DK3129006T3 - Immunsupprimerende formulering - Google Patents

Immunsupprimerende formulering Download PDF

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Publication number
DK3129006T3
DK3129006T3 DK15735733.6T DK15735733T DK3129006T3 DK 3129006 T3 DK3129006 T3 DK 3129006T3 DK 15735733 T DK15735733 T DK 15735733T DK 3129006 T3 DK3129006 T3 DK 3129006T3
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DK
Denmark
Prior art keywords
immunosuppressive
formulation
immunosuppressive formulation
Prior art date
Application number
DK15735733.6T
Other languages
Danish (da)
English (en)
Inventor
Philippe Michel Rene Bouillot
Emeric Reynaud
Original Assignee
Novartis Ag
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 Novartis Ag filed Critical Novartis Ag
Application granted granted Critical
Publication of DK3129006T3 publication Critical patent/DK3129006T3/da

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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
    • A61K9/14—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
    • 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
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Transplantation (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
DK15735733.6T 2014-04-10 2015-04-08 Immunsupprimerende formulering DK3129006T3 (da)

Applications Claiming Priority (2)

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

Publications (1)

Publication Number Publication Date
DK3129006T3 true DK3129006T3 (da) 2021-04-19

Family

ID=53525213

Family Applications (1)

Application Number Title Priority Date Filing Date
DK15735733.6T DK3129006T3 (da) 2014-04-10 2015-04-08 Immunsupprimerende formulering

Country Status (23)

Country Link
US (5) US20170027906A1 (cg-RX-API-DMAC7.html)
EP (1) EP3129006B1 (cg-RX-API-DMAC7.html)
JP (2) JP6679495B2 (cg-RX-API-DMAC7.html)
KR (1) KR102466348B1 (cg-RX-API-DMAC7.html)
CN (1) CN106163502B (cg-RX-API-DMAC7.html)
AR (1) AR100002A1 (cg-RX-API-DMAC7.html)
AU (1) AU2015246038C1 (cg-RX-API-DMAC7.html)
CA (1) CA2942236C (cg-RX-API-DMAC7.html)
CL (1) CL2016002560A1 (cg-RX-API-DMAC7.html)
DK (1) DK3129006T3 (cg-RX-API-DMAC7.html)
EA (1) EA201692043A1 (cg-RX-API-DMAC7.html)
ES (1) ES2865451T3 (cg-RX-API-DMAC7.html)
HU (1) HUE054245T2 (cg-RX-API-DMAC7.html)
IL (1) IL247599B (cg-RX-API-DMAC7.html)
MX (1) MX2016013236A (cg-RX-API-DMAC7.html)
PE (1) PE20161385A1 (cg-RX-API-DMAC7.html)
PH (1) PH12016501841A1 (cg-RX-API-DMAC7.html)
PL (1) PL3129006T3 (cg-RX-API-DMAC7.html)
PT (1) PT3129006T (cg-RX-API-DMAC7.html)
SG (1) SG11201607354PA (cg-RX-API-DMAC7.html)
SI (1) SI3129006T1 (cg-RX-API-DMAC7.html)
TW (1) TW201622707A (cg-RX-API-DMAC7.html)
WO (1) WO2015155711A1 (cg-RX-API-DMAC7.html)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101951966B1 (ko) 2011-01-07 2019-02-25 노파르티스 아게 면역억제제 제제
JP6679495B2 (ja) * 2014-04-10 2020-04-15 ノバルティス アーゲー 免疫抑制製剤
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
WO2019064185A1 (en) 2017-09-27 2019-04-04 Novartis Ag PARENTERAL FORMULATION COMPRISING SITOMOD
CA3074416A1 (en) 2017-09-29 2019-04-04 Novartis Ag Dosing regimen of siponimod
WO2019064212A1 (en) 2017-09-29 2019-04-04 Novartis Ag DOSAGE DIAGRAM OF SIPONIMOD
WO2019144094A1 (en) * 2018-01-22 2019-07-25 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
HUE027696T2 (en) * 2007-10-12 2016-10-28 Novartis Ag Preparations containing sphingosine-1-phosphate (S1P) receptor modulators
GB2473399B (en) 2008-07-16 2012-06-27 Nec Corp Method for reporting information about result of Iu-UP protocol negotiation protocol conversion method,communication network system
US20120115840A1 (en) 2008-12-18 2012-05-10 Lech Ciszewski Hemifumarate salt of 1-[4-[1-(4-cyclohexyl-3-trifluoromethyl-benzyloxyimino)-ethyl]-2-ethyl-benzyl]-azetidine-3-carboxylic acid
BRPI0922457A2 (pt) 2008-12-18 2015-12-15 Novartis Ag forma polimórfica de ácido 1-(4-{1-[(e)-4-ciclo-hexil-3-trifluormetil-benziloxi-imino]-etil)-2-etil-benzil)-azetidino-3-carboxílico"
CA2981830A1 (en) * 2008-12-22 2010-07-01 Novartis Ag Dosage regimen of an s1p receptor agonist
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
KR101951966B1 (ko) * 2011-01-07 2019-02-25 노파르티스 아게 면역억제제 제제
WO2012095853A1 (en) * 2011-01-10 2012-07-19 Novartis Pharma Ag Modified release formulations comprising sip receptor modulators
JP6679495B2 (ja) * 2014-04-10 2020-04-15 ノバルティス アーゲー 免疫抑制製剤

Also Published As

Publication number Publication date
CA2942236C (en) 2023-08-29
JP2020097591A (ja) 2020-06-25
AU2015246038C1 (en) 2018-05-31
KR102466348B1 (ko) 2022-11-10
AU2015246038A1 (en) 2016-09-22
SG11201607354PA (en) 2016-10-28
US20210161860A1 (en) 2021-06-03
IL247599A0 (en) 2016-11-30
AU2015246038B2 (en) 2017-11-30
IL247599B (en) 2020-08-31
PE20161385A1 (es) 2017-01-05
EA201692043A1 (ru) 2017-02-28
MX2016013236A (es) 2017-01-16
CA2942236A1 (en) 2015-10-15
EP3129006A1 (en) 2017-02-15
EP3129006B1 (en) 2021-01-27
US20250073203A1 (en) 2025-03-06
HUE054245T2 (hu) 2021-08-30
CL2016002560A1 (es) 2017-04-07
TW201622707A (zh) 2016-07-01
US20180207128A1 (en) 2018-07-26
PH12016501841A1 (en) 2017-01-09
US20190328705A1 (en) 2019-10-31
WO2015155711A4 (en) 2015-12-10
ES2865451T3 (es) 2021-10-15
CN106163502A (zh) 2016-11-23
JP2017510602A (ja) 2017-04-13
PT3129006T (pt) 2021-04-09
AR100002A1 (es) 2016-08-31
KR20160144366A (ko) 2016-12-16
CN106163502B (zh) 2020-12-01
JP6679495B2 (ja) 2020-04-15
PL3129006T3 (pl) 2021-07-05
SI3129006T1 (sl) 2021-08-31
US20170027906A1 (en) 2017-02-02
WO2015155711A1 (en) 2015-10-15

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