EA201792144A1 - Стабильный препарат для парентерального введения тапентадола - Google Patents

Стабильный препарат для парентерального введения тапентадола

Info

Publication number
EA201792144A1
EA201792144A1 EA201792144A EA201792144A EA201792144A1 EA 201792144 A1 EA201792144 A1 EA 201792144A1 EA 201792144 A EA201792144 A EA 201792144A EA 201792144 A EA201792144 A EA 201792144A EA 201792144 A1 EA201792144 A1 EA 201792144A1
Authority
EA
Eurasian Patent Office
Prior art keywords
tapentadol
relates
pharmaceutical composition
stable preparation
container
Prior art date
Application number
EA201792144A
Other languages
English (en)
Other versions
EA036258B1 (ru
Inventor
Марк Шиллер
Карлос Ван-Хемелрейк
Штефани Штрауб
Эва Корнелия Вульштен
Ульрике Бертрам
Ульрих Райнхольд
Original Assignee
Грюненталь Гмбх
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=EA201792144(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Грюненталь Гмбх filed Critical Грюненталь Гмбх
Publication of EA201792144A1 publication Critical patent/EA201792144A1/ru
Publication of EA036258B1 publication Critical patent/EA036258B1/ru

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)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (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

Изобретение относится к водной фармацевтической композиции для парентерального введения, которая содержит тапентадол или его физиологически приемлемую соль, где концентрация тапентадола находится в диапазоне от 0,10 до 8,00 мг/мл, на основании веса свободного основания тапентадола и на основании общего объема композиции; и где значение рН композиции забуферено и находится в диапазоне от 4,0 до 6,0. Изобретение также относится к контейнеру, который содержит фармацевтическую композицию и способ ее приготовления. Изобретение также относится к набору, который содержит контейнер в соответствии с изобретением в упаковке. Фармацевтическая композиция в соответствии с изобретением особенно пригодна для лечения боли, в особенности острой боли, предпочтительно у пациентов детского возраста.
EA201792144A 2015-03-27 2016-03-23 Стабильный препарат для парентерального введения тапентадола EA036258B1 (ru)

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 (2)

Publication Number Publication Date
EA201792144A1 true EA201792144A1 (ru) 2018-03-30
EA036258B1 EA036258B1 (ru) 2020-10-20

Family

ID=55661386

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201792144A EA036258B1 (ru) 2015-03-27 2016-03-23 Стабильный препарат для парентерального введения тапентадола

Country Status (28)

Country Link
US (2) US20160279078A1 (ru)
EP (2) EP3479823B1 (ru)
JP (1) JP6923447B2 (ru)
KR (1) KR20170132282A (ru)
CN (1) CN107847471A (ru)
AU (1) AU2016239772B2 (ru)
BR (1) BR112017018569A2 (ru)
CA (1) CA2979034A1 (ru)
CL (1) CL2017002306A1 (ru)
CO (1) CO2017009400A2 (ru)
CY (1) CY1121371T1 (ru)
DK (1) DK3273953T3 (ru)
EA (1) EA036258B1 (ru)
EC (1) ECSP17064188A (ru)
ES (2) ES2710299T3 (ru)
HK (1) HK1252705A1 (ru)
HR (1) HRP20190231T1 (ru)
HU (1) HUE042612T2 (ru)
IL (1) IL254136A0 (ru)
LT (1) LT3273953T (ru)
MX (1) MX2017012312A (ru)
PE (1) PE20171651A1 (ru)
PL (1) PL3273953T3 (ru)
PT (2) PT3273953T (ru)
RS (1) RS58301B1 (ru)
SI (1) SI3273953T1 (ru)
TW (1) TW201642843A (ru)
WO (1) WO2016156147A1 (ru)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130022670A1 (en) 2011-03-04 2013-01-24 Gruenenthal Gmbh Aqueous Pharmaceutical Formulation of Tapentadol for Oral Administration
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
BR112019005439A2 (pt) 2016-09-23 2019-06-18 Gruenenthal Gmbh formulação estável para administração parenteral de tapentadol
EP3585370A1 (en) 2017-02-23 2020-01-01 Grünenthal GmbH Tapentadol as local anesthetic

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Also Published As

Publication number Publication date
ECSP17064188A (es) 2018-03-31
JP6923447B2 (ja) 2021-08-18
IL254136A0 (en) 2017-10-31
MX2017012312A (es) 2018-01-18
DK3273953T3 (en) 2019-03-11
HRP20190231T1 (hr) 2019-04-05
PL3273953T3 (pl) 2019-07-31
TW201642843A (zh) 2016-12-16
HK1252705A1 (zh) 2019-05-31
CL2017002306A1 (es) 2018-03-23
EP3273953B1 (en) 2019-01-02
PT3479823T (pt) 2020-09-29
ES2710299T3 (es) 2019-04-24
ES2822113T3 (es) 2021-04-29
BR112017018569A2 (pt) 2018-04-24
EP3273953A1 (en) 2018-01-31
EA036258B1 (ru) 2020-10-20
KR20170132282A (ko) 2017-12-01
CN107847471A (zh) 2018-03-27
PE20171651A1 (es) 2017-11-13
EP3479823A1 (en) 2019-05-08
CA2979034A1 (en) 2016-10-06
EP3479823B1 (en) 2020-09-09
WO2016156147A1 (en) 2016-10-06
AU2016239772B2 (en) 2021-05-13
RS58301B1 (sr) 2019-03-29
US11013701B2 (en) 2021-05-25
US20160279078A1 (en) 2016-09-29
CO2017009400A2 (es) 2018-01-05
PT3273953T (pt) 2019-04-01
HUE042612T2 (hu) 2019-07-29
SI3273953T1 (sl) 2019-03-29
AU2016239772A1 (en) 2017-09-14
LT3273953T (lt) 2019-02-25
US20180125800A1 (en) 2018-05-10
CY1121371T1 (el) 2020-05-29
JP2018509462A (ja) 2018-04-05

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