EA039157B1 - Фармацевтические составы в виде гранул, содержащие диметилфумарат - Google Patents

Фармацевтические составы в виде гранул, содержащие диметилфумарат Download PDF

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Publication number
EA039157B1
EA039157B1 EA201791113A EA201791113A EA039157B1 EA 039157 B1 EA039157 B1 EA 039157B1 EA 201791113 A EA201791113 A EA 201791113A EA 201791113 A EA201791113 A EA 201791113A EA 039157 B1 EA039157 B1 EA 039157B1
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EA
Eurasian Patent Office
Prior art keywords
layer
core
shell
inert core
mass
Prior art date
Application number
EA201791113A
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English (en)
Russian (ru)
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EA201791113A1 (ru
Inventor
Шиам Б. Карки
Питер Заванех
Чеук-Юи Леунг
Калян Васудеван
Ицин Линь
Цзинь Сюй
Андреа Трементоззи
Original Assignee
Байоджен Ма Инк.
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Application filed by Байоджен Ма Инк. filed Critical Байоджен Ма Инк.
Publication of EA201791113A1 publication Critical patent/EA201791113A1/ru
Publication of EA039157B1 publication Critical patent/EA039157B1/ru

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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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • 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
    • A61K9/167—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/2873—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/288—Compounds of unknown constitution, e.g. material from plants or animals
    • 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
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Emergency Medicine (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Botany (AREA)
  • Zoology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
EA201791113A 2014-11-19 2015-11-19 Фармацевтические составы в виде гранул, содержащие диметилфумарат EA039157B1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201462081889P 2014-11-19 2014-11-19
PCT/US2015/061456 WO2016081676A1 (en) 2014-11-19 2015-11-19 Pharmaceutical bead formulations comprising dimethyl fumarate

Publications (2)

Publication Number Publication Date
EA201791113A1 EA201791113A1 (ru) 2017-10-31
EA039157B1 true EA039157B1 (ru) 2021-12-13

Family

ID=54705913

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201791113A EA039157B1 (ru) 2014-11-19 2015-11-19 Фармацевтические составы в виде гранул, содержащие диметилфумарат

Country Status (13)

Country Link
US (1) US11197842B2 (enExample)
EP (1) EP3220898A1 (enExample)
JP (2) JP6843748B2 (enExample)
KR (1) KR20170086063A (enExample)
CN (2) CN107205937A (enExample)
AU (1) AU2015349896B2 (enExample)
CA (1) CA2967647A1 (enExample)
EA (1) EA039157B1 (enExample)
HK (1) HK1244214A1 (enExample)
IL (1) IL252116B (enExample)
MA (1) MA40982A (enExample)
MX (1) MX2017006562A (enExample)
WO (1) WO2016081676A1 (enExample)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2987895A1 (en) 2015-06-01 2016-12-08 Sun Pharmaceutical Industries Ltd. Pharmaceutical compositions of dimethyl fumarate
KR20180108814A (ko) * 2016-02-11 2018-10-04 바이오젠 엠에이 인코포레이티드 다이메틸 퓨마레이트를 포함하는 약제학적 비드 제형
CN110636838A (zh) * 2017-06-23 2019-12-31 阿尔米雷尔有限公司 包含反丁烯二酸二甲酯的药物组合物
KR102868782B1 (ko) 2018-01-12 2025-10-13 (주)메티메디제약 만성 염증성 질환의 치료 방법
TR201818307A2 (tr) * 2018-11-30 2020-06-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Di̇meti̇l fumarat i̇çeren bi̇r kompozi̇syon
JP7224067B2 (ja) * 2019-05-31 2023-02-17 キュラクル カンパニー リミテッド フマル酸ジメチルを含有する腸溶性錠剤
KR20220133807A (ko) * 2021-03-25 2022-10-05 주식회사 큐라클 특정 약동학적 매개변수를 나타내는 디메틸푸마레이트를 유효성분으로 함유한 약학적 조성물

Citations (9)

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Publication number Priority date Publication date Assignee Title
US5213811A (en) * 1991-09-13 1993-05-25 Sterling Drug Inc. Oral sustained-release drug compositions
WO2005034916A1 (en) * 2003-10-03 2005-04-21 Novartis Ag Pharmaceutical multiparticulate composition comprising mycophenolic acid or mycophenolate sodium and combination with rapamycin
WO2006024479A2 (en) * 2004-08-31 2006-03-09 Novartis Ag Pharmaceutical multiparticulate compositions comprising mycophenolic acid or mycophenolate sodium and combination compositions with rapamycin
WO2011100589A1 (en) * 2010-02-12 2011-08-18 Biogen Idec Ma Inc. Neuroprotection in demyelinating diseases
WO2013076216A1 (en) * 2011-11-24 2013-05-30 Synthon Bv Controlled release particles comprising dimethyl fumarate
WO2013119677A1 (en) * 2012-02-07 2013-08-15 Biogen Idec Ma Inc. Pharmaceutical compositions containing dimethyl fumarate
WO2014020156A1 (en) * 2012-08-03 2014-02-06 Forward Pharma A/S Combination therapy for treatment of multiple sclerosis
US20140171504A1 (en) * 2012-12-14 2014-06-19 Georgia Regents Research Institute, Inc. Methods of Treating Sickle Cell Disease and Related Disorders Using Fumaric Acid Esters
WO2014143146A1 (en) * 2013-03-15 2014-09-18 Xenoport, Inc. Methods of administering monomethyl fumarate

