US20060188447A1 - Process for the production of an abuse-proofed dosage form - Google Patents

Process for the production of an abuse-proofed dosage form Download PDF

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Publication number
US20060188447A1
US20060188447A1 US11/348,276 US34827606A US2006188447A1 US 20060188447 A1 US20060188447 A1 US 20060188447A1 US 34827606 A US34827606 A US 34827606A US 2006188447 A1 US2006188447 A1 US 2006188447A1
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US
United States
Prior art keywords
dosage form
process according
abuse
portions
dried
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
US11/348,276
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English (en)
Inventor
Elisabeth Arkenau-Maric
Johannes Bartholomaus
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
Assigned to GRUNENTHAL GMBH reassignment GRUNENTHAL GMBH ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ARKENAU-MARIC, ELISABETH DR., BARTHOLOMAUS, JOHANNES DR.
Publication of US20060188447A1 publication Critical patent/US20060188447A1/en
Priority to US12/140,609 priority Critical patent/US20080311197A1/en
Assigned to JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT reassignment JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT CONFIRMATORY GRANT OF SECURITY INTEREST IN UNITED STATES PATENTS (EXCLUSIVELY LICENSED PATENTS) Assignors: ENDO PHARMACEUTICALS INC.
Assigned to MORGAN STANLEY SENIOR FUNDING, INC., AS ADMINISTRATIVE AGENT reassignment MORGAN STANLEY SENIOR FUNDING, INC., AS ADMINISTRATIVE AGENT SECURITY INTEREST IN EXCLUSIVELY LICENSED PATENTS Assignors: ENDO PHARMACEUTICALS INC.
Assigned to ENDO PHARMACEUTICALS INC. reassignment ENDO PHARMACEUTICALS INC. RELEASE OF SECURITY INTEREST IN EXCLUSIVELY LICENSED PATENTS RECORDED AT REEL/FRAME 25456/172 Assignors: JPMORGAN CHASE BANK N.A., AS ADMINISTRATIVE AGENT
Assigned to ENDO PHARMACEUTICALS SOLUTIONS INC. reassignment ENDO PHARMACEUTICALS SOLUTIONS INC. RELEASE OF PATENT SECURITY INTEREST IN EXCLUSIVELY LICENSED PATENTS Assignors: MORGAN STANLEY SENIOR FUNDING, INC., AS ADMINISTRATIVE AGENT
Assigned to ENDO PHARMACEUTICALS INC. reassignment ENDO PHARMACEUTICALS INC. CORRECTIVE ASSIGNMENT TO CORRECT THE NAME OF RECEIVING PARTY IN RELEASE OF PATENT SECURITY INTEREST IN EXCLUSIVELY LICENSED PATENTS PREVIOUSLY RECORDED ON REEL 032380 FRAME 0157. ASSIGNOR(S) HEREBY CONFIRMS THE RELEASE OF SECURITY INTEREST IN EXCLUSIVELY LICENSED PATENTS.. Assignors: MORGAN STANLEY SENIOR FUNDING, INC., AS ADMINISTRATIVE AGENT
Priority to US14/564,188 priority patent/US20150091201A1/en
Priority to US14/745,661 priority patent/US20150283086A1/en
Priority to US15/255,218 priority patent/US20160367485A1/en
Priority to US15/255,312 priority patent/US10729658B2/en
Abandoned legal-status Critical Current

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    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05—Phenols
    • 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
    • A61K31/33—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
    • A61K9/14—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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • 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
US11/348,276 2005-02-04 2006-02-06 Process for the production of an abuse-proofed dosage form Abandoned US20060188447A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
US12/140,609 US20080311197A1 (en) 2005-02-04 2008-06-17 Process for the production of an abuse-proofed dosage form
US14/564,188 US20150091201A1 (en) 2005-02-04 2014-12-09 Process for the production of an abuse-proofed dosage form
US14/745,661 US20150283086A1 (en) 2005-02-04 2015-06-22 Process for the production of an abuse-proofed dosage form
US15/255,312 US10729658B2 (en) 2005-02-04 2016-09-02 Process for the production of an abuse-proofed dosage form
US15/255,218 US20160367485A1 (en) 2005-02-04 2016-09-02 Process for the production of an abuse-proofed dosage form

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102005005449A DE102005005449A1 (de) 2005-02-04 2005-02-04 Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
DE102005005449.8 2005-02-04

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US12/140,609 Division US20080311197A1 (en) 2005-02-04 2008-06-17 Process for the production of an abuse-proofed dosage form
US14/564,188 Continuation US20150091201A1 (en) 2005-02-04 2014-12-09 Process for the production of an abuse-proofed dosage form

Publications (1)

Publication Number Publication Date
US20060188447A1 true US20060188447A1 (en) 2006-08-24

Family

ID=36218706

Family Applications (6)

