MX2017006562A - Formulaciones farmacéuticas de perlas que comprenden dimetilfumarato. - Google Patents

Formulaciones farmacéuticas de perlas que comprenden dimetilfumarato.

Info

Publication number
MX2017006562A
MX2017006562A MX2017006562A MX2017006562A MX2017006562A MX 2017006562 A MX2017006562 A MX 2017006562A MX 2017006562 A MX2017006562 A MX 2017006562A MX 2017006562 A MX2017006562 A MX 2017006562A MX 2017006562 A MX2017006562 A MX 2017006562A
Authority
MX
Mexico
Prior art keywords
dimethyl fumarate
core
pharmaceutical compositions
pharmaceutical bead
bead formulations
Prior art date
Application number
MX2017006562A
Other languages
English (en)
Inventor
Jin Xu
B Karki Shyam
ZAWANEH Peter
Yui LEUNG Cheuk-
Lin Yiqing
Vasudevan Kalyan
Trementozzi Andrea
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 MX2017006562A publication Critical patent/MX2017006562A/es

Links

Classifications

    • 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
    • A61K9/20Pills, 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
    • 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)
  • 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)

Abstract

La presente invención proporciona composiciones farmacéuticas novedosas de dimetilfumarato; las composiciones farmacéuticas de la presente invención están en forma de una perla y comprenden (i) un núcleo inerte; (ii) una primera capa que rodea el núcleo inerte, en donde la primera capa comprende dimetilfumarato; y (iii) un revestimiento entérico que rodea la primera capa; también se proporcionan también composiciones farmacéuticas en forma de una perla que comprende un núcleo y un recubrimiento entérico que rodea el núcleo, en donde el núcleo comprende dimetilfumarato; también se incluyen métodos de utilizar las composiciones farmacéuticas de la presente invención para tratar la esclerosis múltiple.
MX2017006562A 2014-11-19 2015-11-19 Formulaciones farmacéuticas de perlas que comprenden dimetilfumarato. MX2017006562A (es)

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 (1)

Publication Number Publication Date
MX2017006562A true MX2017006562A (es) 2018-02-19

Family

ID=54705913

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2017006562A MX2017006562A (es) 2014-11-19 2015-11-19 Formulaciones farmacéuticas de perlas que comprenden dimetilfumarato.

Country Status (13)

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

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2016273068A1 (en) 2015-06-01 2017-12-21 Sun Pharmaceutical Industries Ltd. Pharmaceutical compositions of dimethyl fumarate
EA201891803A1 (ru) 2016-02-11 2019-01-31 Байоджен Ма Инк. Фармацевтические составы в форме гранул, содержащие диметилфумарат
MA49448A (fr) * 2017-06-23 2020-04-29 Almirall Sa Compositions pharmaceutiques contenant du fumarate de diméthyle
EP3737363A4 (en) 2018-01-12 2021-10-20 Metimedi Pharmaceuticals Co., Ltd METHODS OF TREATMENT OF CHRONIC INFLAMMATORY DISEASES
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

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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
WO2002085335A1 (en) * 2001-04-18 2002-10-31 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
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
ME02253B (me) * 2004-10-08 2015-12-31 Forward Pharma As Farmaceutske kompozicije sa kontrolisanim oslobađanjem koje sadrže estar fumarne kiseline
EP3295936A1 (en) 2009-01-09 2018-03-21 Forward Pharma A/S Pharmaceutical formulation comprising one or more fumaric acid esters in an erosion matrix
JP2012514623A (ja) * 2009-01-09 2012-06-28 フォーワード・ファルマ・アクティーゼルスカブ 1またはそれ以上のフマル酸エステルを含む医薬組成物
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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Also Published As

Publication number Publication date
KR20170086063A (ko) 2017-07-25
HK1244214A1 (zh) 2018-08-03
EA201791113A1 (ru) 2017-10-31
CN113521029A (zh) 2021-10-22
WO2016081676A1 (en) 2016-05-26
AU2015349896A1 (en) 2017-05-25
JP2017534668A (ja) 2017-11-24
US11197842B2 (en) 2021-12-14
AU2015349896B2 (en) 2021-04-29
JP6843748B2 (ja) 2021-03-17
CN107205937A (zh) 2017-09-26
EP3220898A1 (en) 2017-09-27
US20180153845A1 (en) 2018-06-07
IL252116B (en) 2022-08-01
JP2021088586A (ja) 2021-06-10
CA2967647A1 (en) 2016-05-26
IL252116A0 (en) 2017-07-31
EA039157B1 (ru) 2021-12-13
MA40982A (fr) 2017-09-26

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