BRPI0513300A - forma farmacêutica oral, protegida frente ao abuso, contendo (1r, 2r)-3-(3-dimetilamino-1-etil-2-propil)-fenol - Google Patents

forma farmacêutica oral, protegida frente ao abuso, contendo (1r, 2r)-3-(3-dimetilamino-1-etil-2-propil)-fenol

Info

Publication number
BRPI0513300A
BRPI0513300A BRPI0513300-9A BRPI0513300A BRPI0513300A BR PI0513300 A BRPI0513300 A BR PI0513300A BR PI0513300 A BRPI0513300 A BR PI0513300A BR PI0513300 A BRPI0513300 A BR PI0513300A
Authority
BR
Brazil
Prior art keywords
abuse
phenol
pharmaceutical form
protected
dimethylamino
Prior art date
Application number
BRPI0513300-9A
Other languages
English (en)
Inventor
Johannes Bartholomaus
Heinrich Kugelmann
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=34972022&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI0513300(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from DE102004032103A external-priority patent/DE102004032103A1/de
Application filed by Gruenenthal Gmbh filed Critical Gruenenthal Gmbh
Publication of BRPI0513300A publication Critical patent/BRPI0513300A/pt
Publication of BRPI0513300B1 publication Critical patent/BRPI0513300B1/pt

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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • 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)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Pain & Pain Management (AREA)
  • Addiction (AREA)
  • Psychiatry (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

FORMA FARMACêUTICA ORAL, PROTEGIDA FRENTE AO ABUSO, CONTENDO (1R, 2R)-3-(3-DIMETILAMINO-1-ETIL-2-METIL-PROPIL)-FENOL A presente invenção refere-se a uma forma farmacêutica oral, protegida frente ao abuso, com liberação controlada de (1R-2R)-3-(3-dimetilamino-1-etil-2-metil-propil)-fenol para uma administração única diária, caracterizada pelo fato de que compreende o principio ativo e/ou um ou vários dos seus compostos (A) farmaceuticamente aceitáveis, pelo menos um polímero (C) sintético e/ou natural, adjuvantes de liberação sustentada, opcionalmente outros adjuvantes (B) fisiologicamente compatíveis e opcionalmente uma cera (D), tendo a forma farmacêutica, em cada caso, uma resistência ao rompimento de pelo menos 500 N, preferivelmente de pelo menos 750N. A forma farmacêutica inclui pelo menos um dos seguintes componentes de (a) a (f) que evitam o abuso: (a) pelo menos uma substância que irrita a cavidade nasal e/ou faríngea, (b) pelo menos um agente que aumenta a viscosidade, (c) pelo menos um antagonista para o principio ativo com potencial de abuso, (d) pelo menos um emético, (e) pelo menos um colorante como agente dissuasório, (f) pelo menos uma substância amarga.
BRPI0513300A 2004-07-01 2005-06-29 forma farmacêutica oral, protegida frente ao abuso, contendo (1r, 2r)-3-(3-dimetilamino-1-etil-2- metil-lpropil)-fenol BRPI0513300B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE102004032103A DE102004032103A1 (de) 2004-07-01 2004-07-01 Gegen Missbrauch gesicherte, orale Darreichungsform
US10/890,707 US20060039864A1 (en) 2004-07-01 2004-07-14 Abuse-proofed oral dosage form
PCT/EP2005/006990 WO2006002886A1 (de) 2004-07-01 2005-06-29 Gegen missbrauch gesicherte, orale darreichungsform enthaltend (1r, 2r)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol

Publications (2)

Publication Number Publication Date
BRPI0513300A true BRPI0513300A (pt) 2008-05-06
BRPI0513300B1 BRPI0513300B1 (pt) 2018-11-06

Family

ID=34972022

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0513300A BRPI0513300B1 (pt) 2004-07-01 2005-06-29 forma farmacêutica oral, protegida frente ao abuso, contendo (1r, 2r)-3-(3-dimetilamino-1-etil-2- metil-lpropil)-fenol

Country Status (10)

Country Link
EP (1) EP1786403B1 (pt)
JP (1) JP5700904B2 (pt)
KR (1) KR101204657B1 (pt)
AR (1) AR053304A1 (pt)
AU (1) AU2005259478B2 (pt)
BR (1) BRPI0513300B1 (pt)
CA (1) CA2572352A1 (pt)
NO (1) NO337952B1 (pt)
PL (1) PL1786403T3 (pt)
WO (1) WO2006002886A1 (pt)

