MX2017016509A - Particulas de dimetilfumarato y composiciones farmaceuticas de estas. - Google Patents

Particulas de dimetilfumarato y composiciones farmaceuticas de estas.

Info

Publication number
MX2017016509A
MX2017016509A MX2017016509A MX2017016509A MX2017016509A MX 2017016509 A MX2017016509 A MX 2017016509A MX 2017016509 A MX2017016509 A MX 2017016509A MX 2017016509 A MX2017016509 A MX 2017016509A MX 2017016509 A MX2017016509 A MX 2017016509A
Authority
MX
Mexico
Prior art keywords
particles
dimethyl fumarate
dmf
pharmaceutical compositions
fumarate particles
Prior art date
Application number
MX2017016509A
Other languages
English (en)
Inventor
Irdam Erwin
B Karki Shyam
ZAWANEH Peter
Yui LEUNG Cheuk-
Trementozzi Andrea
BOULAS Pierre
F Kiesman William
Lin Yiqing
Original Assignee
Biogen Ma Inc
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 Biogen Ma Inc filed Critical Biogen Ma Inc
Publication of MX2017016509A publication Critical patent/MX2017016509A/es

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
    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • 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
    • A61K9/1635—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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • 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
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Emergency Medicine (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Organic Chemistry (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La presente invención proporciona partículas de dimetilfumarato (DMF) y métodos de preparación de las partículas de DMF, también se proporcionan partículas recubiertas de DMF que comprenden partículas de DMF recubiertas con un recubrimiento entérico, la invención proporciona también diversas formas de dosificación y métodos para tratar una enfermedad o trastorno (por ejemplo, la esclerosis múltiple).
MX2017016509A 2015-06-17 2016-06-15 Particulas de dimetilfumarato y composiciones farmaceuticas de estas. MX2017016509A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562181061P 2015-06-17 2015-06-17
PCT/US2016/037486 WO2016205270A1 (en) 2015-06-17 2016-06-15 Dimethyl fumarate particles and pharmaceutical compositions thereof

Publications (1)

Publication Number Publication Date
MX2017016509A true MX2017016509A (es) 2018-08-16

Family

ID=56292916

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2017016509A MX2017016509A (es) 2015-06-17 2016-06-15 Particulas de dimetilfumarato y composiciones farmaceuticas de estas.

Country Status (13)

Country Link
US (2) US11291642B2 (es)
EP (1) EP3310341A1 (es)
JP (2) JP2018517735A (es)
KR (1) KR20180018711A (es)
CN (1) CN107920997A (es)
AU (2) AU2016279997B2 (es)
CA (1) CA2989581A1 (es)
EA (1) EA201890068A1 (es)
HK (1) HK1254054A1 (es)
IL (1) IL256296A (es)
MA (1) MA42196A (es)
MX (1) MX2017016509A (es)
WO (1) WO2016205270A1 (es)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR112018008835A8 (pt) * 2015-10-28 2019-02-26 Sun Pharmaceutical Ind Ltd composição farmacêutica oral, composição farmacêutica de liberação pulsátil oral, método para tratar uma condição de doença que requer terapia com fumarato de dimetila e método para tratar esclerose múltipla
CA3013472A1 (en) * 2016-02-11 2017-08-17 Biogen Ma Inc. Pharmaceutical bead formulations comprising dimethyl fumarate
IL273553B1 (en) * 2017-10-02 2024-05-01 Novartis Ag A method for preparing a pharmacy product
US11318682B2 (en) 2018-04-06 2022-05-03 Hewlett-Packard Development Company, L.P. Three-dimensional (3D) object printing based on build material permeability
JP2022504333A (ja) * 2018-10-05 2022-01-13 アイエスピー インヴェストメンツ エルエルシー 水溶性セルロースエーテルを含有する平滑な高固形分フィルムコーティング組成物、その調製方法およびその使用方法
TR201818293A2 (tr) * 2018-11-30 2020-06-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Di̇meti̇l fumarat i̇çeren geci̇kmeli̇ salim sağlayan kapsül
JP2022525926A (ja) * 2019-03-20 2022-05-20 リンドラ セラピューティクス， インコーポレイティド 胃内滞留剤形用のカプセル及びカプセルコーティング
US11590071B2 (en) * 2021-07-06 2023-02-28 King Abdulaziz University Injectable drug delivery implant composition and method of use thereof

