CA2989581A1 - Dimethyl fumarate particles and pharmaceutical compositions thereof - Google Patents

Dimethyl fumarate particles and pharmaceutical compositions thereof Download PDF

Info

Publication number
CA2989581A1
CA2989581A1 CA2989581A CA2989581A CA2989581A1 CA 2989581 A1 CA2989581 A1 CA 2989581A1 CA 2989581 A CA2989581 A CA 2989581A CA 2989581 A CA2989581 A CA 2989581A CA 2989581 A1 CA2989581 A1 CA 2989581A1
Authority
CA
Canada
Prior art keywords
dmf
dosage form
internal layer
particles
controlled release
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
CA2989581A
Other languages
English (en)
French (fr)
Inventor
Pierre BOULAS
Erwin IRDAM
Shyam B. Karki
William F. Kiesman
Cheuk-Yui LEUNG
Yiqing Lin
Andrea TREMENTOZZI
Peter ZAWANEH
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biogen MA Inc
Original Assignee
Boulas Pierre
Leung Cheuk-Yui
Trementozzi Andrea
Zawaneh Peter
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 Boulas Pierre, Leung Cheuk-Yui, Trementozzi Andrea, Zawaneh Peter, Biogen MA Inc filed Critical Boulas Pierre
Publication of CA2989581A1 publication Critical patent/CA2989581A1/en
Pending legal-status Critical Current

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)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Emergency Medicine (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CA2989581A 2015-06-17 2016-06-15 Dimethyl fumarate particles and pharmaceutical compositions thereof Pending CA2989581A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562181061P 2015-06-17 2015-06-17
US62/181,061 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
CA2989581A1 true CA2989581A1 (en) 2016-12-22

Family

ID=56292916

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2989581A Pending CA2989581A1 (en) 2015-06-17 2016-06-15 Dimethyl fumarate particles and pharmaceutical compositions thereof

Country Status (13)

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

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2016344673A1 (en) * 2015-10-28 2018-05-17 Sun Pharmaceutical Industries Limited Pharmaceutical compositions of dimethyl fumarate
JP6902043B2 (ja) * 2016-02-11 2021-07-14 バイオジェン・エムエイ・インコーポレイテッドＢｉｏｇｅｎ ＭＡ Ｉｎｃ． フマル酸ジメチルを含む医薬ビーズ製剤
CA3075720A1 (en) * 2017-10-02 2019-04-11 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
CA3115516C (en) * 2018-10-05 2023-04-25 Isp Investments Llc Smooth high solids film coating composition comprising water soluble cellulose ether, process for preparing the same and method of use thereof
TR201818293A2 (tr) * 2018-11-30 2020-06-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Di̇meti̇l fumarat i̇çeren geci̇kmeli̇ salim sağlayan kapsül
EP3917500A2 (en) * 2019-01-31 2021-12-08 Elektrofi, Inc. Particle formation and morphology
JP2022525482A (ja) * 2019-03-20 2022-05-16 リンドラ セラピューティクス， インコーポレイティド 胃内滞留剤形用のコーティング
MX2021011314A (es) * 2019-03-20 2021-12-10 Lyndra Therapeutics Inc Capsulas y recubrimientos de capsulas para formas de dosificacion de residencia gastrica.
JP2023553274A (ja) * 2020-11-18 2023-12-21 エフビー－エイチアールエス リミテッド ライアビリティ カンパニー ドフェチリド及びメキシレチンを含有する組成物並びにその使用
CN116887866A (zh) 2020-12-03 2023-10-13 巴特尔纪念研究院 聚合物纳米颗粒和dna纳米结构组合物及用于非病毒递送的方法
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
WO2025090498A1 (en) * 2023-10-23 2025-05-01 Isp Investments Llc Encapsulated medium chain fatty acid salts and oral solid dosage forms derived therefrom
US12441996B2 (en) 2023-12-08 2025-10-14 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)

