DK2477611T3 - (z)-2-cyano-3-hydroxybut-2-ensyre-(4'-trifluormethylphenyl)-amidtabletformuleringer med forbedret stabilitet - Google Patents
(z)-2-cyano-3-hydroxybut-2-ensyre-(4'-trifluormethylphenyl)-amidtabletformuleringer med forbedret stabilitet Download PDFInfo
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- DK2477611T3 DK2477611T3 DK10752585.9T DK10752585T DK2477611T3 DK 2477611 T3 DK2477611 T3 DK 2477611T3 DK 10752585 T DK10752585 T DK 10752585T DK 2477611 T3 DK2477611 T3 DK 2477611T3
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C255/00—Carboxylic acid nitriles
- C07C255/01—Carboxylic acid nitriles having cyano groups bound to acyclic carbon atoms
- C07C255/32—Carboxylic acid nitriles having cyano groups bound to acyclic carbon atoms having cyano groups bound to acyclic carbon atoms of a carbon skeleton containing at least one six-membered aromatic ring
- C07C255/42—Carboxylic acid nitriles having cyano groups bound to acyclic carbon atoms having cyano groups bound to acyclic carbon atoms of a carbon skeleton containing at least one six-membered aromatic ring the carbon skeleton being further substituted by singly-bound nitrogen atoms, not being further bound to other hetero atoms
- C07C255/44—Carboxylic acid nitriles having cyano groups bound to acyclic carbon atoms having cyano groups bound to acyclic carbon atoms of a carbon skeleton containing at least one six-membered aromatic ring the carbon skeleton being further substituted by singly-bound nitrogen atoms, not being further bound to other hetero atoms at least one of the singly-bound nitrogen atoms being acylated
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- 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
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/275—Nitriles; Isonitriles
- A61K31/277—Nitriles; Isonitriles having a ring, e.g. verapamil
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- 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
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- 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
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- 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
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- 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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/02—Nasal agents, e.g. decongestants
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P11/06—Antiasthmatics
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- A—HUMAN NECESSITIES
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- A61P17/00—Drugs for dermatological disorders
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P17/06—Antipsoriatics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/04—Drugs for skeletal disorders for non-specific disorders of the connective tissue
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P27/02—Ophthalmic agents
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- 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]
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/02—Nutrients, e.g. vitamins, minerals
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- 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
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
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- 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
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- 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
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- 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
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- 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
- A61P37/08—Antiallergic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
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- Pain & Pain Management (AREA)
- Nutrition Science (AREA)
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- Orthopedic Medicine & Surgery (AREA)
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- Ophthalmology & Optometry (AREA)
- Transplantation (AREA)
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- Inorganic Chemistry (AREA)
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- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (13)
1. Fast farmaceutisk sammensætning, der i det væsentlige består af a) 1 % til 30 % vægt/vægt teriflunomid eller et farmaceutisk acceptabelt basisk additionssalt deraf, b) 5 % til 20 % vægt/vægt opløsningsmiddel, c) 0 % til 40 % vægt/vægt bindemiddel, d) 0,1 % til 2 % vægt/vægt smøremiddel, og e) den resterende procentdel omfatter fortyndingsmidler, forudsat at den faste farmaceutiske sammensætning ikke indeholder kolloidt siliciumdioxid.
2. Fast farmaceutisk sammensætning ifølge krav 1, hvor opløsningsmidlet er udvalgt fra gruppen, der består af carboxymethylcellulose, lavsubstitueret hydroxypropylcellulose, mikrokrystallinsk cellulose, pulveriseret cellulose, croscarmellosenatrium, methylcellulose, polacrilinkalium, natriumalginat, natriumstivelsesglycolat eller en blanding af et eller flere af opløsningsmidlerne.
3. Fast farmaceutisk sammensætning ifølge krav 2, hvor opløsningsmidlet er udvalgt fra gruppen, der består af lavsubstitueret hydroxypropylcellulose, mikrokrystallinsk cellulose, pulveriseret cellulose, croscarmellosenatrium, natriumstivelsesglycolat eller en blanding af et eller flere af opløsningsmidlerne.
4. Fast farmaceutisk sammensætning ifølge krav 1, hvor bindemidlet er udvalgt fra gruppen, der består af akacie, carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, dextrin, gelatine, guargummi, hydroxypropylmethylcellulose, maltodextrin, methylcellulose, natriumalginat, prægelatineret stivelse, kartoffelstivelse, majsstivelse eller kornstivelse og zein eller en blanding af et eller flere af bindemidlerne.
