MX378412B - Composiciones farmaceuticas de donepezilo que tienen un perfil de disolución in vitro o parámetros farmacocinéticos específicos. - Google Patents

Composiciones farmaceuticas de donepezilo que tienen un perfil de disolución in vitro o parámetros farmacocinéticos específicos.

Info

Publication number
MX378412B
MX378412B MX2015011101A MX2015011101A MX378412B MX 378412 B MX378412 B MX 378412B MX 2015011101 A MX2015011101 A MX 2015011101A MX 2015011101 A MX2015011101 A MX 2015011101A MX 378412 B MX378412 B MX 378412B
Authority
MX
Mexico
Prior art keywords
donepezil
dissolution profile
specific
pharmaceutical compositions
pharmacokinetic parameters
Prior art date
Application number
MX2015011101A
Other languages
English (en)
Other versions
MX2015011101A (es
Inventor
Ashish Ashokrao Deshmukh
Chirag Anilkumar Shah
Dhananjay Sadashiv Bakhle
Neha Sharma
Sajeev Chandran
Snehal Ameet Gadve
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 MX2015011101A publication Critical patent/MX2015011101A/es
Publication of MX378412B publication Critical patent/MX378412B/es

Links

Classifications

    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • 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
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; 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
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—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
    • A61K9/48—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
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • A61P25/20—Hypnotics; Sedatives
    • 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
    • A61P25/28—Drugs 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs 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)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Neurology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Anesthesiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

Se proporciona una composición farmacéutica de liberación temporizada que comprende Donepezilo, en la cual la composición exhibe el perfil de disolución in vitro cuando se ensaya en un aparato de disolución de Paletas a 50 rpm en 900 mL de tampón de 6.8 a 37º C, se libera menos de aproximadamente 20% peso/peso de Donepezilo en 3 a 6 horas, y se libera más de 90% peso/peso de Donepezilo después de 12 horas.
MX2015011101A 2013-02-28 2014-02-27 Composiciones farmaceuticas de donepezilo que tienen un perfil de disolución in vitro o parámetros farmacocinéticos específicos. MX378412B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN990KO2012 2013-02-28
PCT/IB2014/059298 WO2014132215A1 (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
MX2015011101A MX2015011101A (es) 2016-04-06
MX378412B true MX378412B (es) 2025-03-10

Family

ID=50288204

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2015011101A MX378412B (es) 2013-02-28 2014-02-27 Composiciones farmaceuticas de donepezilo que tienen un perfil de disolución in vitro o parámetros farmacocinéticos específicos.

Country Status (13)

Country Link
US (1) US10278963B2 (es)
EP (1) EP2961392B1 (es)
JP (1) JP6429807B2 (es)
KR (1) KR102241112B1 (es)
CN (1) CN105209019A (es)
AU (4) AU2014222375A1 (es)
BR (1) BR112015020773A2 (es)
CA (2) CA2902665C (es)
ES (1) ES2841738T3 (es)
MX (1) MX378412B (es)
RU (1) RU2015140501A (es)
WO (1) WO2014132215A1 (es)
ZA (1) ZA201506656B (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7426685B2 (ja) * 2018-06-14 2024-02-02 株式会社東洋新薬 錠剤

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU1738800A (en) * 1998-11-23 2000-06-13 Bonnie Davis Dosage formulations for acetylcholinesterase inhibitors
AP1748A (en) * 2001-03-13 2007-06-11 Penwest Pharmaceuticals Co Chronotherapeutic dosage forms.
US20070196481A1 (en) * 2002-07-25 2007-08-23 Amidon Gregory E Sustained-release tablet composition
WO2005065645A2 (en) * 2003-12-31 2005-07-21 Actavis Group Hf Donepezil formulations
MX2007007836A (es) 2004-12-27 2007-08-20 Eisai R&D Man Co Ltd Metodo para estabilizar un farmaco anti-demencia.
US20070129402A1 (en) * 2004-12-27 2007-06-07 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
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
CN101111245A (zh) * 2005-01-27 2008-01-23 阿雷姆贝克有限公司 左乙拉西坦延长释放制剂
ATE481096T1 (de) 2005-04-06 2010-10-15 Adamas Pharmaceuticals Inc Verfahren und zusammensetzungen zur behandlung von zns-erkrankungen
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
WO2012016708A1 (en) * 2010-08-06 2012-02-09 Ratiopharm Gmbh Oral dosage form comprising dimebolin and donepezil
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
CA2902665A1 (en) 2014-09-04
CA2902665C (en) 2021-03-02
AU2014222372A1 (en) 2015-09-17
AU2014222375A1 (en) 2015-09-17
US20160008335A1 (en) 2016-01-14
CN105209019A (zh) 2015-12-30
AU2018278967B2 (en) 2020-07-30
ZA201506656B (en) 2017-01-25
KR20150123301A (ko) 2015-11-03
CA2902697A1 (en) 2014-09-04
JP6429807B2 (ja) 2018-11-28
BR112015020773A2 (pt) 2017-07-18
WO2014132215A1 (en) 2014-09-04
JP2016510021A (ja) 2016-04-04
RU2015140501A (ru) 2017-03-31
AU2018282448B2 (en) 2020-07-30
KR102241112B1 (ko) 2021-04-15
ES2841738T3 (es) 2021-07-09
US10278963B2 (en) 2019-05-07
AU2018282448A1 (en) 2019-01-17
MX2015011101A (es) 2016-04-06
EP2961392B1 (en) 2020-10-28
AU2018278967A1 (en) 2019-01-17
EP2961392A1 (en) 2016-01-06

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MX378412B (es) Composiciones farmaceuticas de donepezilo que tienen un perfil de disolución in vitro o parámetros farmacocinéticos específicos.