical combination for the treatment of pain |
CN103501773A (zh) | 2011-03-04 | 2014-01-08 | 格吕伦塔尔有限公司 | 用于口服给予的他喷他多含水药物制剂 |
HUE036567T2 (hu) | 2011-07-29 | 2018-07-30 | Gruenenthal Gmbh | 3-[(1S,2S)-3-(dimetilamino)-1-etil-2-metilpropil]fenol intratekális vagy epidurális adagolásra |
BR112015009839A2 (pt) * | 2012-11-01 | 2017-07-11 | Torrent Pharmaceuticals Ltd | composição farmacêutica de tapentadol para administração parenteral |
EP2808319A1 (en) | 2013-05-31 | 2014-12-03 | Arevipharma GmbH | 3-[3-(Dimethylamino)-1-ethyl-2-methylpropyl]phenol resin complex |
EP2845625A1 (en) | 2013-09-04 | 2015-03-11 | Grünenthal GmbH | Tapentadol for use in the treatment of fibromyalgia and chronic fatigue syndrome |
CN103735500B (zh) * | 2014-01-28 | 2016-01-20 | 江苏华泽医药科技有限公司 | 盐酸他喷他多注射液及其制备方法 |
EP3273953B1 (en) | 2015-03-27 | 2019-01-02 | Grünenthal GmbH | Stable formulation for parenteral administration of tapentadol |
AU2017329964B2 (en) | 2016-09-23 | 2022-10-06 | Grünenthal GmbH | Stable formulation for parenteral administration of Tapentadol |
EP3585370A1 (en) | 2017-02-23 | 2020-01-01 | Grünenthal GmbH | Tapentadol as local anesthetic |
MX2021013888A (es) * | 2019-05-16 | 2022-01-24 | Nexus Pharmaceuticals Inc | Composiciones que comprenden efedrina o una sal de efedrina y metodos de fabricacion y uso de las mismas. |
EP4011369A1 (en) * | 2020-12-14 | 2022-06-15 | G.L. Pharma GmbH | Aqueous pharmaceutical composition comprising tapentadol tartrate |
Family Cites Families (24)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB8334422D0 (en) * | 1983-12-23 | 1984-02-01 | Sterwin Ag | Composition |
DE4426245A1 (de) | 1994-07-23 | 1996-02-22 | Gruenenthal Gmbh | 1-Phenyl-3-dimethylamino-propanverbindungen mit pharmakologischer Wirkung |
US6399087B1 (en) * | 2000-12-20 | 2002-06-04 | Amphastar Pharmaceuticals, Inc. | Propofol formulation with enhanced microbial inhibition |
DE10109763A1 (de) * | 2001-02-28 | 2002-09-05 | Gruenenthal Gmbh | Pharmazeutische Salze |
JP4905616B2 (ja) * | 2001-04-19 | 2012-03-28 | ライオン株式会社 | ソフトコンタクトレンズ用点眼剤 |
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 |
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 |
US20040180915A1 (en) * | 2003-03-14 | 2004-09-16 | Xanodyne Pharmacal, Inc. | Methadone-containing compositions for parenteral administration and method of use thereof |
PL1612203T3 (pl) * | 2004-06-28 | 2007-12-31 | Gruenenthal Gmbh | Krystaliczne postacie chlorowodorku (-)-(1R,2R)-3-(3-dimetyloamino-1-etylo-2-metylo-propylo)fenolu |
JP5700904B2 (ja) | 2004-07-01 | 2015-04-15 | グリューネンタール・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング | (1r,2r)−3−(3−ジメチルアミノ−1−エチル−2−メチル−プロピル)フェノールを含有する乱用防止経口投与形態物 |
MX2007013583A (es) * | 2005-04-28 | 2008-03-13 | Theraquest Biosciences Llc | Metodos y composiciones para tratar el dolor. |
CA2649459C (en) * | 2006-04-28 | 2014-07-22 | Gruenenthal Gmbh | Pharmaceutical combination comprising 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol and an nsaid |
BRPI0710682B8 (pt) | 2006-04-28 | 2021-05-25 | Gruenenthal Gmbh | combinação farmacêutica compreendendo 3-(3-dimetilamino-1-etil-2-metil-propil)-fenol e paracetamol |
AU2007278224C1 (en) * | 2006-07-24 | 2012-06-21 | Grünenthal GmbH | Preparation of (2R,3R)-3-(3-methoxyphenyl)-N,N,2-trimethylpentanamine |
EP1905440A1 (de) * | 2006-09-06 | 2008-04-02 | Boehringer Ingelheim Pharma GmbH & Co. KG | Verwendung einer pharmazeutischen Zusammensetzung enthaltend ein Anticholinergikum zur Abtötung von Mikroorganismen und zur Behandlung von Atemwegsinfektionen |
