CO2017009400A2 - Formulación estable para administración parenteral de tapentadol - Google Patents

Formulación estable para administración parenteral de tapentadol

Info

Publication number
CO2017009400A2
CO2017009400A2 CONC2017/0009400A CO2017009400A CO2017009400A2 CO 2017009400 A2 CO2017009400 A2 CO 2017009400A2 CO 2017009400 A CO2017009400 A CO 2017009400A CO 2017009400 A2 CO2017009400 A2 CO 2017009400A2
Authority
CO
Colombia
Prior art keywords
tapentadol
parenteral administration
relates
pharmaceutical composition
stable formulation
Prior art date
Application number
CONC2017/0009400A
Other languages
English (en)
Inventor
Marc Schiller
Hemelrijck Carlos van
Stefanie Straub
Eva Cornelia Wulsten
Ulrike Bertram
Ulrich Reinhold
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=55661386&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CO2017009400(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 CO2017009400A2 publication Critical patent/CO2017009400A2/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
    • A61K47/06—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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Emergency Medicine (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

La invención se relaciona con una composición farmacéutica acuosa para administración parenteral que comprende Tapentadol o un sal fisiológicamente aceptable del mismo, en donde la concentración de Tapentadol queda dentro de la variación de 0.10 hasta 8.00 mg/mL, con base en el peso de la base libre de Tapentadol y con base en el volumen total de la composición; y en donde el valor de pH de la composición se amortigua y queda dentro de la variación de 4.0 hasta 6.0. La invención también se relaciona con un recipiente que comprende la composición farmacéutica y un proceso para la preparación del mismo. La invención también se relaciona con un kit que comprende el contenido de acuerdo con la invención en un empaque. La composición farmacéutica de acuerdo con la invención es particularmente útil para tratar dolor, en especial dolor agudo, de preferencia en pacientes pediátricos.
CONC2017/0009400A 2015-03-27 2017-09-15 Formulación estable para administración parenteral de tapentadol CO2017009400A2 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP15161487 2015-03-27
EP15169730 2015-05-28
PCT/EP2016/056376 WO2016156147A1 (en) 2015-03-27 2016-03-23 Stable formulation for parenteral administration of tapentadol

Publications (1)

Publication Number Publication Date
CO2017009400A2 true CO2017009400A2 (es) 2018-01-05

Family

ID=55661386

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2017/0009400A CO2017009400A2 (es) 2015-03-27 2017-09-15 Formulación estable para administración parenteral de tapentadol

Country Status (28)

Country Link
US (2) US20160279078A1 (es)
EP (2) EP3273953B1 (es)
JP (1) JP6923447B2 (es)
KR (1) KR20170132282A (es)
CN (1) CN107847471A (es)
AU (1) AU2016239772B2 (es)
BR (1) BR112017018569A2 (es)
CA (1) CA2979034A1 (es)
CL (1) CL2017002306A1 (es)
CO (1) CO2017009400A2 (es)
CY (1) CY1121371T1 (es)
DK (1) DK3273953T3 (es)
EA (1) EA036258B1 (es)
EC (1) ECSP17064188A (es)
ES (2) ES2710299T3 (es)
HK (1) HK1252705A1 (es)
HR (1) HRP20190231T1 (es)
HU (1) HUE042612T2 (es)
IL (1) IL254136A0 (es)
LT (1) LT3273953T (es)
MX (1) MX2017012312A (es)
PE (1) PE20171651A1 (es)
PL (1) PL3273953T3 (es)
PT (2) PT3273953T (es)
RS (1) RS58301B1 (es)
SI (1) SI3273953T1 (es)
TW (1) TW201642843A (es)
WO (1) WO2016156147A1 (es)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX351584B (es) 2011-03-04 2017-10-20 Gruenenthal Gmbh Formulacion farmaceutica acuosa de tapentadol para administracion oral.
RS58301B1 (sr) 2015-03-27 2019-03-29 Gruenenthal Gmbh Stabilne formulacije za parenteralnu primenu tapentadola
AU2017329964B2 (en) 2016-09-23 2022-10-06 Grünenthal GmbH Stable formulation for parenteral administration of Tapentadol
WO2018153947A1 (en) 2017-02-23 2018-08-30 Grünenthal GmbH Tapentadol as local anesthetic

Family Cites Families (65)

