JP5730572B2 - 濫用抵抗性製剤 - Google Patents

濫用抵抗性製剤 Download PDF

Info

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
Authority
JP
Japan
Prior art keywords
particles
amount
weight
coated
api
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.)
Active
Application number
JP2010524829A
Other languages
English (en)
Japanese (ja)
Other versions
JP2011517654A (ja
JP2011517654A5 (enExample
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
Original Assignee
シマ ラブス インク.
シマ ラブス インク.
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 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
Application granted granted Critical
Publication of JP5730572B2 publication Critical patent/JP5730572B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

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)
  • Emergency Medicine (AREA)
  • Pain & Pain Management (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
PCT/US2007/020041 WO2008033523A1 (en) 2006-09-15 2007-09-14 Abuse resistant drug formulation
USPCT/US2007/020041 2007-09-14
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 (enExample) 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 (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)

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
EP1429739A1 (en) 2001-09-21 2004-06-23 Egalet A/S 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
ES2570454T3 (es) 2003-03-26 2016-05-18 Egalet Ltd Sistema de liberación controlada de morfina
US20070048228A1 (en) 2003-08-06 2007-03-01 Elisabeth Arkenau-Maric Abuse-proofed dosage form
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
DE102005005446A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
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
NZ586792A (en) 2008-01-25 2012-09-28 Gruenenthal Chemie Tamper resistant controlled release pharmaceutical tablets form having convex and concave surfaces
TWI524904B (zh) 2008-05-09 2016-03-11 歌林達股份有限公司 製備醫藥用固體劑型,尤指錠劑之方法,及製備固體劑型,尤指錠劑之前驅物之方法
AU2010211220B2 (en) 2009-02-06 2013-08-01 Egalet Ltd. Immediate release composition resistant to abuse by intake of alcohol
CA2766179A1 (en) 2009-06-24 2010-12-29 Egalet Ltd. Controlled release formulations
EP2456427B1 (en) 2009-07-22 2015-03-04 Grünenthal GmbH Hot-melt extruded controlled release dosage form
RU2555531C2 (ru) 2009-07-22 2015-07-10 Грюненталь Гмбх Защищенная от применения не по назначению лекарственная форма для чувствительных к окислению опиоидов
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
JP6141583B2 (ja) * 2010-02-24 2017-06-07 シマ ラブス インク. 濫用耐性製剤
CA2798700C (en) * 2010-05-11 2018-08-21 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
US20130171256A1 (en) * 2010-05-11 2013-07-04 Cima Labs Inc. Alcohol-resistant extended release dosage forms comprising venlafaxine
NZ608865A (en) 2010-09-02 2015-03-27 Gruenenthal Chemie Tamper resistant dosage form comprising an anionic polymer
PE20131102A1 (es) 2010-09-02 2013-10-12 Gruenenthal Chemie Forma de dosificacion resistente a manipulacion que comprende una sal inorganica
CN103857386A (zh) 2011-07-29 2014-06-11 格吕伦塔尔有限公司 提供药物立即释放的抗破碎片剂
NO2736495T3 (enExample) 2011-07-29 2018-01-20
BR112014019988A8 (pt) 2012-02-28 2017-07-11 Gruenenthal Gmbh Forma de dosagem resistente a socamento compreendendo um composto farmacologicamente ativo e um polímero aniônico
AR090695A1 (es) 2012-04-18 2014-12-03 Gruenenthal Gmbh Forma de dosificacion farmaceutica resistente a la adulteracion y resistente a la liberacion inmediata de la dosis
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
KR20150059167A (ko) 2012-07-06 2015-05-29 에갈렛 리미티드 제어된 방출을 위한 남용 제지 약학적 조성물
WO2014191397A1 (en) 2013-05-29 2014-12-04 Grünenthal GmbH Tamper-resistant dosage form containing one or more particles
AR096439A1 (es) 2013-05-29 2015-12-30 Gruenenthal Gmbh Forma de dosificación resistente al uso indebido que contiene una o más partículas
CA2917136C (en) 2013-07-12 2022-05-31 Grunenthal Gmbh Tamper-resistant dosage form containing ethylene-vinyl acetate polymer
JP6480936B2 (ja) 2013-11-26 2019-03-13 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 クライオミリングによる粉末状医薬組成物の調製
JP2017518980A (ja) 2014-05-12 2017-07-13 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 タペンタドールを含む、改変防止即時放出カプセル製剤
US9872835B2 (en) 2014-05-26 2018-01-23 Grünenthal GmbH Multiparticles safeguarded against ethanolic dose-dumping
BR112017021475A2 (pt) 2015-04-24 2018-07-10 Gruenenthal Gmbh forma de dosagem resistente à adulteração (tamper) com liberação imediata e resistência contra extração de solvente
US10842750B2 (en) 2015-09-10 2020-11-24 Grünenthal GmbH Protecting oral overdose with abuse deterrent immediate release formulations

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
EP0958813B1 (en) * 1996-09-13 2005-04-06 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
WO2004026262A2 (en) * 2002-09-23 2004-04-01 Verion, Inc. Abuse-resistant pharmaceutical compositions
WO2004064807A1 (en) * 2003-01-23 2004-08-05 Amorepacific Corporation Sustained-release preparations and method for producing the same
TWI347201B (en) * 2003-04-21 2011-08-21 Euro Celtique Sa Pharmaceutical products,uses thereof and methods for preparing the same
JP5501553B2 (ja) * 2003-04-21 2014-05-21 ユーロ−セルティーク エス.エイ. 同時押出逆作用剤粒子を含有する改変防止剤形およびその製造工程
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
MX2010002780A (es) 2010-05-17
EP2200593B1 (en) 2016-08-24
DK2200593T3 (en) 2016-10-03
HUE032012T2 (en) 2017-08-28
JP2011517654A (ja) 2011-06-16
CA2699142A1 (en) 2009-03-19
PL2200593T3 (pl) 2017-02-28
WO2009035474A1 (en) 2009-03-19
ES2611794T3 (es) 2017-05-10
MX336861B (es) 2016-02-04
DK2200593T5 (en) 2016-12-12
EP2200593A1 (en) 2010-06-30
CA2699142C (en) 2016-05-17

Similar Documents

Publication Publication Date Title
JP5730572B2 (ja) 濫用抵抗性製剤
US9216176B2 (en) Abuse resistant drug formulation
JP5357032B2 (ja) 誤用抵抗性製剤
US9474721B2 (en) Abuse-resistant formulations
JP6141583B2 (ja) 濫用耐性製剤
HK1144773B (en) Abuse resistant drug formulation
HK1193567B (en) Abuse resistant drug formulation
HK1134775B (en) Abuse resistant drug formulation
HK1176885A (en) Abuse-resistant formulations

Legal Events

Date Code Title Description
A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20110319

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20110427

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20120620

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20130319

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20130619

A602 Written permission of extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A602

Effective date: 20130626

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20130719

A602 Written permission of extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A602

Effective date: 20130726

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20130819

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20130910

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20140110

A911 Transfer to examiner for re-examination before appeal (zenchi)

Free format text: JAPANESE INTERMEDIATE CODE: A911

Effective date: 20140121

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20140318

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20140618

A602 Written permission of extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A602

Effective date: 20140625

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20140718

A602 Written permission of extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A602

Effective date: 20140728

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20140816

A602 Written permission of extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A602

Effective date: 20140825

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20140918

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20141021

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20150121

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20150213

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20150221

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20150310

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20150408

R150 Certificate of patent or registration of utility model

Ref document number: 5730572

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250