CO2019002557A2 - Formulación estable para la administración parenteral de tapentadol - Google Patents

Formulación estable para la administración parenteral de tapentadol

Info

Publication number
CO2019002557A2
CO2019002557A2 CONC2019/0002557A CO2019002557A CO2019002557A2 CO 2019002557 A2 CO2019002557 A2 CO 2019002557A2 CO 2019002557 A CO2019002557 A CO 2019002557A CO 2019002557 A2 CO2019002557 A2 CO 2019002557A2
Authority
CO
Colombia
Prior art keywords
tapentadol
parenteral administration
composition
stable formulation
depending
Prior art date
Application number
CONC2019/0002557A
Other languages
English (en)
Inventor
Ulrike Bertram
Ulrich Reinhold
Angelika ELLERMANN
Original Assignee
Gruenenthal Gmbh
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=56997349&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CO2019002557(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Gruenenthal Gmbh filed Critical Gruenenthal Gmbh
Publication of CO2019002557A2 publication Critical patent/CO2019002557A2/es

Links

Classifications

    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K9/0012—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
    • 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
    • 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]

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)
  • Emergency Medicine (AREA)
  • Dermatology (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)

Abstract

La invención se refiere a una composición farmacéutica acuosa para la administración parenteral que comprende Tapentadol o una sal fisiológicamente aceptable de este; caracterizada porque la concentración de Tapentadol es mayor que 8.00 mg/mL, en función del peso de la base libre de Tapentadol y en función del volumen total de la composición; donde la composición comprende un sistema amortiguador y donde el valor de pH de la composición se encuentra en el intervalo de mayor que 3.0 a menor que 6.7. La invención también se refiere a un kit que comprende la composición de conformidad con la invención en un embalaje. La composición farmacéutica de conformidad con la invención es particularmente útil para tratar el dolor, especialmente el dolor agudo, preferentemente en pacientes adultos.
CONC2019/0002557A 2016-09-23 2019-03-19 Formulación estable para la administración parenteral de tapentadol CO2019002557A2 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
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
CO2019002557A2 true CO2019002557A2 (es) 2019-05-10

Family

ID=56997349

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2019/0002557A CO2019002557A2 (es) 2016-09-23 2019-03-19 Formulación estable para la administración parenteral de tapentadol

Country Status (16)

Country Link
US (1) US10898452B2 (es)
EP (1) EP3515412A1 (es)
JP (1) JP7160799B2 (es)
KR (1) KR20190057349A (es)
CN (1) CN109996533A (es)
AU (1) AU2017329964B2 (es)
BR (1) BR112019005439A2 (es)
CA (1) CA3037810A1 (es)
CL (1) CL2019000690A1 (es)
CO (1) CO2019002557A2 (es)
EA (1) EA201990744A1 (es)
EC (1) ECSP19019253A (es)
IL (1) IL265477A (es)
MX (1) MX2019003257A (es)
PE (1) PE20190908A1 (es)
WO (1) WO2018055070A1 (es)

