JP2018502168A - 安定な固体フィンゴリモド剤形 - Google Patents

安定な固体フィンゴリモド剤形 Download PDF

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Publication number
JP2018502168A
JP2018502168A JP2017556787A JP2017556787A JP2018502168A JP 2018502168 A JP2018502168 A JP 2018502168A JP 2017556787 A JP2017556787 A JP 2017556787A JP 2017556787 A JP2017556787 A JP 2017556787A JP 2018502168 A JP2018502168 A JP 2018502168A
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JP
Japan
Prior art keywords
fingolimod
dosage form
anionic
pharmaceutically acceptable
sugar alcohol
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
JP2017556787A
Other languages
English (en)
Japanese (ja)
Other versions
JP2018502168A5 (enExample
Inventor
ファンユ リウ
ファンユ リウ
Original Assignee
ハンダ ファーマシューティカルズ エルエルシー
ハンダ ファーマシューティカルズ エルエルシー
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 ハンダ ファーマシューティカルズ エルエルシー, ハンダ ファーマシューティカルズ エルエルシー filed Critical ハンダ ファーマシューティカルズ エルエルシー
Publication of JP2018502168A publication Critical patent/JP2018502168A/ja
Publication of JP2018502168A5 publication Critical patent/JP2018502168A5/ja
Pending legal-status Critical Current

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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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • 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
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Emergency Medicine (AREA)
  • Zoology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Transplantation (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2017556787A 2015-01-20 2016-01-19 安定な固体フィンゴリモド剤形 Pending JP2018502168A (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201562105603P 2015-01-20 2015-01-20
US62/105,603 2015-01-20
US201562216100P 2015-09-09 2015-09-09
US62/216,100 2015-09-09
PCT/US2016/013938 WO2016118515A1 (en) 2015-01-20 2016-01-19 Stable solid fingolimod dosage forms

Publications (2)

Publication Number Publication Date
JP2018502168A true JP2018502168A (ja) 2018-01-25
JP2018502168A5 JP2018502168A5 (enExample) 2019-02-28

Family

ID=56417652

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2017556787A Pending JP2018502168A (ja) 2015-01-20 2016-01-19 安定な固体フィンゴリモド剤形

Country Status (8)

Country Link
US (3) US20230149302A1 (enExample)
EP (1) EP3247341A4 (enExample)
JP (1) JP2018502168A (enExample)
CN (1) CN107530301A (enExample)
AU (1) AU2016209466A1 (enExample)
CA (1) CA2974375A1 (enExample)
TW (1) TW201642842A (enExample)
WO (1) WO2016118515A1 (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2021181411A (ja) * 2020-05-18 2021-11-25 東和薬品株式会社 フィンゴリモドを含む医薬組成物とその製造方法及び安定化方法

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021049420A1 (ja) * 2019-09-13 2021-03-18 株式会社明治 固形食品及び固形乳

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012508215A (ja) * 2008-11-11 2012-04-05 ノバルティス アーゲー 有機化合物
JP2014509652A (ja) * 2011-04-01 2014-04-21 ノバルティス アーゲー ２−アミノ−２−［２−（４−オクチルフェニル）エチル］プロパン−１，３−ジオールを含む製剤

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ592339A (en) * 2003-04-08 2012-09-28 Novartis Ag Solid pharmaceutical compositions of S1P receptor agonist with sugar alcohol
KR101686369B1 (ko) * 2006-09-26 2016-12-13 노파르티스 아게 Ｓ１ｐ 조정제를 포함하는 제약 조성물
EP1923058A1 (en) * 2006-09-26 2008-05-21 Novartis AG Coated pharmaceutical composition comprising an S1P agonist or modulator
EP1923055A1 (en) * 2006-09-26 2008-05-21 Novartis AG Freeze-dried pharmaceutical composition comprising an S1P agonist or modulator
CA2925175A1 (en) * 2007-10-12 2009-04-16 Novartis Ag Compositions comprising sphingosine 1 phosphate (s1p) receptor modulators
US20130095177A1 (en) * 2010-04-22 2013-04-18 Ratiopharm Gmbh Method of preparing an oral dosage form comprising fingolimod
EP2609912A1 (en) * 2011-12-30 2013-07-03 Deva Holding Anonim Sirketi Pharmaceutical combination of fingolimod and nabiximols
US20140199382A1 (en) * 2013-01-11 2014-07-17 Cadila Healthcare Limited Stable pharmaceutical compositions of an s1p receptor agonist
US9925138B2 (en) * 2015-01-20 2018-03-27 Handa Pharmaceuticals, Llc Stable solid fingolimod dosage forms

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012508215A (ja) * 2008-11-11 2012-04-05 ノバルティス アーゲー 有機化合物
JP2014509652A (ja) * 2011-04-01 2014-04-21 ノバルティス アーゲー ２−アミノ−２−［２−（４−オクチルフェニル）エチル］プロパン−１，３−ジオールを含む製剤

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
一般財団法人 日本医薬情報センター（JAPIC） 編集・発行, JAPIC「医療用医薬品集」2014, JPN6019039633, 31 August 2013 (2013-08-31), pages 2293 - 2296, ISSN: 0004271836 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2021181411A (ja) * 2020-05-18 2021-11-25 東和薬品株式会社 フィンゴリモドを含む医薬組成物とその製造方法及び安定化方法
JP7503420B2 (ja) 2020-05-18 2024-06-20 東和薬品株式会社 フィンゴリモドを含む医薬組成物とその製造方法及び安定化方法

Also Published As

Publication number Publication date
CN107530301A (zh) 2018-01-02
EP3247341A1 (en) 2017-11-29
WO2016118515A1 (en) 2016-07-28
US20240050365A1 (en) 2024-02-15
TW201642842A (zh) 2016-12-16
US20250041213A1 (en) 2025-02-06
US20230149302A1 (en) 2023-05-18
AU2016209466A1 (en) 2017-08-10
EP3247341A4 (en) 2018-12-19
CA2974375A1 (en) 2016-07-28

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