JP6902043B2 - フマル酸ジメチルを含む医薬ビーズ製剤 - Google Patents

フマル酸ジメチルを含む医薬ビーズ製剤 Download PDF

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Publication number
JP6902043B2
JP6902043B2 JP2018542269A JP2018542269A JP6902043B2 JP 6902043 B2 JP6902043 B2 JP 6902043B2 JP 2018542269 A JP2018542269 A JP 2018542269A JP 2018542269 A JP2018542269 A JP 2018542269A JP 6902043 B2 JP6902043 B2 JP 6902043B2
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pharmaceutical
layer
composition
bead composition
pharmaceutical bead
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Expired - Fee Related
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JP2018542269A
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English (en)
Japanese (ja)
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JP2019504859A (ja
JP2019504859A5 (enExample
Inventor
カルキ，シャム・ビー
ザワネ，ピーター
レオン，チェク−ユイ
バスデバン，カリヤーン
リン，イーチーン
シュウ，ジン
トレメントッツィ，アンドレア
ネストロフ，イヴァン
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Biogen MA Inc
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Biogen MA Inc
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Publication of JP2019504859A publication Critical patent/JP2019504859A/ja
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Priority to JP2021101599A priority Critical patent/JP2021152050A/ja
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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
    • A61K9/48—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
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, 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
    • A61K9/48—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
    • 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
    • A61K9/14—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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • 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
    • A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Emergency Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2018542269A 2016-02-11 2017-02-08 フマル酸ジメチルを含む医薬ビーズ製剤 Expired - Fee Related JP6902043B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2021101599A JP2021152050A (ja) 2016-02-11 2021-06-18 フマル酸ジメチルを含む医薬ビーズ製剤

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662294054P 2016-02-11 2016-02-11
US62/294,054 2016-02-11
PCT/US2017/016934 WO2017139331A1 (en) 2016-02-11 2017-02-08 Pharmaceutical bead formulations comprising dimethyl fumarate

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2021101599A Division JP2021152050A (ja) 2016-02-11 2021-06-18 フマル酸ジメチルを含む医薬ビーズ製剤

Publications (3)

Publication Number Publication Date
JP2019504859A JP2019504859A (ja) 2019-02-21
JP2019504859A5 JP2019504859A5 (enExample) 2020-03-19
JP6902043B2 true JP6902043B2 (ja) 2021-07-14

Family

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JP2018542269A Expired - Fee Related JP6902043B2 (ja) 2016-02-11 2017-02-08 フマル酸ジメチルを含む医薬ビーズ製剤
JP2021101599A Pending JP2021152050A (ja) 2016-02-11 2021-06-18 フマル酸ジメチルを含む医薬ビーズ製剤

Family Applications After (1)

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JP2021101599A Pending JP2021152050A (ja) 2016-02-11 2021-06-18 フマル酸ジメチルを含む医薬ビーズ製剤

Country Status (12)

Country Link
US (2) US11033509B2 (enExample)
EP (1) EP3413879A1 (enExample)
JP (2) JP6902043B2 (enExample)
KR (1) KR20180108814A (enExample)
CN (1) CN108778256A (enExample)
AU (1) AU2017217464B2 (enExample)
CA (1) CA3013472A1 (enExample)
EA (1) EA201891803A1 (enExample)
IL (1) IL261073A (enExample)
MA (1) MA44010A (enExample)
MX (1) MX391749B (enExample)
WO (1) WO2017139331A1 (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2021152050A (ja) * 2016-02-11 2021-09-30 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

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11723862B2 (en) * 2020-01-17 2023-08-15 Societe Des Produits Nestle S.A. Dosage form with sustained release melatonin pellets
AU2022285951A1 (en) 2021-06-04 2024-01-04 Zim Laboratories Limited Delayed release compositions of dimethyl fumarate
US12303604B1 (en) 2024-10-16 2025-05-20 Currax Pharmaceuticals Llc Pharmaceutical formulations comprising naltrexone and/or bupropion

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE14172396T1 (de) 2004-10-08 2015-01-08 Forward Pharma A/S Gesteuerte Freisetzung von pharmazeutischen Zusammensetzungen mit Fumarinsäureester
US20080187579A1 (en) 2007-02-01 2008-08-07 Pavan Bhat Extended-release dosage form
AU2013203445C1 (en) * 2012-02-07 2017-04-20 Biogen Ma Inc. Pharmaceutical compositions containing dimethyl fumarate
WO2015042294A1 (en) * 2013-09-18 2015-03-26 Xenoport, Inc. Nanoparticle compositions of dimethyl fumarate
US10172794B2 (en) 2013-12-13 2019-01-08 Biogen Ma Inc. Controlled release dosage form for once daily administration of dimethyl fumarate
MA40982A (fr) * 2014-11-19 2017-09-26 Biogen Ma Inc Formulation de bille pharmaceutique comprenant du fumarate de diméthyle
JP2018517735A (ja) * 2015-06-17 2018-07-05 バイオジェン・エムエイ・インコーポレイテッドＢｉｏｇｅｎ ＭＡ Ｉｎｃ． フマル酸ジメチル粒子及びそれらの医薬組成物
CN104971048B (zh) * 2015-07-01 2019-01-18 上海汇伦医药科技有限公司 富马酸二甲酯肠溶微丸及其制备方法
KR20180108814A (ko) * 2016-02-11 2018-10-04 바이오젠 엠에이 인코포레이티드 다이메틸 퓨마레이트를 포함하는 약제학적 비드 제형

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2021152050A (ja) * 2016-02-11 2021-09-30 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

Also Published As

Publication number Publication date
JP2021152050A (ja) 2021-09-30
JP2019504859A (ja) 2019-02-21
IL261073A (en) 2018-10-31
WO2017139331A8 (en) 2017-10-12
US20210369629A1 (en) 2021-12-02
MA44010A (fr) 2018-12-19
US20190046456A1 (en) 2019-02-14
AU2017217464B2 (en) 2022-11-10
MX2018009749A (es) 2019-02-07
WO2017139331A1 (en) 2017-08-17
CA3013472A1 (en) 2017-08-17
US11033509B2 (en) 2021-06-15
AU2017217464A1 (en) 2018-08-30
KR20180108814A (ko) 2018-10-04
CN108778256A (zh) 2018-11-09
EA201891803A1 (ru) 2019-01-31
MX391749B (es) 2025-03-21
EP3413879A1 (en) 2018-12-19

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