AU2017217464B2 - Pharmaceutical bead formulations comprising dimethyl fumarate - Google Patents

Pharmaceutical bead formulations comprising dimethyl fumarate Download PDF

Info

Publication number
AU2017217464B2
AU2017217464B2 AU2017217464A AU2017217464A AU2017217464B2 AU 2017217464 B2 AU2017217464 B2 AU 2017217464B2 AU 2017217464 A AU2017217464 A AU 2017217464A AU 2017217464 A AU2017217464 A AU 2017217464A AU 2017217464 B2 AU2017217464 B2 AU 2017217464B2
Authority
AU
Australia
Prior art keywords
layer
pharmaceutical
inert core
composition
pharmaceutical bead
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.)
Expired - Fee Related
Application number
AU2017217464A
Other languages
English (en)
Other versions
AU2017217464A1 (en
Inventor
Shyam B. Karki
Cheuk-Yui LEUNG
Yiqing Lin
Ivan Nestorov
Andrea TREMENTOZZI
Kalyan VASUDEVAN
Jin Xu
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
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 AU2017217464A1 publication Critical patent/AU2017217464A1/en
Application granted granted Critical
Publication of AU2017217464B2 publication Critical patent/AU2017217464B2/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61K9/48—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
    • A61K9/5047—Cellulose ethers containing no ester groups, 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
    • A61K9/48—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
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/14—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
    • A61K9/167—Agglomerates; 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
    • A61K9/1676—Agglomerates; 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
    • 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
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • 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
    • A61K9/5078—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 with drug-free core
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Emergency Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
AU2017217464A 2016-02-11 2017-02-08 Pharmaceutical bead formulations comprising dimethyl fumarate Expired - Fee Related AU2017217464B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662294054P 2016-02-11 2016-02-11
US62/294,054 2016-02-11
PCT/US2017/016934 WO2017139331A1 (en) 2016-02-11 2017-02-08 Pharmaceutical bead formulations comprising dimethyl fumarate

Publications (2)

Publication Number Publication Date
AU2017217464A1 AU2017217464A1 (en) 2018-08-30
AU2017217464B2 true AU2017217464B2 (en) 2022-11-10

Family

ID=58057304

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2017217464A Expired - Fee Related AU2017217464B2 (en) 2016-02-11 2017-02-08 Pharmaceutical bead formulations comprising dimethyl fumarate

Country Status (12)

Country Link
US (2) US11033509B2 (enExample)
EP (1) EP3413879A1 (enExample)
JP (2) JP6902043B2 (enExample)
KR (1) KR20180108814A (enExample)
CN (1) CN108778256A (enExample)
AU (1) AU2017217464B2 (enExample)
CA (1) CA3013472A1 (enExample)
EA (1) EA201891803A1 (enExample)
IL (1) IL261073A (enExample)
MA (1) MA44010A (enExample)
MX (1) MX391749B (enExample)
WO (1) WO2017139331A1 (enExample)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20180108814A (ko) * 2016-02-11 2018-10-04 바이오젠 엠에이 인코포레이티드 다이메틸 퓨마레이트를 포함하는 약제학적 비드 제형
US11723862B2 (en) * 2020-01-17 2023-08-15 Societe Des Produits Nestle S.A. Dosage form with sustained release melatonin pellets
AU2022285951A1 (en) 2021-06-04 2024-01-04 Zim Laboratories Limited Delayed release compositions of dimethyl fumarate
US12303604B1 (en) 2024-10-16 2025-05-20 Currax Pharmaceuticals Llc Pharmaceutical formulations comprising naltrexone and/or bupropion

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013119677A1 (en) * 2012-02-07 2013-08-15 Biogen Idec Ma Inc. Pharmaceutical compositions containing dimethyl fumarate
WO2015089420A1 (en) * 2013-12-13 2015-06-18 Biogen Idec Ma Inc. Controlled release dosage form for once daily administration of dimethyl fumarate
WO2016081676A1 (en) * 2014-11-19 2016-05-26 Biogen Ma Inc. Pharmaceutical bead formulations comprising dimethyl fumarate
WO2016205270A1 (en) * 2015-06-17 2016-12-22 Biogen Ma Inc. Dimethyl fumarate particles and pharmaceutical compositions thereof

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE14172396T1 (de) 2004-10-08 2015-01-08 Forward Pharma A/S Gesteuerte Freisetzung von pharmazeutischen Zusammensetzungen mit Fumarinsäureester
US20080187579A1 (en) 2007-02-01 2008-08-07 Pavan Bhat Extended-release dosage form
WO2015042294A1 (en) * 2013-09-18 2015-03-26 Xenoport, Inc. Nanoparticle compositions of dimethyl fumarate
CN104971048B (zh) * 2015-07-01 2019-01-18 上海汇伦医药科技有限公司 富马酸二甲酯肠溶微丸及其制备方法
KR20180108814A (ko) * 2016-02-11 2018-10-04 바이오젠 엠에이 인코포레이티드 다이메틸 퓨마레이트를 포함하는 약제학적 비드 제형

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013119677A1 (en) * 2012-02-07 2013-08-15 Biogen Idec Ma Inc. Pharmaceutical compositions containing dimethyl fumarate
WO2015089420A1 (en) * 2013-12-13 2015-06-18 Biogen Idec Ma Inc. Controlled release dosage form for once daily administration of dimethyl fumarate
WO2016081676A1 (en) * 2014-11-19 2016-05-26 Biogen Ma Inc. Pharmaceutical bead formulations comprising dimethyl fumarate
WO2016205270A1 (en) * 2015-06-17 2016-12-22 Biogen Ma Inc. Dimethyl fumarate particles and pharmaceutical compositions thereof

Also Published As

Publication number Publication date
JP2021152050A (ja) 2021-09-30
JP2019504859A (ja) 2019-02-21
IL261073A (en) 2018-10-31
WO2017139331A8 (en) 2017-10-12
US20210369629A1 (en) 2021-12-02
JP6902043B2 (ja) 2021-07-14
MA44010A (fr) 2018-12-19
US20190046456A1 (en) 2019-02-14
MX2018009749A (es) 2019-02-07
WO2017139331A1 (en) 2017-08-17
CA3013472A1 (en) 2017-08-17
US11033509B2 (en) 2021-06-15
AU2017217464A1 (en) 2018-08-30
KR20180108814A (ko) 2018-10-04
CN108778256A (zh) 2018-11-09
EA201891803A1 (ru) 2019-01-31
MX391749B (es) 2025-03-21
EP3413879A1 (en) 2018-12-19

Similar Documents

Publication Publication Date Title
CN101094658B (zh) 用于改进释放至少一种活性成分的多微囊形式的口服药剂
AU2015349896B2 (en) Pharmaceutical bead formulations comprising dimethyl fumarate
US20210369629A1 (en) Pharmaceutical bead formulations comprising dimethyl fumarate
US10561602B2 (en) Controlled extended release pregabalin
JP2008303223A (ja) 脈動用量薬剤経口送達システム
US20210220281A1 (en) Oral pharmaceutical compositions of mesalazine
CA2651890A1 (en) Controlled dose drug delivery system
JP2021152046A (ja) フマル酸ジメチルを含む医薬マトリクス製剤
JP2019504859A5 (enExample)

Legal Events

Date Code Title Description
MK25 Application lapsed reg. 22.2i(2) - failure to pay acceptance fee