CA2548834C - Tamper resistant co-extruded dosage form containing an active agent and an adverse agent and process of making same - Google Patents

Tamper resistant co-extruded dosage form containing an active agent and an adverse agent and process of making same Download PDF

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Publication number
CA2548834C
CA2548834C CA002548834A CA2548834A CA2548834C CA 2548834 C CA2548834 C CA 2548834C CA 002548834 A CA002548834 A CA 002548834A CA 2548834 A CA2548834 A CA 2548834A CA 2548834 C CA2548834 C CA 2548834C
Authority
CA
Canada
Prior art keywords
dosage form
core
active agent
agent
shell
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.)
Expired - Lifetime
Application number
CA002548834A
Other languages
English (en)
French (fr)
Other versions
CA2548834A1 (en
Inventor
Robert P. Flath
John K. Masselink
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.)
Individual
Original Assignee
Euro Celtique SA
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 Euro Celtique SA filed Critical Euro Celtique SA
Publication of CA2548834A1 publication Critical patent/CA2548834A1/en
Application granted granted Critical
Publication of CA2548834C publication Critical patent/CA2548834C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36—Opioid-abuse
    • 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)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Emergency Medicine (AREA)
  • Addiction (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CA002548834A 2003-12-09 2004-12-08 Tamper resistant co-extruded dosage form containing an active agent and an adverse agent and process of making same Expired - Lifetime CA2548834C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US52855003P 2003-12-09 2003-12-09
US60/528,550 2003-12-09
PCT/US2004/041154 WO2005055981A2 (en) 2003-12-09 2004-12-08 Tamper resistant co-extruded dosage form containing an active agent and an adverse agent and process of making same

Publications (2)

Publication Number Publication Date
CA2548834A1 CA2548834A1 (en) 2005-06-23
CA2548834C true CA2548834C (en) 2009-08-11

Family

ID=34676850

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002548834A Expired - Lifetime CA2548834C (en) 2003-12-09 2004-12-08 Tamper resistant co-extruded dosage form containing an active agent and an adverse agent and process of making same

Country Status (13)

Country Link
US (1) US20070269505A1 (enExample)
EP (1) EP1691892B1 (enExample)
JP (3) JP4917893B2 (enExample)
AT (1) ATE355103T1 (enExample)
CA (1) CA2548834C (enExample)
CY (1) CY1106600T1 (enExample)
DE (1) DE602004005076T2 (enExample)
DK (1) DK1691892T3 (enExample)
ES (1) ES2281851T3 (enExample)
PL (1) PL1691892T3 (enExample)
PT (1) PT1691892E (enExample)
SI (1) SI1691892T1 (enExample)
WO (1) WO2005055981A2 (enExample)

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US8075872B2 (en) 2003-08-06 2011-12-13 Gruenenthal Gmbh Abuse-proofed dosage form
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
DE102004032051A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten, festen Darreichungsform
US20070048228A1 (en) 2003-08-06 2007-03-01 Elisabeth Arkenau-Maric Abuse-proofed dosage form
CA2548834C (en) * 2003-12-09 2009-08-11 Euro-Celtique S.A. Tamper resistant co-extruded dosage form containing an active agent and an adverse agent and process of making same
RS50817B (sr) 2004-03-30 2010-08-31 Euro-Celtique S.A. Dozni oblik otporan na promene koji sadrži adsorbenti i sredstvo sa suprotnim dejstvom
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
EP1968539A2 (en) * 2005-12-13 2008-09-17 Biodelivery Sciences International, Inc. Abuse resistant transmucosal drug delivery device
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BR112014001091A2 (pt) 2011-07-29 2017-02-14 Gruenenthal Gmbh comprimido resistente à adulteração que fornece liberação imediata do fármaco
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EP2838512B1 (en) 2012-04-18 2018-08-22 Grünenthal 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
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EP3003279A1 (en) 2013-05-29 2016-04-13 Grünenthal GmbH Tamper-resistant dosage form containing one or more particles
US9737490B2 (en) 2013-05-29 2017-08-22 Grünenthal GmbH Tamper resistant dosage form with bimodal release profile
BR112016000194A8 (pt) 2013-07-12 2019-12-31 Gruenenthal Gmbh forma de dosagem resistente à violação contendo o polímero de acetato de etileno-vinila
EP2835246A1 (en) * 2013-08-05 2015-02-11 Ansa Termoplastici S.r.l. Method and apparatus for producing extruded plastic elements
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WO2015173195A1 (en) 2014-05-12 2015-11-19 Grünenthal GmbH Tamper resistant immediate release capsule formulation comprising tapentadol
EA201692388A1 (ru) 2014-05-26 2017-05-31 Грюненталь Гмбх Лекарственная форма в виде множества частиц, защищенная от вызываемого этанолом сброса дозы
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Also Published As

Publication number Publication date
CY1106600T1 (el) 2012-01-25
EP1691892A2 (en) 2006-08-23
JP2012082214A (ja) 2012-04-26
ES2281851T3 (es) 2007-10-01
CA2548834A1 (en) 2005-06-23
SI1691892T1 (sl) 2007-08-31
PL1691892T3 (pl) 2007-07-31
EP1691892B1 (en) 2007-02-28
US20070269505A1 (en) 2007-11-22
WO2005055981A2 (en) 2005-06-23
PT1691892E (pt) 2007-05-31
DK1691892T3 (da) 2007-06-25
DE602004005076T2 (de) 2007-11-15
ATE355103T1 (de) 2006-03-15
JP4917893B2 (ja) 2012-04-18
JP2007513960A (ja) 2007-05-31
DE602004005076D1 (de) 2007-04-12
JP5473958B2 (ja) 2014-04-16
JP2011126895A (ja) 2011-06-30
WO2005055981A3 (en) 2005-08-11

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