CN107530301A - 稳定的固体芬戈莫德剂型 - Google Patents

稳定的固体芬戈莫德剂型 Download PDF

Info

Publication number
CN107530301A
CN107530301A CN201680006946.6A CN201680006946A CN107530301A CN 107530301 A CN107530301 A CN 107530301A CN 201680006946 A CN201680006946 A CN 201680006946A CN 107530301 A CN107530301 A CN 107530301A
Authority
CN
China
Prior art keywords
fingolimod
dosage form
pharmaceutically acceptable
anionic
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
CN201680006946.6A
Other languages
English (en)
Chinese (zh)
Inventor
刘芳宇
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.)
Handa Pharmaceuticals LLC
Original Assignee
Handa Pharmaceuticals LLC
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 Handa Pharmaceuticals LLC filed Critical Handa Pharmaceuticals LLC
Publication of CN107530301A publication Critical patent/CN107530301A/zh
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
    • A61K31/13—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)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Zoology (AREA)
  • Emergency Medicine (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Transplantation (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CN201680006946.6A 2015-01-20 2016-01-19 稳定的固体芬戈莫德剂型 Pending CN107530301A (zh)

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 (1)

Publication Number Publication Date
CN107530301A true CN107530301A (zh) 2018-01-02

Family

ID=56417652

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201680006946.6A Pending CN107530301A (zh) 2015-01-20 2016-01-19 稳定的固体芬戈莫德剂型

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)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4029380A4 (en) * 2019-09-13 2023-09-13 Meiji Co., Ltd SOLID FOOD AND SOLID MILK
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

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101516345A (zh) * 2006-09-26 2009-08-26 诺瓦提斯公司 包含s1p调节剂的药物组合物
CN103476400A (zh) * 2011-04-01 2013-12-25 诺华股份有限公司 包含2-氨基-2-[2-(4-辛基苯基)乙基]丙-1,3-二醇的制剂

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2400318B (en) * 2003-04-08 2005-08-10 Novartis Ag Pharmaceutical composition comprising an S1P receptor agonist
EP1923055A1 (en) * 2006-09-26 2008-05-21 Novartis AG Freeze-dried pharmaceutical composition comprising an S1P agonist or modulator
PT3103448T (pt) * 2006-09-26 2019-07-12 Novartis Ag Composições farmacêuticas que compreendem um modulador de s1p
AR068986A1 (es) * 2007-10-12 2009-12-23 Novartis Ag Composiciones que comprenden moduladores del receptor de fosfato de esfingosina-1 (s1p)
MX2011004924A (es) * 2008-11-11 2011-05-30 Novartis Ag Sales de fingolimod.
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
CN101516345A (zh) * 2006-09-26 2009-08-26 诺瓦提斯公司 包含s1p调节剂的药物组合物
CN103476400A (zh) * 2011-04-01 2013-12-25 诺华股份有限公司 包含2-氨基-2-[2-(4-辛基苯基)乙基]丙-1,3-二醇的制剂

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
REWAR S等: "International Journal of Research and Development in Pharmacy and Life Sciences", 《INTERNATIONAL JOURNAL OF RESEARCH AND DEVELOPMENT IN PHARMACY AND LIFE SCIENCES》 *

Also Published As

Publication number Publication date
TW201642842A (zh) 2016-12-16
CA2974375A1 (en) 2016-07-28
EP3247341A1 (en) 2017-11-29
US20250041213A1 (en) 2025-02-06
AU2016209466A1 (en) 2017-08-10
US20230149302A1 (en) 2023-05-18
JP2018502168A (ja) 2018-01-25
WO2016118515A1 (en) 2016-07-28
EP3247341A4 (en) 2018-12-19
US20240050365A1 (en) 2024-02-15

Similar Documents

Publication Publication Date Title
US10925829B2 (en) Stable solid fingolimod dosage forms
CN1913876B (zh) 含药物的颗粒和包含这种颗粒的固体制剂
JP6396980B2 (ja) ベンダムスチンの固体投与剤
Sharma et al. A comprehensive review on fast dissolving tablet technology
Pandey et al. Oral disintegrating tablets: a review
CN104244930A (zh) 口腔崩解片及其制造方法
CN101801347A (zh) 包含二氢吡啶类钙通道拮抗剂的改进的药物组合物及其制备方法
CN102686218A (zh) 含纳米微粒的口服固体剂型和使用鱼胶配制所述剂型的方法
EP3527200A1 (en) Lenalidomide oral tablet composition
CN101262852A (zh) 稳定活性药物成分的组合物和方法
US20250041213A1 (en) Stable solid fingolimod dosage form
KR102445606B1 (ko) 레보세티리진을 포함하는 약학 조성물
Agiba et al. Insights into formulation technologies and novel strategies for the design of orally disintegrating dosage forms: A comprehensive industrial review
US20090269393A1 (en) Chewable Bilayer Tablet Formulation
Kumar et al. Development and characterization of melt-in-mouth tablets of haloperidol by sublimation technique
US20180344648A1 (en) Clobazam tablet formulation and process for its preparation
KR20190131192A (ko) 에틸 셀룰로오스로 개질된 당 또는 당알코올 과립을 포함하는 구강붕해정
GB2625579A (en) An orally disintegrating tablet containing gabapentin or pharmaceutically acceptable salts thereof and the process of preparing the same
JP5508311B2 (ja) 低水溶性薬物とともに使用することによく適した圧縮固体状投与形態の製造方法およびそれにより製造された圧縮固体状投与形態
Kumar et al. Fast dissolving drug delivery system: Innovative strategies for drug application
Pradeep Design and in vitro evaluation of mouth dissolving tablets of venlafaxine hydrochloride
EA035891B1 (ru) Быстродиспергируемая фармацевтическая композиция, включающая ингибитор тирозинкиназы
HK1155978B (en) Orally disintegrating tablets
HK1155978A1 (en) Orally disintegrating tablets

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
WD01 Invention patent application deemed withdrawn after publication
WD01 Invention patent application deemed withdrawn after publication

Application publication date: 20180102