SI3946276T1 - Sestavek s podaljšanim sproščanjem, ki obsega tapentadol, in postopek njegove priprave - Google Patents

Sestavek s podaljšanim sproščanjem, ki obsega tapentadol, in postopek njegove priprave

Info

Publication number
SI3946276T1
SI3946276T1 SI202030389T SI202030389T SI3946276T1 SI 3946276 T1 SI3946276 T1 SI 3946276T1 SI 202030389 T SI202030389 T SI 202030389T SI 202030389 T SI202030389 T SI 202030389T SI 3946276 T1 SI3946276 T1 SI 3946276T1
Authority
SI
Slovenia
Prior art keywords
tapentadol
preparation
sustained release
release composition
composition
Prior art date
Application number
SI202030389T
Other languages
English (en)
Inventor
Evangelos Karavas
Efthymios Koutris
Vasiliki Samara
Ioanna Koutri
Anastasia Kalaskani
Andreas Kakouris
Rumit Rajivbhai Shah
Original Assignee
Pharmathen S.A.
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 S.A. filed Critical Pharmathen S.A.
Publication of SI3946276T1 publication Critical patent/SI3946276T1/sl

Links

Classifications

    • 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
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • 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
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Emergency Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
SI202030389T 2019-03-26 2020-03-23 Sestavek s podaljšanim sproščanjem, ki obsega tapentadol, in postopek njegove priprave SI3946276T1 (sl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GR20190100148A GR1009791B (el) 2019-03-26 2019-03-26 Σκευασμα παρατεταμενης αποδεσμευσης που περιλαμβανει ταπενταδολη και μεθοδος παρασκευης αυτου
EP20721146.7A EP3946276B1 (en) 2019-03-26 2020-03-23 Sustained release composition comprising tapentadol and method of preparation thereof
PCT/EP2020/025140 WO2020192970A1 (en) 2019-03-26 2020-03-23 Sustained release composition comprising tapentadol and method of preparation thereof

Publications (1)

Publication Number Publication Date
SI3946276T1 true SI3946276T1 (sl) 2024-05-31

Family

ID=70456723

Family Applications (1)

Application Number Title Priority Date Filing Date
SI202030389T SI3946276T1 (sl) 2019-03-26 2020-03-23 Sestavek s podaljšanim sproščanjem, ki obsega tapentadol, in postopek njegove priprave

Country Status (17)

Country Link
US (1) US20220168241A1 (sl)
EP (1) EP3946276B1 (sl)
AU (1) AU2020246867A1 (sl)
BR (1) BR112021019059A2 (sl)
CA (1) CA3134730A1 (sl)
DK (1) DK3946276T3 (sl)
ES (1) ES2974658T3 (sl)
FI (1) FI3946276T3 (sl)
GR (1) GR1009791B (sl)
HR (1) HRP20240349T1 (sl)
HU (1) HUE065530T2 (sl)
LT (1) LT3946276T (sl)
PL (1) PL3946276T3 (sl)
PT (1) PT3946276T (sl)
RS (1) RS65290B1 (sl)
SI (1) SI3946276T1 (sl)
WO (1) WO2020192970A1 (sl)

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9401894D0 (en) 1994-02-01 1994-03-30 Rhone Poulenc Rorer Ltd New compositions of matter
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
ES2612032T3 (es) 2007-06-04 2017-05-11 Shear/Kershman Laboratories, Inc. Formas farmacéuticas orales basadas en lípidos inviolables para agonistas opiáceos
CN102573805A (zh) * 2009-07-22 2012-07-11 格吕伦塔尔有限公司 热熔挤出的控制释放剂型
WO2012007159A2 (en) * 2010-07-14 2012-01-19 Grünenthal GmbH Novel gastro-retentive dosage forms
FR2979242A1 (fr) 2011-08-29 2013-03-01 Sanofi Sa Comprime contre l'usage abusif, a base de paracetamol et d'oxycodone
EA201500742A1 (ru) 2013-02-05 2015-12-30 Пердью Фарма Л.П. Защищенные от нецелевого использования фармацевтические композиции
CN105682643B (zh) * 2013-07-12 2019-12-13 格吕伦塔尔有限公司 含有乙烯-醋酸乙烯酯聚合物的防篡改剂型
WO2017070462A1 (en) * 2015-10-21 2017-04-27 Nova Southeastern University Compositions for deterring abuse of pharmaceutical products and alcohol
WO2017070566A1 (en) * 2015-10-23 2017-04-27 Kashiv Pharma Llc Enhanced abuse-deterrent formulations of oxycodone

Also Published As

Publication number Publication date
LT3946276T (lt) 2024-04-10
WO2020192970A1 (en) 2020-10-01
EP3946276A1 (en) 2022-02-09
HRP20240349T1 (hr) 2024-05-24
US20220168241A1 (en) 2022-06-02
PT3946276T (pt) 2024-03-15
PL3946276T3 (pl) 2024-05-06
EP3946276B1 (en) 2023-12-13
RS65290B1 (sr) 2024-04-30
AU2020246867A1 (en) 2021-11-18
HUE065530T2 (hu) 2024-06-28
GR1009791B (el) 2020-08-03
CA3134730A1 (en) 2020-10-01
ES2974658T3 (es) 2024-07-01
FI3946276T3 (fi) 2024-03-15
DK3946276T3 (da) 2024-03-18
BR112021019059A2 (pt) 2021-11-30

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