CA3037810A1 - Stable formulation for parenteral administration of tapentadol - Google Patents
Stable formulation for parenteral administration of tapentadol Download PDFInfo
- Publication number
- CA3037810A1 CA3037810A1 CA3037810A CA3037810A CA3037810A1 CA 3037810 A1 CA3037810 A1 CA 3037810A1 CA 3037810 A CA3037810 A CA 3037810A CA 3037810 A CA3037810 A CA 3037810A CA 3037810 A1 CA3037810 A1 CA 3037810A1
- Authority
- CA
- Canada
- Prior art keywords
- composition
- mmol
- conjugate
- tapentadol
- composition according
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
- 239000000203 mixture Substances 0.000 title claims abstract description 537
- KWTWDQCKEHXFFR-SMDDNHRTSA-N tapentadol Chemical compound CN(C)C[C@H](C)[C@@H](CC)C1=CC=CC(O)=C1 KWTWDQCKEHXFFR-SMDDNHRTSA-N 0.000 title claims abstract description 190
- 229960005126 tapentadol Drugs 0.000 title claims abstract description 189
- 238000007911 parenteral administration Methods 0.000 title claims abstract description 16
- 238000009472 formulation Methods 0.000 title description 31
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- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical group [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 44
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- 239000007924 injection Substances 0.000 claims description 24
- 238000002347 injection Methods 0.000 claims description 24
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Classifications
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- 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
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- 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
- A61K47/02—Inorganic compounds
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- 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
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- 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
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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
- A61K9/0012—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
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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
- A61K9/08—Solutions
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- 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
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- 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]
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pain & Pain Management (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Emergency Medicine (AREA)
- Rheumatology (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Inorganic Chemistry (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP16190255.6 | 2016-09-23 | ||
| EP16190255 | 2016-09-23 | ||
| PCT/EP2017/073983 WO2018055070A1 (en) | 2016-09-23 | 2017-09-22 | Stable formulation for parenteral administration of tapentadol |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA3037810A1 true CA3037810A1 (en) | 2018-03-29 |
Family
ID=56997349
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA3037810A Abandoned CA3037810A1 (en) | 2016-09-23 | 2017-09-22 | Stable formulation for parenteral administration of tapentadol |
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|---|---|
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| EP (1) | EP3515412B1 (enExample) |
| JP (1) | JP7160799B2 (enExample) |
| KR (1) | KR20190057349A (enExample) |
| CN (1) | CN109996533A (enExample) |
| AU (1) | AU2017329964B2 (enExample) |
| BR (1) | BR112019005439A2 (enExample) |
| CA (1) | CA3037810A1 (enExample) |
| CL (1) | CL2019000690A1 (enExample) |
| CO (1) | CO2019002557A2 (enExample) |
| EA (1) | EA201990744A1 (enExample) |
| EC (1) | ECSP19019253A (enExample) |
| ES (1) | ES3027562T3 (enExample) |
| IL (1) | IL265477A (enExample) |
| MX (1) | MX2019003257A (enExample) |
| PE (1) | PE20190908A1 (enExample) |
| WO (1) | WO2018055070A1 (enExample) |
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| GB8334422D0 (en) | 1983-12-23 | 1984-02-01 | Sterwin Ag | Composition |
| GB8334423D0 (en) | 1983-12-23 | 1984-02-01 | Sterwin Ag | Composition |
| US4775678A (en) | 1984-10-01 | 1988-10-04 | Schering Corporation | Clotrimazole cream |
| CA2013755C (en) | 1989-04-05 | 1993-11-30 | Simon Benita | Medicinal emulsions |
| DE4426245A1 (de) | 1994-07-23 | 1996-02-22 | Gruenenthal Gmbh | 1-Phenyl-3-dimethylamino-propanverbindungen mit pharmakologischer Wirkung |
| FR2751875B1 (fr) | 1996-08-05 | 1998-12-24 | Scr Newpharm | Nouvelles formulations liquides stables a base de paracetamol et leur mode de preparation |
| US6183758B1 (en) | 1998-01-29 | 2001-02-06 | Highland Laboratories, Inc. | Phytochemicals, nutrients & medication absorption &/or treatment |
| US6211169B1 (en) | 1999-09-29 | 2001-04-03 | Aesgen, Inc. | Stable calcitriol solution for packaging into vials |
| FR2809619B1 (fr) | 2000-06-06 | 2004-09-24 | Pharmatop | Nouvelles formulations aqueuses de principes actifs sensibles a l'oxydation et leur procede d'obtention |
