JP6843748B2 - フマル酸ジメチルを含む医薬ビーズ製剤 - Google Patents

フマル酸ジメチルを含む医薬ビーズ製剤 Download PDF

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Publication number
JP6843748B2
JP6843748B2 JP2017527359A JP2017527359A JP6843748B2 JP 6843748 B2 JP6843748 B2 JP 6843748B2 JP 2017527359 A JP2017527359 A JP 2017527359A JP 2017527359 A JP2017527359 A JP 2017527359A JP 6843748 B2 JP6843748 B2 JP 6843748B2
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nucleus
layer
total weight
weight percentage
pharmaceutical composition
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JP2017527359A
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Japanese (ja)
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JP2017534668A (ja
JP2017534668A5 (enExample
Inventor
カルキ,シャム・ビー
ザワネ,ピーター
レオン,チェク−ユイ
バスデバン,カリヤーン
リン,イーチーン
シュウ,ジン
トレメントッツィ,アンドレア
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Biogen MA Inc
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Biogen MA Inc
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    • 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
    • A61K9/2886Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/225Polycarboxylic acids
    • 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
    • A61K9/1676Agglomerates; 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 having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K9/209Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/282Organic compounds, e.g. fats
    • A61K9/2826Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
    • 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
    • A61K9/2853Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/2873Proteins, e.g. gelatin
    • 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
    • A61K9/288Compounds of unknown constitution, e.g. material from plants or animals
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Emergency Medicine (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Botany (AREA)
  • Zoology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2017527359A 2014-11-19 2015-11-19 フマル酸ジメチルを含む医薬ビーズ製剤 Expired - Fee Related JP6843748B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201462081889P 2014-11-19 2014-11-19
US62/081,889 2014-11-19
PCT/US2015/061456 WO2016081676A1 (en) 2014-11-19 2015-11-19 Pharmaceutical bead formulations comprising dimethyl fumarate

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2021026223A Division JP2021088586A (ja) 2014-11-19 2021-02-22 フマル酸ジメチルを含む医薬ビーズ製剤

Publications (3)

Publication Number Publication Date
JP2017534668A JP2017534668A (ja) 2017-11-24
JP2017534668A5 JP2017534668A5 (enExample) 2018-12-27
JP6843748B2 true JP6843748B2 (ja) 2021-03-17

Family

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Family Applications (2)

Application Number Title Priority Date Filing Date
JP2017527359A Expired - Fee Related JP6843748B2 (ja) 2014-11-19 2015-11-19 フマル酸ジメチルを含む医薬ビーズ製剤
JP2021026223A Pending JP2021088586A (ja) 2014-11-19 2021-02-22 フマル酸ジメチルを含む医薬ビーズ製剤

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2021026223A Pending JP2021088586A (ja) 2014-11-19 2021-02-22 フマル酸ジメチルを含む医薬ビーズ製剤

Country Status (13)

Country Link
US (1) US11197842B2 (enExample)
EP (1) EP3220898A1 (enExample)
JP (2) JP6843748B2 (enExample)
KR (1) KR20170086063A (enExample)
CN (2) CN107205937A (enExample)
AU (1) AU2015349896B2 (enExample)
CA (1) CA2967647A1 (enExample)
EA (1) EA039157B1 (enExample)
HK (1) HK1244214A1 (enExample)
IL (1) IL252116B (enExample)
MA (1) MA40982A (enExample)
MX (1) MX2017006562A (enExample)
WO (1) WO2016081676A1 (enExample)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2987895A1 (en) 2015-06-01 2016-12-08 Sun Pharmaceutical Industries Ltd. Pharmaceutical compositions of dimethyl fumarate
KR20180108814A (ko) * 2016-02-11 2018-10-04 바이오젠 엠에이 인코포레이티드 다이메틸 퓨마레이트를 포함하는 약제학적 비드 제형
CN110636838A (zh) * 2017-06-23 2019-12-31 阿尔米雷尔有限公司 包含反丁烯二酸二甲酯的药物组合物
KR102868782B1 (ko) 2018-01-12 2025-10-13 (주)메티메디제약 만성 염증성 질환의 치료 방법
TR201818307A2 (tr) * 2018-11-30 2020-06-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Di̇meti̇l fumarat i̇çeren bi̇r kompozi̇syon
JP7224067B2 (ja) * 2019-05-31 2023-02-17 キュラクル カンパニー リミテッド フマル酸ジメチルを含有する腸溶性錠剤
KR20220133807A (ko) * 2021-03-25 2022-10-05 주식회사 큐라클 특정 약동학적 매개변수를 나타내는 디메틸푸마레이트를 유효성분으로 함유한 약학적 조성물

