DK2200593T5 - Hog-resistant pharmaceutical formulation - Google Patents

Hog-resistant pharmaceutical formulation Download PDF

Info

Publication number
DK2200593T5
DK2200593T5 DK08742137.6T DK08742137T DK2200593T5 DK 2200593 T5 DK2200593 T5 DK 2200593T5 DK 08742137 T DK08742137 T DK 08742137T DK 2200593 T5 DK2200593 T5 DK 2200593T5
Authority
DK
Denmark
Prior art keywords
coating
weight
amount
coated
api
Prior art date
Application number
DK08742137.6T
Other languages
Danish (da)
English (en)
Other versions
DK2200593T3 (en
Inventor
Walid Habib
Ehab Hamed
Zepeda Manuel A Vega
Original Assignee
Cima Labs Inc
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
Priority claimed from US11/900,851 external-priority patent/US20080069891A1/en
Priority claimed from US12/075,543 external-priority patent/US8445018B2/en
Application filed by Cima Labs Inc filed Critical Cima Labs Inc
Application granted granted Critical
Publication of DK2200593T3 publication Critical patent/DK2200593T3/en
Publication of DK2200593T5 publication Critical patent/DK2200593T5/en

Links

Classifications

    • 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/5073Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Pain & Pain Management (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
DK08742137.6T 2007-09-13 2008-03-19 Hog-resistant pharmaceutical formulation DK2200593T5 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US11/900,851 US20080069891A1 (en) 2006-09-15 2007-09-13 Abuse resistant drug formulation
PCT/US2007/020041 WO2008033523A1 (en) 2006-09-15 2007-09-14 Abuse resistant drug formulation
US12/075,543 US8445018B2 (en) 2006-09-15 2008-03-12 Abuse resistant drug formulation
PCT/US2008/003598 WO2009035474A1 (en) 2007-09-13 2008-03-19 Abuse resistant drug formulation

Publications (2)

Publication Number Publication Date
DK2200593T3 DK2200593T3 (en) 2016-10-03
DK2200593T5 true DK2200593T5 (en) 2016-12-12

Family

ID=39493594

Family Applications (1)

Application Number Title Priority Date Filing Date
DK08742137.6T DK2200593T5 (en) 2007-09-13 2008-03-19 Hog-resistant pharmaceutical formulation

Country Status (9)

Country Link
EP (1) EP2200593B1 (enExample)
JP (1) JP5730572B2 (enExample)
CA (1) CA2699142C (enExample)
DK (1) DK2200593T5 (enExample)
ES (1) ES2611794T3 (enExample)
HU (1) HUE032012T2 (enExample)
MX (1) MX336861B (enExample)
PL (1) PL2200593T3 (enExample)
WO (1) WO2009035474A1 (enExample)

