CL2016002560A1 - Forma de dosificación farmacéutica sólida oral que comprende siponimod, un agente protector de la humedad y opcionalmente un excipiente farmacéutico; procedimiento de preparación. - Google Patents
Forma de dosificación farmacéutica sólida oral que comprende siponimod, un agente protector de la humedad y opcionalmente un excipiente farmacéutico; procedimiento de preparación.Info
- Publication number
- CL2016002560A1 CL2016002560A1 CL2016002560A CL2016002560A CL2016002560A1 CL 2016002560 A1 CL2016002560 A1 CL 2016002560A1 CL 2016002560 A CL2016002560 A CL 2016002560A CL 2016002560 A CL2016002560 A CL 2016002560A CL 2016002560 A1 CL2016002560 A1 CL 2016002560A1
- Authority
- CL
- Chile
- Prior art keywords
- dosage form
- optionally
- siponimod
- protective agent
- pharmaceutical excipient
- Prior art date
Links
- 239000002552 dosage form Substances 0.000 title abstract 4
- 239000000546 pharmaceutical excipient Substances 0.000 title abstract 4
- 229940124531 pharmaceutical excipient Drugs 0.000 title abstract 4
- KIHYPELVXPAIDH-HNSNBQBZSA-N 1-[[4-[(e)-n-[[4-cyclohexyl-3-(trifluoromethyl)phenyl]methoxy]-c-methylcarbonimidoyl]-2-ethylphenyl]methyl]azetidine-3-carboxylic acid Chemical compound CCC1=CC(C(\C)=N\OCC=2C=C(C(C3CCCCC3)=CC=2)C(F)(F)F)=CC=C1CN1CC(C(O)=O)C1 KIHYPELVXPAIDH-HNSNBQBZSA-N 0.000 title abstract 3
- 239000003223 protective agent Substances 0.000 title abstract 3
- 229950005693 siponimod Drugs 0.000 title abstract 3
- 238000000034 method Methods 0.000 title abstract 2
- 239000007787 solid Substances 0.000 title 1
- 239000000203 mixture Substances 0.000 abstract 2
- 150000001875 compounds Chemical class 0.000 abstract 1
- 239000007888 film coating Substances 0.000 abstract 1
- 238000009501 film coating Methods 0.000 abstract 1
- 239000008184 oral solid dosage form Substances 0.000 abstract 1
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
- A61K31/33—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)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201461977806P | 2014-04-10 | 2014-04-10 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CL2016002560A1 true CL2016002560A1 (es) | 2017-04-07 |
Family
ID=53525213
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CL2016002560A CL2016002560A1 (es) | 2014-04-10 | 2016-10-07 | Forma de dosificación farmacéutica sólida oral que comprende siponimod, un agente protector de la humedad y opcionalmente un excipiente farmacéutico; procedimiento de preparación. |
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) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| UA114283C2 (uk) | 2011-01-07 | 2017-05-25 | Новартіс Аг | Композиції імуносупресантів |
| US20170027906A1 (en) * | 2014-04-10 | 2017-02-02 | Philippe Michel Rene Bouillot | Immunosuppressant formulation |
| 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)
| 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 |
-
2015
- 2015-04-08 US US15/300,968 patent/US20170027906A1/en not_active Abandoned
- 2015-04-08 PE PE2016001740A patent/PE20161385A1/es not_active Application Discontinuation
- 2015-04-08 WO PCT/IB2015/052552 patent/WO2015155711A1/en not_active Ceased
- 2015-04-08 CN CN201580018811.7A patent/CN106163502B/zh active Active
- 2015-04-08 DK DK15735733.6T patent/DK3129006T3/da active
- 2015-04-08 KR KR1020167027528A patent/KR102466348B1/ko active Active
- 2015-04-08 AU AU2015246038A patent/AU2015246038C1/en active Active
- 2015-04-08 HU HUE15735733A patent/HUE054245T2/hu unknown
- 2015-04-08 EA EA201692043A patent/EA201692043A1/ru unknown
- 2015-04-08 SG SG11201607354PA patent/SG11201607354PA/en unknown
- 2015-04-08 JP JP2016561629A patent/JP6679495B2/ja active Active
- 2015-04-08 PL PL15735733T patent/PL3129006T3/pl unknown
- 2015-04-08 SI SI201531566T patent/SI3129006T1/sl unknown
- 2015-04-08 CA CA2942236A patent/CA2942236C/en active Active
- 2015-04-08 MX MX2016013236A patent/MX2016013236A/es unknown
- 2015-04-08 ES ES15735733T patent/ES2865451T3/es active Active
- 2015-04-08 PT PT157357336T patent/PT3129006T/pt unknown
- 2015-04-08 EP EP15735733.6A patent/EP3129006B1/en active Active
- 2015-04-09 TW TW104111464A patent/TW201622707A/zh unknown
- 2015-04-10 AR ARP150101084A patent/AR100002A1/es unknown
-
2016
- 2016-09-01 IL IL247599A patent/IL247599B/en active IP Right Grant
- 2016-09-20 PH PH12016501841A patent/PH12016501841A1/en unknown
- 2016-10-07 CL CL2016002560A patent/CL2016002560A1/es unknown
-
2018
- 2018-03-20 US US15/926,699 patent/US20180207128A1/en not_active Abandoned
-
2019
- 2019-03-21 US US16/360,696 patent/US20190328705A1/en not_active Abandoned
-
2020
- 2020-01-24 JP JP2020009871A patent/JP2020097591A/ja not_active Withdrawn
-
2021
- 2021-02-04 US US17/167,635 patent/US20210161860A1/en not_active Abandoned
-
2024
- 2024-03-14 US US18/605,259 patent/US20250073203A1/en active Pending
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