Application Number Title Priority Date Filing Date
US11/348,276 Abandoned US20060188447A1 (en) 2005-02-04 2006-02-06 Process for the production of an abuse-proofed dosage form
US12/140,609 Abandoned US20080311197A1 (en) 2005-02-04 2008-06-17 Process for the production of an abuse-proofed dosage form
US14/564,188 Abandoned US20150091201A1 (en) 2005-02-04 2014-12-09 Process for the production of an abuse-proofed dosage form
US14/745,661 Abandoned US20150283086A1 (en) 2005-02-04 2015-06-22 Process for the production of an abuse-proofed dosage form
US15/255,312 Active US10729658B2 (en) 2005-02-04 2016-09-02 Process for the production of an abuse-proofed dosage form
US15/255,218 Abandoned US20160367485A1 (en) 2005-02-04 2016-09-02 Process for the production of an abuse-proofed dosage form

Family Applications After (5)

Application Number Title Priority Date Filing Date
US12/140,609 Abandoned US20080311197A1 (en) 2005-02-04 2008-06-17 Process for the production of an abuse-proofed dosage form
US14/564,188 Abandoned US20150091201A1 (en) 2005-02-04 2014-12-09 Process for the production of an abuse-proofed dosage form
US14/745,661 Abandoned US20150283086A1 (en) 2005-02-04 2015-06-22 Process for the production of an abuse-proofed dosage form
US15/255,312 Active US10729658B2 (en) 2005-02-04 2016-09-02 Process for the production of an abuse-proofed dosage form
US15/255,218 Abandoned US20160367485A1 (en) 2005-02-04 2016-09-02 Process for the production of an abuse-proofed dosage form

Country Status (12)

Country Link
US (6) US20060188447A1 (zh)
EP (1) EP1845955B1 (zh)
JP (1) JP5265201B2 (zh)
CN (1) CN101111232B (zh)
AR (1) AR054222A1 (zh)
CA (1) CA2595979A1 (zh)
DE (1) DE102005005449A1 (zh)
HK (1) HK1108370A1 (zh)
IL (1) IL185017A (zh)
PE (1) PE20061204A1 (zh)
TW (1) TWI449540B (zh)
WO (1) WO2006082097A1 (zh)

Cited By (51)

