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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JP2013545762A5 (OSRAM
JP2013545762A (ja
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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A—HUMAN NECESSITIES
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    • 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
    • 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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • 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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    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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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
    • A61K9/286—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
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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
    • 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
    • A61K9/5005—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
    • 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
    • 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
    • A61P25/08—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
US41915810P 2010-12-02 2010-12-02
US41915310P 2010-12-02 2010-12-02
EP10193559.1 2010-12-02
EP10193561A EP2468261A1 (en) 2010-12-02 2010-12-02 Formulation of lacosamide
US61/419,158 2010-12-02
EP10193561.7 2010-12-02
EP10193559 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
US201161485354P 2011-05-12 2011-05-12
US201161485361P 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 (OSRAM) 2015-01-22
JP6027539B2 true JP6027539B2 (ja) 2016-11-16

Family

ID=46172318

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Application Number Title Priority Date Filing Date
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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Application Number Title Priority Date Filing Date
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 (OSRAM)
EP (3) EP2646001A2 (OSRAM)
JP (2) JP6027539B2 (OSRAM)
KR (1) KR101980386B1 (OSRAM)
CN (1) CN103561727B (OSRAM)
AU (1) AU2011335415B2 (OSRAM)
BR (1) BR112013013525A2 (OSRAM)
CA (1) CA2817654A1 (OSRAM)
EA (1) EA029180B1 (OSRAM)
IL (1) IL226231B (OSRAM)
MX (1) MX2013005974A (OSRAM)
NZ (1) NZ610701A (OSRAM)
WO (2) WO2012084126A2 (OSRAM)
ZA (1) ZA201303289B (OSRAM)

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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
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KR102852740B1 (ko) 2018-02-02 2025-08-29 알렉스자 파마스티칼즈, 인크. 전기적 응축 에어로졸 디바이스
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
WO2020244615A1 (zh) * 2019-06-06 2020-12-10 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
US12042474B2 (en) 2019-06-06 2024-07-23 Shanghai Aucta Pharmaceuticals Co., Ltd. Lacosamide pharmaceutical composition and dosage form thereof
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
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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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EP2645997B1 (en) 2022-08-10
EP2646001A2 (en) 2013-10-09
US20190008758A1 (en) 2019-01-10
IL226231A0 (en) 2013-07-31
AU2011335415B2 (en) 2016-05-19
EP3766485A1 (en) 2021-01-20
CN103561727A (zh) 2014-02-05
KR101980386B1 (ko) 2019-05-20
EA201390804A1 (ru) 2013-10-30
EA029180B1 (ru) 2018-02-28
NZ610701A (en) 2015-06-26
US20130251813A1 (en) 2013-09-26
CN103561727B (zh) 2018-03-27
CA2817654A1 (en) 2012-06-07
ZA201303289B (en) 2014-02-26
BR112013013525A2 (pt) 2016-10-18
AU2011335415A1 (en) 2013-06-20
US20150104507A1 (en) 2015-04-16
IL226231B (en) 2018-01-31
WO2012072256A3 (en) 2014-01-23
EP2645997A2 (en) 2013-10-09
JP2017031206A (ja) 2017-02-09
MX2013005974A (es) 2013-07-29
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WO2012072256A2 (en) 2012-06-07
JP2013545762A (ja) 2013-12-26

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