TWI394564B (zh) * | 2006-09-21 | 2013-05-01 | Alcon Res Ltd | 自行保存型水性藥學組成物 |
DE102007012165A1 (de) * | 2007-03-12 | 2008-09-18 | Grünenthal GmbH | Verwendung von 1-Phenyl-3-dimethylamino-propanverbindungen zur Therapie des Neuropathieschmerzes |
JP2008266168A (ja) * | 2007-04-18 | 2008-11-06 | Teika Seiyaku Kk | 眼科用剤 |
EP1985292A1 (en) * | 2007-04-23 | 2008-10-29 | Grünenthal GmbH | Titration of tapentadol |
ES2619329T3 (es) | 2007-11-23 | 2017-06-26 | Grünenthal GmbH | Composiciones de tapentadol |
JP5774853B2 (ja) | 2008-01-25 | 2015-09-09 | 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 | 医薬投薬形 |
AR073361A1 (es) * | 2008-09-05 | 2010-11-03 | Gruenenthal Gmbh | Combinacion farmaceutica que comprende 3-(-3-dimetilamino-1-etil-2-metil-propil)-fenol y un antiepileptico. uso |
EP2246044A1 (en) * | 2009-04-21 | 2010-11-03 | Pierre Fabre Dermo-Cosmétique | Paediatric solutions comprising a beta-blocker |
US20100272815A1 (en) * | 2009-04-28 | 2010-10-28 | Actavis Group Ptc Ehf | Amorphous form of tapentadol hydrochloride |
-
2012
- 2012-03-02 EP EP15200814.0A patent/EP3025710A1/en not_active Withdrawn
- 2012-03-02 HU HUE12709792A patent/HUE027514T2/en unknown
- 2012-03-02 CN CN201710217173.2A patent/CN107088226A/zh active Pending
- 2012-03-02 EA EA201600088A patent/EA028149B1/ru not_active IP Right Cessation
- 2012-03-02 DK DK12709792.1T patent/DK2680833T3/da active
- 2012-03-02 AU AU2012224953A patent/AU2012224953C1/en active Active
- 2012-03-02 CN CN201280011685.9A patent/CN103501775A/zh active Pending
- 2012-03-02 MX MX2013010046A patent/MX348831B/es active IP Right Grant
- 2012-03-02 PT PT127097921T patent/PT2680833E/pt unknown
- 2012-03-02 KR KR1020187015692A patent/KR101970468B1/ko active IP Right Grant
- 2012-03-02 US US13/410,945 patent/US20120225951A1/en not_active Abandoned
- 2012-03-02 ES ES12709792.1T patent/ES2573414T3/es active Active
- 2012-03-02 JP JP2013555797A patent/JP2014510067A/ja active Pending
- 2012-03-02 PL PL12709792T patent/PL2680833T3/pl unknown
- 2012-03-02 CA CA2828635A patent/CA2828635C/en not_active Expired - Fee Related
- 2012-03-02 KR KR1020137026184A patent/KR101903351B1/ko active IP Right Grant
- 2012-03-02 WO PCT/EP2012/000905 patent/WO2012119728A1/en active Application Filing
- 2012-03-02 SI SI201230554A patent/SI2680833T1/sl unknown
- 2012-03-02 BR BR112013022213A patent/BR112013022213A2/pt not_active Application Discontinuation
- 2012-03-02 RS RS20160287A patent/RS54711B1/en unknown
- 2012-03-02 EA EA201300990A patent/EA024193B1/ru not_active IP Right Cessation
- 2012-03-02 EP EP12709792.1A patent/EP2680833B1/en active Active
-
2013
- 2013-08-06 IL IL227825A patent/IL227825A/en active IP Right Grant
- 2013-08-28 ZA ZA2013/06479A patent/ZA201306479B/en unknown
-
2014
- 2014-06-24 HK HK14106186.5A patent/HK1194964A1/zh not_active IP Right Cessation
-
2015
- 2015-12-28 US US14/981,223 patent/US20160106688A1/en not_active Abandoned
-
2016
- 2016-04-11 CY CY20161100291T patent/CY1117426T1/el unknown
- 2016-04-18 HR HRP20160400TT patent/HRP20160400T1/hr unknown
-
2017
- 2017-04-04 AU AU2017202214A patent/AU2017202214B2/en active Active
- 2017-08-21 JP JP2017158324A patent/JP6837944B2/ja active Active
-
2020
- 2020-03-13 US US16/818,275 patent/US20200215003A1/en not_active Abandoned
-
2021
- 2021-12-01 JP JP2021195330A patent/JP2022033863A/ja active Pending
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2023
- 2023-03-10 JP JP2023037505A patent/JP2023075244A/ja active Pending
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