AU2014365038B2 - Tamper resistant dosage form with bimodal release profile manufactured by co-extrusion - Google Patents

Tamper resistant dosage form with bimodal release profile manufactured by co-extrusion Download PDF

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Publication number
AU2014365038B2
AU2014365038B2 AU2014365038A AU2014365038A AU2014365038B2 AU 2014365038 B2 AU2014365038 B2 AU 2014365038B2 AU 2014365038 A AU2014365038 A AU 2014365038A AU 2014365038 A AU2014365038 A AU 2014365038A AU 2014365038 B2 AU2014365038 B2 AU 2014365038B2
Authority
AU
Australia
Prior art keywords
segment
active ingredient
pharmacologically active
dosage form
pharmaceutical dosage
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 - Fee Related
Application number
AU2014365038A
Other languages
English (en)
Other versions
AU2014365038A1 (en
Inventor
Lutz Barnscheid
Jana Denker
Anja Geissler
Klaus WENING
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.)
Gruenenthal GmbH
Original Assignee
Gruenenthal GmbH
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 Gruenenthal GmbH filed Critical Gruenenthal GmbH
Publication of AU2014365038A1 publication Critical patent/AU2014365038A1/en
Application granted granted Critical
Publication of AU2014365038B2 publication Critical patent/AU2014365038B2/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pain & Pain Management (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
AU2014365038A 2013-12-16 2014-12-15 Tamper resistant dosage form with bimodal release profile manufactured by co-extrusion Expired - Fee Related AU2014365038B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP13197503.9 2013-12-16
EP13197503 2013-12-16
PCT/EP2014/077748 WO2015091352A1 (en) 2013-12-16 2014-12-15 Tamper resistant dosage form with bimodal release profile manufactured by co-extrusion

Publications (2)

Publication Number Publication Date
AU2014365038A1 AU2014365038A1 (en) 2016-06-30
AU2014365038B2 true AU2014365038B2 (en) 2019-09-12

Family

ID=49882823

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2014365038A Expired - Fee Related AU2014365038B2 (en) 2013-12-16 2014-12-15 Tamper resistant dosage form with bimodal release profile manufactured by co-extrusion

Country Status (7)

Country Link
US (3) US20150164807A1 (enExample)
EP (1) EP3082781A1 (enExample)
JP (2) JP2016540798A (enExample)
AU (1) AU2014365038B2 (enExample)
CA (1) CA2933983A1 (enExample)
MX (1) MX2016007848A (enExample)
WO (1) WO2015091352A1 (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201502077D0 (en) * 2015-02-09 2015-03-25 Cubic Pharmaceuticals Ltd And Delta Pharmaceuticals Ltd Improved hme technology

Citations (5)

* Cited by examiner, † Cited by third party
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WO2008132707A1 (en) * 2007-04-26 2008-11-06 Sigmoid Pharma Limited Manufacture of multiple minicapsules
US20090022798A1 (en) * 2007-07-20 2009-01-22 Abbott Gmbh & Co. Kg Formulations of nonopioid and confined opioid analgesics
US20100104638A1 (en) * 2008-10-27 2010-04-29 Wei-Guo Dai Extended release oral acetaminophen/tramadol dosage form
US20100172989A1 (en) * 2006-01-21 2010-07-08 Abbott Laboratories Abuse resistant melt extruded formulation having reduced alcohol interaction
US20130303623A1 (en) * 2012-05-11 2013-11-14 Grünenthal GmbH Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc

