HRP20170904T1 - Formulacije tableta (4'-trifluormetilfenil)-amida (z)-2-cijano-3-hidroksi-but-2-enske kiseline s poboljšanom stabilnošću - Google Patents

Formulacije tableta (4'-trifluormetilfenil)-amida (z)-2-cijano-3-hidroksi-but-2-enske kiseline s poboljšanom stabilnošću Download PDF

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HRP20170904T1
HRP20170904T1 HRP20170904TT HRP20170904T HRP20170904T1 HR P20170904 T1 HRP20170904 T1 HR P20170904T1 HR P20170904T T HRP20170904T T HR P20170904TT HR P20170904 T HRP20170904 T HR P20170904T HR P20170904 T1 HRP20170904 T1 HR P20170904T1
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solid pharmaceutical
pharmaceutical preparation
preparation according
starch
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HRP20170904TT
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Gerrit Hauck
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Sanofi
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Publication of HRP20170904T1 publication Critical patent/HRP20170904T1/hr

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C255/00Carboxylic acid nitriles
    • C07C255/01Carboxylic acid nitriles having cyano groups bound to acyclic carbon atoms
    • C07C255/32Carboxylic 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
    • C07C255/42Carboxylic 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
    • C07C255/44Carboxylic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/275Nitriles; Isonitriles
    • A61K31/277Nitriles; Isonitriles having a ring, e.g. verapamil
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/02Nasal agents, e.g. decongestants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/04Drugs for skeletal disorders for non-specific disorders of the connective tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/02Nutrients, e.g. vitamins, minerals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Pulmonology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Oncology (AREA)
  • Hematology (AREA)
  • Dermatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Communicable Diseases (AREA)
  • Biomedical Technology (AREA)
  • Diabetes (AREA)
  • Rheumatology (AREA)
  • Neurosurgery (AREA)
  • Ophthalmology & Optometry (AREA)
  • Pain & Pain Management (AREA)
  • Otolaryngology (AREA)
  • Nutrition Science (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Obesity (AREA)
  • Transplantation (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Claims (13)

1. Kruti farmaceutski pripravak naznačen time da u osnovi sadrži a) 1 % do 30 % težinski: težinski Teriflunomida, ili njegove farmaceutski prihvatljive bazične adicijske soli, b) 5 % do 20 % težinski: težinski sredstva za raspadanje, c) 0 % do 40 % težinski: težinski veziva, d) 0.1 % do 2 % težinski: težinski sredstva za podmazivanje i e) preostali postotak obuhvaća sredstva za razrjeđivanje, pod uvjetom da navedeni kruti farmaceutski pripravak na sadrži koloidni silicijev dioksid.
2. Kruti farmaceutski pripravak prema zahtjevu 1 naznačen time da je navedeno sredstvo za raspadanje odabrano iz skupine koju čine karboksimetilceluloza, nisko supstituirana hidroksipropilceluloza, mikrokristalna celuloza, celuloza u prahu, kroskarmeloza natrij, metilceluloza, polakrilin kalij, natrijev alginat, natrijev škrobni glikolat ili smjesa jednog ili više od navedenih sredstava za raspadanje.
3. Kruti farmaceutski pripravak prema zahtjevu 2 naznačen time da je navedeno sredstvo za raspadanje odabrano iz skupine koju čine nisko supstituirana hidroksipropilceluloza, mikrokristalna celuloza, celuloza u prahu, kroskarmeloza natrij, natrijev škrobni glikolat ili smjesa jednog ili više od navedenih sredstava za raspadanje.
4. Kruti farmaceutski pripravak prema zahtjevu 1 naznačen time da je navedeno vezivo odabrano iz skupine koju čine akacija, karboksimetilceluloza, hidroksietilceluloza, hidroksipropilceluloza, dekstrin, želatina, guar guma, hidroksipropil metilceluloza, maltodekstrin, metilceluloza, natrijev alginat, preželatinirani škrob, krumpirov škrob, kukuruzni škrob ili škrob od žitarica i zein ili smjesa jednog ili više od navedenih veziva.
5. Kruti farmaceutski pripravak prema zahtjevu 4 naznačen time da je navedeno vezivo odabrano iz skupine koju čine hidroksipropilceluloza, hidroksipropil metilceluloza, preželatinirani škrob, krumpirov škrob, kukuruzni škrob ili škrob od žitarica ili smjesa jednog ili više od navedenih veziva.
6. Kruti farmaceutski pripravak prema zahtjevu 1 naznačen time da je navedeno sredstvo za podmazivanje odabrano iz skupine koju čine kalcijev stearat, gliceril palmitostearat, natrijev benzoat, natrijev lauril sulfat, natrijev stearil fumarat, stearinska kiselina, talk, cinkov stearat i magnezijev stearat ili smjesa jednog ili više od navedenih sredstava za podmazivanje.
7. Kruti farmaceutski pripravak prema zahtjevu 6 naznačen time da je navedeno sredstvo za podmazivanje odabrano iz skupine koju čine natrijev stearil fumarate i magnezijev stearat ili smjesa jednog ili više od navedenih sredstava za podmazivanje.
8. Kruti farmaceutski pripravak prema zahtjevu 1 naznačen time da navedeno sredstvo za razrjeđivanje je odabrano iz skupine koju čine celuloza, celuloza acetat, dekstrati, dekstrin, dekstroza, fruktoza, 1-O-α-D-glukopiranozil-D-manitol, gliceril palmitostearat, hidrogenizirano biljno ulje, kaolin, laktitol, laktoza, laktoza mono-hidrat, maltitol, manitol, maltodekstrin, maltoza, preželatinirani škrob, natrijev klorid, sorbitol, škrob, sukroza, talk i ksilitol ili smjesa jednog ili više od navedenih sredstava za razrjeđivanje.
9. Kruti farmaceutski pripravak prema zahtjevu 8 naznačen time navedeno sredstvo za razrjeđivanje je odabrano iz skupine koju čine laktoza, laktoza monohidrat, manitol i škrob ili smjesa jednog ili više od navedenih sredstava za razrjeđivanje.
10. Kruti farmaceutski pripravak prema bilo kojem od prethodnih zahtjeva naznačen time da navedeni pripravak je prevučen.
11. Kruti farmaceutski pripravak prema zahtjevu 10, naznačen time da je tableta ili pilula s prevlakom na bazi hipromeloze.
12. Kruti farmaceutski pripravak prema bilo kojem od prethodnih zahtjeva naznačen time da u osnovi sadrži: (a) 2 % do 15 % težinski: težinski Teriflunomida, (b) 7 % do 15 % težinski: težinski sredstva za raspadanje odabranog od jednog ili više od mikrokristalne celuloze ili natrijevog škrobnog glikolata, (c) 15 % do 35 % težinski: težinski veziva odabranog od jednog ili više od hidroksipropilceluloze ili kukuruznog škroba, (d) 0.1 % do 1.0 % težinski: težinski sredstva za podmazivanje odabranog od magnezijevog stearata, te (e) preostali postotak obuhvaća sredstva za razrjeđivanje odabrana od laktoza mono-hidrata.
13. Kruti farmaceutski pripravak prema zahtjevima 1 do 12 naznačen time da je za uporabu u liječenju sepse, alergije, reakcija presadak-protiv-domaćina, reakcija domaćin-protiv-presatka, reumatoidnog artritisa, sistemskog lupusa, multiple skleroze, psorijaze, astme, urtikarije, rinitisa, uveitisa, raka pluća, leukemije, raka jajnika, sarkoma, Kaposijevog sarkoma, meningioma, raka crijeva, raka limfnih čvorova, tumora mozga, raka dojke, raka gušterače, raka prostate ili raka kože.
HRP20170904TT 2009-09-18 2017-06-13 Formulacije tableta (4'-trifluormetilfenil)-amida (z)-2-cijano-3-hidroksi-but-2-enske kiseline s poboljšanom stabilnošću HRP20170904T1 (hr)