* 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
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
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
EP1545477A4 (en) 2002-09-13 2006-11-22 Cydex Inc CAPSULES CONTAINING AQUEOUS FILLING COMPOSITIONS STABILIZED WITH DERIVED 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.
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
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
ATE368639T1 (de) 2004-06-28 2007-08-15 Gruenenthal Gmbh Kristalline formen von (-)-(1r,2r)-3-(3- dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochlorid
DE102004032103A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Gegen Missbrauch gesicherte, orale Darreichungsform
PL1786403T3 (pl) 2004-07-01 2013-10-31 Gruenenthal Gmbh Doustna postać dawki zabezpieczona przed nadużywaniem zawierająca (1R, 2R)-3-(3-dimetyloamino-1-etylo0-2-metylo-propylo)fenol
KR20080026090A (ko) 2005-04-28 2008-03-24 테라퀘스트 바이오사이언시즈 엘엘씨 통증을 치료하기 위한 방법 및 조성물
EA014673B1 (ru) * 2005-08-12 2010-12-30 Бхарат Сирумс Энд Вэксинс Лтд. Водные анестезирующие композиции, содержащие пропофол
TWI329334B (en) 2005-12-02 2010-08-21 Chung Shan Inst Of Science Manufacture method of electromagnetic interference layer for the plasma display panel
US8176534B2 (en) 2005-12-30 2012-05-08 General Instrument Corporation Method and apparatus for provisioning a device to access digital rights management (DRM) services in a universal plug and play (UPnP) network
WO2007127158A2 (en) 2006-04-25 2007-11-08 Croda, Inc Modification of percutaneous absorption of topically active materials
DK2012763T3 (da) 2006-04-28 2011-05-02 Gruenenthal Gmbh Farmaceutisk kombination omfattende 3-(3-dimethylamono-1-ethyl-2-methyl-propyl) phenol og et NSAID
SI2012764T1 (sl) 2006-04-28 2011-03-31 Gruenenthal Chemie Farmacevtska kombinacija, ki obsega 3-(3-dimetilamino-1-etil-2-metil-propil)-fenol in paracetamol
SI2046726T1 (sl) 2006-07-24 2010-05-31 Janssen Pharmaceutica Nv Priprava R R metoksifenil N N 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
SI2596784T1 (sl) 2007-11-23 2017-04-26 Gruenenthal Gmbh Sestavki tapentadola
CA2707969C (en) 2007-12-06 2017-04-18 Pain Therapeutics, Inc. Micronized opioid compositions, formulations and dosage forms and methods of making same
BRPI0906467C1 (pt) 2008-01-25 2021-05-25 Gruenenthal Gmbh forma de dosagem farmacêutica com formato exterior modificado resistente à ruptura e com liberação controlada
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.
JP6216489B2 (ja) 2008-10-30 2017-10-18 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 新規の、効力のあるタペンタドール剤形
JP2012514632A (ja) 2009-01-09 2012-06-28 パナセア バイオテック リミテッド 二段階放出型医薬懸濁剤
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
WO2011071400A1 (en) * 2009-12-10 2011-06-16 Tecnimede - Sociedade Técnico-Medicinal, S.A. Method and composition for preparing stable liquid formulations of paracetamol
WO2011083304A1 (en) 2010-01-05 2011-07-14 Shire Llc Prodrugs of opioids and uses thereof
NZ602572A (en) 2010-03-30 2014-11-28 Phosphagenics Ltd Transdermal delivery patch
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
DK2680834T3 (en) 2011-03-04 2017-12-04 Gruenenthal Gmbh Semi-solid aqueous pharmaceutical composition containing tapentadol
MX351584B (es) 2011-03-04 2017-10-20 Gruenenthal Gmbh Formulacion farmaceutica acuosa de tapentadol para administracion oral.
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
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
GB201309654D0 (en) 2013-05-30 2013-07-17 Euro Celtique Sa Method
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
RS58301B1 (sr) 2015-03-27 2019-03-29 Gruenenthal Gmbh Stabilne formulacije za parenteralnu primenu tapentadola

