JP2016528302A - 低１日用量で投与するためのフマル酸ジメチルを含む医薬組成物 - Google Patents

低１日用量で投与するためのフマル酸ジメチルを含む医薬組成物 Download PDF

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Publication number
JP2016528302A
JP2016528302A JP2016537269A JP2016537269A JP2016528302A JP 2016528302 A JP2016528302 A JP 2016528302A JP 2016537269 A JP2016537269 A JP 2016537269A JP 2016537269 A JP2016537269 A JP 2016537269A JP 2016528302 A JP2016528302 A JP 2016528302A
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Japan
Prior art keywords
weight
dimethyl fumarate
pharmaceutical composition
administered
composition according
Prior art date
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Pending
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JP2016537269A
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Japanese (ja)
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JP2016528302A5 (enExample
Inventor
クリスティン・ガレツカ
クリス・ルントフェルト
ローラント・ルップ
ピーザ・エム・アナスン
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Forward Pharma AS
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Forward Pharma AS
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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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/225—Polycarboxylic acids
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/2009—Inorganic compounds
    • 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
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2016537269A 2013-08-26 2014-08-26 低１日用量で投与するためのフマル酸ジメチルを含む医薬組成物 Pending JP2016528302A (ja)

Applications Claiming Priority (13)

Application Number Priority Date Filing Date Title
US201361870096P 2013-08-26 2013-08-26
US61/870,096 2013-08-26
EP13181735 2013-08-26
EP13181735.5 2013-08-26
US201361895740P 2013-10-25 2013-10-25
EP13190304.9 2013-10-25
EP13190304 2013-10-25
US61/895,740 2013-10-25
US201462035898P 2014-08-11 2014-08-11
US62/035,898 2014-08-11
EP14180569 2014-08-11
EP14180569.7 2014-08-11
PCT/EP2014/068094 WO2015028472A1 (en) 2013-08-26 2014-08-26 Pharmaceutical composition containing dimethyl fumarate for administration at a low daily dose

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2019125372A Division JP2019196371A (ja) 2013-08-26 2019-07-04 低１日用量で投与するためのフマル酸ジメチルを含む医薬組成物

Publications (2)

Publication Number Publication Date
JP2016528302A true JP2016528302A (ja) 2016-09-15
JP2016528302A5 JP2016528302A5 (enExample) 2017-10-05

Family

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Family Applications (2)

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JP2016537269A Pending JP2016528302A (ja) 2013-08-26 2014-08-26 低１日用量で投与するためのフマル酸ジメチルを含む医薬組成物
JP2016537270A Pending JP2016531912A (ja) 2013-08-26 2014-08-26 低１日用量で投与するためのフマル酸ジメチルを含む医薬組成物

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JP2016537270A Pending JP2016531912A (ja) 2013-08-26 2014-08-26 低１日用量で投与するためのフマル酸ジメチルを含む医薬組成物

Country Status (9)

Country Link
US (11) US20160206587A1 (enExample)
EP (4) EP3492072A1 (enExample)
JP (2) JP2016528302A (enExample)
KR (4) KR20210139485A (enExample)
CN (4) CN109223725A (enExample)
AU (6) AU2014314230A1 (enExample)
CA (2) CA2918846A1 (enExample)
EA (2) EA201690107A1 (enExample)
WO (2) WO2015028472A1 (enExample)

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JP2023525084A (ja) * 2020-05-06 2023-06-14 アンシス・エスア 多発性硬化症の処置のためのペプチド及び方法