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US5213811A (en) 1991-09-13 1993-05-25 Sterling Drug Inc. Oral sustained-release drug compositions
ES2157731B1 (es) * 1998-07-21 2002-05-01 Liconsa Liberacion Controlada Preparacion farmaceutica oral de un compuesto de actividad antifungica y procedimiento para su preparacion.
DE10101307A1 (de) * 2001-01-12 2002-08-01 Fumapharm Ag Muri Fumarsäurederivate als NF-kappaB-Inhibitor
US6946146B2 (en) * 2001-04-18 2005-09-20 Nostrum Pharmaceuticals Inc. Coating for a sustained release pharmaceutical composition
DE102005005446A1 (de) * 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
AR045957A1 (es) * 2003-10-03 2005-11-16 Novartis Ag Composicion farmaceutica y combinacion
GB0419355D0 (en) * 2004-08-31 2004-09-29 Novartis Ag Organic compounds
DE14172396T1 (de) * 2004-10-08 2015-01-08 Forward Pharma A/S Gesteuerte Freisetzung von pharmazeutischen Zusammensetzungen mit Fumarinsäureester
CN101056624A (zh) * 2004-10-08 2007-10-17 Adi技术制药股份公司 包含富马酸酯的控释药物组合物
CN109044985A (zh) * 2009-01-09 2018-12-21 前进制药知识产权有限公司 包含溶蚀骨架中的一种或多种富马酸酯的药物制剂
CN102369000A (zh) * 2009-01-09 2012-03-07 前进制药公司 包含一种或多种富马酸酯的药用组合物
DK3045043T3 (da) * 2009-02-26 2020-08-03 Relmada Therapeutics Inc Orale farmaceutiske sammensætninger af 3-hydroxy-n-methylmorphinan med forlænget frigivelse og fremgangsmåde til anvendelse
ME02317B (me) * 2010-02-12 2016-06-20 Biogen Ma Inc Neuroprotekcija kod demijelinizacijskih bolesti
WO2013076216A1 (en) * 2011-11-24 2013-05-30 Synthon Bv Controlled release particles comprising dimethyl fumarate
AU2013203445C1 (en) * 2012-02-07 2017-04-20 Biogen Ma Inc. Pharmaceutical compositions containing dimethyl fumarate
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US20140171504A1 (en) * 2012-12-14 2014-06-19 Georgia Regents Research Institute, Inc. Methods of Treating Sickle Cell Disease and Related Disorders Using Fumaric Acid Esters
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WO2015105757A1 (en) * 2014-01-07 2015-07-16 Biogen Ma Inc. Dimethyl fumarate for treating multiple sclerosis
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Also Published As

Publication number Publication date
AU2015349896B2 (en) 2021-04-29
EA039157B1 (ru) 2021-12-13
EA201791113A1 (ru) 2017-10-31
US20180153845A1 (en) 2018-06-07
CN107205937A (zh) 2017-09-26
CN113521029A (zh) 2021-10-22
HK1244214A1 (zh) 2018-08-03
JP2017534668A (ja) 2017-11-24
WO2016081676A1 (en) 2016-05-26
JP2021088586A (ja) 2021-06-10
IL252116B (en) 2022-08-01
CA2967647A1 (en) 2016-05-26
US11197842B2 (en) 2021-12-14
KR20170086063A (ko) 2017-07-25
MX2017006562A (es) 2018-02-19
IL252116A0 (en) 2017-07-31
MA40982A (fr) 2017-09-26
EP3220898A1 (en) 2017-09-27
AU2015349896A1 (en) 2017-05-25

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