* 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
LT2801354T (lt) * 2004-10-08 2017-06-26 Forward Pharma A/S Kontroliuojamo atpalaidavimo farmacinės kompozicijos, apimančios fumaro rūgšties esterį
HUE043365T2 (hu) 2006-01-18 2019-08-28 Intec Pharma Ltd Kiadóberendezés szer orális bevételéhez
KR101601649B1 (ko) * 2008-04-18 2016-03-09 인텍 파마 리미티드 카르비도파／레보도파 위체류 약물 전달
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
WO2010079222A1 (en) * 2009-01-09 2010-07-15 Forward Pharma A/S Pharmaceutical formulation comprising one or more fumaric acid esters in an erosion matrix
SMT201800098T1 (it) * 2011-06-08 2018-03-08 Biogen Ma Inc Processo per la preparazione di dimetilfumarato cristallino e con purezza elevata
RU2014125430A (ru) * 2011-11-24 2015-12-27 Синтон Бв Контролируемое высвобождение частиц, содержащих диметилфумарат
NZ627980A (en) * 2012-02-07 2016-12-23 Biogen Ma Inc Pharmaceutical compositions containing dimethyl fumarate
US20150079180A1 (en) * 2013-09-18 2015-03-19 Xenoport, Inc. Nanoparticle compositions of dimethyl fumarate
IN2013MU03070A (https=) * 2013-09-25 2015-07-17 Glenmark Pharmaceuticals Ltd
EP3079663A1 (en) * 2013-12-13 2016-10-19 Biogen MA Inc. Controlled release dosage form for once daily administration of dimethyl fumarate
AU2015222880B2 (en) 2014-02-28 2016-11-24 Banner Life Sciences Llc Controlled release enteric soft capsules of fumarate esters

Also Published As

Publication number Publication date
WO2016205270A1 (en) 2016-12-22
JP2018517735A (ja) 2018-07-05
MA42196A (fr) 2018-04-25
AU2016279997B2 (en) 2021-10-21
WO2016205270A8 (en) 2017-01-19
HK1254054A1 (zh) 2019-07-12
US20220362195A1 (en) 2022-11-17
MX387092B (es) 2025-03-19
CN107920997A (zh) 2018-04-17
KR20180018711A (ko) 2018-02-21
AU2016279997A1 (en) 2018-01-18
US11291642B2 (en) 2022-04-05
AU2022200155A1 (en) 2022-02-10
US20190070143A1 (en) 2019-03-07
MX2017016509A (es) 2018-08-16
EP3310341A1 (en) 2018-04-25
EA201890068A1 (ru) 2018-09-28
IL256296A (en) 2018-02-28
JP2022042512A (ja) 2022-03-14

Similar Documents

Publication Publication Date Title
US20220362195A1 (en) Dimethyl fumarate particles and pharmaceutical compositions thereof
US20190091146A1 (en) Controlled Release Dosage Form for Once Daily Administration of Dimethyl Fumarate
CN101022788B (zh) 包含普拉克索或其可药用盐的延长释放小球制剂、其制备方法及其用途
JP5661062B2 (ja) ヒドロコドン放出制御製剤
KR100514467B1 (ko) 신속 붕괴 펠릿
CN109044981B (zh) 一种普瑞巴林胃漂浮型缓释片及其制备方法
US11090279B2 (en) Delayed release cysteamine bead formulation, and methods of making and using same
KR20180090881A (ko) 위 체류 시스템을 위한 기하 구성형태
JP2005524654A (ja) ３８Ｎ／ｃｍ２以下の抗張力を持った核錠と軟質の核錠を保護する被膜を持った投薬物
PL179910B1 (pl) Postac dawkowania o kontrolowanym uwalnianiu zawierajaca azytromycyne PL PL PL PL PL PL PL PL
EP1238662B1 (en) Method for manufacturing drug granules, the drug granules and pharmaceutical preparation containing the drug granules
CA2698330A1 (en) Galenical formulations of organic compounds
CN106619520B (zh) 一种右兰索拉唑钠的干混悬剂及其制备方法
CN101646422A (zh) 缓释剂型
ES2683366T3 (es) Dispersión molecular sólida de fesoterodina
CN101862305A (zh) 一种盐酸氨溴索缓释微丸及制备方法
WO2009048940A2 (en) Diacerein pharmaceutical formulations
JP2013515783A (ja) 膨潤性親水性ポリマーを用いた胃滞留型固体経口投与剤形
CN1568954A (zh) 美沙拉嗪结肠定位释药微丸制剂及其制备方法
WO2014063596A1 (zh) 一种治疗糖尿病的口服制剂
Tamizharasi et al. Floating drug delivery system.
CA3230682A1 (en) Oral formulation of a pyridinone derivate and use thereof in prophylaxis and/or treatment of intestinal fibrosis
Gautam et al. A review on microspheres: Types, methods and evaluation.
CN1729964B (zh) 一种具有膨胀核心的掩味微囊及制备方法
Bagul et al. Stomach specific drug delivery systems: a review

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20210614