JP6679495B2 - 免疫抑制製剤 - Google Patents

免疫抑制製剤 Download PDF

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Publication number
JP6679495B2
JP6679495B2 JP2016561629A JP2016561629A JP6679495B2 JP 6679495 B2 JP6679495 B2 JP 6679495B2 JP 2016561629 A JP2016561629 A JP 2016561629A JP 2016561629 A JP2016561629 A JP 2016561629A JP 6679495 B2 JP6679495 B2 JP 6679495B2
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Prior art keywords
siponimod
weight
formulation
mixture
dosage form
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Japanese (ja)
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JP2017510602A5 (enExample
JP2017510602A (ja
Inventor
マイケル レーン ボウイロット，フィリッペ
マイケル レーン ボウイロット，フィリッペ
レイナウド，エメリック
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ノバルティス アーゲー
ノバルティス アーゲー
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    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/397—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having four-membered rings, e.g. azetidine
    • 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
    • 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
    • A61K9/20—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
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • 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
    • A61K9/5089—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Transplantation (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2016561629A 2014-04-10 2015-04-08 免疫抑制製剤 Active JP6679495B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201461977806P 2014-04-10 2014-04-10
US61/977,806 2014-04-10
PCT/IB2015/052552 WO2015155711A1 (en) 2014-04-10 2015-04-08 Immunosuppressant formulation

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2020009871A Division JP2020097591A (ja) 2014-04-10 2020-01-24 免疫抑制製剤

Publications (3)

Publication Number Publication Date
JP2017510602A JP2017510602A (ja) 2017-04-13
JP2017510602A5 JP2017510602A5 (enExample) 2018-05-17
JP6679495B2 true JP6679495B2 (ja) 2020-04-15

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JP2016561629A Active JP6679495B2 (ja) 2014-04-10 2015-04-08 免疫抑制製剤
JP2020009871A Withdrawn JP2020097591A (ja) 2014-04-10 2020-01-24 免疫抑制製剤

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Country Status (23)

Country Link
US (5) US20170027906A1 (enExample)
EP (1) EP3129006B1 (enExample)
JP (2) JP6679495B2 (enExample)
KR (1) KR102466348B1 (enExample)
CN (1) CN106163502B (enExample)
AR (1) AR100002A1 (enExample)
AU (1) AU2015246038C1 (enExample)
CA (1) CA2942236C (enExample)
CL (1) CL2016002560A1 (enExample)
DK (1) DK3129006T3 (enExample)
EA (1) EA201692043A1 (enExample)
ES (1) ES2865451T3 (enExample)
HU (1) HUE054245T2 (enExample)
IL (1) IL247599B (enExample)
MX (1) MX2016013236A (enExample)
PE (1) PE20161385A1 (enExample)
PH (1) PH12016501841A1 (enExample)
PL (1) PL3129006T3 (enExample)
PT (1) PT3129006T (enExample)
SG (1) SG11201607354PA (enExample)
SI (1) SI3129006T1 (enExample)
TW (1) TW201622707A (enExample)
WO (1) WO2015155711A1 (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2020097591A (ja) * 2014-04-10 2020-06-25 ノバルティス アーゲー 免疫抑制製剤

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
UA114283C2 (uk) 2011-01-07 2017-05-25 Новартіс Аг Композиції імуносупресантів
US11434200B2 (en) 2017-03-09 2022-09-06 Novartis Ag Solid forms comprising an oxime ether compound and a coformer, compositions and methods of use thereof
US11629124B2 (en) 2017-03-09 2023-04-18 Novartis Ag Solid forms comprising an oxime ether compound, compositions and methods of use thereof
US11628137B2 (en) 2017-09-27 2023-04-18 Novartis Ag Parenteral formulation comprising siponimod
MX2020007326A (es) 2017-09-29 2020-09-07 Novartis Ag Regimen de dosificacion de siponimod.
EP3687530A1 (en) 2017-09-29 2020-08-05 Novartis AG Dosing regimen of siponimod
US11673860B2 (en) 2018-01-22 2023-06-13 Teva Pharmaceuticals International Gmbh Crystalline siponimod fumaric acid and polymorphs thereof
CN109908095A (zh) * 2019-04-08 2019-06-21 肇庆学院 一种西尼莫德片剂及制备方法
WO2021214717A1 (en) 2020-04-23 2021-10-28 Novartis Ag Dosing regimen for the use of siponimod for the treatment of acute respiratory distress syndrome
CN113633632A (zh) * 2021-09-09 2021-11-12 暨南大学附属第一医院（广州华侨医院） siponimod在制备抗肿瘤转移药物中的应用
WO2024126409A1 (en) 2022-12-12 2024-06-20 Synthon B.V. Pharmaceutical composition of siponimod