Family Cites Families (68)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB8334423D0 (en) 1983-12-23 1984-02-01 Sterwin Ag Composition
GB8334422D0 (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
EP1485078B1 (en) 2002-03-15 2012-09-26 Cypress Bioscience, Inc. Milnacipran for the treatment of irritable bowel syndrome
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.
EP2174663A1 (en) 2003-01-08 2010-04-14 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
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.
DE102004032103A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Gegen Missbrauch gesicherte, orale Darreichungsform
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.
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
US20080039405A1 (en) 2006-04-25 2008-02-14 Croda, Inc. Modification of percutaneous absorption of topically active materials
CN101426485B (zh) 2006-04-28 2013-02-13 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
MX2008013779A (es) 2006-04-28 2008-11-14 Gruenenthal Gmbh Combinacion farmaceutica que comprende 3-(3-dimetilamino-1-etil-2- metil-propil)-fenol y paracetamol.
PT2046726E (pt) 2006-07-24 2010-04-15 Janssen Pharmaceutica Nv Preparação da (2r,3r)-3-(3-metoxifenil)-n,n,2- trimetilpentanamina
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
EP1992334A1 (en) 2007-05-08 2008-11-19 Docpharma NV/SA Storage-stable formulation of oxidation-sensitive phenolic drug, especially paracetamol, comprises aqueous drug solution deoxygenated by a temperature-controlled manufacturing process of the formulation
KR101784777B1 (ko) 2007-11-23 2017-11-06 그뤼넨탈 게엠베하 타펜타돌 조성물
EP2559428A1 (en) 2007-12-06 2013-02-20 Pain Therapeutics, Inc. Micronized opioid compositions and dosage forms and methods of making same
TWI454288B (zh) 2008-01-25 2014-10-01 Gruenenthal Chemie 藥物劑型
CA2721014A1 (en) 2008-04-08 2009-10-15 Acino Pharma Ag Aqueous pharmaceutical formulation
PL2352494T3 (pl) 2008-10-30 2020-03-31 Grünenthal GmbH Nowe i silne postaci dawkowania tapentadolu
RU2011133020A (ru) 2009-01-09 2013-02-20 Панацеа Биотек Лтд. Фармацевтические суспензии двойного высвобождения
WO2010100477A2 (en) 2009-03-03 2010-09-10 Shire Llc Amino acid and peptide carbamate prodrugs of tapentadol and uses thereof
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
JP5615821B2 (ja) 2009-08-05 2014-10-29 ナガセ医薬品株式会社 インジゴカルミン製剤
US20120245230A1 (en) 2009-12-10 2012-09-27 Tecnimede-Sociedade Tecnico- Medicinal, S.A. Method and composition for preparing stable liquid formulations of paracetamol
US20110190267A1 (en) 2010-01-05 2011-08-04 Shire Pharmaceuticals, Inc. Prodrugs of opioids and uses thereof
CN102821791B (zh) 2010-03-30 2015-06-17 磷肌酸有限公司 透皮递送贴剂
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
MX344473B (es) * 2011-03-04 2016-12-16 Gruenenthal Gmbh Composicion farmaceutica acuosa semisolida que contiene tapentadol.
RS54711B1 (en) * 2011-03-04 2016-08-31 Grünenthal GmbH PARENTERAL TAPENTADOL ADMINISTRATION
LT2680832T (lt) 2011-03-04 2019-10-25 Gruenenthal Gmbh Tapentadolio vandeninė farmacinė kompozicija, skirta vartoti geriant
IN2012DE00912A (es) 2012-03-27 2015-09-11 Fresenius Kabi Oncology Ltd
CN103159633B (zh) 2012-07-06 2015-08-12 江苏恩华药业股份有限公司 他喷他多的制备方法及用于制备他喷他多的化合物
JP6360488B2 (ja) * 2012-11-01 2018-07-18 トレント・ファーマシューティカルズ・リミテッドＴｏｒｒｅｎｔ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ Ｌｉｍｉｔｅｄ 非経口投与のためのタペンタドールの薬学的組成物
AU2014230834B9 (en) * 2013-03-14 2017-08-31 Fresenius Kabi Deutschland Gmbh Injectable morphine formulations
GB201309654D0 (en) 2013-05-30 2013-07-17 Euro Celtique Sa Method
CN103735550B (zh) 2013-12-25 2015-11-18 上海市闸北区中心医院 一种治疗慢性肾脏病心肌损伤的药物组合物及其应用
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
PT3479823T (pt) * 2015-03-27 2020-09-29 Gruenenthal Gmbh Formulação estável para administração parentérica de tapentadol
WO2018153947A1 (en) * 2017-02-23 2018-08-30 Grünenthal GmbH Tapentadol as local anesthetic

Also Published As

Publication number Publication date
WO2018055070A1 (en) 2018-03-29
JP2019529442A (ja) 2019-10-17
ECSP19019253A (es) 2019-03-29
US10898452B2 (en) 2021-01-26
CL2019000690A1 (es) 2019-06-14
EP3515412A1 (en) 2019-07-31
JP7160799B2 (ja) 2022-10-25
MX2019003257A (es) 2019-06-10
IL265477A (en) 2019-05-30
PE20190908A1 (es) 2019-06-26
AU2017329964A1 (en) 2019-03-14
EA201990744A1 (ru) 2019-08-30
CA3037810A1 (en) 2018-03-29
US20180085328A1 (en) 2018-03-29
CN109996533A (zh) 2019-07-09
AU2017329964B2 (en) 2022-10-06
KR20190057349A (ko) 2019-05-28
BR112019005439A2 (pt) 2019-06-18

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