5. Fast farmaceutisk sammensætning ifølge krav 4, hvor bindemidlet er udvalgt fra gruppen, der består af hydroxypropylcellulose, hydroxypropylmethylcellulose, prægelatineret stivelse, kartoffelstivelse, majsstivelse eller kornstivelse eller en blanding af et eller flere af bindemidlerne.
6. Fast farmaceutisk sammensætning ifølge krav 1, hvor smøremidlet er udvalgt fra gruppen, der består af calciumstearat, glycerylpalmitostearat, natriumbenzoat, natriumlaurylsulfat, natriumstearylfumarat, stearinsyre, talkum, zinkstearat og magnesiumstearat eller en blanding af et eller flere af smøremidlerne.
7. Fast farmaceutisk sammensætning ifølge krav 6, hvor smøremidlet er udvalgt fra gruppen, der består af natriumstearylfumarat og magnesiumstearat eller en blanding af et eller flere af smøremidlerne.
8. Fast farmaceutisk sammensætning ifølge krav 1, hvor fortyndingsmidlet er udvalgt fra gruppen, der består af cellulose, celluloseacetat, dextrater, dextrin, dextrose, fructose, Ι-Ο-α-D-glucopyranosyl-D-mannitol, glycerylpalmitostearat, hydrogeneret vegetabilsk olie, kaolin, lactitol, lactose, lactosemonohydrat, maltitol, mannitol, maltodextrin, maltose, prægelatineret stivelse, natriumchlorid, sorbitol, stivelser, saccharose, talkum og xylitol eller en blanding af et eller flere af fortyndingsmidlerne.
9. Fast farmaceutisk sammensætning ifølge krav 8, hvor fortyndingsmidlet er udvalgt fra gruppen, der består af lactose, lactosemonohydrat, mannitol og stivelser eller en blanding af et eller flere af fortyndingsmidlerne.
10. Fast farmaceutisk sammensætning ifølge et hvilket som helst af ovennævnte krav, hvor sammensætningen er overtrukket.
11. Fast farmaceutisk sammensætning ifølge krav 10, som er en tablet eller en pille med et hypromellosebaseret overtræk.
12. Fast farmaceutisk sammensætning ifølge et hvilket som helst af ovennævnte krav, der i det væsentlige består af: (a) 2 % til 15 % vægt/vægt teriflunomid, (b) 7 % til 15 % vægt/vægt opløsningsmiddel udvalgt blandt en eller flere af mikrokrystallinsk cellulose eller natriumstivelsesglycolat, (c) 15 % til 35 % vægt/vægt bindemiddel udvalgt blandt en eller flere af hydroxypropylcellulose eller majsstivelse, (d) 0,1 % til 1,0 % vægt/vægt smøremiddel udvalgt blandt magnesiumstearat; og (e) den resterende procentdel omfatter fortyndingsmidler udvalgt blandt lactosemonohydrat.
13. Fast farmaceutisk sammensætning ifølge kravene 1 til 12 til anvendelse til behandling af sepsis, allergi, graft-versus-host-reaktioner, host-versus-graft-reaktioner, rheumatoid arthritis, systemisk lupus erythematosus, multipel sklerose, psoriasis, astma, urticaria, rhinitis, uveitis, lungecancer, leukæmi, ovariecancer, sarkom, Kaposis sarkom, meningiom, intestinalcancer, lymfeknudecancer, hjernetumorer, brystcancer, pancreascancer, prostatacancer eller hudcancer.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP09290716 | 2009-09-18 | ||
| US36338210P | 2010-07-12 | 2010-07-12 | |
| PCT/EP2010/063439 WO2011032929A1 (en) | 2009-09-18 | 2010-09-14 | (z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2477611T3 true DK2477611T3 (da) | 2017-07-10 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK10752585.9T DK2477611T3 (da) | 2009-09-18 | 2010-09-14 | (z)-2-cyano-3-hydroxybut-2-ensyre-(4'-trifluormethylphenyl)-amidtabletformuleringer med forbedret stabilitet |
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Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| NZ598744A (en) * | 2009-09-18 | 2013-11-29 | Sanofi Sa | (z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability |
| RU2493845C1 (ru) * | 2012-06-07 | 2013-09-27 | Общество с ограниченной ответственностью "ВАЛЕНТА ИНТЕЛЛЕКТ" | Композиция для лечения рассеянного склероза (варианты) |
