CN113521029A - 包含富马酸二甲酯的药物珠粒制剂 - Google Patents

包含富马酸二甲酯的药物珠粒制剂 Download PDF

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Publication number
CN113521029A
CN113521029A CN202110852686.7A CN202110852686A CN113521029A CN 113521029 A CN113521029 A CN 113521029A CN 202110852686 A CN202110852686 A CN 202110852686A CN 113521029 A CN113521029 A CN 113521029A
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China
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layer
core
total weight
pharmaceutical composition
inert core
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Pending
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CN202110852686.7A
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English (en)
Chinese (zh)
Inventor
S·B·卡基
P·扎瓦纳
梁绰睿
K·瓦苏德范
林毅清
徐进
A·特雷蒙托兹
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Biogan Ma Co
Biogen Inc
Biogen MA Inc
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Biogan Ma Co
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Publication of CN113521029A publication Critical patent/CN113521029A/zh
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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

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Emergency Medicine (AREA)
  • Neurology (AREA)
  • Biomedical Technology (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)
CN202110852686.7A 2014-11-19 2015-11-19 包含富马酸二甲酯的药物珠粒制剂 Pending CN113521029A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201462081889P 2014-11-19 2014-11-19
US62/081,889 2014-11-19
CN201580073821.0A CN107205937A (zh) 2014-11-19 2015-11-19 包含富马酸二甲酯的药物珠粒制剂

Related Parent Applications (1)

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CN201580073821.0A Division CN107205937A (zh) 2014-11-19 2015-11-19 包含富马酸二甲酯的药物珠粒制剂

Publications (1)

Publication Number Publication Date
CN113521029A true CN113521029A (zh) 2021-10-22

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CN202110852686.7A Pending CN113521029A (zh) 2014-11-19 2015-11-19 包含富马酸二甲酯的药物珠粒制剂
CN201580073821.0A Pending CN107205937A (zh) 2014-11-19 2015-11-19 包含富马酸二甲酯的药物珠粒制剂

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Country Status (13)

Country Link
US (1) US11197842B2 (enExample)
EP (1) EP3220898A1 (enExample)
JP (2) JP6843748B2 (enExample)
KR (1) KR20170086063A (enExample)
CN (2) CN113521029A (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)

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WO2016194004A1 (en) 2015-06-01 2016-12-08 Sun Pharmaceutical Industries Ltd. 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
WO2018234584A1 (en) * 2017-06-23 2018-12-27 Almirall, S.A. Pharmaceutical compositions comprising dimethyl fumarate
SG11202006601VA (en) 2018-01-12 2020-08-28 Metimedi Pharmaceuticals Co Ltd Methods of treating chronic inflammatory diseases
TR201818307A2 (tr) * 2018-11-30 2020-06-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Di̇meti̇l fumarat i̇çeren bi̇r kompozi̇syon
AU2020283238B2 (en) * 2019-05-31 2022-07-07 Curacle Co., Ltd. Enteric tablet containing dimethyl fumarate
KR20220133807A (ko) * 2021-03-25 2022-10-05 주식회사 큐라클 특정 약동학적 매개변수를 나타내는 디메틸푸마레이트를 유효성분으로 함유한 약학적 조성물

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040054001A1 (en) * 2001-01-12 2004-03-18 Joshi Rajendra Kumar Fumaric acid derivatives as nf-kappab inhibitors
CN101010070A (zh) * 2004-08-31 2007-08-01 诺瓦提斯公司 药物组合物
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
US20120034274A1 (en) * 2009-01-09 2012-02-09 Forward Pharma A/S Pharmaceutical composition comprising one or more fumaric acid esters
CN102369001A (zh) * 2009-01-09 2012-03-07 前进制药公司 包含溶蚀骨架中的一种或多种富马酸酯的药物制剂
CN104027311A (zh) * 2014-05-09 2014-09-10 万特制药(海南)有限公司 一种含有富马酸二甲酯的肠溶缓释微丸
CN104220061A (zh) * 2012-02-07 2014-12-17 比奥根艾迪克依蒙菲利亚公司 含有富马酸二甲酯的药物组合物

