PE20190908A1 - Formulacion estable para la administracion parenteral de tapentadol - Google Patents

Formulacion estable para la administracion parenteral de tapentadol

Info

Publication number
PE20190908A1
PE20190908A1 PE2019000676A PE2019000676A PE20190908A1 PE 20190908 A1 PE20190908 A1 PE 20190908A1 PE 2019000676 A PE2019000676 A PE 2019000676A PE 2019000676 A PE2019000676 A PE 2019000676A PE 20190908 A1 PE20190908 A1 PE 20190908A1
Authority
PE
Peru
Prior art keywords
tapentadol
parenteral administration
composition
pharmaceutical composition
free base
Prior art date
Application number
PE2019000676A
Other languages
English (en)
Inventor
Angelika ELLERMANN
Ulrich Reinhold
Ulrike Bertram
Original Assignee
Gruenenthal Chemie
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=PE20190908(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Gruenenthal Chemie filed Critical Gruenenthal Chemie
Publication of PE20190908A1 publication Critical patent/PE20190908A1/es

Links

Classifications

    • 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
    • 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
    • A61K9/08—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

Se refiere a una composicion farmaceutica acuosa para administracion parenteral que comprende Tapentadol (base libre) o una sal fisiologicamente aceptable de este; caracterizada porque la concentracion de Tapentadol es mayor que 8.00 mg/mL, en funcion del peso de la base libre de Tapentadol y en funcion del volumen total de la composicion; donde la composicion comprende un sistema amortiguador y donde el valor de pH de la composicion se encuentra en el intervalo de mayor que 3.0 a menor que 6. 7, al ajustar, especialmente reducir el valor de pH de la composicion farmaceutica para administracion parenteral tiene un efecto de estabilizacion de manera que la descomposicion de Tapentadol pueda reducirse considerablemente. La invencion tambien se refiere a un kit que comprende la composicion de conformidad con la invencion en un embalaje. La composicion farmaceutica de conformidad con la invencion es particularmente util para tratar el dolor, especialmente el dolor agudo, preferentemente en pacientes adultos.
PE2019000676A 2016-09-23 2017-09-22 Formulacion estable para la administracion parenteral de tapentadol PE20190908A1 (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
PE20190908A1 true PE20190908A1 (es) 2019-06-26

Family

ID=56997349

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2019000676A PE20190908A1 (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
AU614465B2 (en) 1989-04-05 1991-08-29 Yissum Research Development Company Of The Hebrew University Of Jerusalem 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
WO2004024126A1 (en) 2002-09-13 2004-03-25 Cydex, 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.
PT1599222E (pt) 2003-01-08 2009-06-12 Novartis Vaccines & Diagnostic Composições aquosas estabilizadas que contêm um inibidor da via do factor tecidular (tfpi) ou uma variante do inibidor da via do factor tecidular
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
ATE368639T1 (de) 2004-06-28 2007-08-15 Gruenenthal Gmbh Kristalline formen von (-)-(1r,2r)-3-(3- dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochlorid
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.
DE102004032103A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Gegen Missbrauch gesicherte, orale Darreichungsform
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
WO2007127158A2 (en) 2006-04-25 2007-11-08 Croda, Inc Modification of percutaneous absorption of topically active materials
NZ571939A (en) 2006-04-28 2011-10-28 Gruenenthal Chemie Pharmaceutical combination comprising 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol and an NSAID
EP2012764B1 (en) 2006-04-28 2011-01-12 Grünenthal GmbH Pharmaceutical combination comprising 3-(3-dimethylamino-1-ethyl-2-methyl-propyl) -phenol and paracetamol
CN101495447B (zh) 2006-07-24 2013-05-29 詹森药业有限公司 (2r,3r)-3-(3-甲氧苯基)-n,n,2-三甲基戊胺的制备
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
CN104958282B (zh) 2007-11-23 2018-05-29 格吕伦塔尔有限公司 他喷他多组合物
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
CA2713128C (en) 2008-01-25 2016-04-05 Gruenenthal Gmbh Pharmaceutical dosage form
CA2721014A1 (en) 2008-04-08 2009-10-15 Acino Pharma Ag Aqueous pharmaceutical formulation
RU2599846C2 (ru) 2008-10-30 2016-10-20 Грюненталь Гмбх Новые и эффективные лекарственые формы тапентадола
WO2010089767A1 (en) 2009-01-09 2010-08-12 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
WO2011016487A1 (ja) 2009-08-05 2011-02-10 ナガセ医薬品株式会社 インジゴカルミン製剤
WO2011071400A1 (en) 2009-12-10 2011-06-16 Tecnimede - Sociedade Técnico-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
CA2828631C (en) 2011-03-04 2019-10-15 Grunenthal Gmbh Aqueous pharmaceutical formulation of tapentadol for oral administration
WO2012119728A1 (en) 2011-03-04 2012-09-13 Grünenthal GmbH Parenteral administration of tapentadol
CA2828637C (en) 2011-03-04 2019-06-11 Grunenthal Gmbh Semisolid aqueous pharmaceutical composition containing tapentadol
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
WO2014068372A1 (en) * 2012-11-01 2014-05-08 Torrent Pharmaceuticals Ltd Pharmaceutical composition of tapentadol for parenteral administration
JP6215970B2 (ja) 2013-03-14 2017-10-18 フレゼニウス カービ ドイチュラント ゲーエムベーハー 注射可能なモルヒネ製剤
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
PT3273953T (pt) 2015-03-27 2019-04-01 Gruenenthal Gmbh Formulação estável para administração parentérica de tapentadol
EP3585370A1 (en) * 2017-02-23 2020-01-01 Grünenthal GmbH Tapentadol as local anesthetic

Also Published As

Publication number Publication date
CA3037810A1 (en) 2018-03-29
US20180085328A1 (en) 2018-03-29
JP7160799B2 (ja) 2022-10-25
CN109996533A (zh) 2019-07-09
ECSP19019253A (es) 2019-03-29
KR20190057349A (ko) 2019-05-28
WO2018055070A1 (en) 2018-03-29
EA201990744A1 (ru) 2019-08-30
CL2019000690A1 (es) 2019-06-14
JP2019529442A (ja) 2019-10-17
IL265477A (en) 2019-05-30
CO2019002557A2 (es) 2019-05-10
EP3515412A1 (en) 2019-07-31
AU2017329964A1 (en) 2019-03-14
BR112019005439A2 (pt) 2019-06-18
MX2019003257A (es) 2019-06-10
AU2017329964B2 (en) 2022-10-06
US10898452B2 (en) 2021-01-26

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