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US9629807B2 (en) 2003-08-06 2017-04-25 Grünenthal GmbH Abuse-proofed dosage form
US9636303B2 (en) 2010-09-02 2017-05-02 Gruenenthal Gmbh Tamper resistant dosage form comprising an anionic polymer
US9655853B2 (en) 2012-02-28 2017-05-23 Grünenthal GmbH Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer
US9675610B2 (en) 2002-06-17 2017-06-13 Grünenthal GmbH Abuse-proofed dosage form
US9737490B2 (en) 2013-05-29 2017-08-22 Grünenthal GmbH Tamper resistant dosage form with bimodal release profile
US9750701B2 (en) 2008-01-25 2017-09-05 Grünenthal GmbH Pharmaceutical dosage form
US9855263B2 (en) 2015-04-24 2018-01-02 Grünenthal GmbH Tamper-resistant dosage form with immediate release and resistance against solvent extraction
US9872835B2 (en) 2014-05-26 2018-01-23 Grünenthal GmbH Multiparticles safeguarded against ethanolic dose-dumping
US10058548B2 (en) 2003-08-06 2018-08-28 Grünenthal GmbH Abuse-proofed dosage form
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
US10080721B2 (en) 2009-07-22 2018-09-25 Gruenenthal Gmbh Hot-melt extruded pharmaceutical dosage form
US10130591B2 (en) 2003-08-06 2018-11-20 Grünenthal GmbH Abuse-proofed dosage form
US10154966B2 (en) 2013-05-29 2018-12-18 Grünenthal GmbH Tamper-resistant dosage form containing one or more particles
US10201502B2 (en) 2011-07-29 2019-02-12 Gruenenthal Gmbh Tamper-resistant tablet providing immediate drug release
US10300141B2 (en) 2010-09-02 2019-05-28 Grünenthal GmbH Tamper resistant dosage form comprising inorganic salt
US10449547B2 (en) 2013-11-26 2019-10-22 Grünenthal GmbH Preparation of a powdery pharmaceutical composition by means of cryo-milling
US10624862B2 (en) 2013-07-12 2020-04-21 Grünenthal GmbH Tamper-resistant dosage form containing ethylene-vinyl acetate polymer
US10695297B2 (en) 2011-07-29 2020-06-30 Grünenthal GmbH Tamper-resistant tablet providing immediate drug release
US10729658B2 (en) 2005-02-04 2020-08-04 Grünenthal GmbH Process for the production of an abuse-proofed dosage form
US10842750B2 (en) 2015-09-10 2020-11-24 Grünenthal GmbH Protecting oral overdose with abuse deterrent immediate release formulations

