ECSP19019253A - Formulación estable para la administración parenteral de tapentadol - Google Patents

Formulación estable para la administración parenteral de tapentadol

Info

Publication number
ECSP19019253A
ECSP19019253A ECSENADI201919253A ECDI201919253A ECSP19019253A EC SP19019253 A ECSP19019253 A EC SP19019253A EC SENADI201919253 A ECSENADI201919253 A EC SENADI201919253A EC DI201919253 A ECDI201919253 A EC DI201919253A EC SP19019253 A ECSP19019253 A EC SP19019253A
Authority
EC
Ecuador
Prior art keywords
tapentadol
parenteral administration
composition
stable formulation
function
Prior art date
Application number
ECSENADI201919253A
Other languages
English (en)
Inventor
Ulrich Reinhold
Ulrike Bertram
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=ECSP19019253(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 ECSP19019253A publication Critical patent/ECSP19019253A/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]

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)

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.
ECSENADI201919253A 2016-09-23 2019-03-19 Formulación estable para la administración parenteral de tapentadol ECSP19019253A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP16190255 2016-09-23

Publications (1)

Publication Number Publication Date
ECSP19019253A true ECSP19019253A (es) 2019-03-29

Family

ID=56997349

Family Applications (1)

Application Number Title Priority Date Filing Date
ECSENADI201919253A ECSP19019253A (es) 2016-09-23 2019-03-19 Formulación estable para la administración parenteral de tapentadol

Country Status (17)

Country Link
US (1) US10898452B2 (es)
EP (1) EP3515412B1 (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)
ES (1) ES3027562T3 (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
CA2479350A1 (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
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.
DE602004019761D1 (de) 2003-01-08 2009-04-16 Novartis Vaccines & Diagnostic Stabilisierte wässrige zusammensetzungen mit gewebefaktorinhibitor (tfpi) oder gewebefaktorinhibitor-variante
US20040180915A1 (en) 2003-03-14 2004-09-16 Xanodyne Pharmacal, Inc. Methadone-containing compositions for parenteral administration and method of use thereof
US20060111382A1 (en) 2004-05-17 2006-05-25 Pharmacofore, Inc. Compositions and methods for treating or preventing pain
PT1612203E (pt) 2004-06-28 2007-08-20 Gruenenthal Gmbh ''formas cristalinas de cloridrato de (-) - (1r,2r) - 3 -(3-dimetilamino-l-etil - 2 - metilpropil) fenol''
DE102004032103A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Gegen Missbrauch gesicherte, orale Darreichungsform
BRPI0513300B1 (pt) 2004-07-01 2018-11-06 Gruenenthal Gmbh forma farmacêutica oral, protegida frente ao abuso, contendo (1r, 2r)-3-(3-dimetilamino-1-etil-2- metil-lpropil)-fenol
EP1893190A4 (en) 2005-04-28 2010-07-28 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
PL2012764T3 (pl) 2006-04-28 2011-04-29 Gruenenthal Gmbh Kombinacja farmaceutyczna zawierająca 3-(3-dimetyloamino-1-etylo-2-metylopropylo)fenol i Paracetamol
ATE502629T1 (de) 2006-04-28 2011-04-15 Gruenenthal Gmbh Pharmazeutische kombination mit 3- (3- dimethylamino-1-ethyl-2-methyl-propyl) phenol und einem nsar
BRPI0714671B8 (pt) 2006-07-24 2023-03-21 Janssen Pharmaceutica Nv Preparação de (2r,3r)-3-(3-metoxifenil)-n,n,2-trimetilpentanamina e compostos intermediários
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
RS55769B1 (sr) 2007-11-23 2017-07-31 Gruenenthal Gmbh Kompozicije tapentadola
AU2008335360A1 (en) 2007-12-06 2009-06-18 Pain Therapeutics, Inc. Micronized opioid compositions, formulations and dosage forms and methods of making same
CA2713128C (en) 2008-01-25 2016-04-05 Gruenenthal Gmbh Pharmaceutical dosage form
EP2280688B1 (en) 2008-04-08 2012-01-25 Acino Pharma AG Aqueous pharmaceutical formulation
RU2673882C1 (ru) 2008-10-30 2018-12-03 Грюненталь Гмбх Новые и эффективные лекарственные формы тапентадола
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
CN102711726A (zh) 2009-12-10 2012-10-03 特克尼梅德医疗技术股份公司 用于制备扑热息痛稳定液体制剂的方法和组合物
US20110190267A1 (en) 2010-01-05 2011-08-04 Shire Pharmaceuticals, Inc. Prodrugs of opioids and uses thereof
ES2829386T3 (es) 2010-03-30 2021-05-31 Phosphagenics Ltd Parche de administración transdérmica
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
ES2910085T3 (es) * 2011-03-04 2022-05-11 Gruenenthal Gmbh Composición farmacéutica acuosa semisólida que contiene tapentadol
CN103501775A (zh) * 2011-03-04 2014-01-08 格吕伦塔尔有限公司 他喷他多的胃肠外给药
MX388963B (es) 2011-03-04 2025-03-20 Gruenenthal Gmbh Formulacion farmaceutica acuosa de tapentadol para administracion oral
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
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
PE20171651A1 (es) * 2015-03-27 2017-11-13 Gruenenthal Chemie Formulacion estable para administracion parenteral de tapentadol
EP3585370A1 (en) * 2017-02-23 2020-01-01 Grünenthal GmbH Tapentadol as local anesthetic

Also Published As

Publication number Publication date
CL2019000690A1 (es) 2019-06-14
JP2019529442A (ja) 2019-10-17
CN109996533A (zh) 2019-07-09
AU2017329964B2 (en) 2022-10-06
US20180085328A1 (en) 2018-03-29
EP3515412A1 (en) 2019-07-31
US10898452B2 (en) 2021-01-26
EA201990744A1 (ru) 2019-08-30
CA3037810A1 (en) 2018-03-29
BR112019005439A2 (pt) 2019-06-18
EP3515412B1 (en) 2025-04-23
CO2019002557A2 (es) 2019-05-10
AU2017329964A1 (en) 2019-03-14
WO2018055070A1 (en) 2018-03-29
PE20190908A1 (es) 2019-06-26
IL265477A (en) 2019-05-30
KR20190057349A (ko) 2019-05-28
JP7160799B2 (ja) 2022-10-25
MX2019003257A (es) 2019-06-10
ES3027562T3 (en) 2025-06-16
EP3515412C0 (en) 2025-04-23

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