ES2582779T3 - Forma de dosificación oral de acetaminofeno/tramadol de liberación prolongada - Google Patents

Forma de dosificación oral de acetaminofeno/tramadol de liberación prolongada Download PDF

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Publication number
ES2582779T3
ES2582779T3 ES09740619.3T ES09740619T ES2582779T3 ES 2582779 T3 ES2582779 T3 ES 2582779T3 ES 09740619 T ES09740619 T ES 09740619T ES 2582779 T3 ES2582779 T3 ES 2582779T3
Authority
ES
Spain
Prior art keywords
tramadol
acetaminophen
dosage form
oral dosage
extended release
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
ES09740619.3T
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English (en)
Inventor
Wei-guo DAI
Liang-Chang Dong
Tae-Hong Choi
Sung Joo Hwang
Jae Hyun Kim
Dong Ho Lee
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Alza Corp
Original Assignee
Alza Corp
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
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=41514164&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2582779(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Alza Corp filed Critical Alza Corp
Application granted granted Critical
Publication of ES2582779T3 publication Critical patent/ES2582779T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • 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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • 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
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • 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
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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]
    • A61P29/02—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rheumatology (AREA)
  • Emergency Medicine (AREA)
  • Neurosurgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Immunology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

Una composición farmacéutica que comprende un acetaminofeno y un material de tramadol complejado, que presenta liberación sostenida coordinada tras la disolución produciendo la liberación acumulativa coordinada de tramadol y la liberación acumulativa de acetaminofeno con el tiempo, en la que el material de tramadol complejado se forma en complejo usando carragenina.

Description

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Claims (1)

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ES09740619.3T 2008-10-27 2009-10-23 Forma de dosificación oral de acetaminofeno/tramadol de liberación prolongada Active ES2582779T3 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10861808P 2008-10-27 2008-10-27
US108618P 2008-10-27
PCT/US2009/061803 WO2010062524A1 (en) 2008-10-27 2009-10-23 Extended release oral acetaminophen/tramadol dosage form

Publications (1)

Publication Number Publication Date
ES2582779T3 true ES2582779T3 (es) 2016-09-15

Family

ID=41514164

Family Applications (1)

Application Number Title Priority Date Filing Date
ES09740619.3T Active ES2582779T3 (es) 2008-10-27 2009-10-23 Forma de dosificación oral de acetaminofeno/tramadol de liberación prolongada

Country Status (26)

Country Link
US (1) US20100104638A1 (es)
EP (1) EP2362768B1 (es)
JP (1) JP5713911B2 (es)
KR (3) KR101631140B1 (es)
CN (2) CN107028908A (es)
AU (1) AU2009320181B2 (es)
BR (1) BRPI0920082A2 (es)
CA (1) CA2741751C (es)
CL (1) CL2011000935A1 (es)
CO (1) CO6331423A2 (es)
CR (1) CR20110287A (es)
EA (1) EA023149B1 (es)
EC (1) ECSP11011009A (es)
ES (1) ES2582779T3 (es)
HK (1) HK1162915A1 (es)
HN (1) HN2011001184A (es)
IL (1) IL212453A (es)
MX (1) MX339867B (es)
MY (1) MY161550A (es)
NI (1) NI201100079A (es)
NZ (1) NZ592325A (es)
PE (1) PE20110855A1 (es)
TW (1) TWI561257B (es)
UA (1) UA102706C2 (es)
WO (1) WO2010062524A1 (es)
ZA (1) ZA201103880B (es)