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US20040234602A1 (en) 2001-09-21 2004-11-25 Gina Fischer Polymer release system
WO2003084518A2 (fr) 2002-04-09 2003-10-16 Flamel Technologies Suspension orale de microcapsules de principes actifs
US8877241B2 (en) 2003-03-26 2014-11-04 Egalet Ltd. Morphine controlled release system
DE102004032051A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten, festen Darreichungsform
DE10361596A1 (de) 2003-12-24 2005-09-29 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
US8075872B2 (en) 2003-08-06 2011-12-13 Gruenenthal Gmbh Abuse-proofed dosage form
DE102004032049A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Gegen Missbrauch gesicherte, orale Darreichungsform
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EA201400590A1 (ru) 2011-11-17 2014-11-28 Грюненталь Гмбх Устойчивая к разрушению пероральная фармацевтическая лекарственная форма, содержащая фармакологически активный ингредиент, опиоидный антагонист и/или средство, вызывающее отвращение, полиалкиленоксид и анионный полимер
WO2013127830A1 (en) 2012-02-28 2013-09-06 Grünenthal GmbH Tamper-resistant pharmaceutical dosage form comprising nonionic surfactant
AR090695A1 (es) 2012-04-18 2014-12-03 Gruenenthal Gmbh Forma de dosificacion farmaceutica resistente a la adulteracion y resistente a la liberacion inmediata de la dosis
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CA2877183A1 (en) 2012-07-06 2014-01-09 Egalet Ltd. Abuse deterrent pharmaceutical compositions for controlled release
WO2014106865A1 (en) * 2013-01-07 2014-07-10 Alkem Laboratories Ltd. Abuse-proofed, extended release pharmaceutical composition comprising tapentadol or a pharmaceutically acceptable salt thereof and processes for preparing thereof
EP2808319A1 (en) 2013-05-31 2014-12-03 Arevipharma GmbH 3-[3-(Dimethylamino)-1-ethyl-2-methylpropyl]phenol resin complex
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MX2016007848A (es) 2013-12-16 2016-09-07 Gruenenthal Gmbh Forma de dosificacion resistente a alteraciones con perfil de liberacion bimodal fabricado mediante co-extrusion.
MX2016014738A (es) 2014-05-12 2017-03-06 Gruenenthal Gmbh Formulacion en capsula de liberacion inmediata resistente a alteraciones que comprende tapentadol.
CA2975653A1 (en) 2015-02-03 2016-08-11 Grunenthal Gmbh Tamper-resistant dosage form comprising a polyethylene glycol graft copolymer
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JP2018513864A (ja) 2015-04-24 2018-05-31 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 粒子及びマトリックスから２種の薬物の急速放出をもたらすタンパレジスタントな固定用量組合せ
AU2016251853A1 (en) 2015-04-24 2017-11-23 Grünenthal GmbH Tamper-resistant fixed dose combination providing fast release of two drugs from different particles
BR112017022856A2 (pt) 2015-04-24 2018-07-17 Gruenenthal Gmbh combinação de dose fixa inviolável que proporciona rápida liberação de duas drogas a partir de partículas
DK3377049T3 (en) 2015-11-17 2021-04-12 Msn Laboratories Private Ltd Crystalline forms of tapentadol salts and process for preparation thereof
KR20170003380U (ko) 2016-03-21 2017-09-29 정화정 공기주입식 간판의 받침장치
US20170296476A1 (en) 2016-04-15 2017-10-19 Grünenthal GmbH Modified release abuse deterrent dosage forms
WO2018007507A1 (en) 2016-07-06 2018-01-11 Grünenthal GmbH Reinforced pharmaceutical dosage form
EP3490537A1 (en) 2016-08-01 2019-06-05 Grünenthal GmbH Tamper resistant dosage form comprising an anionic polysaccharide
BR112019002789A2 (pt) 2016-08-12 2019-05-21 Grünenthal GmbH formulação de efedrina resistente à adulteração e seus derivados
AU2017329964B2 (en) 2016-09-23 2022-10-06 Grünenthal GmbH Stable formulation for parenteral administration of Tapentadol
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EP3698776A1 (en) 2019-02-19 2020-08-26 Grünenthal GmbH Tamper-resistant dosage form with immediate release and resistance against solvent extraction
DE202021003994U1 (de) 2020-03-02 2022-04-12 Grünenthal GmbH Dosierungsform mit verlängerter Freisetzung von Tapentadol-Phosphorsäuresalz
RS65074B1 (sr) * 2020-03-02 2024-02-29 Gruenenthal Gmbh Dozni oblik sa produženim oslobađanjem soli tapentadola sa fosfornom kiselinom
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US10369109B2 (en) 2002-06-17 2019-08-06 Grünenthal GmbH Abuse-proofed dosage form
US9675610B2 (en) 2002-06-17 2017-06-13 Grünenthal GmbH Abuse-proofed dosage form
US10058548B2 (en) 2003-08-06 2018-08-28 Grünenthal GmbH Abuse-proofed dosage form
US10130591B2 (en) 2003-08-06 2018-11-20 Grünenthal GmbH Abuse-proofed dosage form
US9629807B2 (en) 2003-08-06 2017-04-25 Grünenthal GmbH Abuse-proofed dosage form
US10729658B2 (en) 2005-02-04 2020-08-04 Grünenthal GmbH Process for the production of an abuse-proofed dosage form
US9750701B2 (en) 2008-01-25 2017-09-05 Grünenthal GmbH Pharmaceutical dosage form
US10080721B2 (en) 2009-07-22 2018-09-25 Gruenenthal Gmbh Hot-melt extruded pharmaceutical dosage form
US9636303B2 (en) 2010-09-02 2017-05-02 Gruenenthal Gmbh Tamper resistant dosage form comprising an anionic polymer
US10300141B2 (en) 2010-09-02 2019-05-28 Grünenthal GmbH Tamper resistant dosage form comprising inorganic salt
US10201502B2 (en) 2011-07-29 2019-02-12 Gruenenthal Gmbh Tamper-resistant tablet providing immediate drug release
US10695297B2 (en) 2011-07-29 2020-06-30 Grünenthal GmbH Tamper-resistant tablet providing immediate drug release
US10864164B2 (en) 2011-07-29 2020-12-15 Grünenthal GmbH Tamper-resistant tablet providing immediate drug release
US9655853B2 (en) 2012-02-28 2017-05-23 Grünenthal GmbH Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
US9737490B2 (en) 2013-05-29 2017-08-22 Grünenthal GmbH Tamper resistant dosage form with bimodal release profile
US10154966B2 (en) 2013-05-29 2018-12-18 Grünenthal GmbH Tamper-resistant dosage form containing one or more particles
US10624862B2 (en) 2013-07-12 2020-04-21 Grünenthal GmbH Tamper-resistant dosage form containing ethylene-vinyl acetate polymer
US10449547B2 (en) 2013-11-26 2019-10-22 Grünenthal GmbH Preparation of a powdery pharmaceutical composition by means of cryo-milling
US9872835B2 (en) 2014-05-26 2018-01-23 Grünenthal GmbH Multiparticles safeguarded against ethanolic dose-dumping
US9855263B2 (en) 2015-04-24 2018-01-02 Grünenthal GmbH Tamper-resistant dosage form with immediate release and resistance against solvent extraction
US10842750B2 (en) 2015-09-10 2020-11-24 Grünenthal GmbH Protecting oral overdose with abuse deterrent immediate release formulations

Also Published As

Publication number Publication date
KR101204657B1 (ko) 2012-11-27
NO20070578L (no) 2007-01-31
BRPI0513300B1 (pt) 2018-11-06
AU2005259478A1 (en) 2006-01-12
AR053304A1 (es) 2007-05-02
CA2572352A1 (en) 2006-01-12
JP2008504328A (ja) 2008-02-14
JP5700904B2 (ja) 2015-04-15
PL1786403T3 (pl) 2013-10-31
WO2006002886A1 (de) 2006-01-12
KR20070039041A (ko) 2007-04-11
AU2005259478B2 (en) 2010-07-15
NO337952B1 (no) 2016-07-18
EP1786403B1 (de) 2013-07-24
EP1786403A1 (de) 2007-05-23

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