DK3941443T3 - Depotsammensætning, som omfatter tapentadol oxalat og fremgangsmåde til formulering heraf - Google Patents

Depotsammensætning, som omfatter tapentadol oxalat og fremgangsmåde til formulering heraf Download PDF

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Publication number
DK3941443T3
DK3941443T3 DK20721145.9T DK20721145T DK3941443T3 DK 3941443 T3 DK3941443 T3 DK 3941443T3 DK 20721145 T DK20721145 T DK 20721145T DK 3941443 T3 DK3941443 T3 DK 3941443T3
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DK
Denmark
Prior art keywords
tapentadol
oxalate
formulation
spot composition
spot
Prior art date
Application number
DK20721145.9T
Other languages
English (en)
Inventor
Evangelos Karavas
Efthymios Koutris
Vasiliki Samara
Ioanna Koutri
Anastasia Kalaskani
Christina Kiziridi
Andreas Kakouris
Original Assignee
Pharmathen Sa
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
Application filed by Pharmathen Sa filed Critical Pharmathen Sa
Application granted granted Critical
Publication of DK3941443T3 publication Critical patent/DK3941443T3/da

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/20Hypnotics; Sedatives
DK20721145.9T 2019-03-22 2020-03-20 Depotsammensætning, som omfatter tapentadol oxalat og fremgangsmåde til formulering heraf DK3941443T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GR20190100138A GR1009751B (el) 2019-03-22 2019-03-22 Σκευασμα παρατεταμενης αποδεσμευσης που περιλαμβανει οξαλικη ταπενταδολη και μεθοδος παρασκευης αυτου
PCT/EP2020/025139 WO2020192969A1 (en) 2019-03-22 2020-03-20 Sustained release composition comprising tapentadol oxalate and method of preparation thereof

Publications (1)

Publication Number Publication Date
DK3941443T3 true DK3941443T3 (da) 2024-03-18

Family

ID=70456722

Family Applications (1)

Application Number Title Priority Date Filing Date
DK20721145.9T DK3941443T3 (da) 2019-03-22 2020-03-20 Depotsammensætning, som omfatter tapentadol oxalat og fremgangsmåde til formulering heraf

Country Status (12)

Country Link
US (1) US20220202720A1 (da)
EP (1) EP3941443B1 (da)
AU (1) AU2020248971A1 (da)
BR (1) BR112021018896A2 (da)
CA (1) CA3134455A1 (da)
DK (1) DK3941443T3 (da)
FI (1) FI3941443T3 (da)
GR (1) GR1009751B (da)
LT (1) LT3941443T (da)
PT (1) PT3941443T (da)
RS (1) RS65287B1 (da)
WO (1) WO2020192969A1 (da)

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4426245A1 (de) 1994-07-23 1996-02-22 Gruenenthal Gmbh 1-Phenyl-3-dimethylamino-propanverbindungen mit pharmakologischer Wirkung
DE10336400A1 (de) * 2003-08-06 2005-03-24 Grünenthal GmbH Gegen Missbrauch gesicherte Darreichungsform
FR2897267A1 (fr) 2006-02-16 2007-08-17 Flamel Technologies Sa Formes pharmaceutiques multimicroparticulaires pour administration per os
US20080069891A1 (en) 2006-09-15 2008-03-20 Cima Labs, Inc. Abuse resistant drug formulation
FR2936709B1 (fr) 2008-10-02 2012-05-11 Ethypharm Sa Comprimes alcoolo-resistants.
EP2555756B1 (en) 2010-04-07 2018-08-22 Lupin Limited Controlled release pharmaceutical compositions of tapentadol
US20130059010A1 (en) 2010-05-14 2013-03-07 Ethypharm Alcohol-resistant oral pharmaceutical form
EP2714015B1 (en) 2011-06-01 2017-03-15 FMC Corporation Controlled release solid dose forms
JP2014524925A (ja) * 2011-07-29 2014-09-25 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 即時薬剤放出を提供するタンパーレジスタント錠剤
EP3122337A4 (en) * 2014-03-26 2017-11-08 Sun Pharma Advanced Research Company Ltd Abuse deterrent immediate release coated reservoir solid dosage form
WO2015157150A1 (en) * 2014-04-07 2015-10-15 Banner Life Sciences Llc Opioid abuse-deterrent controlled release formulations
US20180303757A1 (en) * 2015-10-23 2018-10-25 Kashiv Pharma Llc Enhanced abuse-deterrent formulations of oxycodone
US20190054024A1 (en) * 2017-08-16 2019-02-21 HUMANWELL PHARMACEUTICAL US, Inc. Solid Dosage Forms

Also Published As

Publication number Publication date
CA3134455A1 (en) 2020-10-01
GR1009751B (el) 2020-05-29
RS65287B1 (sr) 2024-04-30
LT3941443T (lt) 2024-03-25
FI3941443T3 (fi) 2024-03-15
EP3941443B1 (en) 2023-12-13
AU2020248971A1 (en) 2021-11-18
PT3941443T (pt) 2024-03-15
US20220202720A1 (en) 2022-06-30
WO2020192969A1 (en) 2020-10-01
BR112021018896A2 (pt) 2021-11-30
EP3941443A1 (en) 2022-01-26

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