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DE3612211A1 (de) 1986-04-11 1987-10-15 Basf Ag Kontinuierliches verfahren zum tablettieren
DE19710008A1 (de) * 1997-03-12 1998-09-17 Basf Ag Feste, mindestens zweiphasige Zubereitungsformen eines Opioid-Analgeticums mit verzögerter Freisetzung
AU3024399A (en) 1998-04-03 1999-10-25 Bm Research A/S Controlled release composition
US7141250B2 (en) 2001-08-06 2006-11-28 Euro-Celtique S.A. Pharmaceutical formulation containing bittering agent
WO2003024430A1 (en) 2001-09-21 2003-03-27 Egalet A/S Morphine polymer release system
DE10252667A1 (de) 2002-11-11 2004-05-27 Grünenthal GmbH Spirocyclische Cyclohexan-Derivate
ES2307003T3 (es) 2003-03-26 2008-11-16 Egalet A/S Composiciones matriciales para el suministro controlado de sustancias medicamentosas.
DE10361596A1 (de) 2003-12-24 2005-09-29 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
WO2005016313A1 (de) 2003-08-06 2005-02-24 Grünenthal GmbH Gegen missbrauch gesicherte 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
DE10360792A1 (de) 2003-12-23 2005-07-28 Grünenthal GmbH Spirocyclische Cyclohexan-Derivate
WO2005102286A1 (de) 2004-04-22 2005-11-03 Grünenthal GmbH Verfahren zur herstellung einer gegen missbrauch gesicherten, festen darreinchungsform
WO2006002883A1 (de) 2004-07-01 2006-01-12 Grünenthal GmbH Verfahren zur herstellung einer gegen missbrauch gesicherten, festen darreichungsform unter verwendung eines planetwalzenextruders
EP1765303B2 (de) 2004-07-01 2022-11-23 Grünenthal GmbH Gegen missbrauch gesicherte, oral tablette
PL1786403T3 (pl) 2004-07-01 2013-10-31 Gruenenthal Gmbh Doustna postać dawki zabezpieczona przed nadużywaniem zawierająca (1R, 2R)-3-(3-dimetyloamino-1-etylo0-2-metylo-propylo)fenol
JP4563787B2 (ja) * 2004-12-10 2010-10-13 日立プラズマディスプレイ株式会社 プラズマディスプレイ装置及びその制御方法
DE102005005449A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
JP5161075B2 (ja) 2005-06-03 2013-03-13 エガレット エイ／エス 分散媒体の第１フラクションとマトリックスの第２フラクションを有し、第２フラクションが胃腸の液体に少なくとも部分的に最初に曝される固形の医薬組成物
MX2008009267A (es) * 2006-01-21 2008-10-09 Abbott Gmbh & Co Kg Forma farmaceutica y metodo para la administracion de farmacos de abuso.
US20090317355A1 (en) * 2006-01-21 2009-12-24 Abbott Gmbh & Co. Kg, Abuse resistant melt extruded formulation having reduced alcohol interaction
CA2930487A1 (en) 2007-01-16 2008-07-24 Egalet Ltd. Use of i) a polyglycol and ii) an active drug substance for the preparation of a pharmaceutical composition for i)mitigating the risk of alcohol induced dose dumping and/or ii) reducing the risk of drug abuse
DE102007011485A1 (de) 2007-03-07 2008-09-11 Grünenthal GmbH Darreichungsform mit erschwertem Missbrauch
EP2155167A2 (en) 2007-06-04 2010-02-24 Egalet A/S Controlled release pharmaceutical compositions for prolonged effect
EP2249811A1 (en) 2008-01-25 2010-11-17 Grünenthal GmbH Pharmaceutical dosage form
US20100203129A1 (en) 2009-01-26 2010-08-12 Egalet A/S Controlled release formulations with continuous efficacy
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CA2766179A1 (en) 2009-06-24 2010-12-29 Egalet Ltd. Controlled release formulations
PE20121067A1 (es) * 2009-07-22 2012-09-05 Gruenenthal Chemie Forma de dosificacion de liberacion controlada extruida por fusion en caliente
PT2838512T (pt) * 2012-04-18 2018-11-09 Gruenenthal Gmbh Forma farmacêutica resistente à adulteração e resistente à libertação inesperada de alta quantidade (dose-dumping)

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100172989A1 (en) * 2006-01-21 2010-07-08 Abbott Laboratories Abuse resistant melt extruded formulation having reduced alcohol interaction
WO2008132707A1 (en) * 2007-04-26 2008-11-06 Sigmoid Pharma Limited Manufacture of multiple minicapsules
US20090022798A1 (en) * 2007-07-20 2009-01-22 Abbott Gmbh & Co. Kg Formulations of nonopioid and confined opioid analgesics
US20100104638A1 (en) * 2008-10-27 2010-04-29 Wei-Guo Dai Extended release oral acetaminophen/tramadol dosage form
US20130303623A1 (en) * 2012-05-11 2013-11-14 Grünenthal GmbH Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc

Also Published As

Publication number Publication date
US20180221307A1 (en) 2018-08-09
US20160338976A1 (en) 2016-11-24
JP2019172688A (ja) 2019-10-10
AU2014365038A1 (en) 2016-06-30
EP3082781A1 (en) 2016-10-26
MX2016007848A (es) 2016-09-07
WO2015091352A1 (en) 2015-06-25
US20150164807A1 (en) 2015-06-18
CA2933983A1 (en) 2015-06-25
JP2016540798A (ja) 2016-12-28

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Legal Events

Date Code Title Description
MK25 Application lapsed reg. 22.2i(2) - failure to pay acceptance fee