JP5730572B2 - 濫用抵抗性製剤 - Google Patents

濫用抵抗性製剤 Download PDF

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Publication number
JP5730572B2
JP5730572B2 JP2010524829A JP2010524829A JP5730572B2 JP 5730572 B2 JP5730572 B2 JP 5730572B2 JP 2010524829 A JP2010524829 A JP 2010524829A JP 2010524829 A JP2010524829 A JP 2010524829A JP 5730572 B2 JP5730572 B2 JP 5730572B2
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amount
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coated
api
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Japanese (ja)
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JP2011517654A (ja
JP2011517654A5 (https=
Inventor
ハビブ、ワリド
ハメド、イハブ
ゼペダ、マヌエル、エー． ベガ
ゼペダ、マヌエル、エー． ベガ
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シマ ラブス インク．
シマ ラブス インク．
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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 シマ ラブス インク．, シマ ラブス インク． filed Critical シマ ラブス インク．
Publication of JP2011517654A publication Critical patent/JP2011517654A/ja
Publication of JP2011517654A5 publication Critical patent/JP2011517654A5/ja
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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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—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
    • 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
    • A61K9/20—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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5073—Microcapsules 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
    • 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

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  • 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)
JP2010524829A 2007-09-13 2008-03-19 濫用抵抗性製剤 Active JP5730572B2 (ja)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US11/900,851 2007-09-13
US11/900,851 US20080069891A1 (en) 2006-09-15 2007-09-13 Abuse resistant drug formulation
USPCT/US2007/020041 2007-09-14
PCT/US2007/020041 WO2008033523A1 (en) 2006-09-15 2007-09-14 Abuse resistant drug formulation
US12/075,543 2008-03-12
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 (3)

Publication Number Publication Date
JP2011517654A JP2011517654A (ja) 2011-06-16
JP2011517654A5 JP2011517654A5 (https=) 2012-06-07
JP5730572B2 true JP5730572B2 (ja) 2015-06-10

Family

ID=39493594

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2010524829A Active JP5730572B2 (ja) 2007-09-13 2008-03-19 濫用抵抗性製剤

Country Status (9)

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

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2025195851A1 (de) * 2024-03-18 2025-09-25 Glatt Gesellschaft Mit Beschränkter Haftung Umhüllter granulatpartikel und dessen verwendung zur herstellung von tabletten durch selektives lasersintern