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NZ608196A (en) 2008-08-19 2014-09-26 Xenoport Inc Prodrugs of methyl, hydrogen fumarate, pharmaceutical compositions thereof, and methods of use
EP2887934A1 (en) 2012-08-22 2015-07-01 XenoPort, Inc. Methods of administering monomethyl fumarate and prodrugs thereof having reduced side effects
US20140348915A9 (en) 2012-08-22 2014-11-27 Xenoport, Inc. Oral Dosage Forms of Methyl Hydrogen Fumarate and Prodrugs Thereof
US10179118B2 (en) 2013-03-24 2019-01-15 Arbor Pharmaceuticals, Llc Pharmaceutical compositions of dimethyl fumarate
WO2014197860A1 (en) 2013-06-07 2014-12-11 Xenoport, Inc. Method of making monomethyl fumarate
US9421182B2 (en) 2013-06-21 2016-08-23 Xenoport, Inc. Cocrystals of dimethyl fumarate
US9416096B2 (en) 2013-09-06 2016-08-16 Xenoport, Inc. Crystalline forms of (N,N-Diethylcarbamoyl)methyl methyl (2E)but-2-ene-1,4-dioate, methods of synthesis and use
IN2013MU03070A (enExample) * 2013-09-25 2015-07-17 Glenmark Pharmaceuticals Ltd
US9636318B2 (en) 2015-08-31 2017-05-02 Banner Life Sciences Llc Fumarate ester dosage forms
US9326965B2 (en) 2014-02-28 2016-05-03 Banner Life Sciences Llc Controlled release fumarate esters
US10098863B2 (en) 2014-02-28 2018-10-16 Banner Life Sciences Llc Fumarate esters
US9326947B1 (en) 2014-02-28 2016-05-03 Banner Life Sciences Llc Controlled release fumarate esters
US9999672B2 (en) 2014-03-24 2018-06-19 Xenoport, Inc. Pharmaceutical compositions of fumaric acid esters
MA40982A (fr) * 2014-11-19 2017-09-26 Biogen Ma Inc Formulation de bille pharmaceutique comprenant du fumarate de diméthyle
US10085961B2 (en) 2015-06-01 2018-10-02 Sun Pharmaceutical Industries Limited Pharmaceutical compositions of dimethyl fumarate
WO2017040272A1 (en) * 2015-08-31 2017-03-09 Banner Life Sciences Llc Fumarate ester dosage forms
BR112018013184A2 (pt) * 2015-12-31 2018-12-11 Zaklady Farmaceutyczne Polpharma S.A. processo para preparação de um granulado revestido entérico compreendendo dimetilfumarato
KR101800956B1 (ko) * 2016-04-04 2018-01-25 주식회사 와이제이테크 파이토스핑고신과 효모추출물을 유효성분으로 포함하는 탈모방지 및 발모촉진용 조성물
RU2616605C1 (ru) * 2016-04-07 2017-04-18 Олег Ростиславович Михайлов Кристаллическая бета - модификация (Е)-диметилбутендиоата, способ её получения и фармацевтическая композиция на её основе
GR1009149B (el) * 2016-10-25 2017-10-31 Φαρματεν Αβεε Φαρμακευτικα σκευασματα που περιλαμβανουν εναν εστερα φουμαρικου οξεως και μεθοδος παραγωγης αυτων
WO2020106330A1 (en) * 2018-07-18 2020-05-28 Pillsy, Inc. Smart drug delivery and monitoring device, kit, and method of use for pill compounds
WO2020053218A1 (en) * 2018-09-13 2020-03-19 Almirall, S.A. Treatment of psoriasis
TR201818859A2 (tr) * 2018-12-07 2020-06-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Di̇meti̇l fumarat ve en az bi̇r kas gevşeti̇ci̇ ajan i̇çeren bi̇r kombi̇nasyon
AU2020283238B2 (en) * 2019-05-31 2022-07-07 Curacle Co., Ltd. Enteric tablet containing dimethyl fumarate
WO2021142062A1 (en) 2020-01-10 2021-07-15 Banner Life Sciences Llc Fumarate ester dosage forms with enhanced gastrointestinal tolerability
EP4313023A1 (en) * 2021-04-02 2024-02-07 Biogen MA Inc. Combination treatment methods of multiple sclerosis
CN115707456A (zh) * 2021-08-19 2023-02-21 成都百裕制药股份有限公司 一种富马酸二甲酯肠溶微片及其制备方法
US20230083647A1 (en) * 2021-09-10 2023-03-16 Battelle Energy Alliance, Llc Reusable structures containing isotopes for simulating radioactive contamination environments, and methods of formation

