BR112015022567A2 - composições compreendendo um opioide e um ingrediente farmacêutico ativo adicional para início rápido e duração prolongada de analgesia que podem ser administradas sem alimento - Google Patents

composições compreendendo um opioide e um ingrediente farmacêutico ativo adicional para início rápido e duração prolongada de analgesia que podem ser administradas sem alimento

Info

Publication number
BR112015022567A2
BR112015022567A2 BR112015022567A BR112015022567A BR112015022567A2 BR 112015022567 A2 BR112015022567 A2 BR 112015022567A2 BR 112015022567 A BR112015022567 A BR 112015022567A BR 112015022567 A BR112015022567 A BR 112015022567A BR 112015022567 A2 BR112015022567 A2 BR 112015022567A2
Authority
BR
Brazil
Prior art keywords
opioid
analgesia
compositions
additional active
rapid onset
Prior art date
Application number
BR112015022567A
Other languages
English (en)
Inventor
R Devarakonda Krishna
j giuliani Michael
A Heasley Ralph
Shelby Susan
K Gupta Vishal
Original Assignee
Mallinckrodt Llc
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 Mallinckrodt Llc filed Critical Mallinckrodt Llc
Publication of BR112015022567A2 publication Critical patent/BR112015022567A2/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
    • A61K31/33—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
    • 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
    • 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
    • A61K9/20—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
    • 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
    • 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)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pain & Pain Management (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Emergency Medicine (AREA)
  • Neurology (AREA)
  • Rheumatology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

resumo patente de invenção: "composições compreendendo um opioide e um ingrediente farmacêutico ativo adicional para início rápido e duração prolongada de analgesia que podem ser administradas sem alimento". a presente invenção refere-se a composições farmacêuticas compreendendo um opioide e um ingrediente farmacêutico ativo adicional, em que a composição exibe propriedades retentivas gástricas que são obtidas por uma combinação da propriedade física da composição e liberação do opioide, em que na administração a um indivíduo, a composição tem pelo menos um parâmetro farmacocinético que difere em menos do que cerca de 30% quando o indivíduo está em um estado jejuado quando comparado a um estado alimentado. a presente invenção também fornece composição farmacêutica compreendendo oxicodona e acetaminofeno que fornece um início rápido de analgesia, e níveis reduzidos de acetaminofeno próximo ao término do intervalo de dosagem. é também fornecida uma composição farmacêutica de liberação prolongada compreendendo oxicodona e acetaminofeno que fornece potencial de abuso reduzido.
BR112015022567A 2013-03-15 2014-02-24 composições compreendendo um opioide e um ingrediente farmacêutico ativo adicional para início rápido e duração prolongada de analgesia que podem ser administradas sem alimento BR112015022567A2 (pt)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201361798525P 2013-03-15 2013-03-15
US201361794848P 2013-03-15 2013-03-15
US201361871690P 2013-08-29 2013-08-29
US201361871956P 2013-08-30 2013-08-30
US201461926027P 2014-01-10 2014-01-10
US201461928509P 2014-01-17 2014-01-17
PCT/US2014/018101 WO2014149397A1 (en) 2013-03-15 2014-02-24 Compositions comprising an opioid and an additional active pharmaceutical ingredient for rapid onset and extended duration of analgesia that may be administered without regard to food

Publications (1)

Publication Number Publication Date
BR112015022567A2 true BR112015022567A2 (pt) 2017-07-18

Family

ID=50290266

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112015022567A BR112015022567A2 (pt) 2013-03-15 2014-02-24 composições compreendendo um opioide e um ingrediente farmacêutico ativo adicional para início rápido e duração prolongada de analgesia que podem ser administradas sem alimento

Country Status (7)

Country Link
US (1) US20140275143A1 (pt)
EP (1) EP2968169A1 (pt)
JP (1) JP2016512248A (pt)
CN (1) CN105209021A (pt)
BR (1) BR112015022567A2 (pt)
CA (1) CA2903200A1 (pt)
WO (1) WO2014149397A1 (pt)