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US20050031546A1 (en) * 2003-08-06 2005-02-10 Johannes Bartholomaus Abuse-proffed dosage form
US20080020032A1 (en) * 2006-07-21 2008-01-24 Michael Crowley Hydrophobic abuse deterrent delivery system for hydromorphone
WO2008033523A1 (en) 2006-09-15 2008-03-20 Cima Labs Inc. Abuse resistant drug formulation
US20080280975A1 (en) * 2005-11-02 2008-11-13 Theraquest Biosciences, Inc. Methods of preventing the serotonin syndrome and compositions for use thereof
US20090082466A1 (en) * 2006-01-27 2009-03-26 Najib Babul Abuse Resistant and Extended Release Formulations and Method of Use Thereof
US20100210732A1 (en) * 2005-11-02 2010-08-19 Najib Babul Methods of Preventing the Serotonin Syndrome and Compositions for Use Therefor
US20100249045A1 (en) * 2005-11-02 2010-09-30 Theraquest Biosciences, Inc. Multimodal Abuse Resistant and Extended Release Opioid Formulations
US8075872B2 (en) 2003-08-06 2011-12-13 Gruenenthal Gmbh Abuse-proofed dosage form
US8114384B2 (en) 2004-07-01 2012-02-14 Gruenenthal Gmbh Process for the production of an abuse-proofed solid dosage form
US8192722B2 (en) 2003-08-06 2012-06-05 Grunenthal Gmbh Abuse-proof dosage form
WO2012085657A2 (en) 2010-12-23 2012-06-28 Purdue Pharma L.P. Tamper resistant solid oral dosage forms
US8337888B2 (en) 2001-08-06 2012-12-25 Purdue Pharma L.P. Pharmaceutical formulation containing gelling agent
US8383152B2 (en) 2008-01-25 2013-02-26 Gruenenthal Gmbh Pharmaceutical dosage form
US20140070453A1 (en) * 2011-05-03 2014-03-13 Shl Group Ab Mold Assembly and Method for Manufacturing a Syringe Container
US8722086B2 (en) 2007-03-07 2014-05-13 Gruenenthal Gmbh Dosage form with impeded abuse
US8808740B2 (en) 2010-12-22 2014-08-19 Purdue Pharma L.P. Encased tamper resistant controlled release dosage forms
US9005660B2 (en) 2009-02-06 2015-04-14 Egalet Ltd. Immediate release composition resistant to abuse by intake of alcohol
US9023394B2 (en) 2009-06-24 2015-05-05 Egalet Ltd. Formulations and methods for the controlled release of active drug substances
US9149533B2 (en) 2013-02-05 2015-10-06 Purdue Pharma L.P. Tamper resistant pharmaceutical formulations
US9161917B2 (en) 2008-05-09 2015-10-20 Grünenthal GmbH Process for the preparation of a solid dosage form, in particular a tablet, for pharmaceutical use and process for the preparation of a precursor for a solid dosage form, in particular a tablet
US9486413B2 (en) 2006-08-25 2016-11-08 Purdue Pharma L.P. Tamper resistant dosage forms
US9579285B2 (en) 2010-02-03 2017-02-28 Gruenenthal Gmbh Preparation of a powdery pharmaceutical composition by means of an extruder
US9616030B2 (en) 2013-03-15 2017-04-11 Purdue Pharma L.P. Tamper resistant pharmaceutical formulations
US9636303B2 (en) 2010-09-02 2017-05-02 Gruenenthal Gmbh Tamper resistant dosage form comprising an anionic polymer
US9642809B2 (en) 2007-06-04 2017-05-09 Egalet Ltd. Controlled release pharmaceutical compositions for prolonged effect
US9655853B2 (en) 2012-02-28 2017-05-23 Grünenthal GmbH Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer
US9675610B2 (en) 2002-06-17 2017-06-13 Grünenthal GmbH Abuse-proofed dosage form
US9737490B2 (en) 2013-05-29 2017-08-22 Grünenthal GmbH Tamper resistant dosage form with bimodal release profile
US9855263B2 (en) 2015-04-24 2018-01-02 Grünenthal GmbH Tamper-resistant dosage form with immediate release and resistance against solvent extraction
US9872835B2 (en) 2014-05-26 2018-01-23 Grünenthal GmbH Multiparticles safeguarded against ethanolic dose-dumping
US9913814B2 (en) 2014-05-12 2018-03-13 Grünenthal GmbH Tamper resistant immediate release capsule formulation comprising tapentadol
US9925146B2 (en) 2009-07-22 2018-03-27 Grünenthal GmbH Oxidation-stabilized tamper-resistant dosage form
US10058548B2 (en) 2003-08-06 2018-08-28 Grünenthal GmbH Abuse-proofed dosage form
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
US10080721B2 (en) 2009-07-22 2018-09-25 Gruenenthal Gmbh Hot-melt extruded pharmaceutical dosage form
US10154966B2 (en) 2013-05-29 2018-12-18 Grünenthal GmbH Tamper-resistant dosage form containing one or more particles
US10201502B2 (en) 2011-07-29 2019-02-12 Gruenenthal Gmbh Tamper-resistant tablet providing immediate drug release
US10300141B2 (en) 2010-09-02 2019-05-28 Grünenthal GmbH Tamper resistant dosage form comprising inorganic salt
US10335373B2 (en) 2012-04-18 2019-07-02 Grunenthal Gmbh Tamper resistant and dose-dumping resistant pharmaceutical dosage form
US10449547B2 (en) 2013-11-26 2019-10-22 Grünenthal GmbH Preparation of a powdery pharmaceutical composition by means of cryo-milling
US10525053B2 (en) 2002-07-05 2020-01-07 Collegium Pharmaceutical, Inc. Abuse-deterrent pharmaceutical compositions of opioids and other drugs
US10624862B2 (en) 2013-07-12 2020-04-21 Grünenthal GmbH Tamper-resistant dosage form containing ethylene-vinyl acetate polymer
US10632201B2 (en) 2017-10-19 2020-04-28 Capsugel Belgium Nv Immediate release abuse deterrent formulations
US10646485B2 (en) 2016-06-23 2020-05-12 Collegium Pharmaceutical, Inc. Process of making stable abuse-deterrent oral formulations
US10668060B2 (en) 2009-12-10 2020-06-02 Collegium Pharmaceutical, Inc. Tamper-resistant pharmaceutical compositions of opioids and other drugs
US10695297B2 (en) 2011-07-29 2020-06-30 Grünenthal GmbH Tamper-resistant tablet providing immediate drug release
US10729658B2 (en) 2005-02-04 2020-08-04 Grünenthal GmbH Process for the production of an abuse-proofed dosage form
US10842750B2 (en) 2015-09-10 2020-11-24 Grünenthal GmbH Protecting oral overdose with abuse deterrent immediate release formulations
US11224576B2 (en) 2003-12-24 2022-01-18 Grünenthal GmbH Process for the production of an abuse-proofed dosage form
US11844865B2 (en) 2004-07-01 2023-12-19 Grünenthal GmbH Abuse-proofed oral dosage form
US11964056B1 (en) 2023-09-27 2024-04-23 Purdue Pharma L.P Tamper resistant dosage forms

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US20150091201A1 (en) 2015-04-02
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US20160367485A1 (en) 2016-12-22
JP5265201B2 (ja) 2013-08-14
US20080311197A1 (en) 2008-12-18
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US20160367486A1 (en) 2016-12-22
US20150283086A1 (en) 2015-10-08
EP1845955A1 (de) 2007-10-24
WO2006082097A1 (de) 2006-08-10
US10729658B2 (en) 2020-08-04
IL185017A (en) 2016-05-31
IL185017A0 (en) 2007-12-03
HK1108370A1 (zh) 2008-05-09
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EP1845955B1 (de) 2015-05-27
AR054222A1 (es) 2007-06-13

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