| 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 |
| DE10112325A1 (de) | 2001-03-13 | 2002-10-02 | Fresenius Kabi De Gmbh | Lagerstabile Fertiginfusionslösungen des Paracetamols |
| 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 |
| US6638981B2 (en) | 2001-08-17 | 2003-10-28 | Epicept Corporation | Topical compositions and methods for treating pain |
| 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 |
| FR2832063B1 (fr) | 2001-11-15 | 2004-08-27 | Aguettant Lab | Procede de production de solutions stables de substances phenoliques et les solutions en resultant |
| JP2005526079A (ja) | 2002-03-15 | 2005-09-02 | サイプレス バイオサイエンス， インコーポレイテッド | 内蔵痛症候群を処置するためのｎｅおよび５−ｈｔ再取り込み阻害剤 |
| 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 |
| US20040101563A1 (en) | 2002-07-18 | 2004-05-27 | Kundu Subhas C. | Storage stable antihistaminic syrup formulations |
| RU2359698C2 (ru) | 2002-09-13 | 2009-06-27 | Сайдекс, Инк. | Капсулы, содержащие водные наполняющие композиции, стабилизированные производным циклодекстрина |
| US6888993B2 (en) | 2002-11-27 | 2005-05-03 | Corning Incorporated | Dispersion compensating optical fiber for SMF and transmission link including same |
| ITMI20022748A1 (it) | 2002-12-23 | 2004-06-24 | Eurand Int | Dispersioni solide stabilizzate di farmaco in un carrier organico e procedimento per la loro preparazione. |
| EP1599222B1 (en) | 2003-01-08 | 2009-03-04 | Novartis Vaccines and Diagnostics, Inc. | Stabilized aqueous compositions comprising tissue factor pathway inhibitor (tfpi) or tissue factor pathway inhibitor variant |
| US20040180915A1 (en) | 2003-03-14 | 2004-09-16 | Xanodyne Pharmacal, Inc. | Methadone-containing compositions for parenteral administration and method of use thereof |
| JP2007538091A (ja) | 2004-05-17 | 2007-12-27 | ファーマコフォア・インコーポレイテッド | 痛みを処置または予防するための組成物および方法 |
| SI1612203T1 (sl) | 2004-06-28 | 2007-12-31 | Gruenenthal Chemie | Kristalne oblike (-)-(1R,2R)-3-(3-dimetilamino-1-etil-2-metilpropil)-fenol hidroklorida |
| KR101204657B1 (ko) | 2004-07-01 | 2012-11-27 | 그뤼넨탈 게엠베하 | (1r,2r)-3-(3-디메틸아미노-1-에틸-2-메틸-프로필)-페놀을 함유하는 남용 방지 경구 투여 제형 |
| DE102004032103A1 (de) | 2004-07-01 | 2006-01-19 | Grünenthal GmbH | Gegen Missbrauch gesicherte, orale Darreichungsform |
| US20110098284A1 (en) | 2005-04-28 | 2011-04-28 | Najib Babul | 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 |
| EP2010145A2 (en) | 2006-04-25 | 2009-01-07 | Croda, Inc. | Modification of percutaneous absorption of topically active materials |
| PL2012763T3 (pl) | 2006-04-28 | 2011-08-31 | Gruenenthal Gmbh | Kombinacja farmaceutyczna zawierająca 3-(3-dimetyloamino-1-etylo-2-metylo-propylo)-fenol i NSAID |
| WO2007128413A1 (en) | 2006-04-28 | 2007-11-15 | Grünenthal GmbH | Pharmaceutical combination comprising 3- ( 3-dimethylamino-1-ethyl-2-methyl-propyl) -phenol and paracetamol |
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-
2017
- 2017-09-22 CN CN201780058585.4A patent/CN109996533A/zh active Pending
- 2017-09-22 BR BR112019005439A patent/BR112019005439A2/pt not_active Application Discontinuation
- 2017-09-22 KR KR1020197011410A patent/KR20190057349A/ko not_active Withdrawn
- 2017-09-22 MX MX2019003257A patent/MX2019003257A/es unknown
- 2017-09-22 US US15/712,812 patent/US10898452B2/en active Active
- 2017-09-22 EA EA201990744A patent/EA201990744A1/ru unknown
- 2017-09-22 ES ES17777835T patent/ES3027562T3/es active Active
- 2017-09-22 PE PE2019000676A patent/PE20190908A1/es unknown
- 2017-09-22 CA CA3037810A patent/CA3037810A1/en not_active Abandoned
- 2017-09-22 EP EP17777835.4A patent/EP3515412B1/en active Active
- 2017-09-22 AU AU2017329964A patent/AU2017329964B2/en active Active
- 2017-09-22 JP JP2019515433A patent/JP7160799B2/ja active Active
- 2017-09-22 WO PCT/EP2017/073983 patent/WO2018055070A1/en not_active Ceased
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2019
- 2019-03-18 CL CL2019000690A patent/CL2019000690A1/es unknown
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- 2019-03-19 IL IL265477A patent/IL265477A/en unknown
- 2019-03-19 CO CONC2019/0002557A patent/CO2019002557A2/es unknown
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| EP3515412A1 (en) | 2019-07-31 |
| US20180085328A1 (en) | 2018-03-29 |
| ES3027562T3 (en) | 2025-06-16 |
| JP7160799B2 (ja) | 2022-10-25 |
| PE20190908A1 (es) | 2019-06-26 |
| BR112019005439A2 (pt) | 2019-06-18 |
| AU2017329964A1 (en) | 2019-03-14 |
| US10898452B2 (en) | 2021-01-26 |
| CN109996533A (zh) | 2019-07-09 |
| AU2017329964B2 (en) | 2022-10-06 |
| EP3515412B1 (en) | 2025-04-23 |
| ECSP19019253A (es) | 2019-03-29 |
| CO2019002557A2 (es) | 2019-05-10 |
| IL265477A (en) | 2019-05-30 |
| EP3515412C0 (en) | 2025-04-23 |
| CL2019000690A1 (es) | 2019-06-14 |
| MX2019003257A (es) | 2019-06-10 |
| JP2019529442A (ja) | 2019-10-17 |
| KR20190057349A (ko) | 2019-05-28 |
| EA201990744A1 (ru) | 2019-08-30 |
| WO2018055070A1 (en) | 2018-03-29 |
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