Citations (1)

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JP2012514624A (ja) * 2009-01-09 2012-06-28 フォーワード・ファルマ・アクティーゼルスカブ 浸食マトリックス中に１またはそれ以上のフマル酸エステルを含む医薬製剤

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DE19814358C2 (de) 1998-03-31 2002-01-17 Fumapharm Ag Muri Verwendung von Alkylhydrogenfumaraten zur Behandlung von Psoriasis, psoriatischer Arthritis, Neurodermitis und Enteritis regionalis Crohn
DE19848260C2 (de) 1998-10-20 2002-01-17 Fumapharm Ag Muri Fumarsäure-Mikrotabletten
DE19853487A1 (de) 1998-11-19 2000-05-25 Fumapharm Ag Muri Verwendung von Dialkylfumaraten
EP3470064A1 (en) * 2004-10-08 2019-04-17 Fwp Ip Aps Controlled release pharmaceutical compositions comprising a fumaric acid ester
CN101304732A (zh) * 2005-10-07 2008-11-12 Adi技术制药股份公司 包含富马酸酯的控释药物组合物
EP1951206A1 (en) * 2005-10-07 2008-08-06 Aditech Pharma AB Controlled release pharmaceutical compositions comprising a fumaric acid ester
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Patent Citations (1)

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JP2012514624A (ja) * 2009-01-09 2012-06-28 フォーワード・ファルマ・アクティーゼルスカブ 浸食マトリックス中に１またはそれ以上のフマル酸エステルを含む医薬製剤

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023525084A (ja) * 2020-05-06 2023-06-14 アンシス・エスア 多発性硬化症の処置のためのペプチド及び方法

Also Published As

Publication number Publication date
AU2019268052B2 (en) 2021-09-02
US20160206587A1 (en) 2016-07-21
AU2021269434A1 (en) 2021-12-16
CN109453133A (zh) 2019-03-12
EP3492072A1 (en) 2019-06-05
US20170231943A1 (en) 2017-08-17
US20190125711A1 (en) 2019-05-02
US20210290582A1 (en) 2021-09-23
US20180092875A1 (en) 2018-04-05
KR20210139485A (ko) 2021-11-22
AU2014314230A1 (en) 2016-04-07
KR20160046813A (ko) 2016-04-29
CN109223725A (zh) 2019-01-18
AU2019268049B2 (en) 2021-08-26
CA2918846A1 (en) 2015-03-05
EA201690102A1 (ru) 2016-06-30
CN105682648A (zh) 2016-06-15
AU2019268049A1 (en) 2019-12-05
EP3517102A1 (en) 2019-07-31
AU2019268052A1 (en) 2019-12-05
US20180021289A1 (en) 2018-01-25
CN105658207A (zh) 2016-06-08
EP3038606A1 (en) 2016-07-06
KR20160045728A (ko) 2016-04-27
AU2021215272A1 (en) 2021-09-02
JP2016531912A (ja) 2016-10-13
WO2015028473A1 (en) 2015-03-05
US20160206586A1 (en) 2016-07-21
US20190201369A1 (en) 2019-07-04
US20180338946A1 (en) 2018-11-29
EA201690107A1 (ru) 2016-10-31
US20180256530A1 (en) 2018-09-13
US20220168255A1 (en) 2022-06-02
WO2015028472A1 (en) 2015-03-05
KR20210147082A (ko) 2021-12-06
AU2014314231A1 (en) 2016-03-03
EP3038605A1 (en) 2016-07-06
CA2918852A1 (en) 2015-03-05

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