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 alimentoInfo
- 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
Links
- 239000000203 mixture Substances 0.000 title abstract 5
- 239000008186 active pharmaceutical agent Substances 0.000 title abstract 3
- 230000036592 analgesia Effects 0.000 title abstract 3
- 230000002035 prolonged effect Effects 0.000 title abstract 2
- 239000008194 pharmaceutical composition Substances 0.000 abstract 3
- RJEIGSKSSKIIHG-RKXJKUSZSA-N (4r,4as,7ar,12bs)-4a-hydroxy-9-methoxy-3-methyl-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one;n-(4-hydroxyphenyl)acetamide Chemical compound CC(=O)NC1=CC=C(O)C=C1.O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(OC)C2=C5[C@@]13CCN4C RJEIGSKSSKIIHG-RKXJKUSZSA-N 0.000 abstract 2
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 abstract 2
- 230000002496 gastric effect Effects 0.000 abstract 1
- 229960005489 paracetamol Drugs 0.000 abstract 1
- 230000000704 physical effect Effects 0.000 abstract 1
- 238000013268 sustained release Methods 0.000 abstract 1
- 239000012730 sustained-release form Substances 0.000 abstract 1
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.
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)
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)
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 |
-
2014
- 2014-02-24 US US14/188,582 patent/US20140275143A1/en not_active Abandoned
- 2014-02-24 EP EP14711051.4A patent/EP2968169A1/en not_active Withdrawn
- 2014-02-24 CA CA2903200A patent/CA2903200A1/en not_active Abandoned
- 2014-02-24 BR BR112015022567A patent/BR112015022567A2/pt active Search and Examination
- 2014-02-24 WO PCT/US2014/018101 patent/WO2014149397A1/en active Application Filing
- 2014-02-24 JP JP2016500370A patent/JP2016512248A/ja not_active Withdrawn
- 2014-02-24 CN CN201480026908.8A patent/CN105209021A/zh active Pending
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. |
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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. |
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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 |