Applications Claiming Priority (4)

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
EP10752585.9A EP2477611B1 (en) 2009-09-18 2010-09-14 (z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability

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HRP20170904T1 true HRP20170904T1 (hr) 2017-09-08

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HRP20170904TT HRP20170904T1 (hr) 2009-09-18 2017-06-13 Formulacije tableta (4'-trifluormetilfenil)-amida (z)-2-cijano-3-hidroksi-but-2-enske kiseline s poboljšanom stabilnošću

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US (5) US20120172427A1 (hr)
EP (1) EP2477611B1 (hr)
JP (1) JP2013505213A (hr)
KR (1) KR101547880B1 (hr)
CN (4) CN104739821B (hr)
AR (1) AR078383A1 (hr)
AU (2) AU2010297357B2 (hr)
BR (1) BR112012006184B1 (hr)
CA (1) CA2772275A1 (hr)
CL (1) CL2015000047A1 (hr)
CO (1) CO6511244A2 (hr)
CR (2) CR20170078A (hr)
CY (1) CY1119364T1 (hr)
DK (1) DK2477611T3 (hr)
DO (1) DOP2012000070A (hr)
ES (1) ES2625731T3 (hr)
GT (1) GT201200075A (hr)
HK (2) HK1206245A1 (hr)
HN (1) HN2012000576A (hr)
HR (1) HRP20170904T1 (hr)
HU (1) HUE032963T2 (hr)
IL (3) IL218492A (hr)
JO (1) JO3327B1 (hr)
LT (1) LT2477611T (hr)
MA (1) MA33585B1 (hr)
ME (1) ME02765B (hr)
MX (1) MX336663B (hr)
MY (1) MY155613A (hr)
NZ (2) NZ617025A (hr)
PE (2) PE20121478A1 (hr)
PL (1) PL2477611T3 (hr)
PT (1) PT2477611T (hr)
RS (1) RS56074B1 (hr)
RU (2) RU2681079C2 (hr)
SI (1) SI2477611T1 (hr)
TN (1) TN2012000061A1 (hr)
TW (2) TWI522130B (hr)
UA (2) UA107582C2 (hr)
UY (1) UY32889A (hr)
WO (1) WO2011032929A1 (hr)

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