KR102241113B1 - 특정한 체외 용해 프로파일 또는 약리역학 파라미터를 갖는 도네페질의 약제학적 조성물 - Google Patents

특정한 체외 용해 프로파일 또는 약리역학 파라미터를 갖는 도네페질의 약제학적 조성물 Download PDF

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KR102241113B1
KR102241113B1 KR1020157026728A KR20157026728A KR102241113B1 KR 102241113 B1 KR102241113 B1 KR 102241113B1 KR 1020157026728 A KR1020157026728 A KR 1020157026728A KR 20157026728 A KR20157026728 A KR 20157026728A KR 102241113 B1 KR102241113 B1 KR 102241113B1
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composition
donepezil
delete delete
release
administered
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KR20150123302A (ko
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다난제이 사다시브 바클레
치라그 아니쿠마르 사하
스네할 아밋 가드브
네하 샤르마
사지브 찬드란
아쉬스 아쇼크라오 데쉬무크
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루핀 리미티드
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    • 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, 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
    • A61K9/20Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846Poly(meth)acrylates
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, 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
    • A61K9/5005Wall 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
    • 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
    • A61K9/5078Microcapsules 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 with drug-free core
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/20Hypnotics; Sedatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Hospice & Palliative Care (AREA)
  • Anesthesiology (AREA)
  • Psychiatry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
KR1020157026728A 2013-02-28 2014-02-27 특정한 체외 용해 프로파일 또는 약리역학 파라미터를 갖는 도네페질의 약제학적 조성물 Expired - Fee Related KR102241113B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN991KO2012 2013-02-28
IN991/KOL/2012 2013-02-28
PCT/IB2014/059302 WO2014132218A1 (en) 2013-02-28 2014-02-27 Pharmaceutical compositions of donepezil having specific in vitro dissolution profile or pharmacokinetics parameters

Publications (2)

Publication Number Publication Date
KR20150123302A KR20150123302A (ko) 2015-11-03
KR102241113B1 true KR102241113B1 (ko) 2021-04-15

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Application Number Title Priority Date Filing Date
KR1020157026728A Expired - Fee Related KR102241113B1 (ko) 2013-02-28 2014-02-27 특정한 체외 용해 프로파일 또는 약리역학 파라미터를 갖는 도네페질의 약제학적 조성물

Country Status (11)

Country Link
US (1) US20160015698A1 (enExample)
EP (1) EP2961393B1 (enExample)
JP (1) JP6429808B2 (enExample)
KR (1) KR102241113B1 (enExample)
CN (1) CN105163723A (enExample)
BR (1) BR112015020771A2 (enExample)
ES (1) ES2842208T3 (enExample)
MX (1) MX378413B (enExample)
RU (1) RU2015140567A (enExample)
WO (1) WO2014132218A1 (enExample)
ZA (1) ZA201506665B (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102142026B1 (ko) * 2017-05-31 2020-08-06 주식회사 대웅제약 방출제어가 용이한 서방성 약물 미립자의 제조방법

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070129402A1 (en) * 2004-12-27 2007-06-07 Eisai Research Institute Sustained release formulations

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JP5558648B2 (ja) * 1998-11-23 2014-07-23 デイビス、ボニー アセチルコリンエステラーゼ阻害剤のための投与製剤
US20030190360A1 (en) * 2001-03-13 2003-10-09 Baichwal Anand R. Chronotherapeutic dosage forms containing glucocorticosteroid and methods of treatment
MY136318A (en) * 2002-07-25 2008-09-30 Pharmacia Corp Sustained-release tablet composition
CA2552221A1 (en) 2003-12-31 2005-07-21 Actavis Group Hf Donepezil formulations
US20090208579A1 (en) * 2004-12-27 2009-08-20 Eisai R & D Management Co., Ltd. Matrix Type Sustained-Release Preparation Containing Basic Drug or Salt Thereof, and Method for Manufacturing the Same
EP1830886B1 (en) * 2004-12-27 2016-04-13 Eisai R&D Management Co., Ltd. Method for stabilizing anti-dementia drug
US20060280789A1 (en) 2004-12-27 2006-12-14 Eisai Research Institute Sustained release formulations
US20060159753A1 (en) 2004-12-27 2006-07-20 Eisai Co. Ltd. Matrix type sustained-release preparation containing basic drug or salt thereof
CN101090737B (zh) * 2004-12-27 2010-09-08 卫材R&D管理有限公司 稳定抗痴呆药物的方法
EA014249B1 (ru) * 2005-01-27 2010-10-29 Алембик Лимитед Формуляция леветирацетама длительного высвобождения
EP1874282B1 (en) * 2005-04-06 2010-09-15 Adamas Pharmaceuticals, Inc. Methods and compositions for treatment of cns disorders
WO2011069076A2 (en) 2009-12-04 2011-06-09 Dr. Reddy's Laboratories Ltd. Sustained release donepezil formulations
US20110218216A1 (en) 2010-01-29 2011-09-08 Kumaravel Vivek Extended release pharmaceutical composition of donepezil
EP2366378A1 (en) * 2010-03-01 2011-09-21 Dexcel Pharma Technologies Ltd. Sustained-release donepezil formulations
GB201003734D0 (en) * 2010-03-05 2010-04-21 Univ Strathclyde Delayed prolonged drug delivery
CN102309465B (zh) * 2010-06-30 2015-04-22 天津药物研究院 含盐酸多奈哌齐活性成分的缓释片及其制备方法和用途
WO2012035409A1 (en) * 2010-09-14 2012-03-22 Rubicon Research Private Limited Sustained release compositions of anti-alzheimer's agents

Patent Citations (1)

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Publication number Priority date Publication date Assignee Title
US20070129402A1 (en) * 2004-12-27 2007-06-07 Eisai Research Institute Sustained release formulations

Also Published As

Publication number Publication date
JP2016513133A (ja) 2016-05-12
RU2015140567A (ru) 2017-03-31
US20160015698A1 (en) 2016-01-21
EP2961393A1 (en) 2016-01-06
CN105163723A (zh) 2015-12-16
MX2015011099A (es) 2016-04-06
WO2014132218A1 (en) 2014-09-04
ZA201506665B (en) 2017-02-22
KR20150123302A (ko) 2015-11-03
BR112015020771A2 (pt) 2017-07-18
JP6429808B2 (ja) 2018-11-28
EP2961393B1 (en) 2020-10-28
MX378413B (es) 2025-03-10
ES2842208T3 (es) 2021-07-13

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