HK1244214A1 - 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
HK1244214A1
HK1244214A1 HK18103739.0A HK18103739A HK1244214A1 HK 1244214 A1 HK1244214 A1 HK 1244214A1 HK 18103739 A HK18103739 A HK 18103739A HK 1244214 A1 HK1244214 A1 HK 1244214A1
Authority
HK
Hong Kong
Prior art keywords
dimethyl fumarate
core
pharmaceutical compositions
pharmaceutical bead
bead formulations
Prior art date
Application number
HK18103739.0A
Other languages
English (en)
Chinese (zh)
Inventor
Shyam B. Karki
Peter ZAWANEH
Cheuk-Yui LEUNG
Kalyan VASUDEVAN
Yiqing Lin
Jin Xu
Andrea TREMENTOZZI
Original Assignee
比奥根Ma公司
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 比奥根Ma公司 filed Critical 比奥根Ma公司
Publication of HK1244214A1 publication Critical patent/HK1244214A1/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886Dragees; 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/225Polycarboxylic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167Agglomerates; 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
    • A61K9/1676Agglomerates; 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/282Organic compounds, e.g. fats
    • A61K9/2826Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846Poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/2853Organic 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)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/2873Proteins, e.g. gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/288Compounds of unknown constitution, e.g. material from plants or animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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
    • A61K9/5078Microcapsules 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators

Landscapes

  • 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)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (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)
HK18103739.0A 2014-11-19 2015-11-19 包含富马酸二甲酯的药物珠粒制剂 HK1244214A1 (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
PCT/US2015/061456 WO2016081676A1 (en) 2014-11-19 2015-11-19 Pharmaceutical bead formulations comprising dimethyl fumarate

Publications (1)

Publication Number Publication Date
HK1244214A1 true HK1244214A1 (zh) 2018-08-03

Family

ID=54705913

Family Applications (1)

Application Number Title Priority Date Filing Date
HK18103739.0A HK1244214A1 (zh) 2014-11-19 2015-11-19 包含富马酸二甲酯的药物珠粒制剂

Country Status (13)

Country Link
US (1) US11197842B2 (https=)
EP (1) EP3220898A1 (https=)
JP (2) JP6843748B2 (https=)
KR (1) KR20170086063A (https=)
CN (2) CN113521029A (https=)
AU (1) AU2015349896B2 (https=)
CA (1) CA2967647A1 (https=)
EA (1) EA039157B1 (https=)
HK (1) HK1244214A1 (https=)
IL (1) IL252116B (https=)
MA (1) MA40982A (https=)
MX (1) MX2017006562A (https=)
WO (1) WO2016081676A1 (https=)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016194004A1 (en) 2015-06-01 2016-12-08 Sun Pharmaceutical Industries Ltd. Pharmaceutical compositions of dimethyl fumarate
CA3013472A1 (en) * 2016-02-11 2017-08-17 Biogen Ma Inc. Pharmaceutical bead formulations comprising dimethyl fumarate
KR20200018458A (ko) 2017-06-23 2020-02-19 알미랄, 에스.에이. 디메틸 푸마레이트를 포함하는 약학 조성물
CA3087953C (en) 2018-01-12 2025-11-25 Metimedi Pharmaceuticals Co., Ltd. METHODS OF TREATMENT FOR 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
WO2022203432A1 (ko) * 2021-03-25 2022-09-29 주식회사 큐라클 특정 약동학적 매개변수를 나타내는 디메틸푸마레이트를 유효성분으로 함유한 약학적 조성물

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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.
DE10101307A1 (de) * 2001-01-12 2002-08-01 Fumapharm Ag Muri Fumarsäurederivate als NF-kappaB-Inhibitor
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
GB0419355D0 (en) * 2004-08-31 2004-09-29 Novartis Ag Organic compounds
PL2316430T3 (pl) * 2004-10-08 2012-11-30 Forward Pharma As Kompozycje farmaceutyczne o kontrolowanym uwalnianiu, zawierające ester kwasu fumarowego
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
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
EP2379062A1 (en) * 2009-01-09 2011-10-26 Forward Pharma A/S Pharmaceutical composition comprising one or more fumaric acid esters
WO2010099508A1 (en) * 2009-02-26 2010-09-02 Theraquest Biosciences, Inc. Extended release oral pharmaceutical compositions of 3-hydroxy-n-methylmorphinan and method of use
EP2982371A1 (en) * 2010-02-12 2016-02-10 Biogen MA Inc. Dimethyl fumarate with glatiramer acetate or interferon-beta for treating multiple sclerosis
WO2013076216A1 (en) * 2011-11-24 2013-05-30 Synthon Bv Controlled release particles comprising dimethyl fumarate
CN114146081A (zh) * 2012-02-07 2022-03-08 比奥根玛公司 含有富马酸二甲酯的药物组合物
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
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Also Published As

Publication number Publication date
IL252116A0 (en) 2017-07-31
MX2017006562A (es) 2018-02-19
JP2021088586A (ja) 2021-06-10
IL252116B (en) 2022-08-01
AU2015349896A1 (en) 2017-05-25
EA039157B1 (ru) 2021-12-13
WO2016081676A1 (en) 2016-05-26
US11197842B2 (en) 2021-12-14
JP6843748B2 (ja) 2021-03-17
CA2967647A1 (en) 2016-05-26
JP2017534668A (ja) 2017-11-24
EA201791113A1 (ru) 2017-10-31
US20180153845A1 (en) 2018-06-07
CN107205937A (zh) 2017-09-26
EP3220898A1 (en) 2017-09-27
KR20170086063A (ko) 2017-07-25
AU2015349896B2 (en) 2021-04-29
CN113521029A (zh) 2021-10-22
MA40982A (fr) 2017-09-26

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