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US20070048228A1 (en) 2003-08-06 2007-03-01 Elisabeth Arkenau-Maric Abuse-proofed dosage form
DE10361596A1 (de) * 2003-12-24 2005-09-29 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
DE10336400A1 (de) 2003-08-06 2005-03-24 Grünenthal GmbH Gegen Missbrauch gesicherte Darreichungsform
DE102004032049A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Gegen Missbrauch gesicherte, orale Darreichungsform
DE102005005449A1 (de) * 2005-02-04 2006-08-10 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
RU2493830C2 (ru) 2008-01-25 2013-09-27 Грюненталь Гмбх Лекарственная форма
BRPI0912014A2 (pt) 2008-05-09 2019-03-06 Grünenthal GmbH processo para a preparação de uma formulação em pó intermediária e uma forma de dosagem sólida final sob uso de uma etapa de congelamento por atomização
TW201105316A (en) 2009-07-22 2011-02-16 Gruenenthal Gmbh Hot-melt extruded pharmaceutical dosage form
KR101747156B1 (ko) * 2009-07-22 2017-06-27 그뤼넨탈 게엠베하 산화-안정화된 탬퍼-내성 용량형
PE20131102A1 (es) 2010-09-02 2013-10-12 Gruenenthal Chemie Forma de dosificacion resistente a manipulacion que comprende una sal inorganica
CN103179954A (zh) 2010-09-02 2013-06-26 格吕伦塔尔有限公司 包含阴离子聚合物的抗破碎剂型
BR112013028668A2 (pt) * 2011-05-06 2017-01-24 Glaxosmithkline Llc formulações de paracetamol de liberação sustentada
US10702485B2 (en) 2011-07-09 2020-07-07 Syntrix Biosystems Inc. Compositions and methods for overcoming resistance to tramadol
MX348491B (es) 2011-07-29 2017-06-15 Gruenenthal Gmbh Tableta a prueba de manipulacion que proporciona liberacion inmediata de fármaco.
PT2736497T (pt) 2011-07-29 2017-11-30 Gruenenthal Gmbh Comprimido resistente a adulteração proporcionando libertação imediata de fármaco
WO2013127831A1 (en) 2012-02-28 2013-09-06 Grünenthal GmbH Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer
AU2013248351B2 (en) 2012-04-18 2018-04-26 Grunenthal Gmbh Tamper resistant and dose-dumping resistant pharmaceutical dosage form
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US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
AR096439A1 (es) 2013-05-29 2015-12-30 Gruenenthal Gmbh Forma de dosificación resistente al uso indebido que contiene una o más partículas
DE102013009114A1 (de) 2013-05-29 2014-12-04 Franz Gerstheimer Pharmazeutische Zusammensetzung zur Überwindung von Metabolisierungsproblemen
US10154966B2 (en) 2013-05-29 2018-12-18 Grünenthal GmbH Tamper-resistant dosage form containing one or more particles
EA032465B1 (ru) 2013-07-12 2019-05-31 Грюненталь Гмбх Защищенная от применения не по назначению пероральная фармацевтическая лекарственная форма, содержащая этиленвинилацетатный полимер, и способ ее изготовления
EP3052089B1 (en) * 2013-09-30 2017-08-30 Athena Drug Delivery Solutions Pvt Ltd. Tramadol hydrochloride and paracetamol orally disintegrating composition and process for preparing the same
JP6480936B2 (ja) 2013-11-26 2019-03-13 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 クライオミリングによる粉末状医薬組成物の調製
EP3079668A1 (en) 2013-12-09 2016-10-19 Durect Corporation Pharmaceutically active agent complexes, polymer complexes, and compositions and methods involving the same
EP3082781A1 (en) 2013-12-16 2016-10-26 Grünenthal GmbH Tamper resistant dosage form with bimodal release profile manufactured by co-extrusion
EP3142646A1 (en) 2014-05-12 2017-03-22 Grünenthal GmbH Tamper resistant immediate release capsule formulation comprising tapentadol
CN106456550A (zh) 2014-05-26 2017-02-22 格吕伦塔尔有限公司 避免乙醇剂量倾泻的多颗粒
AU2016251854A1 (en) 2015-04-24 2017-10-19 Grunenthal Gmbh Tamper-resistant dosage form with immediate release and resistance against solvent extraction
EP3346991A1 (en) 2015-09-10 2018-07-18 Grünenthal GmbH Protecting oral overdose with abuse deterrent immediate release formulations
GB2567493B (en) 2017-10-13 2019-12-18 Altus Formulation Inc Starch-based release modifying excipients and pharmaceutical compositions derived therefrom
ES2913642T3 (es) * 2017-10-13 2022-06-03 Altus Formulation Inc Excipientes modificadores de la liberación a base de almidón y composiciones farmacéuticas derivadas de los mismos
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Also Published As

Publication number Publication date
KR20130137720A (ko) 2013-12-17
UA102706C2 (ru) 2013-08-12
WO2010062524A1 (en) 2010-06-03
ECSP11011009A (es) 2011-06-30
CA2741751A1 (en) 2010-06-03
BRPI0920082A2 (pt) 2019-09-24
PE20110855A1 (es) 2011-12-05
NI201100079A (es) 2011-10-21
MY161550A (en) 2017-04-28
ZA201103880B (en) 2012-10-31
EA023149B1 (ru) 2016-04-29
AU2009320181A1 (en) 2010-06-03
HN2011001184A (es) 2014-09-01
MX2011004403A (es) 2011-05-25
KR20110119845A (ko) 2011-11-02
AU2009320181B2 (en) 2015-08-27
MX339867B (es) 2016-06-14
CL2011000935A1 (es) 2011-10-21
IL212453A (en) 2017-03-30
NZ592325A (en) 2012-09-28
IL212453A0 (en) 2011-06-30
CO6331423A2 (es) 2011-10-20
EP2362768A1 (en) 2011-09-07
US20100104638A1 (en) 2010-04-29
KR101631140B1 (ko) 2016-06-20
EP2362768B1 (en) 2016-04-20
JP5713911B2 (ja) 2015-05-07
KR20110036858A (ko) 2011-04-11
CN107028908A (zh) 2017-08-11
CR20110287A (es) 2011-11-10
EA201170616A1 (ru) 2011-12-30
TW201028180A (en) 2010-08-01
JP2012506907A (ja) 2012-03-22
HK1162915A1 (zh) 2012-09-07
CN102264355A (zh) 2011-11-30
TWI561257B (en) 2016-12-11
CA2741751C (en) 2017-05-09

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