JP2016512248A - 食事に関係なく投与され得る、痛覚消失の急速な開始および期間の延長のためのオピオイドおよびさらなる活性医薬成分を含む組成物 - Google Patents

食事に関係なく投与され得る、痛覚消失の急速な開始および期間の延長のためのオピオイドおよびさらなる活性医薬成分を含む組成物 Download PDF

Info

Publication number
JP2016512248A
JP2016512248A JP2016500370A JP2016500370A JP2016512248A JP 2016512248 A JP2016512248 A JP 2016512248A JP 2016500370 A JP2016500370 A JP 2016500370A JP 2016500370 A JP2016500370 A JP 2016500370A JP 2016512248 A JP2016512248 A JP 2016512248A
Authority
JP
Japan
Prior art keywords
dosage form
oxycodone
acetaminophen
administered
crushed
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.)
Withdrawn
Application number
JP2016500370A
Other languages
English (en)
Japanese (ja)
Other versions
JP2016512248A5 (OSRAM
Inventor
クリシュナ アール. デバラコンダ,
クリシュナ アール. デバラコンダ,
マイケル ジェイ. ジュリアーニ,
マイケル ジェイ. ジュリアーニ,
ヴィシャル ケイ. グプタ,
ヴィシャル ケイ. グプタ,
ラルフ エー. ヒースリー,
ラルフ エー. ヒースリー,
スーザン シェルビー,
スーザン シェルビー,
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.)
Mallinckrodt Inc
Original Assignee
Mallinckrodt Inc
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 Inc filed Critical Mallinckrodt Inc
Publication of JP2016512248A publication Critical patent/JP2016512248A/ja
Publication of JP2016512248A5 publication Critical patent/JP2016512248A5/ja
Withdrawn legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/485Morphinan derivatives, e.g. morphine, codeine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, 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
    • 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
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs 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)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pain & Pain Management (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Emergency Medicine (AREA)
  • Biomedical Technology (AREA)
  • Rheumatology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2016500370A 2013-03-15 2014-02-24 食事に関係なく投与され得る、痛覚消失の急速な開始および期間の延長のためのオピオイドおよびさらなる活性医薬成分を含む組成物 Withdrawn JP2016512248A (ja)

Applications Claiming Priority (13)

Application Number Priority Date Filing Date Title
US201361798525P 2013-03-15 2013-03-15
US201361794848P 2013-03-15 2013-03-15
US61/794,848 2013-03-15
US61/798,525 2013-03-15
US201361871690P 2013-08-29 2013-08-29
US61/871,690 2013-08-29
US201361871956P 2013-08-30 2013-08-30
US61/871,956 2013-08-30
US201461926027P 2014-01-10 2014-01-10
US61/926,027 2014-01-10
US201461928509P 2014-01-17 2014-01-17
US61/928,509 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 (2)

Publication Number Publication Date
JP2016512248A true JP2016512248A (ja) 2016-04-25
JP2016512248A5 JP2016512248A5 (OSRAM) 2017-03-30

Family

ID=50290266

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2016500370A Withdrawn JP2016512248A (ja) 2013-03-15 2014-02-24 食事に関係なく投与され得る、痛覚消失の急速な開始および期間の延長のためのオピオイドおよびさらなる活性医薬成分を含む組成物

Country Status (7)

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

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
ATE495732T1 (de) 2003-03-26 2011-02-15 Egalet As Morphin-system mit kontrollierter freisetzung
DE10361596A1 (de) 2003-12-24 2005-09-29 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
DE102005005446A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
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
EP2155167A2 (en) 2007-06-04 2010-02-24 Egalet A/S Controlled release pharmaceutical compositions for prolonged effect
EP2393484A1 (en) 2009-02-06 2011-12-14 Egalet Ltd. Immediate release composition resistant to abuse by intake of alcohol
EP2445487A2 (en) 2009-06-24 2012-05-02 Egalet Ltd. Controlled release formulations
PL2456424T3 (pl) 2009-07-22 2013-12-31 Gruenenthal Gmbh Stabilizowana przed utlenianiem odporna na naruszenie postać dawkowania
PE20131102A1 (es) 2010-09-02 2013-10-12 Gruenenthal Chemie Forma de dosificacion resistente a manipulacion que comprende una sal inorganica
US8658631B1 (en) 2011-05-17 2014-02-25 Mallinckrodt Llc Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration 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
NO2736497T3 (OSRAM) 2011-07-29 2018-01-20
CA2839123A1 (en) 2011-07-29 2013-02-07 Grunenthal Gmbh Tamper-resistant tablet providing immediate drug release
DK2838512T3 (en) 2012-04-18 2018-11-19 Gruenenthal Gmbh MANIPULATED AND DOSAGE DUMPED PHARMACEUTICAL DOSAGE FORM
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
BR112016000194A8 (pt) 2013-07-12 2019-12-31 Gruenenthal Gmbh forma de dosagem resistente à violação contendo o polímero de acetato de etileno-vinila
WO2015078891A1 (en) 2013-11-26 2015-06-04 Farmaceutici Formenti S.P.A. Preparation of a powdery pharmaceutical composition by means of cryo-milling
CN106572980A (zh) 2014-05-12 2017-04-19 格吕伦塔尔有限公司 包含他喷他多的防篡改即释胶囊制剂
MX2017013643A (es) * 2015-04-24 2018-03-08 Gruenenthal Gmbh Combinacion de dosis fija resistente a la manipulacion que proporciona una liberacion rapida de dos farmacos desde particulas y una 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
CN109982690A (zh) * 2016-05-11 2019-07-05 雷尔玛达治疗公司 耐磨的阿片样物质制剂
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
AU2009223061B2 (en) * 2008-03-11 2014-10-09 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
US8658631B1 (en) * 2011-05-17 2014-02-25 Mallinckrodt Llc Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia

Also Published As

Publication number Publication date
BR112015022567A2 (pt) 2017-07-18
EP2968169A1 (en) 2016-01-20
CA2903200A1 (en) 2014-09-25
US20140275143A1 (en) 2014-09-18
WO2014149397A1 (en) 2014-09-25
CN105209021A (zh) 2015-12-30

Similar Documents

Publication Publication Date Title
JP2016512248A (ja) 食事に関係なく投与され得る、痛覚消失の急速な開始および期間の延長のためのオピオイドおよびさらなる活性医薬成分を含む組成物
US8790694B2 (en) Gastric retentive extended release pharmaceutical compositions
US9468636B2 (en) Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
US8858963B1 (en) Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia
JP5607550B2 (ja) 非オピオイド鎮痛剤及びオピオイド鎮痛剤の組合せを含む胃保持性持続放出剤形
EP1931315B1 (en) Sustained release formulations of nalbuphine
US9789103B2 (en) Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment
JP5422388B2 (ja) ロバスト性持続放出製剤
JP2016512247A (ja) 食事に関係なく投与され得る急速な開始および延長された痛覚消失のためのヒドロコドンおよびアセトアミノフェンを含む延長放出組成物
JP2010505948A (ja) オキシモルフォンのロバスト性持続放出製剤およびその使用方法
JP2010505947A (ja) オキシモルフォンのロバスト性持続放出製剤
HK1152469B (en) Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20170222

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20170222

A761 Written withdrawal of application

Free format text: JAPANESE INTERMEDIATE CODE: A761

Effective date: 20170719