MX387092B - Particulas de dimetilfumarato y composiciones farmaceuticas de estas. - Google Patents

Particulas de dimetilfumarato y composiciones farmaceuticas de estas.

Info

Publication number
MX387092B
MX387092B MX2017016509A MX2017016509A MX387092B MX 387092 B MX387092 B MX 387092B MX 2017016509 A MX2017016509 A MX 2017016509A MX 2017016509 A MX2017016509 A MX 2017016509A MX 387092 B MX387092 B MX 387092B
Authority
MX
Mexico
Prior art keywords
particles
dimethyl fumarate
dmf
pharmaceutical compositions
fumarate particles
Prior art date
Application number
MX2017016509A
Other languages
English (en)
Spanish (es)
Other versions
MX2017016509A (es
Inventor
Andrea Trementozzi
Cheuk- Yui LEUNG
Erwin Irdam
Peter Zawaneh
Pierre Boulas
Shyam B Karki
William F Kiesman
Yiqing Lin
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
Publication of MX387092B publication Critical patent/MX387092B/es

Links

Classifications

    • 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
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Emergency Medicine (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
MX2017016509A 2015-06-17 2016-06-15 Particulas de dimetilfumarato y composiciones farmaceuticas de estas. MX387092B (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 (2)

Publication Number Publication Date
MX2017016509A MX2017016509A (es) 2018-08-16
MX387092B true MX387092B (es) 2025-03-19

Family

ID=56292916

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2017016509A MX387092B (es) 2015-06-17 2016-06-15 Particulas de dimetilfumarato y composiciones farmaceuticas de estas.

Country Status (13)

Country Link
US (2) US11291642B2 (enExample)
EP (1) EP3310341A1 (enExample)
JP (2) JP2018517735A (enExample)
KR (1) KR20180018711A (enExample)
CN (1) CN107920997A (enExample)
AU (2) AU2016279997B2 (enExample)
CA (1) CA2989581A1 (enExample)
EA (1) EA201890068A1 (enExample)
HK (1) HK1254054A1 (enExample)
IL (1) IL256296A (enExample)
MA (1) MA42196A (enExample)
MX (1) MX387092B (enExample)
WO (1) WO2016205270A1 (enExample)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180318246A1 (en) * 2015-10-28 2018-11-08 Sun Pharmaceutical Industries Limited Pharmaceutical compositions of dimethyl fumarate
CA3013472A1 (en) * 2016-02-11 2017-08-17 Biogen Ma Inc. Pharmaceutical bead formulations comprising dimethyl fumarate
EP3691616A1 (en) * 2017-10-02 2020-08-12 Novartis AG Method for preparing a pharmaceutical product
WO2019194826A1 (en) 2018-04-06 2019-10-10 Hewlett-Packard Development Company, L.P. Three-dimensional (3d) object printing based on build material permeability
CN113165338B (zh) * 2018-10-05 2023-04-11 埃斯普投资有限公司 包含水溶性纤维素醚的光滑的高固体膜包衣组合物及其制备工艺
TR201818293A2 (tr) * 2018-11-30 2020-06-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Di̇meti̇l fumarat i̇çeren geci̇kmeli̇ salim sağlayan kapsül
AU2020214626B2 (en) * 2019-01-31 2025-10-16 Halozyme Hypercon, Inc. Particle formation and morphology
CN113840596A (zh) * 2019-03-20 2021-12-24 林德拉治疗公司 用于胃滞留剂型的衣层
IL286512B2 (en) * 2019-03-20 2026-03-01 Lyndra Therapeutics Inc Capsules and capsule coatings for stomach-retaining dosage forms
EP4247354A4 (en) * 2020-11-18 2025-02-19 Fb-Hrs, Llc COMPOSITIONS CONTAINING DOFETILIDE AND MEXILETINE AND THEIR USES
IL303390A (en) 2020-12-03 2023-08-01 Battelle Memorial Institute Compositions of polymer nanoparticles and DNA nanostructures and methods for non-viral transport
WO2022216977A1 (en) 2021-04-07 2022-10-13 Batelle Memorial Institute Rapid design, build, test, and learn technologies for identifying and using non-viral carriers
AU2022285951A1 (en) 2021-06-04 2024-01-04 Zim Laboratories Limited Delayed release compositions of dimethyl fumarate
US11590071B2 (en) * 2021-07-06 2023-02-28 King Abdulaziz University Injectable drug delivery implant composition and method of use thereof
WO2025072751A1 (en) 2023-09-29 2025-04-03 Battelle Memorial Institute Polymer nanoparticle compositions for in vivo expression of polypeptides
CN122318997A (zh) * 2023-10-23 2026-06-30 埃斯普投资有限公司 包封的中链脂肪酸盐及其衍生的口服固体剂型
AU2024393766A1 (en) 2023-12-08 2026-06-18 Battelle Memorial Institute Use of dna origami nanostructures for molecular information based data storage systems
US12303604B1 (en) 2024-10-16 2025-05-20 Currax Pharmaceuticals Llc Pharmaceutical formulations comprising naltrexone and/or bupropion

Family Cites Families (19)

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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
SI1799196T1 (sl) 2004-10-08 2016-10-28 Forward Pharma A/S Farmacevtski sestavki z nadzorovanim sproščanjem, obsegajoči ester fumarne kisline
DK2997953T3 (en) * 2006-01-18 2019-04-15 Intec Pharma Ltd ADMINISTRATION ORAL ADMINISTRATION
DK2276473T3 (en) * 2008-04-18 2017-01-09 Intec Pharma Ltd GASTRORETENTIV drug TO carbidopa / levodopa
EP2564839B1 (en) * 2009-01-09 2016-05-11 Forward Pharma A/S Pharmaceutical formulation comprising one or more fumaric acid esters in an erosion matrix
EP2379062A1 (en) * 2009-01-09 2011-10-26 Forward Pharma A/S Pharmaceutical composition comprising one or more fumaric acid esters
PE20141639A1 (es) * 2011-06-08 2014-11-08 Biogen Idec Inc Proceso para preparar fumarato de dimetilo de alta pureza y cristalino
RU2014125430A (ru) * 2011-11-24 2015-12-27 Синтон Бв Контролируемое высвобождение частиц, содержащих диметилфумарат
CA2862885C (en) * 2012-02-07 2020-06-02 Biogen Ma Inc. Pharmaceutical compositions containing dimethyl fumarate
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US10172794B2 (en) 2013-12-13 2019-01-08 Biogen Ma Inc. Controlled release dosage form for once daily administration of dimethyl fumarate
CA2939990C (en) * 2014-02-28 2018-07-10 Banner Life Sciences Llc Controlled release enteric soft capsules of fumarate esters

Also Published As

Publication number Publication date
KR20180018711A (ko) 2018-02-21
WO2016205270A1 (en) 2016-12-22
EA201890068A1 (ru) 2018-09-28
AU2016279997A1 (en) 2018-01-18
JP2022042512A (ja) 2022-03-14
CA2989581A1 (en) 2016-12-22
MA42196A (fr) 2018-04-25
CN107920997A (zh) 2018-04-17
US11291642B2 (en) 2022-04-05
US20220362195A1 (en) 2022-11-17
JP2018517735A (ja) 2018-07-05
US20190070143A1 (en) 2019-03-07
AU2016279997B2 (en) 2021-10-21
IL256296A (en) 2018-02-28
AU2022200155A1 (en) 2022-02-10
EP3310341A1 (en) 2018-04-25
MX2017016509A (es) 2018-08-16
WO2016205270A8 (en) 2017-01-19
HK1254054A1 (zh) 2019-07-12

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