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ES2157731B1 (es) * 1998-07-21 2002-05-01 Liconsa Liberacion Controlada Preparacion farmaceutica oral de un compuesto de actividad antifungica y procedimiento para su preparacion.
DE10101307A1 (de) * 2001-01-12 2002-08-01 Fumapharm Ag Muri Fumarsäurederivate als NF-kappaB-Inhibitor
US6946146B2 (en) * 2001-04-18 2005-09-20 Nostrum Pharmaceuticals Inc. Coating for a sustained release pharmaceutical composition
DE102005005446A1 (de) * 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
DE14172396T1 (de) * 2004-10-08 2015-01-08 Forward Pharma A/S Gesteuerte Freisetzung von pharmazeutischen Zusammensetzungen mit Fumarinsäureester
CN101056624A (zh) * 2004-10-08 2007-10-17 Adi技术制药股份公司 包含富马酸酯的控释药物组合物
CN109044985A (zh) * 2009-01-09 2018-12-21 前进制药知识产权有限公司 包含溶蚀骨架中的一种或多种富马酸酯的药物制剂
CN102369000A (zh) * 2009-01-09 2012-03-07 前进制药公司 包含一种或多种富马酸酯的药用组合物
DK3045043T3 (da) * 2009-02-26 2020-08-03 Relmada Therapeutics Inc Orale farmaceutiske sammensætninger af 3-hydroxy-n-methylmorphinan med forlænget frigivelse og fremgangsmåde til anvendelse
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Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5213811A (en) * 1991-09-13 1993-05-25 Sterling Drug Inc. Oral sustained-release drug compositions
WO2005034916A1 (en) * 2003-10-03 2005-04-21 Novartis Ag Pharmaceutical multiparticulate composition comprising mycophenolic acid or mycophenolate sodium and combination with rapamycin
WO2006024479A2 (en) * 2004-08-31 2006-03-09 Novartis Ag Pharmaceutical multiparticulate compositions comprising mycophenolic acid or mycophenolate sodium and combination compositions with rapamycin
WO2011100589A1 (en) * 2010-02-12 2011-08-18 Biogen Idec Ma Inc. Neuroprotection in demyelinating diseases
WO2013076216A1 (en) * 2011-11-24 2013-05-30 Synthon Bv Controlled release particles comprising dimethyl fumarate
WO2013119677A1 (en) * 2012-02-07 2013-08-15 Biogen Idec Ma Inc. Pharmaceutical compositions containing dimethyl fumarate
WO2014020156A1 (en) * 2012-08-03 2014-02-06 Forward Pharma A/S Combination therapy for treatment of multiple sclerosis
US20140171504A1 (en) * 2012-12-14 2014-06-19 Georgia Regents Research Institute, Inc. Methods of Treating Sickle Cell Disease and Related Disorders Using Fumaric Acid Esters
WO2014143146A1 (en) * 2013-03-15 2014-09-18 Xenoport, Inc. Methods of administering monomethyl fumarate

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COHEN, J.A.: "The future of multiple sclerosis treatment", JOURNAL OF NEUROLOGICAL SCIENCES., ELSEVIER SCIENTIFIC PUBLISHING CO, AMSTERDAM., NL, vol. 277, 1 February 2009 (2009-02-01), NL , pages S55 - S61, XP025912540, ISSN: 0022-510X, DOI: 10.1016/S0022-510X(09)70015-2 *

Also Published As

Publication number Publication date
JP6843748B2 (ja) 2021-03-17
AU2015349896B2 (en) 2021-04-29
EA201791113A1 (ru) 2017-10-31
US20180153845A1 (en) 2018-06-07
CN107205937A (zh) 2017-09-26
CN113521029A (zh) 2021-10-22
HK1244214A1 (zh) 2018-08-03
JP2017534668A (ja) 2017-11-24
WO2016081676A1 (en) 2016-05-26
JP2021088586A (ja) 2021-06-10
IL252116B (en) 2022-08-01
CA2967647A1 (en) 2016-05-26
US11197842B2 (en) 2021-12-14
KR20170086063A (ko) 2017-07-25
MX2017006562A (es) 2018-02-19
IL252116A0 (en) 2017-07-31
MA40982A (fr) 2017-09-26
EP3220898A1 (en) 2017-09-27
AU2015349896A1 (en) 2017-05-25

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