CA2903200A1 - 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 - Google Patents

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 Download PDF

Info

Publication number
CA2903200A1
CA2903200A1 CA2903200A CA2903200A CA2903200A1 CA 2903200 A1 CA2903200 A1 CA 2903200A1 CA 2903200 A CA2903200 A CA 2903200A CA 2903200 A CA2903200 A CA 2903200A CA 2903200 A1 CA2903200 A1 CA 2903200A1
Authority
CA
Canada
Prior art keywords
dosage form
oxycodone
acetaminophen
administered
subject
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.)
Abandoned
Application number
CA2903200A
Other languages
English (en)
French (fr)
Inventor
Krishna R. DEVARAKONDA
Michael J. Giuliani
Vishal K. Gupta
Ralph A. Heasley
Susan Shelby
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 LLC
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 CA2903200A1 publication Critical patent/CA2903200A1/en
Abandoned legal-status Critical Current

Links

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)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CA2903200A 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 Abandoned CA2903200A1 (en)

Applications Claiming Priority (13)

Application Number Priority Date Filing Date Title
US201361794848P 2013-03-15 2013-03-15
US201361798525P 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 (1)

Publication Number Publication Date
CA2903200A1 true CA2903200A1 (en) 2014-09-25

Family

ID=50290266

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2903200A Abandoned CA2903200A1 (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

Country Status (7)

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

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
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
DE10361596A1 (de) 2003-12-24 2005-09-29 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten 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
NZ580972A (en) 2007-06-04 2012-02-24 Egalet Ltd 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
RU2567723C2 (ru) 2009-07-22 2015-11-10 Грюненталь Гмбх Стабильная при окислении, прочная на излом лекарственная форма
EP2611426B1 (en) 2010-09-02 2014-06-25 Grünenthal GmbH Tamper resistant dosage form comprising inorganic salt
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
US8741885B1 (en) 2011-05-17 2014-06-03 Mallinckrodt Llc Gastric retentive extended release pharmaceutical compositions
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
US20130028972A1 (en) 2011-07-29 2013-01-31 Grunenthal Gmbh Tamper-resistant tablet providing immediate drug release
JP2014524925A (ja) 2011-07-29 2014-09-25 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 即時薬剤放出を提供するタンパーレジスタント錠剤
CA2868142A1 (en) 2012-04-18 2013-10-24 Grunenthal Gmbh Tamper resistant and dose-dumping resistant pharmaceutical dosage form
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
JP6445537B2 (ja) 2013-05-29 2018-12-26 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 1個または複数の粒子を含有する改変防止(tamper−resistant)剤形
BR112016000194A8 (pt) 2013-07-12 2019-12-31 Gruenenthal Gmbh forma de dosagem resistente à violação contendo o polímero de acetato de etileno-vinila
BR112016010482B1 (pt) 2013-11-26 2022-11-16 Grünenthal GmbH Preparação de uma composição farmacêutica em pó por meio de criomoagem
JP2017518980A (ja) 2014-05-12 2017-07-13 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 タペンタドールを含む、改変防止即時放出カプセル製剤
WO2016170093A1 (en) * 2015-04-24 2016-10-27 Grünenthal GmbH Tamper-resistant fixed dose combination providing fast release of two drugs from particles and a matrix
JP2018526414A (ja) 2015-09-10 2018-09-13 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 乱用抑止性の即放性製剤を用いた経口過剰摂取に対する保護
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
WO2017196445A1 (en) * 2016-05-11 2017-11-16 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
CN102105136B (zh) * 2008-03-11 2014-11-26 蒂宝制药公司 包含非-阿片类止痛剂和阿片类止痛剂的组合的胃滞留型缓释剂型
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
CN105209021A (zh) 2015-12-30
WO2014149397A1 (en) 2014-09-25
JP2016512248A (ja) 2016-04-25
BR112015022567A2 (pt) 2017-07-18
EP2968169A1 (en) 2016-01-20
US20140275143A1 (en) 2014-09-18

Similar Documents

Publication Publication Date Title
CA2903200A1 (en) 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
US8790694B2 (en) Gastric retentive extended release pharmaceutical compositions
US9539328B2 (en) Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia
US9468636B2 (en) Combination composition comprising oxycodone 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
US20140288113A1 (en) Extended Release Compositions Comprising Hydrocodone And Acetaminophen For Rapid Onset And Prolonged Analgesia That May Be Administered Without Regard To Food
US20130316002A1 (en) Compositions and methods for treating gastrointestinal motility dysfunction
US12053464B2 (en) Pharmaceutical dosage forms
US10420726B2 (en) Abuse deterrent compositions and methods of use
WO2017192608A1 (en) Immediate release drug formulation combining opioid and nonopioid analgesics with abuse deterrence and overdose protection
US20160256453A1 (en) Opioid receptor antagonist for use in treating patients with severe constipation induced by high opiate dosage regimen

Legal Events

Date Code Title Description
FZDE Discontinued

Effective date: 20190226

FZDE Discontinued

Effective date: 20190226