CA2918846A1 - Pharmaceutical composition containing dimethyl fumarate for administration at a low daily dose - Google Patents

Pharmaceutical composition containing dimethyl fumarate for administration at a low daily dose Download PDF

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Publication number
CA2918846A1
CA2918846A1 CA2918846A CA2918846A CA2918846A1 CA 2918846 A1 CA2918846 A1 CA 2918846A1 CA 2918846 A CA2918846 A CA 2918846A CA 2918846 A CA2918846 A CA 2918846A CA 2918846 A1 CA2918846 A1 CA 2918846A1
Authority
CA
Canada
Prior art keywords
weight
pharmaceutical composition
dimethyl fumarate
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.)
Abandoned
Application number
CA2918846A
Other languages
English (en)
French (fr)
Inventor
Christin Galetzka
Chris Rundfeldt
Roland Rupp
Peder M. Andersen
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.)
FWP IP ApS
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
Publication of CA2918846A1 publication Critical patent/CA2918846A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • 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

Landscapes

  • 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)
CA2918846A 2013-08-26 2014-08-26 Pharmaceutical composition containing dimethyl fumarate for administration at a low daily dose Abandoned CA2918846A1 (en)

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

Publications (1)

Publication Number Publication Date
CA2918846A1 true CA2918846A1 (en) 2015-03-05

Family

ID=52585633

Family Applications (2)

Application Number Title Priority Date Filing Date
CA2918846A Abandoned CA2918846A1 (en) 2013-08-26 2014-08-26 Pharmaceutical composition containing dimethyl fumarate for administration at a low daily dose
CA2918852A Abandoned CA2918852A1 (en) 2013-08-26 2014-08-26 Pharmaceutical composition containing dimethyl fumarate for administration at a low daily dose

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA2918852A Abandoned CA2918852A1 (en) 2013-08-26 2014-08-26 Pharmaceutical composition containing dimethyl fumarate for administration at a low daily dose

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)

Families Citing this family (29)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
MX2022013911A (es) * 2020-05-06 2022-11-30 Imcyse Sa Peptidos y metodos para el tratamiento de esclerosis multiple.
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

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
HUE030169T2 (en) * 2009-01-09 2017-05-29 Forward Pharma As Pharmaceutical formulation comprising one or more fumaric acid esters in an erosion matrix
US20120034274A1 (en) * 2009-01-09 2012-02-09 Forward Pharma A/S Pharmaceutical composition comprising one or more fumaric acid esters

Also Published As

Publication number Publication date
JP2016528302A (ja) 2016-09-15
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
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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Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20190826

EEER Examination request

Effective date: 20190826

EEER Examination request

Effective date: 20190826

FZDE Discontinued

Effective date: 20230531