EA201891803A1 - Фармацевтические составы в форме гранул, содержащие диметилфумарат - Google Patents

Фармацевтические составы в форме гранул, содержащие диметилфумарат

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Publication number
EA201891803A1
EA201891803A1 EA201891803A EA201891803A EA201891803A1 EA 201891803 A1 EA201891803 A1 EA 201891803A1 EA 201891803 A EA201891803 A EA 201891803A EA 201891803 A EA201891803 A EA 201891803A EA 201891803 A1 EA201891803 A1 EA 201891803A1
Authority
EA
Eurasian Patent Office
Prior art keywords
granules
pharmaceutical compositions
pharmaceutical composition
granules containing
composition
Prior art date
Application number
EA201891803A
Other languages
English (en)
Inventor
Шиам Б. Карки
Питер Заванех
Чеук-Юи Леунг
Калян Васудеван
Ицин Линь
Цзинь Сюй
Андреа Трементоззи
Иван Несторов
Original Assignee
Байоджен Ма Инк.
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 Байоджен Ма Инк. filed Critical Байоджен Ма Инк.
Publication of EA201891803A1 publication Critical patent/EA201891803A1/ru

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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
    • A61K9/48—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
    • A61K9/5005—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
    • 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
    • A61K9/5005—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
    • 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

Abstract

В данном изобретении предложены новые фармацевтические композиции на основе диметилфумарата. Фармацевтические композиции по данному изобретению содержат первую фармацевтическую композицию в форме гранул и вторую фармацевтическую композицию в форме гранул, причем первая фармацевтическая композиция в форме гранул представляет собой покрытую энтеросолюбильной оболочкой композицию с быстрым высвобождением, а вторая фармацевтическая композиция в форме гранул представляет собой покрытую энтеросолюбильной оболочкой композицию с контролируемым высвобождением, при этом как первая фармацевтическая композиция в форме гранул, так и вторая фармацевтическая композиция в форме гранул содержат диметилфумарат. Также включены способы применения фармацевтических композиций по данному изобретению для лечения рассеянного склероза.
EA201891803A 2016-02-11 2017-02-08 Фармацевтические составы в форме гранул, содержащие диметилфумарат EA201891803A1 (ru)

Applications Claiming Priority (2)

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

Publications (1)

Publication Number Publication Date
EA201891803A1 true EA201891803A1 (ru) 2019-01-31

Family

ID=58057304

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201891803A EA201891803A1 (ru) 2016-02-11 2017-02-08 Фармацевтические составы в форме гранул, содержащие диметилфумарат

Country Status (12)

Country Link
US (2) US11033509B2 (ru)
EP (1) EP3413879A1 (ru)
JP (2) JP6902043B2 (ru)
KR (1) KR20180108814A (ru)
CN (1) CN108778256A (ru)
AU (1) AU2017217464B2 (ru)
CA (1) CA3013472A1 (ru)
EA (1) EA201891803A1 (ru)
IL (1) IL261073A (ru)
MA (1) MA44010A (ru)
MX (1) MX2018009749A (ru)
WO (1) WO2017139331A1 (ru)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20180108814A (ko) * 2016-02-11 2018-10-04 바이오젠 엠에이 인코포레이티드 다이메틸 퓨마레이트를 포함하는 약제학적 비드 제형

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2523796T1 (es) * 2004-10-08 2014-12-01 Forward Pharma A/S Composición farmacéutica de liberación controlada que comprende éster de ácido fumárico
US20080187579A1 (en) 2007-02-01 2008-08-07 Pavan Bhat Extended-release dosage form
SG11201404705YA (en) * 2012-02-07 2014-10-30 Biogen Idec Inc Pharmaceutical compositions containing dimethyl fumarate
US20150079180A1 (en) * 2013-09-18 2015-03-19 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
CN107920997A (zh) 2015-06-17 2018-04-17 比奥根Ma公司 富马酸二甲酯颗粒和其药物组合物
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

Also Published As

Publication number Publication date
CN108778256A (zh) 2018-11-09
WO2017139331A1 (en) 2017-08-17
AU2017217464B2 (en) 2022-11-10
IL261073A (en) 2018-10-31
JP2019504859A (ja) 2019-02-21
KR20180108814A (ko) 2018-10-04
US20190046456A1 (en) 2019-02-14
JP6902043B2 (ja) 2021-07-14
JP2021152050A (ja) 2021-09-30
CA3013472A1 (en) 2017-08-17
MA44010A (fr) 2018-12-19
MX2018009749A (es) 2019-02-07
US20210369629A1 (en) 2021-12-02
AU2017217464A1 (en) 2018-08-30
EP3413879A1 (en) 2018-12-19
US11033509B2 (en) 2021-06-15
WO2017139331A8 (en) 2017-10-12

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