Families Citing this family (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7776314B2 (en) 2002-06-17 2010-08-17 Grunenthal Gmbh Abuse-proofed dosage system
EP1610767B1 (en) 2003-03-26 2011-01-19 Egalet A/S Morphine controlled release system
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
DE102005005446A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
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
EP2155167A2 (en) 2007-06-04 2010-02-24 Egalet A/S Controlled release pharmaceutical compositions for prolonged effect
NZ594207A (en) 2009-02-06 2013-03-28 Egalet Ltd Immediate release composition resistant to abuse by intake of alcohol
AU2010265213B2 (en) 2009-06-24 2012-08-23 Egalet Ltd. Controlled release formulations
KR101747156B1 (ko) 2009-07-22 2017-06-27 그뤼넨탈 게엠베하 산화-안정화된 탬퍼-내성 용량형
MX2013002377A (es) 2010-09-02 2013-04-29 Gruenenthal Gmbh Forma de dosificacion resistente a manipulacion que comprende una sal inorganica.
US9050335B1 (en) 2011-05-17 2015-06-09 Mallinckrodt Llc Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia
US8858963B1 (en) 2011-05-17 2014-10-14 Mallinckrodt Llc Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia
US8741885B1 (en) 2011-05-17 2014-06-03 Mallinckrodt Llc Gastric retentive extended release pharmaceutical compositions
EA201400173A1 (ru) 2011-07-29 2014-06-30 Грюненталь Гмбх Устойчивая к разрушению таблетка, которая обеспечивает немедленное высвобождение лекарственного средства
EA201400172A1 (ru) 2011-07-29 2014-06-30 Грюненталь Гмбх Устойчивая к разрушению таблетка, которая обеспечивает немедленное высвобождение лекарственного средства
JP6282261B2 (ja) 2012-04-18 2018-02-21 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 不正使用防止および過量放出防止医薬剤形
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
AU2014273227B2 (en) 2013-05-29 2019-08-15 Grunenthal Gmbh Tamper-resistant dosage form containing one or more particles
CA2917136C (en) 2013-07-12 2022-05-31 Grunenthal Gmbh Tamper-resistant dosage form containing ethylene-vinyl acetate polymer
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
AU2015261060A1 (en) 2014-05-12 2016-11-03 Grunenthal Gmbh Tamper resistant immediate release capsule formulation comprising Tapentadol
BR112017022335A2 (pt) * 2015-04-24 2018-07-10 Gruenenthal Gmbh combinação de dose fixa inviolável que fornece rápida liberação de dois fármacos a partir de partículas e matriz
CA2998259A1 (en) 2015-09-10 2017-03-16 Grunenthal Gmbh Protecting oral overdose with abuse deterrent immediate release formulations
US9861629B1 (en) 2015-10-07 2018-01-09 Banner Life Sciences Llc Opioid abuse deterrent dosage forms
US10335405B1 (en) 2016-05-04 2019-07-02 Patheon Softgels, Inc. Non-burst releasing pharmaceutical composition
SG11201810646VA (en) * 2016-05-11 2019-01-30 Relmada Therapeutics Inc Abrasion-resistant opioid formulations
US10335375B2 (en) 2017-05-30 2019-07-02 Patheon Softgels, Inc. Anti-overingestion abuse deterrent compositions
CN109512796A (zh) * 2018-12-26 2019-03-26 甘肃普安制药股份有限公司 一种氨酚羟考酮胶囊填充方法

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030092724A1 (en) * 2001-09-18 2003-05-15 Huaihung Kao Combination sustained release-immediate release oral dosage forms with an opioid analgesic and a non-opioid analgesic
CA2720108C (en) * 2008-03-11 2016-06-07 Depomed, Inc. Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
US8597681B2 (en) * 2009-12-22 2013-12-03 Mallinckrodt Llc Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
US9050335B1 (en) * 2011-05-17 2015-06-09 Mallinckrodt Llc Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia

Also Published As

Publication number Publication date
US20140275143A1 (en) 2014-09-18
WO2014149397A1 (en) 2014-09-25
JP2016512248A (ja) 2016-04-25
CN105209021A (zh) 2015-12-30
CA2903200A1 (en) 2014-09-25
EP2968169A1 (en) 2016-01-20

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 5A ANUIDADE.

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: EM VIRTUDE DO ARQUIVAMENTO PUBLICADO NA RPI 2502 DE 18-12-2018 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDO O ARQUIVAMENTO DO PEDIDO DE PATENTE, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI