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HRP20100674T1 - Farmaceutski pripravak koji sadrzi omega-karboksiaril supstituirani difenil ureu za lijecenje raka - Google Patents

Farmaceutski pripravak koji sadrzi omega-karboksiaril supstituirani difenil ureu za lijecenje raka Download PDF

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Publication number
HRP20100674T1
HRP20100674T1 HR20100674T HRP20100674T HRP20100674T1 HR P20100674 T1 HRP20100674 T1 HR P20100674T1 HR 20100674 T HR20100674 T HR 20100674T HR P20100674 T HRP20100674 T HR P20100674T HR P20100674 T1 HRP20100674 T1 HR P20100674T1
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pharmaceutical preparation
preparation according
proportion
active agent
pharmaceutical
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HR20100674T
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Schckler Fritz
Wollenschl�ger Axel
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Bayer Schering Pharma Aktiengesellschaft
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Application filed by Bayer Schering Pharma Aktiengesellschaft filed Critical Bayer Schering Pharma Aktiengesellschaft
Publication of HRP20100674T1 publication Critical patent/HRP20100674T1/hr

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    • 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
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4409Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 4, e.g. isoniazid, iproniazid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4412Non condensed pyridines; Hydrogenated derivatives thereof having oxo groups directly attached to the heterocyclic ring
    • 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
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2813Inorganic compounds
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61P35/00Antineoplastic agents
    • A61P35/04Antineoplastic agents specific for metastasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
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  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
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  • Bioinformatics & Cheminformatics (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Oncology (AREA)
  • Hematology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Farmaceutski pripravak naznacen time da je tableta koja sadrzi p-toluensulfonsku kiselu sol 4{4-[3-(4-kloro-3-trifluorometilfenil)-ureido]-fenoksi}-piridin-2-karboksilne kiselina metil amida kao aktivno sredstvo koje ima udio od najmanje 55% tezinski pripravka. Patent sadrzi jos 19 patentnih zahtjeva.

Claims (20)

1. Farmaceutski pripravak naznačen time da je tableta koja sadrži p-toluensulfonsku kiselu sol 4{4-[3-(4-kloro-3-trifluorometilfenil)-ureido]-fenoksi}-piridin-2-karboksilne kiselina metil amida kao aktivno sredstvo koje ima udio od najmanje 55% težinski pripravka.
2. Farmaceutski pripravak prema zahtjevu 1 naznačen time da aktivno sredstvo ima udio od najmanje 75% težinski pripravka.
3. Farmaceutski pripravak prema zahtjevu 1 naznačen time da punilo ima udio od 3 do 20 %, sredstvo za raspadanje ima udio od 5 do 12 %, vezivo ima udio od 0.5 do 8 %, lubrikant ima udio od 0.2 do 0.8 % i surfaktant ima udio od 0.1 do 2 % težinski pripravka.
4. Farmaceutski pripravak prema zahtjevu 2 naznačen time da je mikrokristalinična celuloza kao punilo u udjelu od 3 do 20 %, kroskarmeloza natrij kao sredstvo za raspadanje u udjelu od 5 do 12 %, hipromelozu kao vezivo u udjelu od 0.5 do 8 %, magnezijev stearat kao lubrikant u udjelu od 0.2 do 8 % i natrijev lauril sulfat kao surfaktant u udjelu od 0.1 do 2 % težinski pripravka.
5. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 4 naznačen time da je tableta sa neposrednim otpuštanjem.
6. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 5 naznačen time da je aktivno sredstvo mikronizirano.
7. Farmaceutski pripravak prema zahtjevu 6 naznačen time da mikronizirani oblik ima veličinu čestica od 0.5 do 10 µm.
8. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 7 naznačen time da sadrži vodu u količini manjoj od ili jednakoj 6 % težinski pripravka.
9. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 8 naznačen time da ima čvrstoću od više od 80 N.
10. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 9 naznačen time da je ovalna tableta sa najdužom dimenzijom manjom od ili jednakom 25 mm.
11. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 9 naznačen time da je okrugla tableta sa promjerom manjim od ili jednakim 13 mm.
12. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 11 naznačen time da količina aktivnog sredstva je od 54 mg do 1096 mg.
13. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 12 naznačen time da je za oralnu primjenu.
14. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 13 naznačen time da je u kombinaciji s jednim ili više citotoksičnih sredstava, inhibitora transdukcije signala ili s drugim anti-karcinomskim sredstvima ili terapijama, kao i sa smjesama i njihovim kombinacijama.
15. Postupak proizvodnje farmaceutskog pripravka prema bilo kojem od zahtjeva 1 do 14 naznačen time da je aktivno sredstvo pomiješano s najmanje jednom farmaceutski prihvatljivom pomoćnom tvari.
16. Postupak prema zahtjevu 15 naznačen time da: a) aktivno sredstvo i barem jedna farmaceutski prihvatljiva pomoćna tvar su mokro granulirane, b) granulat je pomiješan sa lubrikantom i po izboru s jednom ili više dodatnih farmaceutski prihvatljivih pomoćnih tvari, c) granulat je nakon miješanja podijeljen na pojedinačne jedinice, d) te se produkt iz koraka c) po potrebi prevlači sa jednom ili više dodatnih farmaceutski prihvatljivih pomoćnih tvari.
17. Postupak prema bilo kojem od zahtjeva 15 ili 16 naznačen time da se produkt iz koraka c) prevlači sa jednom ili više dodatnih farmaceutski prihvatljivih pomoćnih tvari.
18. Postupak prema zahtjevu 15 naznačen time da su aktivno sredstvo i barem jedna farmaceutski prihvatljiva pomoćna tvar pomiješane bez granulacije i direktno komprimirane u tablete.
19. Postupak prema zahtjevu 15 naznačen time da su aktivno sredstvo samo ili aktivno sredstvo i barem jedna farmaceutski prihvatljiva pomoćna tvar tretirane postupkom suhe granulacije i zatim komprimirane u tablete.
20. Uporaba farmaceutskog pripravka prema bilo kojem od zahtjeva 1 do 14 naznačena time da je za proizvodnju lijeka za liječenje hiper-proliferativnih poremećaja kod sisavaca, uključujući rak.
HR20100674T 2005-03-07 2010-12-06 Farmaceutski pripravak koji sadrzi omega-karboksiaril supstituirani difenil ureu za lijecenje raka HRP20100674T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US65882705P 2005-03-07 2005-03-07
PCT/EP2006/001574 WO2006094626A1 (en) 2005-03-07 2006-02-22 Pharmaceutical composition comprising an omega- carboxyaryl substituted diphenyl urea for the treatment of cancer

