MX2019003257A - Formulacion estable para la administracion parenteral de tapentadol. - Google Patents

Formulacion estable para la administracion parenteral de tapentadol.

Info

Publication number
MX2019003257A
MX2019003257A MX2019003257A MX2019003257A MX2019003257A MX 2019003257 A MX2019003257 A MX 2019003257A MX 2019003257 A MX2019003257 A MX 2019003257A MX 2019003257 A MX2019003257 A MX 2019003257A MX 2019003257 A MX2019003257 A MX 2019003257A
Authority
MX
Mexico
Prior art keywords
tapentadol
parenteral administration
composition
stable formulation
relates
Prior art date
Application number
MX2019003257A
Other languages
English (en)
Inventor
Bertram Ulrike
Reinhold Ulrich
Ellermann Angelika
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=MX2019003257(A) "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 MX2019003257A publication Critical patent/MX2019003257A/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
    • 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
    • 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
    • A61K9/08—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]

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.
MX2019003257A 2016-09-23 2017-09-22 Formulacion estable para la administracion parenteral de tapentadol. MX2019003257A (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
MX2019003257A true MX2019003257A (es) 2019-06-10

Family

ID=56997349

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2019003257A MX2019003257A (es) 2016-09-23 2017-09-22 Formulacion estable para la administracion 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
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
WO2003077897A1 (en) 2002-03-15 2003-09-25 Cypress Bioscience, Inc. Ne and 5-ht reuptake inhibitors for treating visceral pain syndromes
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
AU2003275329B2 (en) 2002-09-13 2008-04-03 Cydex Pharmaceuticals, Inc. Capsules containing aqueous fill compositions stabilized with derivatized cyclodextrin
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.
DK1599222T3 (da) 2003-01-08 2009-04-27 Novartis Vaccines & Diagnostic Stabiliserede vandige pr parater omfattende v vsfaktorvej-inhibitor (TFPI) eller v vsfaktorvej-inhibitorvariant
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
EP1612203B1 (en) 2004-06-28 2007-08-01 Grünenthal GmbH Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
DE102004032103A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Gegen Missbrauch gesicherte, orale Darreichungsform
EP1786403B1 (de) 2004-07-01 2013-07-24 Grünenthal GmbH Gegen missbrauch gesicherte, orale darreichungsform enthaltend (1r, 2r)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol
CN101208081A (zh) 2005-04-28 2008-06-25 谢拉奎斯特生物科学有限公司 治疗疼痛的方法和组合物
TWI329334B (en) 2005-12-02 2010-08-21 Chung Shan Inst Of Science Manufacture method of electromagnetic interference layer for the plasma display panel
WO2007127158A2 (en) 2006-04-25 2007-11-08 Croda, Inc Modification of percutaneous absorption of topically active materials
AU2007247480B8 (en) 2006-04-28 2013-04-11 Grunenthal Gmbh Pharmaceutical combination comprising 3- (3-dimethylamino-1-ethyl-2-methyl-propyl) -phenol and an NSAID
PL2012764T3 (pl) 2006-04-28 2011-04-29 Gruenenthal Gmbh Kombinacja farmaceutyczna zawierająca 3-(3-dimetyloamino-1-etylo-2-metylopropylo)fenol i Paracetamol
DE602007004494D1 (de) 2006-07-24 2010-03-11 Janssen Pharmaceutica Nv Herstellung von (2r,3r)-3-(3-methoxyphenyl)-n,n,2- trimethylpentanamin
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
KR101972299B1 (ko) 2007-11-23 2019-08-16 그뤼넨탈 게엠베하 타펜타돌 조성물
JP2011506342A (ja) 2007-12-06 2011-03-03 ペイン セラピューティクス インコーポレイテッド 微粉化オピオイド組成物、製剤および剤形、ならびにそれらの製造方法
AU2009207796B2 (en) 2008-01-25 2014-03-27 Grunenthal Gmbh Pharmaceutical dosage form
BRPI0822580A2 (pt) 2008-04-08 2015-06-23 Acino Pharma Ag Composto, recipiente, processo para produzir uma composição, uso de uma composição, e, método para controle ou prevenção de doenças infecciosas.
BRPI0921725A2 (pt) 2008-10-30 2016-01-05 Grüenthal GmbH formas de dosagem potentes do tapentadol
SG172833A1 (en) 2009-01-09 2011-08-29 Panacea Biotec Ltd Dual release pharmaceutical suspension
US20100227921A1 (en) 2009-03-03 2010-09-09 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
RU2553350C2 (ru) 2010-03-30 2015-06-10 Фосфейдженикс Лимитед Трансдермальные пластыри
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
US9446008B2 (en) 2011-03-04 2016-09-20 Gruenenthal Gmbh Semisolid aqueous pharmaceutical composition containing tapentadol
RS59491B1 (sr) * 2011-03-04 2019-12-31 Gruenenthal Gmbh Vodena farmaceutska formulacija tapentadola za oralnu primenu
CN107088226A (zh) 2011-03-04 2017-08-25 格吕伦塔尔有限公司 他喷他多的胃肠外给药
US20150073000A1 (en) 2012-03-27 2015-03-12 Fresenius Kabi Oncology Limited Stable ready-to-use pharmaceutical composition of pemetrexed
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
US9629818B2 (en) * 2012-11-01 2017-04-25 Torrent Pharmaceuticals Ltd. Pharmaceutical composition of tapentadol for parenteral administration
US9072781B2 (en) * 2013-03-14 2015-07-07 Becton, Dickinson France S.A.S. 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
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
WO2018153947A1 (en) * 2017-02-23 2018-08-30 Grünenthal GmbH Tapentadol as local anesthetic

