CA2933983A1 - 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

Info

Publication number
CA2933983A1
CA2933983A1 CA2933983A CA2933983A CA2933983A1 CA 2933983 A1 CA2933983 A1 CA 2933983A1 CA 2933983 A CA2933983 A CA 2933983A CA 2933983 A CA2933983 A CA 2933983A CA 2933983 A1 CA2933983 A1 CA 2933983A1
Authority
CA
Canada
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.)
Abandoned
Application number
CA2933983A
Other languages
English (en)
French (fr)
Inventor
Anja Geissler
Jana Denker
Klaus WENING
Lutz Barnscheid
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 CA2933983A1 publication Critical patent/CA2933983A1/en
Abandoned legal-status Critical Current

Links

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)
CA2933983A 2013-12-16 2014-12-15 Tamper resistant dosage form with bimodal release profile manufactured by co-extrusion Abandoned CA2933983A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP13197503 2013-12-16
EP13197503.9 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 (1)

Publication Number Publication Date
CA2933983A1 true CA2933983A1 (en) 2015-06-25

Family

ID=49882823

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2933983A Abandoned CA2933983A1 (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

Family Cites Families (35)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
WO1999051208A1 (en) 1998-04-03 1999-10-14 Bm Research A/S Controlled release composition
US7141250B2 (en) 2001-08-06 2006-11-28 Euro-Celtique S.A. Pharmaceutical formulation containing bittering agent
EP1429744A1 (en) 2001-09-21 2004-06-23 Egalet A/S Morphine polymer release system
DE10252667A1 (de) 2002-11-11 2004-05-27 Grünenthal GmbH Spirocyclische Cyclohexan-Derivate
DE602004025159D1 (de) 2003-03-26 2010-03-04 Egalet As Matrixzubereitungen für die kontrollierte Darreichung von Arzneistoffen
DE102005005446A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
HRP20070456T3 (en) * 2003-08-06 2007-11-30 Grnenthal Gmbh Dosage form that is safeguarded from abuse
DE10336400A1 (de) 2003-08-06 2005-03-24 Grünenthal GmbH Gegen Missbrauch gesicherte Darreichungsform
DE10361596A1 (de) 2003-12-24 2005-09-29 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
DE10360792A1 (de) 2003-12-23 2005-07-28 Grünenthal GmbH Spirocyclische Cyclohexan-Derivate
EP1740156B8 (de) 2004-04-22 2012-07-11 Grünenthal GmbH Verfahren zur herstellung einer gegen missbrauch gesicherten, festen darreinchungsform
EP1765298B1 (de) 2004-07-01 2012-10-24 Gruenenthal Gmbh Verfahren zur herstellung einer gegen missbrauch gesicherten, festen darreichungsform unter verwendung eines planetwalzenextruders
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
CA2572491A1 (en) 2004-07-01 2006-01-12 Gruenenthal Gmbh Oral dosage form safeguarded against abuse
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
CA2611081C (en) 2005-06-03 2016-05-31 Egalet A/S A drug delivery system for delivering active substances dispersed in a dispersion medium
US20090317355A1 (en) * 2006-01-21 2009-12-24 Abbott Gmbh & Co. Kg, Abuse resistant melt extruded formulation having reduced alcohol interaction
US20090022798A1 (en) * 2007-07-20 2009-01-22 Abbott Gmbh & Co. Kg Formulations of nonopioid and confined opioid analgesics
US20100172989A1 (en) 2006-01-21 2010-07-08 Abbott Laboratories Abuse resistant melt extruded formulation having reduced alcohol interaction
MX2008009267A (es) * 2006-01-21 2008-10-09 Abbott Gmbh & Co Kg Forma farmaceutica y metodo para la administracion de farmacos de abuso.
EP2104493A2 (en) 2007-01-16 2009-09-30 Egalet A/S Use of i) a polyglycol and n) 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
CA2685118C (en) * 2007-04-26 2016-11-01 Sigmoid Pharma Limited Manufacture of multiple minicapsules
EP2155167A2 (en) 2007-06-04 2010-02-24 Egalet A/S Controlled release pharmaceutical compositions for prolonged effect
KR101616246B1 (ko) 2008-01-25 2016-05-02 그뤼넨탈 게엠베하 약제학적 투여형
CN107028908A (zh) 2008-10-27 2017-08-11 阿尔扎公司 对乙酰氨基酚/曲马多口服延释剂型
EP2389169A1 (en) 2009-01-26 2011-11-30 Egalet A/S Controlled release formulations with continuous efficacy
EP2393487B1 (en) 2009-02-06 2016-11-02 Egalet Ltd. Pharmaceutical compositions resistant to abuse
EP2445487A2 (en) 2009-06-24 2012-05-02 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
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

Also Published As

Publication number Publication date
AU2014365038B2 (en) 2019-09-12
US20180221307A1 (en) 2018-08-09
WO2015091352A1 (en) 2015-06-25
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
US20150164807A1 (en) 2015-06-18
JP2016540798A (ja) 2016-12-28

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Legal Events

Date Code Title Description
FZDE Discontinued

Effective date: 20210308

FZDE Discontinued

Effective date: 20210308