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.)
Euro Celtique SA
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

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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5084Mixtures 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • 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
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/30Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36Opioid-abuse
    • 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)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Emergency Medicine (AREA)
  • Addiction (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (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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CA2519556C (en) 2003-04-21 2011-01-18 Benjamin Oshlack Tamper resistant dosage form comprising co-extruded, adverse agent particles and process of making same
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DE102004032051A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten, festen Darreichungsform
DE10361596A1 (de) 2003-12-24 2005-09-29 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
US8075872B2 (en) 2003-08-06 2011-12-13 Gruenenthal Gmbh Abuse-proofed dosage form
US20070048228A1 (en) 2003-08-06 2007-03-01 Elisabeth Arkenau-Maric Abuse-proofed dosage form
US20070269505A1 (en) * 2003-12-09 2007-11-22 Flath Robert P Tamper Resistant Co-Extruded Dosage Form Containing An Active Agent And An Adverse Agent And Process Of Making Same
CA2557839C (en) 2004-03-30 2011-05-10 Euro-Celtique S.A. Tamper resistant dosage form comprising an adsorbent and an adverse agent
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DE102005005449A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
US9522188B2 (en) 2005-12-13 2016-12-20 Biodelivery Sciences International, Inc. Abuse resistant transmucosal drug delivery device
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PE20120631A1 (es) 2009-07-22 2012-06-06 Gruenenthal Chemie Forma de dosificacion resistente a la manipulacion para opioides sensibles a la oxidacion
WO2012028318A1 (en) 2010-09-02 2012-03-08 Grünenthal GmbH Tamper resistant dosage form comprising an anionic polymer
ES2486791T3 (es) 2010-09-02 2014-08-19 Grünenthal GmbH Forma de dosificación resistente a la manipulación que comprende una sal inorgánica
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SI2736495T1 (sl) 2011-07-29 2017-12-29 Gruenenthal Gmbh Tableta, odporna proti zlorabi, ki zagotavlja takojšnje sproščanje zdravila
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JP6158810B2 (ja) 2011-08-18 2017-07-05 バイオデリバリー サイエンシズ インターナショナル,インコーポレーテッド ブプレノルフィンの乱用抵抗性粘膜付着性送達デバイス
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EP2819656A1 (en) 2012-02-28 2015-01-07 Grünenthal GmbH Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer
RS57913B1 (sr) 2012-04-18 2019-01-31 Gruenenthal Gmbh Farmaceutske dozne forme otporne na neovlašćenu upotrebu i naglo oslobađanje celokupne doze
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
US20140275149A1 (en) 2013-03-15 2014-09-18 Inspirion Delivery Technologies, Llc Abuse deterrent compositions and methods of use
US9737490B2 (en) 2013-05-29 2017-08-22 Grünenthal GmbH Tamper resistant dosage form with bimodal release profile
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
US10624862B2 (en) 2013-07-12 2020-04-21 Grünenthal GmbH Tamper-resistant dosage form containing ethylene-vinyl acetate polymer
EP2835246A1 (en) * 2013-08-05 2015-02-11 Ansa Termoplastici S.r.l. Method and apparatus for producing extruded plastic elements
AU2014356581C1 (en) 2013-11-26 2020-05-28 Grunenthal Gmbh Preparation of a powdery pharmaceutical composition by means of cryo-milling
AU2015261060A1 (en) 2014-05-12 2016-11-03 Grunenthal Gmbh Tamper resistant immediate release capsule formulation comprising Tapentadol
EP3148512A1 (en) 2014-05-26 2017-04-05 Grünenthal GmbH Multiparticles safeguarded against ethanolic dose-dumping
US10729685B2 (en) 2014-09-15 2020-08-04 Ohemo Life Sciences Inc. Orally administrable compositions and methods of deterring abuse by intranasal administration
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Also Published As

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

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