JP2018517735A - フマル酸ジメチル粒子及びそれらの医薬組成物 - Google Patents

フマル酸ジメチル粒子及びそれらの医薬組成物 Download PDF

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Publication number
JP2018517735A
JP2018517735A JP2017565133A JP2017565133A JP2018517735A JP 2018517735 A JP2018517735 A JP 2018517735A JP 2017565133 A JP2017565133 A JP 2017565133A JP 2017565133 A JP2017565133 A JP 2017565133A JP 2018517735 A JP2018517735 A JP 2018517735A
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JP
Japan
Prior art keywords
dmf
inner layer
dosage form
controlled release
polymer
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Pending
Application number
JP2017565133A
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English (en)
Japanese (ja)
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JP2018517735A5 (https=
Inventor
ボウラス，ピエール
イルダム，アーウィン
カルキ，シャム・ビー
キースマン，ウィリアム・エフ
レオン，チェク−ユイ
リン，イーチーン
トレメントッツィ，アンドレア
ザワネ，ピーター
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Biogen MA Inc
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Biogen MA Inc
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Publication of JP2018517735A publication Critical patent/JP2018517735A/ja
Publication of JP2018517735A5 publication Critical patent/JP2018517735A5/ja
Priority to JP2021184469A priority Critical patent/JP2022042512A/ja
Pending legal-status Critical Current

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Classifications

    • 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
    • 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
    • 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)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (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)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2017565133A 2015-06-17 2016-06-15 フマル酸ジメチル粒子及びそれらの医薬組成物 Pending JP2018517735A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2021184469A JP2022042512A (ja) 2015-06-17 2021-11-12 フマル酸ジメチル粒子及びそれらの医薬組成物

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
JP2021184469A Division JP2022042512A (ja) 2015-06-17 2021-11-12 フマル酸ジメチル粒子及びそれらの医薬組成物

Publications (2)

Publication Number Publication Date
JP2018517735A true JP2018517735A (ja) 2018-07-05
JP2018517735A5 JP2018517735A5 (https=) 2019-07-18

Family

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Family Applications (2)

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JP2017565133A Pending JP2018517735A (ja) 2015-06-17 2016-06-15 フマル酸ジメチル粒子及びそれらの医薬組成物
JP2021184469A Pending JP2022042512A (ja) 2015-06-17 2021-11-12 フマル酸ジメチル粒子及びそれらの医薬組成物

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Country Status (13)

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

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022523510A (ja) * 2019-01-31 2022-04-25 エレクトロフィ，インコーポレイテッド 粒子形成及び形態構造
JP2022525482A (ja) * 2019-03-20 2022-05-16 リンドラ セラピューティクス， インコーポレイティド 胃内滞留剤形用のコーティング
JP2022525926A (ja) * 2019-03-20 2022-05-20 リンドラ セラピューティクス， インコーポレイティド 胃内滞留剤形用のカプセル及びカプセルコーティング

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AU2016344673A1 (en) * 2015-10-28 2018-05-17 Sun Pharmaceutical Industries Limited Pharmaceutical compositions of dimethyl fumarate
JP6902043B2 (ja) * 2016-02-11 2021-07-14 バイオジェン・エムエイ・インコーポレイテッドＢｉｏｇｅｎ ＭＡ Ｉｎｃ． フマル酸ジメチルを含む医薬ビーズ製剤
CA3075720A1 (en) * 2017-10-02 2019-04-11 Novartis Ag Method for preparing a pharmaceutical product
WO2019194826A1 (en) 2018-04-06 2019-10-10 Hewlett-Packard Development Company, L.P. Three-dimensional (3d) object printing based on build material permeability
CA3115516C (en) * 2018-10-05 2023-04-25 Isp Investments Llc Smooth high solids film coating composition comprising water soluble cellulose ether, process for preparing the same and method of use thereof
TR201818293A2 (tr) * 2018-11-30 2020-06-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Di̇meti̇l fumarat i̇çeren geci̇kmeli̇ salim sağlayan kapsül
JP2023553274A (ja) * 2020-11-18 2023-12-21 エフビー－エイチアールエス リミテッド ライアビリティ カンパニー ドフェチリド及びメキシレチンを含有する組成物並びにその使用
CN116887866A (zh) 2020-12-03 2023-10-13 巴特尔纪念研究院 聚合物纳米颗粒和dna纳米结构组合物及用于非病毒递送的方法
WO2022216977A1 (en) 2021-04-07 2022-10-13 Batelle Memorial Institute Rapid design, build, test, and learn technologies for identifying and using non-viral carriers
AU2022285951A1 (en) 2021-06-04 2024-01-04 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
US12441996B2 (en) 2023-12-08 2025-10-14 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

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WO2013076216A1 (en) * 2011-11-24 2013-05-30 Synthon Bv Controlled release particles comprising dimethyl fumarate
JP2014522413A (ja) * 2011-06-08 2014-09-04 バイオジェン・アイデック・エムエイ・インコーポレイテッド 高純度結晶性ジメチルフマラートの調製方法
WO2015044853A2 (en) * 2013-09-25 2015-04-02 Glenmark Pharmaceuticals Limited; Glenmark Generics Limited Process for preparation of dimethyl fumarate

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JP2014522413A (ja) * 2011-06-08 2014-09-04 バイオジェン・アイデック・エムエイ・インコーポレイテッド 高純度結晶性ジメチルフマラートの調製方法
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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022523510A (ja) * 2019-01-31 2022-04-25 エレクトロフィ，インコーポレイテッド 粒子形成及び形態構造
JP2022525482A (ja) * 2019-03-20 2022-05-16 リンドラ セラピューティクス， インコーポレイティド 胃内滞留剤形用のコーティング
JP2022525926A (ja) * 2019-03-20 2022-05-20 リンドラ セラピューティクス， インコーポレイティド 胃内滞留剤形用のカプセル及びカプセルコーティング
JP2025066761A (ja) * 2019-03-20 2025-04-23 リンドラ セラピューティクス， インコーポレイティド 胃内滞留剤形用のカプセル及びカプセルコーティング
JP2025067914A (ja) * 2019-03-20 2025-04-24 リンドラ セラピューティクス， インコーポレイティド 胃内滞留剤形用のコーティング
US12447130B2 (en) 2019-03-20 2025-10-21 Lyndra Therapeutics, Inc. Capsules and capsule coatings for gastric residence dosage forms
US12582608B2 (en) 2019-03-20 2026-03-24 Nortiva Bio, Inc. Coatings for gastric residence dosage forms

Also Published As

Publication number Publication date
WO2016205270A1 (en) 2016-12-22
CA2989581A1 (en) 2016-12-22
MA42196A (fr) 2018-04-25
AU2016279997B2 (en) 2021-10-21
WO2016205270A8 (en) 2017-01-19
HK1254054A1 (zh) 2019-07-12
US20220362195A1 (en) 2022-11-17
MX387092B (es) 2025-03-19
CN107920997A (zh) 2018-04-17
KR20180018711A (ko) 2018-02-21
AU2016279997A1 (en) 2018-01-18
US11291642B2 (en) 2022-04-05
AU2022200155A1 (en) 2022-02-10
US20190070143A1 (en) 2019-03-07
MX2017016509A (es) 2018-08-16
EP3310341A1 (en) 2018-04-25
EA201890068A1 (ru) 2018-09-28
IL256296A (en) 2018-02-28
JP2022042512A (ja) 2022-03-14

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