CN105682648A - 用于以低的日剂量施用的含富马酸二甲酯的药物组合物 - Google Patents

用于以低的日剂量施用的含富马酸二甲酯的药物组合物 Download PDF

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Publication number
CN105682648A
CN105682648A CN201480047438.3A CN201480047438A CN105682648A CN 105682648 A CN105682648 A CN 105682648A CN 201480047438 A CN201480047438 A CN 201480047438A CN 105682648 A CN105682648 A CN 105682648A
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CN
China
Prior art keywords
weight
dimethyl fumarate
pharmaceutical composition
administered
composition according
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
CN201480047438.3A
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English (en)
Chinese (zh)
Inventor
C.加莱茨卡
C.伦德费尔特
R.鲁普
P.M.安德森
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Advance Pharmaceutical Co
Qianjin Pharmaceutical Intellectual Property Co ltd
Original Assignee
Forward Pharma AS
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 Forward Pharma AS filed Critical Forward Pharma AS
Priority to CN201811202821.8A priority Critical patent/CN109453133A/zh
Publication of CN105682648A publication Critical patent/CN105682648A/zh
Pending legal-status Critical Current

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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)
CN201480047438.3A 2013-08-26 2014-08-26 用于以低的日剂量施用的含富马酸二甲酯的药物组合物 Pending CN105682648A (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201811202821.8A CN109453133A (zh) 2013-08-26 2014-08-26 用于以低的日剂量施用的含富马酸二甲酯的药物组合物

Applications Claiming Priority (13)

Application Number Priority Date Filing Date Title
US201361870096P 2013-08-26 2013-08-26
US61/870096 2013-08-26
EP13181735 2013-08-26
EP13181735.5 2013-08-26
US201361895740P 2013-10-25 2013-10-25
EP13190304 2013-10-25
EP13190304.9 2013-10-25
US61/895740 2013-10-25
US201462035898P 2014-08-11 2014-08-11
US62/035898 2014-08-11
EP14180569.7 2014-08-11
EP14180569 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
CN201811202821.8A Division CN109453133A (zh) 2013-08-26 2014-08-26 用于以低的日剂量施用的含富马酸二甲酯的药物组合物

Publications (1)

Publication Number Publication Date
CN105682648A true CN105682648A (zh) 2016-06-15

Family

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Family Applications (4)

Application Number Title Priority Date Filing Date
CN201480047436.4A Pending CN105658207A (zh) 2013-08-26 2014-08-26 用于以低的日剂量施用的含富马酸二甲酯的药物组合物
CN201811202821.8A Pending CN109453133A (zh) 2013-08-26 2014-08-26 用于以低的日剂量施用的含富马酸二甲酯的药物组合物
CN201480047438.3A Pending CN105682648A (zh) 2013-08-26 2014-08-26 用于以低的日剂量施用的含富马酸二甲酯的药物组合物
CN201811067557.1A Pending CN109223725A (zh) 2013-08-26 2014-08-26 用于以低的日剂量施用的含富马酸二甲酯的药物组合物

Family Applications Before (2)

Application Number Title Priority Date Filing Date
CN201480047436.4A Pending CN105658207A (zh) 2013-08-26 2014-08-26 用于以低的日剂量施用的含富马酸二甲酯的药物组合物
CN201811202821.8A Pending CN109453133A (zh) 2013-08-26 2014-08-26 用于以低的日剂量施用的含富马酸二甲酯的药物组合物

Family Applications After (1)

Application Number Title Priority Date Filing Date
CN201811067557.1A Pending CN109223725A (zh) 2013-08-26 2014-08-26 用于以低的日剂量施用的含富马酸二甲酯的药物组合物

Country Status (9)

Country Link
US (11) US20160206587A1 (enExample)
EP (4) EP3492072A1 (enExample)
JP (2) JP2016531912A (enExample)
KR (4) KR20160045728A (enExample)
CN (4) CN105658207A (enExample)
AU (6) AU2014314230A1 (enExample)
CA (2) CA2918852A1 (enExample)
EA (2) EA201690107A1 (enExample)
WO (2) WO2015028473A1 (enExample)

