JP6027539B2 - ラコサミドの１日１回投与用製剤 - Google Patents

ラコサミドの１日１回投与用製剤 Download PDF

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Publication number
JP6027539B2
JP6027539B2 JP2013541248A JP2013541248A JP6027539B2 JP 6027539 B2 JP6027539 B2 JP 6027539B2 JP 2013541248 A JP2013541248 A JP 2013541248A JP 2013541248 A JP2013541248 A JP 2013541248A JP 6027539 B2 JP6027539 B2 JP 6027539B2
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Prior art keywords
lacosamide
weight
formulation
matrix
release
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Japanese (ja)
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JP2013545762A (ja
JP2013545762A5 (pt-pt
Inventor
ヴィリ カヴェロ
ヴィリ カヴェロ
マルティン アレクサンダー シューベルト
マルティン アレクサンダー シューベルト
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UCB Pharma GmbH
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UCB Pharma GmbH
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Priority claimed from EP10193561A external-priority patent/EP2468261A1/en
Application filed by UCB Pharma GmbH filed Critical UCB Pharma GmbH
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    • 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
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
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    • 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
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
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    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
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    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
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    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—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
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    • A—HUMAN NECESSITIES
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    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
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    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
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    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
    • 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
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    • 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
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P25/08—Antiepileptics; Anticonvulsants
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • 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
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Psychology (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2013541248A 2010-12-02 2011-12-01 ラコサミドの１日１回投与用製剤 Active JP6027539B2 (ja)

Applications Claiming Priority (17)

Application Number Priority Date Filing Date Title
US41915310P 2010-12-02 2010-12-02
US41915810P 2010-12-02 2010-12-02
EP10193561.7 2010-12-02
EP10193561A EP2468261A1 (en) 2010-12-02 2010-12-02 Formulation of lacosamide
EP10193559.1 2010-12-02
EP10193559 2010-12-02
US61/419,158 2010-12-02
US61/419,153 2010-12-02
US201161444447P 2011-02-18 2011-02-18
US201161444439P 2011-02-18 2011-02-18
US61/444,447 2011-02-18
US61/444,439 2011-02-18
US201161485361P 2011-05-12 2011-05-12
US201161485354P 2011-05-12 2011-05-12
US61/485,354 2011-05-12
US61/485,361 2011-05-12
PCT/EP2011/006027 WO2012072256A2 (en) 2010-12-02 2011-12-01 Once daily formulation of lacosamide

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2016202383A Division JP6357687B2 (ja) 2010-12-02 2016-10-14 ラコサミドの１日１回投与用製剤

Publications (3)

Publication Number Publication Date
JP2013545762A JP2013545762A (ja) 2013-12-26
JP2013545762A5 JP2013545762A5 (pt-pt) 2015-01-22
JP6027539B2 true JP6027539B2 (ja) 2016-11-16

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ID=46172318

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JP2013541248A Active JP6027539B2 (ja) 2010-12-02 2011-12-01 ラコサミドの１日１回投与用製剤
JP2016202383A Active JP6357687B2 (ja) 2010-12-02 2016-10-14 ラコサミドの１日１回投与用製剤

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JP2016202383A Active JP6357687B2 (ja) 2010-12-02 2016-10-14 ラコサミドの１日１回投与用製剤

Country Status (14)

Country Link
US (4) US20130251813A1 (pt-pt)
EP (3) EP2645997B1 (pt-pt)
JP (2) JP6027539B2 (pt-pt)
KR (1) KR101980386B1 (pt-pt)
CN (1) CN103561727B (pt-pt)
AU (1) AU2011335415B2 (pt-pt)
BR (1) BR112013013525A2 (pt-pt)
CA (1) CA2817654A1 (pt-pt)
EA (1) EA029180B1 (pt-pt)
IL (1) IL226231B (pt-pt)
MX (1) MX2013005974A (pt-pt)
NZ (1) NZ610701A (pt-pt)
WO (2) WO2012072256A2 (pt-pt)
ZA (1) ZA201303289B (pt-pt)

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CN106551900A (zh) * 2016-12-05 2017-04-05 北京万全德众医药生物技术有限公司 一种拉科酰胺口服溶液及其制备工艺
HRP20240106T1 (hr) * 2016-12-09 2024-04-12 Alexza Pharmaceuticals, Inc. Alprazolam za uporabu u liječenju epilepsije
KR102083241B1 (ko) 2018-02-14 2020-03-02 환인제약 주식회사 라코사미드를 함유하는 약제학적 서방성 조성물
CN110833528A (zh) * 2018-08-17 2020-02-25 北京万全德众医药生物技术有限公司 一种拉科酰胺脂质体冻干粉针剂及其制备方法
CN109010301B (zh) * 2018-09-05 2021-01-26 上海上药第一生化药业有限公司 一种拉考沙胺晶型ii片剂及其制备方法和应用
CN114404393B (zh) * 2019-06-06 2023-02-24 上海奥科达生物医药科技有限公司 一种拉考沙胺药物组合物及其药物制剂
CN112022804A (zh) * 2020-09-28 2020-12-04 健民药业集团股份有限公司 一种拉考沙胺口服溶液及制备方法
WO2022194198A1 (zh) * 2021-03-17 2022-09-22 上海博志研新药物技术有限公司 一种拉考沙胺药物组合物、其制备方法及应用
WO2024054987A1 (en) * 2022-09-08 2024-03-14 The Children's Hospital Of Philadlphia Gpcr latrophilin-3 as biomarker for detecting increased risk for mild brain injury and methods of use thereof for diagnosis and treatment of the same
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KR101980386B1 (ko) 2019-05-20
AU2011335415A1 (en) 2013-06-20
EP2646001A2 (en) 2013-10-09
ZA201303289B (en) 2014-02-26
JP2017031206A (ja) 2017-02-09
US20190054009A1 (en) 2019-02-21
EP2645997A2 (en) 2013-10-09
CN103561727A (zh) 2014-02-05
US20130251813A1 (en) 2013-09-26
JP2013545762A (ja) 2013-12-26
IL226231A0 (en) 2013-07-31
BR112013013525A2 (pt) 2016-10-18
WO2012072256A3 (en) 2014-01-23
AU2011335415B2 (en) 2016-05-19
KR20150034579A (ko) 2015-04-03
EA201390804A1 (ru) 2013-10-30
WO2012084126A2 (en) 2012-06-28
MX2013005974A (es) 2013-07-29
NZ610701A (en) 2015-06-26
CA2817654A1 (en) 2012-06-07
JP6357687B2 (ja) 2018-07-18
CN103561727B (zh) 2018-03-27
EP2645997B1 (en) 2022-08-10
US20190008758A1 (en) 2019-01-10
WO2012072256A2 (en) 2012-06-07
IL226231B (en) 2018-01-31
US20150104507A1 (en) 2015-04-16
WO2012084126A3 (en) 2013-05-02
EP3766485A1 (en) 2021-01-20

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