Families Citing this family (39)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040234602A1 (en) 2001-09-21 2004-11-25 Gina Fischer Polymer release system
EP1429744A1 (en) 2001-09-21 2004-06-23 Egalet A/S Morphine polymer release system
US7776314B2 (en) 2002-06-17 2010-08-17 Grunenthal Gmbh Abuse-proofed dosage system
WO2004084868A1 (en) 2003-03-26 2004-10-07 Egalet A/S Morphine controlled release system
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
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
EP2155167A2 (en) 2007-06-04 2010-02-24 Egalet A/S Controlled release pharmaceutical compositions for prolonged effect
CA2713128C (en) 2008-01-25 2016-04-05 Gruenenthal Gmbh Pharmaceutical dosage form
AU2009243681B2 (en) 2008-05-09 2013-12-19 Grunenthal Gmbh Process for the preparation of an intermediate powder formulation and a final solid dosage form under usage of a spray congealing step
NZ594207A (en) 2009-02-06 2013-03-28 Egalet Ltd Immediate release composition resistant to abuse by intake of alcohol
NZ597283A (en) 2009-06-24 2013-07-26 Egalet Ltd Controlled release formulations
KR101738369B1 (ko) 2009-07-22 2017-05-22 그뤼넨탈 게엠베하 핫 멜트 압출된 제어 방출 투여형
CN102639118B (zh) 2009-07-22 2015-07-29 格吕伦塔尔有限公司 氧化稳定的抗干扰剂型
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
WO2011106416A2 (en) * 2010-02-24 2011-09-01 Cima Labs Inc. Abuse-resistant formulations
WO2011143119A1 (en) * 2010-05-11 2011-11-17 Cima Labs Inc. Alcohol-resistant extended release dosage forms comprising venlafaxine
AU2011253216B2 (en) * 2010-05-11 2016-10-20 Cima Labs Inc. Alcohol-resistant formulations
CA2798702A1 (en) * 2010-05-11 2011-11-17 Cima Labs Inc. Alcoholresistant metoprolol-containing extended-release oral dosage forms
BR112013005194A2 (pt) 2010-09-02 2016-05-03 Gruenenthal Gmbh forma de dosagem resistente à violação compreendendo sal inorgânico
TWI516286B (zh) 2010-09-02 2016-01-11 歌林達股份有限公司 含陰離子聚合物之抗破碎劑型
BR112014001091A2 (pt) 2011-07-29 2017-02-14 Gruenenthal Gmbh comprimido resistente à adulteração que fornece liberação imediata do fármaco
EA201400172A1 (ru) 2011-07-29 2014-06-30 Грюненталь Гмбх Устойчивая к разрушению таблетка, которая обеспечивает немедленное высвобождение лекарственного средства
MX356421B (es) 2012-02-28 2018-05-29 Gruenenthal Gmbh Forma de dosificacion resistente a la manipulacion indebida que comprende un compuesto farmacologicamente activo y un polimero anionico.
EP2838512B1 (en) 2012-04-18 2018-08-22 Grünenthal GmbH Tamper resistant and dose-dumping resistant pharmaceutical dosage form
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
BR112015000150A2 (pt) 2012-07-06 2017-06-27 Egalet Ltd composições farmacêuticas dissuasoras de abuso de liberação controlada
EP3003279A1 (en) 2013-05-29 2016-04-13 Grünenthal GmbH Tamper-resistant dosage form containing one or more particles
US9737490B2 (en) 2013-05-29 2017-08-22 Grünenthal GmbH Tamper resistant dosage form with bimodal release profile
BR112016000194A8 (pt) 2013-07-12 2019-12-31 Gruenenthal Gmbh forma de dosagem resistente à violação contendo o polímero de acetato de etileno-vinila
EP3073994A1 (en) 2013-11-26 2016-10-05 Grünenthal GmbH Preparation of a powdery pharmaceutical composition by means of cryo-milling
WO2015173195A1 (en) 2014-05-12 2015-11-19 Grünenthal GmbH Tamper resistant immediate release capsule formulation comprising tapentadol
EA201692388A1 (ru) 2014-05-26 2017-05-31 Грюненталь Гмбх Лекарственная форма в виде множества частиц, защищенная от вызываемого этанолом сброса дозы
WO2016170097A1 (en) 2015-04-24 2016-10-27 Grünenthal GmbH Tamper-resistant dosage form with immediate release and resistance against solvent extraction
JP2018526414A (ja) 2015-09-10 2018-09-13 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 乱用抑止性の即放性製剤を用いた経口過剰摂取に対する保護

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
US20060153915A1 (en) * 2003-01-23 2006-07-13 Amorepacific Corporation Sustained-release preparations and method for producing the same
MY135852A (en) * 2003-04-21 2008-07-31 Euro Celtique Sa Pharmaceutical products
EP1615625A4 (en) * 2003-04-21 2010-12-15 Euro Celtique Sa SAFETY DOSING FORM WITH COEXTRUDED PARTICLES OF AN UNWANTED MEDIUM AND METHOD OF MANUFACTURING THEREOF
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

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2025195851A1 (de) * 2024-03-18 2025-09-25 Glatt Gesellschaft Mit Beschränkter Haftung Umhüllter granulatpartikel und dessen verwendung zur herstellung von tabletten durch selektives lasersintern

Also Published As

Publication number Publication date
HUE032012T2 (en) 2017-08-28
MX2010002780A (es) 2010-05-17
DK2200593T3 (en) 2016-10-03
ES2611794T3 (es) 2017-05-10
CA2699142A1 (en) 2009-03-19
EP2200593A1 (en) 2010-06-30
PL2200593T3 (pl) 2017-02-28
MX336861B (es) 2016-02-04
JP2011517654A (ja) 2011-06-16
WO2009035474A1 (en) 2009-03-19
DK2200593T5 (en) 2016-12-12
EP2200593B1 (en) 2016-08-24
CA2699142C (en) 2016-05-17

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