Also Published As

Publication number Publication date
AU2017329964A1 (en) 2019-03-14
US10898452B2 (en) 2021-01-26
EP3515412A1 (en) 2019-07-31
US20180085328A1 (en) 2018-03-29
BR112019005439A2 (pt) 2019-06-18
WO2018055070A1 (en) 2018-03-29
KR20190057349A (ko) 2019-05-28
JP7160799B2 (ja) 2022-10-25
AU2017329964B2 (en) 2022-10-06
CO2019002557A2 (es) 2019-05-10
JP2019529442A (ja) 2019-10-17
CN109996533A (zh) 2019-07-09
CL2019000690A1 (es) 2019-06-14
CA3037810A1 (en) 2018-03-29
PE20190908A1 (es) 2019-06-26
ECSP19019253A (es) 2019-03-29
IL265477A (en) 2019-05-30
EA201990744A1 (ru) 2019-08-30

Similar Documents

Publication Publication Date Title
EP4233892A3 (en) Stable anti-ifnar1 formulation
US20200237664A1 (en) Methotrexate Composition
CY1124546T1 (el) Υγρο σκευασμα για εισπνοη που περιεχει rpl554
CA3030422C (en) Stabilizing excipients for therapeutic protein formulations
MX2021005012A (es) Compuestos, composiciones farmacéuticas y métodos de preparación de compuestos y de su uso como inhibidores de la cinasa atr.
MX2022003072A (es) Uso de pridopidina para el tratamiento de la disminucion funcional.
SG10201903619YA (en) Carbazole derivatives
MX2017012312A (es) Formulacion estable para administracion parenteral de tapentadol.
HUP0105173A2 (hu) Adagolási módszer és készítmény sürgősségi fogamzásgátlásra
NZ702342A (en) Pharmaceutical formulation
JP2014237607A (ja) ペメトレキセドを含む注射用組成物
MX2015009546A (es) Dosificacion aumentada de efavirenz para el tratamiento de cancer.
MX2019003257A (es) Formulacion estable para la administracion parenteral de tapentadol.
ZA202200331B (en) Naltrexone formulation
TW200626133A (en) Oral medication for twice-daily administration
EA202090965A1 (ru) Водные композиции биластина
EA202090416A1 (ru) Способы лечения симптомов гастропареза с использованием велусетрага
MX2016003327A (es) Composicion farmaceutica de citrato de sildenafilo en forma de suspension para uso oral.
AR104051A1 (es) Formulación estable para administración parenteral de tapentadol
MX2018008443A (es) Composición farmacéutica que comprende nebivolol con tasa de disolución mejorada.
ZA202301927B (en) Phytonadione compositions
PH12020500001A1 (en) Non-pulsatile prolonged-release betahistine oral solid compositions
ZA202104167B (en) Compounds for use in the treatment of parkinson's disease
ZA202200330B (en) Pharmaceutical composition of imatinib
UA123395U (uk) Фармацевтична композиція ністатину у формі оральної суспензії