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US5213811A (en) 1991-09-13 1993-05-25 Sterling Drug Inc. Oral sustained-release drug compositions
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.
AU2002248792B2 (en) * 2001-04-18 2006-09-21 Nostrum Pharmaceuticals Inc. A novel coating for a sustained release pharmaceutical composition
DE102005005446A1 (de) * 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
AR045957A1 (es) * 2003-10-03 2005-11-16 Novartis Ag Composicion farmaceutica y combinacion
ES2525497T3 (es) * 2004-10-08 2015-10-09 Forward Pharma A/S Composiciones farmacéuticas de liberación controlada que comprenden un éster de ácido fumárico
EP2448406B1 (en) * 2009-02-26 2016-04-20 Relmada Therapeutics, Inc. Extended release oral pharmaceutical compositions of 3-hydroxy-n-methylmorphinan and method of use
SI2533634T1 (sl) * 2010-02-12 2016-01-29 Biogen Ma Inc. Nevroprotekcija pri demielinizacijskih boleznih
RU2014125430A (ru) * 2011-11-24 2015-12-27 Синтон Бв Контролируемое высвобождение частиц, содержащих диметилфумарат
EP2692343A1 (en) 2012-08-03 2014-02-05 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
US20140178468A1 (en) * 2012-12-24 2014-06-26 Ranbaxy Laboratories Limited Multiparticulate extended-release composition of mesalamine
WO2014143146A1 (en) 2013-03-15 2014-09-18 Xenoport, Inc. Methods of administering monomethyl fumarate
CN105682648A (zh) * 2013-08-26 2016-06-15 前进制药公司 用于以低的日剂量施用的含富马酸二甲酯的药物组合物
WO2015105757A1 (en) * 2014-01-07 2015-07-16 Biogen Ma Inc. Dimethyl fumarate for treating multiple sclerosis

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040054001A1 (en) * 2001-01-12 2004-03-18 Joshi Rajendra Kumar Fumaric acid derivatives as nf-kappab inhibitors
CN101010070A (zh) * 2004-08-31 2007-08-01 诺瓦提斯公司 药物组合物
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
US20120034274A1 (en) * 2009-01-09 2012-02-09 Forward Pharma A/S Pharmaceutical composition comprising one or more fumaric acid esters
CN102369001A (zh) * 2009-01-09 2012-03-07 前进制药公司 包含溶蚀骨架中的一种或多种富马酸酯的药物制剂
CN104220061A (zh) * 2012-02-07 2014-12-17 比奥根艾迪克依蒙菲利亚公司 含有富马酸二甲酯的药物组合物
CN104027311A (zh) * 2014-05-09 2014-09-10 万特制药(海南)有限公司 一种含有富马酸二甲酯的肠溶缓释微丸

Also Published As

Publication number Publication date
AU2015349896A1 (en) 2017-05-25
JP2017534668A (ja) 2017-11-24
IL252116A0 (en) 2017-07-31
MX2017006562A (es) 2018-02-19
JP6843748B2 (ja) 2021-03-17
EP3220898A1 (en) 2017-09-27
CN107205937A (zh) 2017-09-26
IL252116B (en) 2022-08-01
MA40982A (fr) 2017-09-26
HK1244214A1 (zh) 2018-08-03
WO2016081676A1 (en) 2016-05-26
CA2967647A1 (en) 2016-05-26
KR20170086063A (ko) 2017-07-25
JP2021088586A (ja) 2021-06-10
EA039157B1 (ru) 2021-12-13
US11197842B2 (en) 2021-12-14
US20180153845A1 (en) 2018-06-07
AU2015349896B2 (en) 2021-04-29
EA201791113A1 (ru) 2017-10-31

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Application publication date: 20211022