Publications (1)

Publication Number Publication Date
HRP20100674T1 true HRP20100674T1 (hr) 2011-01-31

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ID=36507604

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HR20100674T HRP20100674T1 (hr) 2005-03-07 2010-12-06 Farmaceutski pripravak koji sadrzi omega-karboksiaril supstituirani difenil ureu za lijecenje raka

Country Status (38)

Country Link
US (2) US9737488B2 (hr)
EP (1) EP1868579B1 (hr)
JP (1) JP5304241B2 (hr)
KR (1) KR101335932B1 (hr)
CN (2) CN101132779B (hr)
AR (1) AR054234A1 (hr)
AT (1) ATE482693T1 (hr)
AU (1) AU2006222365B2 (hr)
BR (1) BRPI0608840B8 (hr)
CA (1) CA2601955C (hr)
CR (1) CR9348A (hr)
CU (1) CU23821A3 (hr)
CY (1) CY1111065T1 (hr)
DE (1) DE602006017188D1 (hr)
DK (1) DK1868579T3 (hr)
DO (1) DOP2006000057A (hr)
ES (1) ES2351612T3 (hr)
GT (1) GT200600096A (hr)
HK (2) HK1118019A1 (hr)
HN (1) HN2006009702A (hr)
HR (1) HRP20100674T1 (hr)
IL (1) IL185517A (hr)
MA (1) MA29378B1 (hr)
MX (1) MX2007010856A (hr)
MY (1) MY162319A (hr)
NO (1) NO343834B1 (hr)
NZ (1) NZ561178A (hr)
PE (1) PE20061345A1 (hr)
PL (1) PL1868579T3 (hr)
PT (1) PT1868579E (hr)
SG (1) SG160364A1 (hr)
SI (1) SI1868579T1 (hr)
TN (1) TNSN07341A1 (hr)
TW (1) TWI324928B (hr)
UA (1) UA93673C2 (hr)
UY (1) UY29410A1 (hr)
WO (1) WO2006094626A1 (hr)
ZA (1) ZA200707638B (hr)

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