EA201800403A1 - Способ получения покрытого кишечнорастворимой оболочкой гранулята, содержащего диметилфумарат - Google Patents

Способ получения покрытого кишечнорастворимой оболочкой гранулята, содержащего диметилфумарат

Info

Publication number
EA201800403A1
EA201800403A1 EA201800403A EA201800403A EA201800403A1 EA 201800403 A1 EA201800403 A1 EA 201800403A1 EA 201800403 A EA201800403 A EA 201800403A EA 201800403 A EA201800403 A EA 201800403A EA 201800403 A1 EA201800403 A1 EA 201800403A1
Authority
EA
Eurasian Patent Office
Prior art keywords
dimethylfumarate
granulate
obtaining coated
intestinal solution
present
Prior art date
Application number
EA201800403A
Other languages
English (en)
Inventor
Прземыслав Сцоцзен
Александра Дрозд
Марек Цичоцки
Original Assignee
Заклады Фармацеутицне Польфарма С.А.
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 Заклады Фармацеутицне Польфарма С.А. filed Critical Заклады Фармацеутицне Польфарма С.А.
Publication of EA201800403A1 publication Critical patent/EA201800403A1/ru

Links

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
    • A61K9/14—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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • 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
    • A61K9/1611—Inorganic compounds
    • 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
    • A61K9/20—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
    • A61K9/286—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
    • A61K9/2886—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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Настоящее изобретение относится к способу получения перорального фармацевтического препарата в виде покрытого кишечнорастворимой оболочкой гранулята, содержащего диметилфумарат и фармацевтически приемлемые вспомогательные вещества. Настоящее изобретение также относится к пероральному фармацевтическому препарату в виде покрытого кишечнорастворимой оболочкой гранулята, полученному в соответствии с способом по настоящему изобретению, и к применению этого препарата в лечении рассеянного склероза.
EA201800403A 2015-12-31 2016-12-23 Способ получения покрытого кишечнорастворимой оболочкой гранулята, содержащего диметилфумарат EA201800403A1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP15460146 2015-12-31
PCT/EP2016/002175 WO2017114593A1 (en) 2015-12-31 2016-12-23 Process for preparation of an enteric coated granulate comprising dimethyl fumarate

Publications (1)

Publication Number Publication Date
EA201800403A1 true EA201800403A1 (ru) 2018-12-28

Family

ID=55129503

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201800403A EA201800403A1 (ru) 2015-12-31 2016-12-23 Способ получения покрытого кишечнорастворимой оболочкой гранулята, содержащего диметилфумарат

Country Status (11)

Country Link
US (1) US11013693B2 (ru)
EP (1) EP3397247B1 (ru)
CN (1) CN108472260B (ru)
AU (1) AU2016382661B2 (ru)
BR (1) BR112018013184A2 (ru)
CA (1) CA3007483C (ru)
EA (1) EA201800403A1 (ru)
ES (1) ES2953440T3 (ru)
PL (1) PL3397247T3 (ru)
UA (1) UA124456C2 (ru)
WO (1) WO2017114593A1 (ru)

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
CN101304732A (zh) * 2005-10-07 2008-11-12 Adi技术制药股份公司 包含富马酸酯的控释药物组合物
US20080299196A1 (en) * 2005-10-07 2008-12-04 Aditech Pharma Ab Controlled Release Pharmaceutical Compositions Comprising a Fumaric Acid Ester
KR101699912B1 (ko) * 2009-01-09 2017-01-25 포워드 파마 에이/에스 1종 이상의 푸마르산 에스테르를 침식 매트릭스에 함유하는 제제
RU2014125430A (ru) 2011-11-24 2015-12-27 Синтон Бв Контролируемое высвобождение частиц, содержащих диметилфумарат
MX370785B (es) * 2012-02-07 2020-01-06 Biogen Ma Inc Composiciones farmacéuticas que contienen fumarato de dimetilo.
WO2014160633A1 (en) 2013-03-24 2014-10-02 Xenoport, Inc. Pharmaceutical compositions of dimethyl fumarate
CN109223725A (zh) * 2013-08-26 2019-01-18 前进制药知识产权有限公司 用于以低的日剂量施用的含富马酸二甲酯的药物组合物
DK3079666T3 (da) 2013-12-12 2021-03-22 Almirall Sa Farmaceutiske sammensætninger omfattende dimethylfumarat
CN104288774B (zh) 2014-04-21 2018-10-09 河南省健康伟业生物医药研究股份有限公司 一种肠溶包衣、富马酸二甲酯肠溶制剂及其制备方法
CN104352441B (zh) * 2014-10-16 2017-06-09 山东百诺医药股份有限公司 一种富马酸二甲酯肠溶微丸及其制备方法
CN104490849A (zh) * 2014-11-24 2015-04-08 广东东阳光药业有限公司 一种高密度的富马酸二甲酯肠溶颗粒及其制备方法

Also Published As

Publication number Publication date
ES2953440T3 (es) 2023-11-13
BR112018013184A2 (pt) 2018-12-11
AU2016382661B2 (en) 2022-05-19
EP3397247C0 (en) 2023-06-07
CA3007483A1 (en) 2017-07-06
PL3397247T3 (pl) 2023-09-18
AU2016382661A1 (en) 2018-06-28
EP3397247B1 (en) 2023-06-07
UA124456C2 (uk) 2021-09-22
WO2017114593A1 (en) 2017-07-06
CN108472260A (zh) 2018-08-31
US11013693B2 (en) 2021-05-25
CN108472260B (zh) 2021-08-10
EP3397247A1 (en) 2018-11-07
CA3007483C (en) 2021-12-07
US20200163887A1 (en) 2020-05-28

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