CN102770127B - 抗滥用制剂 - Google Patents

抗滥用制剂 Download PDF

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Publication number
CN102770127B
CN102770127B CN201180011055.7A CN201180011055A CN102770127B CN 102770127 B CN102770127 B CN 102770127B CN 201180011055 A CN201180011055 A CN 201180011055A CN 102770127 B CN102770127 B CN 102770127B
Authority
CN
China
Prior art keywords
dosage form
weight
amount
granules
hydrocodone
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.)
Expired - Fee Related
Application number
CN201180011055.7A
Other languages
English (en)
Chinese (zh)
Other versions
CN102770127A (zh
Inventor
伊哈勃·哈米德
卡里·卡拉灵
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.)
Cima Labs Inc
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
Application filed by Cima Labs Inc filed Critical Cima Labs Inc
Publication of CN102770127A publication Critical patent/CN102770127A/zh
Application granted granted Critical
Publication of CN102770127B publication Critical patent/CN102770127B/zh
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • 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
    • A61K9/2004—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
    • A61K9/2077—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
    • 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
    • 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
    • A61K9/5015—Organic compounds, e.g. fats, sugars
    • 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
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Emergency Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CN201180011055.7A 2010-02-24 2011-02-23 抗滥用制剂 Expired - Fee Related CN102770127B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US30758810P 2010-02-24 2010-02-24
US61/307,588 2010-02-24
PCT/US2011/025914 WO2011106416A2 (en) 2010-02-24 2011-02-23 Abuse-resistant formulations

Publications (2)

Publication Number Publication Date
CN102770127A CN102770127A (zh) 2012-11-07
CN102770127B true CN102770127B (zh) 2015-04-15

Family

ID=43896837

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201180011055.7A Expired - Fee Related CN102770127B (zh) 2010-02-24 2011-02-23 抗滥用制剂

Country Status (11)

Country Link
US (2) US20130209560A1 (enExample)
EP (1) EP2538928B1 (enExample)
JP (1) JP6141583B2 (enExample)
CN (1) CN102770127B (enExample)
AU (1) AU2011220813B2 (enExample)
CA (1) CA2790108C (enExample)
ES (1) ES2628886T3 (enExample)
IL (1) IL221409A (enExample)
MX (1) MX347753B (enExample)
NZ (1) NZ602075A (enExample)
WO (1) WO2011106416A2 (enExample)

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US10179130B2 (en) 1999-10-29 2019-01-15 Purdue Pharma L.P. Controlled release hydrocodone formulations
KR100889069B1 (ko) 1999-10-29 2009-03-17 유로-셀티크 소시에떼 아노뉨 서방성 하이드로코돈 제형
HU230686B1 (en) 2000-10-30 2017-08-28 Euro Celtique Sa Controlled release hydrocodone compositions
US20040253310A1 (en) 2001-09-21 2004-12-16 Gina Fischer Morphine polymer release system
EP2957281A1 (en) 2001-09-21 2015-12-23 Egalet Ltd. Polymer release system
ES2360102T3 (es) 2003-03-26 2011-05-31 Egalet A/S Sistema para la liberación controlada de morfina.
US8821928B2 (en) 2007-06-04 2014-09-02 Egalet Ltd. Controlled release pharmaceutical compositions for prolonged effect
MX2010009990A (es) 2008-03-11 2010-12-15 Depomed Inc Formas de dosificación gástricas retentivas de liberación prolongada que comprenden combinaciones de un analgésico no opioide y un analgésico opioide.
US8372432B2 (en) 2008-03-11 2013-02-12 Depomed, Inc. Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
WO2010089132A1 (en) 2009-02-06 2010-08-12 Egalet A/S Immediate release composition resistant to abuse by intake of alcohol
AU2010265213B2 (en) 2009-06-24 2012-08-23 Egalet Ltd. Controlled release formulations
US8597681B2 (en) 2009-12-22 2013-12-03 Mallinckrodt Llc Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
US9198861B2 (en) 2009-12-22 2015-12-01 Mallinckrodt Llc Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
AU2011346757B2 (en) 2010-12-22 2015-08-20 Purdue Pharma L.P. Encased tamper resistant controlled release dosage forms
US8741885B1 (en) 2011-05-17 2014-06-03 Mallinckrodt Llc Gastric retentive extended release pharmaceutical compositions
US8858963B1 (en) 2011-05-17 2014-10-14 Mallinckrodt Llc Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia
US9050335B1 (en) 2011-05-17 2015-06-09 Mallinckrodt Llc Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia
WO2012166474A1 (en) * 2011-06-01 2012-12-06 Fmc Corporation Controlled release solid dose forms
NZ704011A (en) 2012-07-06 2016-04-29 Egalet Ltd Abuse deterrent pharmaceutical compositions for controlled release
CA2883077C (en) 2012-09-03 2017-03-07 Daiichi Sankyo Company, Limited Hydromorphone hydrochloride-containing oral sustained-release pharmaceutical composition
JP6850131B2 (ja) 2014-07-03 2021-03-31 スペックジーエックス エルエルシー 非セルロース多糖を含む、乱用抑止性即時放出製剤
US9132096B1 (en) 2014-09-12 2015-09-15 Alkermes Pharma Ireland Limited Abuse resistant pharmaceutical compositions
US9861629B1 (en) 2015-10-07 2018-01-09 Banner Life Sciences Llc Opioid abuse deterrent dosage forms
US10335405B1 (en) 2016-05-04 2019-07-02 Patheon Softgels, Inc. Non-burst releasing pharmaceutical composition
WO2018013771A1 (en) * 2016-07-13 2018-01-18 Cima Labs Inc. Treatment of pain using hydrocodone formulations
WO2018119033A1 (en) * 2016-12-20 2018-06-28 Cima Labs Inc. Abuse-resistant and abuse-deterrent dosage forms
US10335375B2 (en) 2017-05-30 2019-07-02 Patheon Softgels, Inc. Anti-overingestion abuse deterrent compositions
CA3112030A1 (en) 2018-09-25 2020-04-02 SpecGx LLC Abuse deterrent immediate release capsule dosage forms
IT201800011125A1 (it) 2018-12-14 2020-06-14 Dpl Pharma S P A Composizioni farmaceutiche orali solide comprendenti matrici monolitiche complesse per la somministrazione cronotropica di medicamenti nel tratto gastroenterico
IT202000011050A1 (it) 2020-05-14 2021-11-14 Mogon Pharmaceuticals Sagl Composizioni orali solide comprendenti matrici monolitiche composite per la somministrazione cronotropica nel tratto gastroenterico di ingredienti attivi
IT202000011053A1 (it) 2020-05-14 2021-11-14 Int Health Science S R L Composizioni orali solide comprendenti matrici monolitiche composite per la somministrazione cronotropica nel tratto gastroenterico di alimenti, integratori alimentari, nutraceutici, dispositivi medici