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3733161A1 (en) * 2007-10-12 2020-11-04 Novartis AG Compositions comprising sphingosine 1 phosphate (s1p) receptor modulators
CN102090133A (zh) 2008-07-16 2011-06-08 日本电气株式会社 用于报告Iu-UP协议协商结果信息的方法、协议转换方法、通信网络系统、互通设备、用于获取Iu-UP协议协商结果信息的设备以及计算机可读的信息记录介质
WO2010071794A1 (en) 2008-12-18 2010-06-24 Novartis Ag New polymorphic form of 1- (4- { l- [ (e) -4-cyclohexyl--3-trifluoromethyl-benzyloxyimino] -ethyl) -2-ethyl-benzy l) -azetidine-3-carboxylic
PL2676953T3 (pl) 2008-12-18 2017-09-29 Novartis Ag Sól hemifumaranowa kwasu 1-[4-[1-(4-cykloheksylo-3-trifluorometylobenzyloksyimino)-etylo]-2-etylobenzylo]-azetydyno-3-karboksylowego
BRPI0923213A2 (pt) * 2008-12-22 2016-01-26 Novaris Ag regime de dosagem de um agonista do receptor para s1p.
CN101480374A (zh) * 2009-01-20 2009-07-15 苏州中化药品工业有限公司 一种稳定的固体药物组合物
UA114283C2 (uk) * 2011-01-07 2017-05-25 Новартіс Аг Композиції імуносупресантів
WO2012095853A1 (en) * 2011-01-10 2012-07-19 Novartis Pharma Ag Modified release formulations comprising sip receptor modulators
US20170027906A1 (en) * 2014-04-10 2017-02-02 Philippe Michel Rene Bouillot Immunosuppressant formulation

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2020097591A (ja) * 2014-04-10 2020-06-25 ノバルティス アーゲー 免疫抑制製剤

Also Published As

Publication number Publication date
SG11201607354PA (en) 2016-10-28
US20170027906A1 (en) 2017-02-02
WO2015155711A1 (en) 2015-10-15
AU2015246038A1 (en) 2016-09-22
PL3129006T3 (pl) 2021-07-05
CL2016002560A1 (es) 2017-04-07
AU2015246038C1 (en) 2018-05-31
KR102466348B1 (ko) 2022-11-10
EP3129006B1 (en) 2021-01-27
PH12016501841A1 (en) 2017-01-09
ES2865451T3 (es) 2021-10-15
US20180207128A1 (en) 2018-07-26
CA2942236C (en) 2023-08-29
US20210161860A1 (en) 2021-06-03
CN106163502B (zh) 2020-12-01
JP2017510602A (ja) 2017-04-13
IL247599B (en) 2020-08-31
CA2942236A1 (en) 2015-10-15
US20190328705A1 (en) 2019-10-31
AR100002A1 (es) 2016-08-31
CN106163502A (zh) 2016-11-23
PE20161385A1 (es) 2017-01-05
JP2020097591A (ja) 2020-06-25
DK3129006T3 (da) 2021-04-19
WO2015155711A4 (en) 2015-12-10
US20250073203A1 (en) 2025-03-06
HUE054245T2 (hu) 2021-08-30
IL247599A0 (en) 2016-11-30
TW201622707A (zh) 2016-07-01
EP3129006A1 (en) 2017-02-15
AU2015246038B2 (en) 2017-11-30
SI3129006T1 (sl) 2021-08-31
MX2016013236A (es) 2017-01-16
KR20160144366A (ko) 2016-12-16
PT3129006T (pt) 2021-04-09
EA201692043A1 (ru) 2017-02-28

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