| EP3071199A2 (en) * | 2013-11-22 | 2016-09-28 | Genzyme Corporation | Novel methods for treating neurodegenerative diseases |
| CN103656657A (zh) * | 2013-12-18 | 2014-03-26 | 北京科源创欣科技有限公司 | 特立氟胺药物组合物及制备方法 |
| RU2715236C2 (ru) | 2014-03-26 | 2020-02-26 | Астекс Терапьютикс Лтд | Комбинации |
| US20160058730A1 (en) * | 2014-08-29 | 2016-03-03 | Cadila Healthcare Limited | Pharmaceutical compositions of teriflunomide |
| WO2016079687A1 (en) * | 2014-11-18 | 2016-05-26 | Lupin Limited | Oral pharmaceutical composition of teriflunomide |
| TWI719960B (zh) | 2015-02-10 | 2021-03-01 | 英商阿斯迪克治療公司 | 新穎組成物 |
| US20180147148A1 (en) | 2015-05-23 | 2018-05-31 | Ftf Pharma Private Limited | Pharmaceutical composition of teriflunomide |
| US11096934B2 (en) | 2015-09-01 | 2021-08-24 | The Broad Institute, Inc. | Compounds and methods useful for treating or preventing hematological cancers |
| WO2017037645A1 (en) * | 2015-09-02 | 2017-03-09 | Leiutis Pharmaceuticals Pvt Ltd | Stable pharmaceutical formulations of teriflunomide |
| WO2017056104A1 (en) * | 2015-09-28 | 2017-04-06 | Natco Pharma Limited | Stable pharmaceutical compositions of teriflunomide |
| WO2017125841A1 (en) * | 2016-01-20 | 2017-07-27 | Emcure Pharmaceuticals Limited | Pharmaceutical compositions of teriflunomide |
| JOP20190207A1 (ar) | 2017-03-14 | 2019-09-10 | Actelion Pharmaceuticals Ltd | تركيبة صيدلانية تشتمل على بونيسيمود |
| RS65302B1 (sr) * | 2019-07-17 | 2024-04-30 | Cytokinetics Inc | Oralne formulacije inhibitora srčanog sarkomera |
| DK4178548T3 (da) * | 2020-07-07 | 2024-08-19 | Celgene Corp | Farmaceutiske sammensætninger omfattende (S)-4-(4-(4-(((2-(2,6-DIOXOPIPERIDIN-3-YL)-1-OXOISOINDOLIN-4-YL)OXY)METHYL)BENZYL)PIPERAZIN-1-YL)-3-FLUORBENZONITRIL |
| WO2022085015A1 (en) * | 2020-10-24 | 2022-04-28 | V-Ensure Pharma Technologies Private Limited | A solid oral composition of teriflunomide |
| GR1010137B (el) | 2020-12-15 | 2021-12-07 | Φαρματεν Α.Β.Ε.Ε., | Στερεη φαρμακοτεχνικη μορφη αμεσης αποδεσμευσης περιεχουσα τεριφλουνομιδη και μεθοδος παρασκευης αυτης |
| TR202022336A2 (tr) * | 2020-12-30 | 2022-07-21 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | A film coated tablet comprising teriflunomide |
| EP4382097A1 (en) | 2022-11-25 | 2024-06-12 | Sanovel Ilac Sanayi Ve Ticaret A.S. | A tablet comprising teriflunomide |
| TR2022017840A1 (tr) * | 2022-11-25 | 2024-06-21 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Teri̇flunomi̇d i̇çeren bi̇r tablet |
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| AU2005295511A1 (en) * | 2004-10-19 | 2006-04-27 | Aventis Pharmaceuticals Inc. | Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluoromethylphenyl)-amide for treating inflammatory bowel disease |
| TWI275029B (en) * | 2005-11-18 | 2007-03-01 | Hon Hai Prec Ind Co Ltd | An embedded system and method for processing data thereof |
| EP1810676B1 (en) | 2006-01-24 | 2008-11-12 | Teva Pharmaceutical Industries Limited | Levetiracetam formulations and methods for their manufacture |
| DE102006017896A1 (de) | 2006-04-13 | 2007-10-25 | Tiefenbacher Pharmachemikalien Alfred E. Tiefenbacher Gmbh & Co. Kg | Leflunomid enthaltende pharmazeutische Zusammensetzungen |
| EP1990048A3 (en) | 2007-05-08 | 2009-05-06 | Ulrike Wiebelitz | Therapy of benign prostatic hyperplasia (bph) |
| NZ598744A (en) * | 2009-09-18 | 2013-11-29 | Sanofi Sa | (z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability |
| EP2762135A1 (en) * | 2013-02-04 | 2014-08-06 | Sanofi | Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients |
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