CN105163723A - 具有特定体外溶解曲线或药动学参数的多奈哌齐的药物组合物 - Google Patents

具有特定体外溶解曲线或药动学参数的多奈哌齐的药物组合物 Download PDF

Info

Publication number
CN105163723A
CN105163723A CN201480024046.5A CN201480024046A CN105163723A CN 105163723 A CN105163723 A CN 105163723A CN 201480024046 A CN201480024046 A CN 201480024046A CN 105163723 A CN105163723 A CN 105163723A
Authority
CN
China
Prior art keywords
donepezil
compositions
time
administration
compositionss
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.)
Pending
Application number
CN201480024046.5A
Other languages
English (en)
Chinese (zh)
Inventor
D·S·巴贺利
C·A·沙阿
S·A·加德夫
N·沙玛
S·詹德兰
A·A·德希穆克
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
Publication of CN105163723A publication Critical patent/CN105163723A/zh
Pending legal-status Critical Current

Links

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)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Anesthesiology (AREA)
  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
CN201480024046.5A 2013-02-28 2014-02-27 具有特定体外溶解曲线或药动学参数的多奈哌齐的药物组合物 Pending CN105163723A (zh)

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 (1)

Publication Number Publication Date
CN105163723A true CN105163723A (zh) 2015-12-16

Family

ID=50288205

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201480024046.5A Pending CN105163723A (zh) 2013-02-28 2014-02-27 具有特定体外溶解曲线或药动学参数的多奈哌齐的药物组合物

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 (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
US20110237623A1 (en) * 2010-03-01 2011-09-29 Adel Penhasi Sustained-release donepezil formulation
CN102309465A (zh) * 2010-06-30 2012-01-11 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

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2351347A1 (en) * 1998-11-23 2000-06-02 Bonnie Davis Dosage formulations for acetylcholinesterase inhibitors
US20030190360A1 (en) * 2001-03-13 2003-10-09 Baichwal Anand R. Chronotherapeutic dosage forms containing glucocorticosteroid and methods of treatment
US20070196481A1 (en) * 2002-07-25 2007-08-23 Amidon Gregory E Sustained-release tablet composition
CA2552221A1 (en) * 2003-12-31 2005-07-21 Actavis Group Hf Donepezil formulations
US20070129402A1 (en) * 2004-12-27 2007-06-07 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
NZ555693A (en) 2004-12-27 2010-10-29 Eisai R&D Man Co Ltd Matrix type sustained-release preparation containing donepezil
US20060159753A1 (en) 2004-12-27 2006-07-20 Eisai Co. Ltd. Matrix type sustained-release preparation containing basic drug or salt thereof
US20060280789A1 (en) 2004-12-27 2006-12-14 Eisai Research Institute Sustained release formulations
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
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
GB201003734D0 (en) * 2010-03-05 2010-04-21 Univ Strathclyde Delayed prolonged drug delivery
WO2012035409A1 (en) * 2010-09-14 2012-03-22 Rubicon Research Private Limited Sustained release compositions of anti-alzheimer's agents

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
US20110237623A1 (en) * 2010-03-01 2011-09-29 Adel Penhasi Sustained-release donepezil formulation
CN102309465A (zh) * 2010-06-30 2012-01-11 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

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
喻东山: "胆碱酯酶抑制药治疗阿尔茨海默病", 《医药导报》 *
黄流清、邵福源: "Alzheimer病相关的睡眠障碍", 《临床精神医学杂志》 *

Also Published As

Publication number Publication date
US20160015698A1 (en) 2016-01-21
MX2015011099A (es) 2016-04-06
RU2015140567A (ru) 2017-03-31
JP6429808B2 (ja) 2018-11-28
EP2961393B1 (en) 2020-10-28
KR20150123302A (ko) 2015-11-03
KR102241113B1 (ko) 2021-04-15
JP2016513133A (ja) 2016-05-12
ZA201506665B (en) 2017-02-22
EP2961393A1 (en) 2016-01-06
MX378413B (es) 2025-03-10
ES2842208T3 (es) 2021-07-13
BR112015020771A2 (pt) 2017-07-18
WO2014132218A1 (en) 2014-09-04

Similar Documents

Publication Publication Date Title
KR101752014B1 (ko) 고용량 및 저용량 약물들의 조합을 포함하는 구강붕해정 조성물
CN103417505B (zh) 具有双相释药行为的石杉碱甲控释制剂及其制备方法
US20120093938A1 (en) Orally disintegrating tablets comprising diphenhydramine
KR20160045728A (ko) 디메틸푸마레이트를 포함하는 일일 저용량 투여용 약제학적 조성물
WO2011101863A2 (en) Extended release pharmaceutical compositions of lacosamide
JP2008528494A (ja) 医薬製剤および使用方法
US20130236544A1 (en) Stable pharmaceutical compositions of fesoterodine
JP2021506944A (ja) 持続放出ミドドリン塩酸塩組成物及び使用方法
US20110033506A1 (en) Combination dosage form of low-dose modafinil and low-dose sildenafil
JP2024540082A (ja) バルベナジン組成物
AU2018282448B2 (en) Pharmaceutical compositions of donepezil having specific in vitro dissolution profile or pharmacokinetics parameters
EP2961393B1 (en) Pharmaceutical compositions of donepezil having specific in vitro dissolution profile or pharmacokinetics parameters
CN101677960A (zh) 美金刚胺的药物组合物
JP7714473B2 (ja) ピリミジニルアミノピラゾール化合物の調節放出製剤および処置方法
WO2020264092A1 (en) Atomoxetine hydrochloride extended release compositions and methods of use
CN121129799A (zh) 一种多重释放的缓控释组合物制剂及其制备方法和用途
JP2008520607A (ja) (+)−(2s,3s)−2−(3−クロロフェニル)−3,5,5−トリメチル−2−モルホリノール配合の医薬組成物

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
WD01 Invention patent application deemed withdrawn after publication
WD01 Invention patent application deemed withdrawn after publication

Application publication date: 20151216