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2725623A1 (fr) 1994-10-18 1996-04-19 Flamel Tech Sa Microcapsules medicamenteuses et/ou nutritionnelles pour administration per os
US5972389A (en) 1996-09-19 1999-10-26 Depomed, Inc. Gastric-retentive, oral drug dosage forms for the controlled-release of sparingly soluble drugs and insoluble matter
DE19853487A1 (de) 1998-11-19 2000-05-25 Fumapharm Ag Muri Verwendung von Dialkylfumaraten
IL133196A0 (en) 1999-11-29 2001-03-19 Yissum Res Dev Co Gastroretentive controlled release pharmaceutical dosage forms
DE10101307A1 (de) * 2001-01-12 2002-08-01 Fumapharm Ag Muri Fumarsäurederivate als NF-kappaB-Inhibitor
US8101209B2 (en) 2001-10-09 2012-01-24 Flamel Technologies Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles
US6723340B2 (en) 2001-10-25 2004-04-20 Depomed, Inc. Optimal polymer mixtures for gastric retentive tablets
DE14172398T1 (de) * 2004-10-08 2015-01-08 Forward Pharma A/S Gesteuerte Freisetzung von pharmazeutischen Zusammensetzungen mit Fumarinsäureester
TR201902010T4 (tr) 2006-01-18 2019-03-21 Intec Pharma Ltd Bir ajanın oral alımına yönelik taşıyıcı cihaz.
EP2276473B1 (en) * 2008-04-18 2016-09-14 Intec Pharma Ltd. Gastroretentive drug delivery for carbidopa/levodopa
WO2010079221A1 (en) * 2009-01-09 2010-07-15 Forward Pharma A/S Pharmaceutical composition comprising one or more fumaric acid esters
PT2564839T (pt) * 2009-01-09 2016-07-14 Forward Pharma As Formulação farmacêutica compreendendo um ou mais ésteres de ácido fumárico numa matriz de erosão
HUE036085T2 (hu) * 2011-06-08 2018-06-28 Biogen Ma Inc Nagy tisztaságú és kristályos dimetil-fumarát elõállítására szolgáló eljárás
RU2014125430A (ru) * 2011-11-24 2015-12-27 Синтон Бв Контролируемое высвобождение частиц, содержащих диметилфумарат
CN114146079A (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
WO2015042294A1 (en) 2013-09-18 2015-03-26 Xenoport, Inc. Nanoparticle compositions of dimethyl fumarate
WO2015044853A2 (en) * 2013-09-25 2015-04-02 Glenmark Pharmaceuticals Limited; Glenmark Generics Limited Process for preparation 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
DK3110408T3 (en) * 2014-02-28 2019-04-29 Banner Life Sciences Llc ENTERY SOFT CAPS OF CONTROLLED RELEASE FUMAR TESTERS

Also Published As

Publication number Publication date
US20190070143A1 (en) 2019-03-07
KR20180018711A (ko) 2018-02-21
JP2022042512A (ja) 2022-03-14
HK1254054A1 (zh) 2019-07-12
MA42196A (fr) 2018-04-25
AU2022200155A1 (en) 2022-02-10
AU2016279997A1 (en) 2018-01-18
EA201890068A1 (ru) 2018-09-28
US20220362195A1 (en) 2022-11-17
JP2018517735A (ja) 2018-07-05
AU2016279997B2 (en) 2021-10-21
CA2989581A1 (en) 2016-12-22
WO2016205270A8 (en) 2017-01-19
US11291642B2 (en) 2022-04-05
CN107920997A (zh) 2018-04-17
WO2016205270A1 (en) 2016-12-22
IL256296A (en) 2018-02-28
EP3310341A1 (en) 2018-04-25

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