AU2016279997B2 - Dimethyl fumarate particles and pharmaceutical compositions thereof - Google Patents

Dimethyl fumarate particles and pharmaceutical compositions thereof Download PDF

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Publication number
AU2016279997B2
AU2016279997B2 AU2016279997A AU2016279997A AU2016279997B2 AU 2016279997 B2 AU2016279997 B2 AU 2016279997B2 AU 2016279997 A AU2016279997 A AU 2016279997A AU 2016279997 A AU2016279997 A AU 2016279997A AU 2016279997 B2 AU2016279997 B2 AU 2016279997B2
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AU
Australia
Prior art keywords
dmf
particles
dosage form
hours
less
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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.)
Ceased
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AU2016279997A
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English (en)
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AU2016279997A1 (en
Inventor
Pierre BOULAS
Erwin IRDAM
Shyam B. Karki
William F. Kiesman
Cheuk-Yui LEUNG
Yiqing Lin
Andrea TREMENTOZZI
Peter ZAWANEH
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Biogen MA Inc
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Biogen MA Inc
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Publication of AU2016279997A1 publication Critical patent/AU2016279997A1/en
Application granted granted Critical
Publication of AU2016279997B2 publication Critical patent/AU2016279997B2/en
Priority to AU2022200155A priority Critical patent/AU2022200155A1/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • 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
    • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Emergency Medicine (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AU2016279997A 2015-06-17 2016-06-15 Dimethyl fumarate particles and pharmaceutical compositions thereof Ceased AU2016279997B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2022200155A AU2022200155A1 (en) 2015-06-17 2022-01-12 Dimethyl fumarate particles and pharmaceutical compositions thereof

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562181061P 2015-06-17 2015-06-17
US62/181,061 2015-06-17
PCT/US2016/037486 WO2016205270A1 (en) 2015-06-17 2016-06-15 Dimethyl fumarate particles and pharmaceutical compositions thereof

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2022200155A Division AU2022200155A1 (en) 2015-06-17 2022-01-12 Dimethyl fumarate particles and pharmaceutical compositions thereof

Publications (2)

Publication Number Publication Date
AU2016279997A1 AU2016279997A1 (en) 2018-01-18
AU2016279997B2 true AU2016279997B2 (en) 2021-10-21

Family

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Family Applications (2)

Application Number Title Priority Date Filing Date
AU2016279997A Ceased AU2016279997B2 (en) 2015-06-17 2016-06-15 Dimethyl fumarate particles and pharmaceutical compositions thereof
AU2022200155A Abandoned AU2022200155A1 (en) 2015-06-17 2022-01-12 Dimethyl fumarate particles and pharmaceutical compositions thereof

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2022200155A Abandoned AU2022200155A1 (en) 2015-06-17 2022-01-12 Dimethyl fumarate particles and pharmaceutical compositions thereof

Country Status (13)

Country Link
US (2) US11291642B2 (enExample)
EP (1) EP3310341A1 (enExample)
JP (2) JP2018517735A (enExample)
KR (1) KR20180018711A (enExample)
CN (1) CN107920997A (enExample)
AU (2) AU2016279997B2 (enExample)
CA (1) CA2989581A1 (enExample)
EA (1) EA201890068A1 (enExample)
HK (1) HK1254054A1 (enExample)
IL (1) IL256296A (enExample)
MA (1) MA42196A (enExample)
MX (1) MX387092B (enExample)
WO (1) WO2016205270A1 (enExample)

Families Citing this family (18)