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101151022A (zh) * 2005-02-08 2008-03-26 弗拉梅技术公司 抗滥用微粒口服剂型
CN101453994A (zh) * 2006-05-24 2009-06-10 弗拉梅技术公司 延长释药的多微粒口服药物剂型

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US4959219A (en) * 1988-08-15 1990-09-25 Fisons Corporation Coating barriers comprising ethyl cellulose
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
US6024981A (en) 1997-04-16 2000-02-15 Cima Labs Inc. Rapidly dissolving robust dosage form
KR100889069B1 (ko) * 1999-10-29 2009-03-17 유로-셀티크 소시에떼 아노뉨 서방성 하이드로코돈 제형
DE10025948A1 (de) * 2000-05-26 2001-11-29 Gruenenthal Gmbh Wirkstoffkombination
DE10025947A1 (de) * 2000-05-26 2001-11-29 Gruenenthal Gmbh Wirkstoffkombination enthaltend Montirelin und eine Verbindung mit opioider Wirksamkeit
AU2002303718B2 (en) * 2001-05-11 2008-02-28 Endo Pharmaceuticals, Inc. Abuse-resistant opioid dosage form
US6813297B2 (en) * 2002-07-16 2004-11-02 Agilent Technologies, Inc. Material systems for long wavelength lasers grown on GaSb or InAs substrates
US7815934B2 (en) * 2002-09-20 2010-10-19 Alpharma Pharmaceuticals, Llc Sequestering subunit and related compositions and methods
US20070141147A1 (en) * 2005-12-21 2007-06-21 Auriga Laboratories, Inc. Sequential release pharmaceutical formulations
US20080069891A1 (en) 2006-09-15 2008-03-20 Cima Labs, Inc. Abuse resistant drug formulation
US8445018B2 (en) * 2006-09-15 2013-05-21 Cima Labs Inc. Abuse resistant drug formulation
ES2611794T3 (es) * 2007-09-13 2017-05-10 Cima Labs Inc. Formulación de medicamentos resistentes al abuso
CA2707980C (en) * 2007-12-17 2015-05-12 Labopharm Inc. Misuse preventative, controlled release formulation

Patent Citations (2)

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Publication number Priority date Publication date Assignee Title
CN101151022A (zh) * 2005-02-08 2008-03-26 弗拉梅技术公司 抗滥用微粒口服剂型
CN101453994A (zh) * 2006-05-24 2009-06-10 弗拉梅技术公司 延长释药的多微粒口服药物剂型

Also Published As

Publication number Publication date
AU2011220813A1 (en) 2012-09-27
CA2790108C (en) 2016-05-31
IL221409A (en) 2017-04-30
ES2628886T3 (es) 2017-08-04
IL221409A0 (en) 2012-10-31
WO2011106416A2 (en) 2011-09-01
WO2011106416A3 (en) 2012-03-01
JP6141583B2 (ja) 2017-06-07
EP2538928B1 (en) 2017-05-03
US20180049974A1 (en) 2018-02-22
JP2013520514A (ja) 2013-06-06
MX347753B (es) 2017-05-10
CA2790108A1 (en) 2011-09-01
AU2011220813B2 (en) 2016-05-19
MX2012009780A (es) 2012-09-12
NZ602075A (en) 2014-01-31
EP2538928A2 (en) 2013-01-02
CN102770127A (zh) 2012-11-07
US20130209560A1 (en) 2013-08-15

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C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
C14 Grant of patent or utility model
GR01 Patent grant
CF01 Termination of patent right due to non-payment of annual fee

Granted publication date: 20150415

Termination date: 20200223

CF01 Termination of patent right due to non-payment of annual fee