Also Published As

Publication number Publication date
ES2822113T3 (es) 2021-04-29
SI3273953T1 (sl) 2019-03-29
CL2017002306A1 (es) 2018-03-23
MX2017012312A (es) 2018-01-18
EP3273953A1 (en) 2018-01-31
US20180125800A1 (en) 2018-05-10
JP2018509462A (ja) 2018-04-05
ECSP17064188A (es) 2018-03-31
IL254136A0 (en) 2017-10-31
AU2016239772A1 (en) 2017-09-14
JP6923447B2 (ja) 2021-08-18
CA2979034A1 (en) 2016-10-06
US11013701B2 (en) 2021-05-25
EA036258B1 (ru) 2020-10-20
PE20171651A1 (es) 2017-11-13
BR112017018569A2 (pt) 2018-04-24
CN107847471A (zh) 2018-03-27
US20160279078A1 (en) 2016-09-29
EP3479823A1 (en) 2019-05-08
ES2710299T3 (es) 2019-04-24
DK3273953T3 (en) 2019-03-11
CY1121371T1 (el) 2020-05-29
LT3273953T (lt) 2019-02-25
KR20170132282A (ko) 2017-12-01
EP3479823B1 (en) 2020-09-09
TW201642843A (zh) 2016-12-16
WO2016156147A1 (en) 2016-10-06
EP3273953B1 (en) 2019-01-02
HUE042612T2 (hu) 2019-07-29
PT3273953T (pt) 2019-04-01
RS58301B1 (sr) 2019-03-29
HRP20190231T1 (hr) 2019-04-05
AU2016239772B2 (en) 2021-05-13
EA201792144A1 (ru) 2018-03-30
PL3273953T3 (pl) 2019-07-31
PT3479823T (pt) 2020-09-29
HK1252705A1 (zh) 2019-05-31

Similar Documents

Publication Publication Date Title
CO2017009400A2 (es) Formulación estable para administración parenteral de tapentadol
CY1126062T1 (el) Σταθερη φαρμακοτεχνικη μορφη anti-ifnar1
CY1124546T1 (el) Υγρο σκευασμα για εισπνοη που περιεχει rpl554
EA201790989A1 (ru) Стабильный препарат раствора белка, содержащего анти-vegf антитело в высокой концентрации
CO6680698A2 (es) Formulación de premezcla de dexmedetomidina
EA201492021A1 (ru) Антительный состав
BR112015018252A2 (pt) composição farmacêutica aquosa de dose fixa estável para administração nasal para um ser humano, composição de suspensão aquosa farmacêutica de dose fixa estável para administração nasal para um ser humano, suspensão estável adequada para administração nasal a um ser humano, método para tratar rinite em um ser humano necessitando do mesmo, uso da composição farmacêutica para administração nasal, método para liberar uma composição farmacêutica e kit
JP2014510067A5 (es)
CL2020000625A1 (es) Proceso para formulación farmacéutica liofilizada de una proteína terapéutica.
NZ702342A (en) Pharmaceutical formulation
UY31790A (es) Utilización de dronedarona para preparar un medicamento para el tratamiento de pacientes con arritmia y que tienen un incremento del nivel de creatinina debido a la administración de dronedarona
BR112019025215A2 (pt) Solução farmacêutica aquosa, solução tampão aquosa, kit, e, métodos de continuamente preparar uma solução farmacêutica aquosa e de tratamento de doenças do sistema nervoso central
BR112017025527A2 (pt) preparação farmacêutica líquida, e, método para fabricar uma suspensão de celocoxibe.
AR104051A1 (es) Formulación estable para administración parenteral de tapentadol
ECSP19019253A (es) Formulación estable para la administración parenteral de tapentadol
EA201200754A1 (ru) Традиционное китайское лекарственное средство, содержащее экстракты дан-шен (danshen) и сан-ки (sanqi), и его применение
CY1120282T1 (el) Φαρμακευτικη συνθεση κιτρικης σιλδεναφιλης με την μορφη ενος εναιωρηματος για εκ του στοματος χρηση
EA201100682A1 (ru) Стабильная фармацевтическая композиция, содержащая прегабалин, капсула, ее содержащая, способ получения и применение
UA123395U (uk) Фармацевтична композиція ністатину у формі оральної суспензії
Khrystiuk et al. The study of the rheological properties of paste with natural zeolite
FI3556351T3 (fi) Farmaseuttinen koostumus veren rautatasojen parantamiseksi, joka käsittää rauta (III) polymaltoosista ja toisesta aktiivisesta aineesta, joka sopii raudan absorptioon, joka on valittu kalsium folinaattipentahydraatista, C-vitamiinista tai molempien yhdistelmästä
MY194675A (en) Use of parkia speciosa empty pod extract in alleviating cardiac hypertrophy
PL408096A1 (pl) Produkt farmaceutyczny z ekstraktem roślinnym oraz zestaw produktu farmaceutycznego z ekstraktem roślinnym
TR201818990A2 (tr) Sefdi̇ni̇r i̇çeren tablet formülasyonu
MA44557A1 (fr) Vaccin contre le rotavirus sans tampon, stable en milieu acide, et d'un faible volume de dose à administrer