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HRP20140640T1 (hr) 2008-08-19 2014-11-21 Xenoport, Inc. Prolijekovi monometil estera fumarne kiseline, farmaceutski sastavi iz toga i postupci njihove uporabe
EP2887935A1 (en) 2012-08-22 2015-07-01 XenoPort, Inc. Oral dosage forms of methyl hydrogen fumarate and prodrugs thereof
CA2882713A1 (en) 2012-08-22 2014-02-27 Xenoport, Inc. Methods of administering monomethyl fumarate and prodrugs thereof having reduced side effects
WO2014160633A1 (en) 2013-03-24 2014-10-02 Xenoport, Inc. Pharmaceutical compositions of dimethyl fumarate
WO2014197860A1 (en) 2013-06-07 2014-12-11 Xenoport, Inc. Method of making monomethyl fumarate
WO2014205392A1 (en) 2013-06-21 2014-12-24 Xenoport, Inc. Cocrystals of dimethyl fumarate
TW201516020A (zh) 2013-09-06 2015-05-01 Xenoport Inc （ｎ，ｎ－二乙基胺甲醯基）甲基（２ｅ）丁－２－烯－１，４－二酸甲酯之晶形、合成方法及用途
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
US9326947B1 (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
ES2713157T3 (es) 2014-02-28 2019-05-20 Banner Life Sciences Llc Cápsulas blandas entéricas de liberación controlada de ésteres de fumarato
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
WO2017114593A1 (en) * 2015-12-31 2017-07-06 Zaklady Farmaceutyczne Polpharma S.A. Process for preparation of an enteric coated granulate comprising dimethyl fumarate
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
PH12021552668A1 (en) * 2019-05-31 2022-09-19 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
AU2021210629A1 (en) * 2020-05-06 2022-12-08 Imcyse Sa Peptides and methods for the treatment of multiple sclerosis
WO2022212893A1 (en) * 2021-04-02 2022-10-06 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

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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
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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

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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
CN102369001A (zh) * 2009-01-09 2012-03-07 前进制药公司 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

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LUDWIG KAPPOS，等: "Efficacy and safety of oral fumarate in patients with relapsing-remitting multiple sclerosis: a multicentre,randomised, double-blind, placebo-controlled phase IIb study", 《LANCET》 *
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Also Published As

Publication number Publication date
US20190125711A1 (en) 2019-05-02
US20180092875A1 (en) 2018-04-05
AU2021215272A1 (en) 2021-09-02
WO2015028472A1 (en) 2015-03-05
AU2019268052A1 (en) 2019-12-05
US20190201369A1 (en) 2019-07-04
AU2014314231A1 (en) 2016-03-03
KR20210147082A (ko) 2021-12-06
EA201690102A1 (ru) 2016-06-30
KR20210139485A (ko) 2021-11-22
AU2021269434A1 (en) 2021-12-16
AU2019268049A1 (en) 2019-12-05
KR20160046813A (ko) 2016-04-29
EA201690107A1 (ru) 2016-10-31
EP3517102A1 (en) 2019-07-31
AU2014314230A1 (en) 2016-04-07
CN105658207A (zh) 2016-06-08
JP2016531912A (ja) 2016-10-13
CA2918846A1 (en) 2015-03-05
US20180338946A1 (en) 2018-11-29
US20180256530A1 (en) 2018-09-13
EP3038606A1 (en) 2016-07-06
US20160206586A1 (en) 2016-07-21
JP2016528302A (ja) 2016-09-15
CN109453133A (zh) 2019-03-12
AU2019268049B2 (en) 2021-08-26
EP3038605A1 (en) 2016-07-06
US20220168255A1 (en) 2022-06-02
WO2015028473A1 (en) 2015-03-05
KR20160045728A (ko) 2016-04-27
AU2019268052B2 (en) 2021-09-02
US20210290582A1 (en) 2021-09-23
EP3492072A1 (en) 2019-06-05
US20180021289A1 (en) 2018-01-25
US20170231943A1 (en) 2017-08-17
CN109223725A (zh) 2019-01-18
US20160206587A1 (en) 2016-07-21
CA2918852A1 (en) 2015-03-05

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C06 Publication
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C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
TA01 Transfer of patent application right
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Effective date of registration: 20180918

Address after: Copenhagen, Denmark

Applicant after: Advance pharmaceutical Co.

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CI02 Correction of invention patent application
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Number: 41-02

Volume: 34

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Application publication date: 20160615