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MX2018005345A (es) * 2015-10-28 2018-08-14 Sun Pharmaceutical Ind Ltd Composiciones farmaceuticas de dimetil fumarato.
EP3413879A1 (en) 2016-02-11 2018-12-19 Biogen MA Inc. Pharmaceutical bead formulations comprising dimethyl fumarate
CA3075720A1 (en) * 2017-10-02 2019-04-11 Novartis Ag Method for preparing a pharmaceutical product
US11318682B2 (en) 2018-04-06 2022-05-03 Hewlett-Packard Development Company, L.P. Three-dimensional (3D) object printing based on build material permeability
EP3860849A4 (en) * 2018-10-05 2022-06-22 ISP Investments LLC SMOOTH HIGH SOLIDS FILM COATING COMPOSITION WITH WATER SOLUBLE CELLULOSE ETHER, PROCESS FOR ITS PRODUCTION
TR201818293A2 (tr) * 2018-11-30 2020-06-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Di̇meti̇l fumarat i̇çeren geci̇kmeli̇ salim sağlayan kapsül
WO2020160323A2 (en) * 2019-01-31 2020-08-06 Elektrofi, Inc. Particle formation and morphology
AU2020240108B2 (en) * 2019-03-20 2025-12-04 Lyndra Therapeutics, Inc. Capsules and capsule coatings for gastric residence dosage forms
CN113840596A (zh) * 2019-03-20 2021-12-24 林德拉治疗公司 用于胃滞留剂型的衣层
CN116669715A (zh) * 2020-11-18 2023-08-29 Fb-Hrs有限责任公司 含有多非利特和美西律的组合物及其应用
WO2022120194A1 (en) 2020-12-03 2022-06-09 Battelle Memorial Institute Polymer nanoparticle and dna nanostructure compositions and methods for non-viral delivery
IL307454A (en) 2021-04-07 2023-12-01 Battelle Memorial Institute Technologies for rapid design, construction, testing, learning to identify and use non-viral vectors
WO2022254356A1 (en) 2021-06-04 2022-12-08 Zim Laboratories Limited Delayed release compositions of dimethyl fumarate
US11590071B2 (en) * 2021-07-06 2023-02-28 King Abdulaziz University Injectable drug delivery implant composition and method of use thereof
WO2025072751A1 (en) 2023-09-29 2025-04-03 Battelle Memorial Institute Polymer nanoparticle compositions for in vivo expression of polypeptides
WO2025090498A1 (en) * 2023-10-23 2025-05-01 Isp Investments Llc Encapsulated medium chain fatty acid salts and oral solid dosage forms derived therefrom
WO2025122954A1 (en) 2023-12-08 2025-06-12 Battelle Memorial Institute Use of dna origami nanostructures for molecular information based data storage systems
US12303604B1 (en) 2024-10-16 2025-05-20 Currax Pharmaceuticals Llc Pharmaceutical formulations comprising naltrexone and/or bupropion

Citations (6)

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WO2010079222A1 (en) * 2009-01-09 2010-07-15 Forward Pharma A/S Pharmaceutical formulation comprising one or more fumaric acid esters in an erosion matrix
WO2012170923A1 (en) * 2011-06-08 2012-12-13 Biogen Idec Ma Inc. Process for preparing high purity and crystalline dimethyl fumarate
WO2015042294A1 (en) * 2013-09-18 2015-03-26 Xenoport, Inc. Nanoparticle compositions of dimethyl fumarate
WO2015044853A2 (en) * 2013-09-25 2015-04-02 Glenmark Pharmaceuticals Limited; Glenmark Generics Limited Process for preparation of dimethyl fumarate
WO2015089420A1 (en) * 2013-12-13 2015-06-18 Biogen Idec Ma Inc. Controlled release dosage form for once daily administration of dimethyl fumarate
WO2015130998A1 (en) * 2014-02-28 2015-09-03 Banner Life Sciences Llc Controlled release enteric soft capsules of fumarate esters

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DE19853487A1 (de) 1998-11-19 2000-05-25 Fumapharm Ag Muri Verwendung von Dialkylfumaraten
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DE10101307A1 (de) * 2001-01-12 2002-08-01 Fumapharm Ag Muri Fumarsäurederivate als NF-kappaB-Inhibitor
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WO2010079222A1 (en) * 2009-01-09 2010-07-15 Forward Pharma A/S Pharmaceutical formulation comprising one or more fumaric acid esters in an erosion matrix
WO2012170923A1 (en) * 2011-06-08 2012-12-13 Biogen Idec Ma Inc. Process for preparing high purity and crystalline dimethyl fumarate
WO2015042294A1 (en) * 2013-09-18 2015-03-26 Xenoport, Inc. Nanoparticle compositions of dimethyl fumarate
WO2015044853A2 (en) * 2013-09-25 2015-04-02 Glenmark Pharmaceuticals Limited; Glenmark Generics Limited Process for preparation of dimethyl fumarate
WO2015089420A1 (en) * 2013-12-13 2015-06-18 Biogen Idec Ma Inc. Controlled release dosage form for once daily administration of dimethyl fumarate
WO2015130998A1 (en) * 2014-02-28 2015-09-03 Banner Life Sciences Llc Controlled release enteric soft capsules of fumarate esters

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Also Published As

Publication number Publication date
MX2017016509A (es) 2018-08-16
MX387092B (es) 2025-03-19
KR20180018711A (ko) 2018-02-21
EA201890068A1 (ru) 2018-09-28
WO2016205270A1 (en) 2016-12-22
IL256296A (en) 2018-02-28
WO2016205270A8 (en) 2017-01-19
HK1254054A1 (zh) 2019-07-12
MA42196A (fr) 2018-04-25
AU2016279997A1 (en) 2018-01-18
CN107920997A (zh) 2018-04-17
US11291642B2 (en) 2022-04-05
AU2022200155A1 (en) 2022-02-10
JP2018517735A (ja) 2018-07-05
US20220362195A1 (en) 2022-11-17
US20190070143A1 (en) 2019-03-07
CA2989581A1 (en) 2016-12-22
EP3310341A1 (en) 2018-04-25
JP2022042512A (ja) 2022-03-14

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