ES2842208T3 - Composiciones farmacéuticas de donepezilo que tienen perfil de disolución in vitro o parámetros farmacocinéticos específicos - Google Patents

Composiciones farmacéuticas de donepezilo que tienen perfil de disolución in vitro o parámetros farmacocinéticos específicos Download PDF

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Publication number
ES2842208T3
ES2842208T3 ES14710647T ES14710647T ES2842208T3 ES 2842208 T3 ES2842208 T3 ES 2842208T3 ES 14710647 T ES14710647 T ES 14710647T ES 14710647 T ES14710647 T ES 14710647T ES 2842208 T3 ES2842208 T3 ES 2842208T3
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ES
Spain
Prior art keywords
donepezil
release control
composition
release
sleep
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
ES14710647T
Other languages
English (en)
Spanish (es)
Inventor
Dhananjay Bakhle
Chirag Shah
Snehal Gadve
Neha Sharma
Sajeev Chandran
Ashish Deshmukh
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.)
Lupin Ltd
Original Assignee
Lupin Ltd
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 Lupin Ltd filed Critical Lupin Ltd
Application granted granted Critical
Publication of ES2842208T3 publication Critical patent/ES2842208T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Anesthesiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
ES14710647T 2013-02-28 2014-02-27 Composiciones farmacéuticas de donepezilo que tienen perfil de disolución in vitro o parámetros farmacocinéticos específicos Active ES2842208T3 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN991KO2012 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 (1)

Publication Number Publication Date
ES2842208T3 true ES2842208T3 (es) 2021-07-13

Family

ID=50288205

Family Applications (1)

Application Number Title Priority Date Filing Date
ES14710647T Active ES2842208T3 (es) 2013-02-28 2014-02-27 Composiciones farmacéuticas de donepezilo que tienen perfil de disolución in vitro o parámetros farmacocinéticos específicos

Country Status (11)

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

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

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000030446A1 (en) * 1998-11-23 2000-06-02 Bonnie Davis Dosage formulations for acetylcholinesterase inhibitors
NZ527832A (en) * 2001-03-13 2006-03-31 Penwest Pharmaceuticals Co Chronotherapeutic dosage forms
AR040680A1 (es) * 2002-07-25 2005-04-13 Pharmacia Corp Composicion de tabletas de liberacion sostenida
WO2005065645A2 (en) * 2003-12-31 2005-07-21 Actavis Group Hf Donepezil formulations
CN101090738A (zh) * 2004-12-27 2007-12-19 卫材R&D管理有限公司 含有碱性药物或其盐的基质型缓释制剂及其制备方法
US20060159753A1 (en) 2004-12-27 2006-07-20 Eisai Co. Ltd. Matrix type sustained-release preparation containing basic drug or salt thereof
US20070129402A1 (en) 2004-12-27 2007-06-07 Eisai Research Institute Sustained release formulations
US20060280789A1 (en) 2004-12-27 2006-12-14 Eisai Research Institute Sustained release 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
JP2008525313A (ja) 2004-12-27 2008-07-17 エーザイ・アール・アンド・ディー・マネジメント株式会社 抗痴呆薬の安定化方法
EA014249B1 (ru) * 2005-01-27 2010-10-29 Алембик Лимитед Формуляция леветирацетама длительного высвобождения
JP5666087B2 (ja) * 2005-04-06 2015-02-12 アダマス・ファーマシューティカルズ・インコーポレーテッド Cns関連疾患の治療のための方法及び組成物
US20130059003A1 (en) 2009-12-04 2013-03-07 Dr. Reddy's Laboratories, Inc. 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

Also Published As

Publication number Publication date
JP2016513133A (ja) 2016-05-12
MX378413B (es) 2025-03-10
RU2015140567A (ru) 2017-03-31
EP2961393A1 (en) 2016-01-06
WO2014132218A1 (en) 2014-09-04
CN105163723A (zh) 2015-12-16
MX2015011099A (es) 2016-04-06
KR102241113B1 (ko) 2021-04-15
JP6429808B2 (ja) 2018-11-28
ZA201506665B (en) 2017-02-22
US20160015698A1 (en) 2016-01-21
KR20150123302A (ko) 2015-11-03
EP2961393B1 (en) 2020-10-28
BR112015020771A2 (pt) 2017-07-18

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