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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    • 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
    • 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
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; 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
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Inorganic Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dermatology (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
EP13181735.5 2013-08-26
EP13181735 2013-08-26
US61/870096 2013-08-26
US201361895740P 2013-10-25 2013-10-25
EP13190304 2013-10-25
US61/895740 2013-10-25
EP13190304.9 2013-10-25
US201462035898P 2014-08-11 2014-08-11
US62/035898 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
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
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
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
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 After (3)

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
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) US20160206586A1 (https=)
EP (4) EP3038605A1 (https=)
JP (2) JP2016531912A (https=)
KR (4) KR20160045728A (https=)
CN (4) CN105682648A (https=)
AU (6) AU2014314231A1 (https=)
CA (2) CA2918846A1 (https=)
EA (2) EA201690102A1 (https=)
WO (2) WO2015028472A1 (https=)

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RU2554347C2 (ru) 2008-08-19 2015-06-27 Ксенопорт, Инк. Пролекарства метилгидрофумарата, фармацевтические композиции с ними и способы применения
US10945984B2 (en) 2012-08-22 2021-03-16 Arbor Pharmaceuticals, Llc Methods of administering monomethyl fumarate and prodrugs thereof having reduced side effects
CA2882730C (en) 2012-08-22 2019-12-31 Arbor Pharmaceuticals, Llc 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
US9302977B2 (en) 2013-06-07 2016-04-05 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 (https=) * 2013-09-25 2015-07-17 Glenmark Pharmaceuticals Ltd
ES2713157T3 (es) 2014-02-28 2019-05-20 Banner Life Sciences Llc Cápsulas blandas entéricas de liberación controlada de ésteres de fumarato
US9326947B1 (en) 2014-02-28 2016-05-03 Banner Life Sciences Llc Controlled release fumarate esters
US9636318B2 (en) 2015-08-31 2017-05-02 Banner Life Sciences Llc Fumarate ester dosage forms
US10098863B2 (en) 2014-02-28 2018-10-16 Banner Life Sciences Llc 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
WO2016194004A1 (en) * 2015-06-01 2016-12-08 Sun Pharmaceutical Industries Ltd. Pharmaceutical compositions of dimethyl fumarate
WO2017040272A1 (en) * 2015-08-31 2017-03-09 Banner Life Sciences Llc Fumarate ester dosage forms
EP3397247B1 (en) * 2015-12-31 2023-06-07 Zaklady Farmaceutyczne Polpharma SA 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
AU2020283238B2 (en) * 2019-05-31 2022-07-07 Curacle Co., Ltd. Enteric tablet containing dimethyl fumarate
US11903918B2 (en) 2020-01-10 2024-02-20 Banner Life Sciences Llc Fumarate ester dosage forms with enhanced gastrointestinal tolerability
AR122023A1 (es) * 2020-05-06 2022-08-03 Imcyse Sa Péptidos y métodos para el tratamiento de esclerosis múltiple
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

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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
US20090304790A1 (en) * 2004-10-08 2009-12-10 Aditech Pharma Ab Controlled release pharmaceutical compositions comprising a fumaric acid ester
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
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

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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
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

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Also Published As

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

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C06 Publication
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SE01 Entry into force of request for substantive examination
TA01 Transfer of patent application right
TA01 Transfer of patent application right

Effective date of registration: 20180918

Address after: Copenhagen, Denmark

Applicant after: Advance pharmaceutical Co.

Address before: Copenhagen, Denmark

Applicant before: FORWARD PHARMA A/S

CI02 Correction of invention patent application
CI02 Correction of invention patent application

Correction item: Applicant|Address

Correct: Forward Pharma AS|Copenhagen, Denmark

False: Advance pharmaceutical company|Copenhagen, Denmark

Number: 41-02

Volume: 34

TA01 Transfer of patent application right
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Effective date of registration: 20181122

Address after: Copenhagen, Denmark

Applicant after: Qianjin Pharmaceutical Intellectual Property Co.,Ltd.

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Applicant after: Advance pharmaceutical Co.

Address before: Copenhagen, Denmark

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WD01 Invention patent application deemed withdrawn after publication
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Application publication date: 20160615