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US20040253310A1 (en) 2001-09-21 2004-12-16 Gina Fischer Morphine polymer release system
WO2003024429A1 (en) 2001-09-21 2003-03-27 Egalet A/S Polymer release system
US7776314B2 (en) 2002-06-17 2010-08-17 Grunenthal Gmbh Abuse-proofed dosage system
EP1610767B1 (en) 2003-03-26 2011-01-19 Egalet A/S Morphine controlled release system
DE10336400A1 (de) 2003-08-06 2005-03-24 Grünenthal GmbH Gegen Missbrauch gesicherte Darreichungsform
DE102005005446A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
DE10361596A1 (de) 2003-12-24 2005-09-29 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
US20070048228A1 (en) 2003-08-06 2007-03-01 Elisabeth Arkenau-Maric Abuse-proofed dosage form
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
WO2008148798A2 (en) 2007-06-04 2008-12-11 Egalet A/S Controlled release pharmaceutical compositions for prolonged effect
JP5774853B2 (ja) 2008-01-25 2015-09-09 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 医薬投薬形
WO2009135680A1 (en) 2008-05-09 2009-11-12 Grünenthal GmbH Process for the preparation of an intermediate powder formulation and a final solid dosage form under usage of a spray congealing step
CA2751667C (en) 2009-02-06 2016-12-13 Egalet Ltd. Immediate release composition resistant to abuse by intake of alcohol
EP2445487A2 (en) 2009-06-24 2012-05-02 Egalet Ltd. Controlled release formulations
PL2997965T3 (pl) 2009-07-22 2019-06-28 Grünenthal GmbH Odporna na manipulacje postać dawkowania opioidów wrażliwych na utlenianie
WO2011009602A1 (en) 2009-07-22 2011-01-27 Grünenthal GmbH Hot-melt extruded controlled release dosage form
WO2011084593A2 (en) * 2009-12-17 2011-07-14 Cima Labs Inc. Abuse-resistant formulations
US20110150989A1 (en) * 2009-12-22 2011-06-23 Mallinkckrodt Inc. Methods of Producing Stabilized Solid Dosage Pharmaceutical Compositions Containing Morphinans
CA2790108C (en) * 2010-02-24 2016-05-31 Cima Labs Inc. Abuse-resistant formulations
EP2568969A2 (en) * 2010-05-11 2013-03-20 Cima Labs Inc. Alcohol-resistant formulations
EP2579857A1 (en) * 2010-05-11 2013-04-17 Cima Labs Inc. Alcohol-resistant extended release dosage forms comprising venlafaxine
EP2568977A1 (en) * 2010-05-11 2013-03-20 Cima Labs Inc. Alcohol-resistant metoprolol-containing extended- release oral dosage forms
ES2487244T3 (es) 2010-09-02 2014-08-20 Grünenthal GmbH Forma de dosificación resistente a la manipulación que comprende un polímero aniónico
EP2611426B1 (en) 2010-09-02 2014-06-25 Grünenthal GmbH Tamper resistant dosage form comprising inorganic salt
US20130028972A1 (en) 2011-07-29 2013-01-31 Grunenthal Gmbh Tamper-resistant tablet providing immediate drug release
CA2839123A1 (en) 2011-07-29 2013-02-07 Grunenthal Gmbh Tamper-resistant tablet providing immediate drug release
JP6117249B2 (ja) 2012-02-28 2017-04-19 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 薬理学的に活性な化合物および陰イオン性ポリマーを含むタンパーレジスタント剤形
HRP20181716T1 (hr) 2012-04-18 2018-12-28 Grünenthal GmbH Farmaceutski oblik doziranja otporan na zlonamjernu uporabu i naglo oslobađanje cjelokupne doze
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
MX2014015880A (es) 2012-07-06 2015-08-05 Egalet Ltd Composiciones farmaceuticas disuasivas de abuso para liberacion controlada.
US9737490B2 (en) 2013-05-29 2017-08-22 Grünenthal GmbH Tamper resistant dosage form with bimodal release profile
WO2014191397A1 (en) 2013-05-29 2014-12-04 Grünenthal GmbH Tamper-resistant dosage form containing one or more particles
WO2015004245A1 (en) 2013-07-12 2015-01-15 Grünenthal GmbH Tamper-resistant dosage form containing ethylene-vinyl acetate polymer
HK1224189A1 (zh) 2013-11-26 2017-08-18 Grünenthal GmbH 通过低温研磨制备粉状药物组合物
MX2016014738A (es) 2014-05-12 2017-03-06 Gruenenthal Gmbh Formulacion en capsula de liberacion inmediata resistente a alteraciones que comprende tapentadol.
MX2016015417A (es) 2014-05-26 2017-02-22 Gruenenthal Gmbh Multiparticulas protegidas contra vertido de dosis etanolico.
EA035434B1 (ru) 2015-04-24 2020-06-15 Грюненталь Гмбх Защищенная от применения не по назначению лекарственная форма с немедленным высвобождением и устойчивостью к экстракции растворителями
EP3346991A1 (en) 2015-09-10 2018-07-18 Grünenthal GmbH Protecting oral overdose with abuse deterrent immediate release formulations
DE102024107711A1 (de) * 2024-03-18 2025-09-18 Glatt Gesellschaft Mit Beschränkter Haftung Vorläufermaterial und Verwendung eines Vorläufermaterials zur Herstellung von Tabletten

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US5234957A (en) 1991-02-27 1993-08-10 Noven Pharmaceuticals, Inc. Compositions and methods for topical administration of pharmaceutically active agents
US5178878A (en) 1989-10-02 1993-01-12 Cima Labs, Inc. Effervescent dosage form with microparticles
US5223264A (en) 1989-10-02 1993-06-29 Cima Labs, Inc. Pediatric effervescent dosage form
US5266331A (en) * 1991-11-27 1993-11-30 Euroceltique, S.A. Controlled release oxycodone compositions
US6238704B1 (en) * 1996-09-13 2001-05-29 Shionogi & Co., Ltd. Sustained-release preparation utilizing thermal change and process for the production thereof
US6024981A (en) 1997-04-16 2000-02-15 Cima Labs Inc. Rapidly dissolving robust dosage form
EP1551402A4 (en) * 2002-09-23 2009-05-27 Verion Inc PHARMACEUTICAL COMPOSITIONS NOT INDUCING ABUSE
CN100500130C (zh) * 2003-01-23 2009-06-17 株式会社太平洋 缓释制剂及其制备方法
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
TWI347201B (en) * 2003-04-21 2011-08-21 Euro Celtique Sa Pharmaceutical products,uses thereof and methods for preparing the same
DE10336400A1 (de) * 2003-08-06 2005-03-24 Grünenthal GmbH Gegen Missbrauch gesicherte Darreichungsform
US20060263429A1 (en) * 2005-05-20 2006-11-23 Hengsheng Feng Compressible mixture, compressed pharmaceutical compositions, and method of preparation thereof

Also Published As

Publication number Publication date
MX2010002780A (es) 2010-05-17
CA2699142A1 (en) 2009-03-19
JP5730572B2 (ja) 2015-06-10
EP2200593B1 (en) 2016-08-24
WO2009035474A1 (en) 2009-03-19
DK2200593T3 (en) 2016-10-03
ES2611794T3 (es) 2017-05-10
EP2200593A1 (en) 2010-06-30
MX336861B (es) 2016-02-04
CA2699142C (en) 2016-05-17
JP2011517654A (ja) 2011-06-16
HUE032012T2 (en) 2017-08-28
PL2200593T3 (pl) 2017-02-28

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