HRP20230753T3 - Farmaceutski pripravci koji sadrže nilotinib - Google Patents

Farmaceutski pripravci koji sadrže nilotinib

Info

Publication number
HRP20230753T3
HRP20230753T3 HRP20230753TT HRP20230753T HRP20230753T3 HR P20230753 T3 HRP20230753 T3 HR P20230753T3 HR P20230753T T HRP20230753T T HR P20230753TT HR P20230753 T HRP20230753 T HR P20230753T HR P20230753 T3 HRP20230753 T3 HR P20230753T3
Authority
HR
Croatia
Prior art keywords
granules
poloxamer
pharmaceutical preparation
methyl
pharmaceutically acceptable
Prior art date
Application number
HRP20230753TT
Other languages
English (en)
Inventor
Nathalie Bruneau
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=37684496&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20230753(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis Ag filed Critical Novartis Ag
Publication of HRP20230753T3 publication Critical patent/HRP20230753T3/hr

Links

Classifications

    • 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
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • 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
    • 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
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Claims (13)

1. Farmaceutski pripravak, naznačen time, da je u obliku kapsule koji sadrži granule koje sadrže terapijski spoj u čvrstoj smjesi s najmanje jednom farmaceutski prihvatljivom pomoćnom tvari, pri čemu je navedeni terapijski spoj 4-Metil-3-[[4-(3-piridinil)-2-pirimidinil]amino]-N[5-(4-metil-1H-imidazol-1-il)-3-(trifluorometil)fenil] benzamid: [image] ili njegova farmaceutski prihvatljiva sol, i pri čemu navedene granule nadalje sadrže surfaktant koji je poloksamer.
2. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da je navedeni surfaktant u koncentraciji do i uključujući 1% težine navedenog farmaceutskog pripravka.
3. Farmaceutski pripravak prema patentnom zahtjevu 1 ili 2, naznačen time, da je navedeno terapijsko sredstvo nilotinib hidroklorid monohidrat.
4. Farmaceutski pripravak prema patentnom zahtjevu 1, 2 ili 3, naznačen time, da je navedeni surfaktant poloksamer 188.
5. Farmaceutski pripravak prema patentnom zahtjevu 1, 2, 3 ili 4, naznačen time, da nadalje sadrži sredstvo za povećanje skliskosti.
6. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 5, naznačen time, da nadalje sadrži laktozu monohidrat u količini manjoj od 40% težine pripravka.
7. Postupak za pripremu farmaceutskog pripravka, naznačen time, da obuhvaća korake: stvaranje praškaste smjese terapijskog spoja koji je 4-Metil-3-[[4-(3-piridinil)-2-pirimidinil]amino]-N[5-(4-metil-1H-imidazol-1-il)-3-(trifluorometil)fenil] benzamid, ili njegova farmaceutski prihvatljiva sol, i najmanje jedne farmaceutski prihvatljive pomoćne tvari; mokro miješanje i gnječenje praškaste smjese s tekućinom za granulaciju da se oblikuju vlažne granule; i sušenje vlažnih granula da se oblikuju granule, pri čemu praškasta smjesa sadrži poloksamer.
8. Postupak prema patentnom zahtjevu 7, naznačen time, da nadalje uključuje obradu granula u kapsulu.
9. Postupak prema patentnom zahtjevu 7 ili 8, naznačen time, da tekućina za granulaciju sadrži vodu.
10. Postupak prema patentnom zahtjevu 9, naznačen time, da je tekućina za granulaciju prisutna u koncentraciji od 10% do 25% težine praškaste smjese.
11. Postupak prema bilo kojem od patentnih zahtjeva 7 do 10, naznačen time, da nadalje uključuje korak prosijavanja granula.
12. Postupak prema bilo kojem od patentnih zahtjeva 7 do 11, naznačen time, da se vlažne granule suše do vrijednosti gubitka sušenjem manjeg ili jednakog oko dva posto težine vlažnih granula prije sušenja.
13. Postupak prema patentnom zahtjevu 12, naznačen time, da navedeni poloksamer je poloksamer 188.
HRP20230753TT 2006-09-27 2007-09-25 Farmaceutski pripravci koji sadrže nilotinib HRP20230753T3 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP06121371A EP1923053A1 (en) 2006-09-27 2006-09-27 Pharmaceutical compositions comprising nilotinib or its salt
EP21194622.3A EP3984528B1 (en) 2006-09-27 2007-09-25 Pharmaceutical compositions comprising nilotinib

Publications (1)

Publication Number Publication Date
HRP20230753T3 true HRP20230753T3 (hr) 2023-10-27

Family

ID=37684496

Family Applications (2)

Application Number Title Priority Date Filing Date
HRP20230753TT HRP20230753T3 (hr) 2006-09-27 2007-09-25 Farmaceutski pripravci koji sadrže nilotinib
HRP20151383TT HRP20151383T4 (hr) 2006-09-27 2007-09-25 Farmaceutski pripravci koji sadrže nilotinib ili njegovu sol

Family Applications After (1)

Application Number Title Priority Date Filing Date
HRP20151383TT HRP20151383T4 (hr) 2006-09-27 2007-09-25 Farmaceutski pripravci koji sadrže nilotinib ili njegovu sol

Country Status (35)

Country Link
US (2) US8293756B2 (hr)
EP (4) EP1923053A1 (hr)
JP (2) JP5567340B2 (hr)
KR (2) KR20090076931A (hr)
CN (2) CN101516344A (hr)
AR (1) AR062980A1 (hr)
AU (1) AU2007301977B2 (hr)
BR (1) BRPI0719438B1 (hr)
CA (1) CA2662571C (hr)
CL (1) CL2007002766A1 (hr)
CO (1) CO6160288A2 (hr)
CY (2) CY1117021T1 (hr)
DK (2) DK2068839T3 (hr)
ES (3) ES2556625T5 (hr)
FI (2) FI3984528T3 (hr)
HK (1) HK1133193A1 (hr)
HR (2) HRP20230753T3 (hr)
HU (2) HUE063083T2 (hr)
IL (1) IL197496A (hr)
JO (1) JO3757B1 (hr)
LT (1) LT3984528T (hr)
MA (1) MA30807B1 (hr)
MX (1) MX2009003184A (hr)
MY (1) MY148237A (hr)
NO (2) NO347404B1 (hr)
NZ (1) NZ575317A (hr)
PE (2) PE20120626A1 (hr)
PL (2) PL3984528T3 (hr)
PT (2) PT3984528T (hr)
RU (1) RU2469707C2 (hr)
SI (2) SI2068839T2 (hr)
TN (1) TN2009000093A1 (hr)
TW (3) TWI428333B (hr)
WO (1) WO2008037716A2 (hr)
ZA (1) ZA200901511B (hr)

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Also Published As

Publication number Publication date
SI2068839T2 (sl) 2023-01-31
HK1133193A1 (en) 2010-03-19
NO346639B1 (no) 2022-11-07
HRP20151383T1 (hr) 2016-01-15
HUE028204T2 (en) 2016-12-28
JO3757B1 (ar) 2021-01-31
SI3984528T1 (sl) 2023-09-29
CO6160288A2 (es) 2010-05-20
BRPI0719438B1 (pt) 2022-04-19
IL197496A (en) 2016-04-21
LT3984528T (lt) 2023-08-10
FI3984528T3 (fi) 2023-07-27
US20130023549A1 (en) 2013-01-24
ES2951547T3 (es) 2023-10-23
CY1117021T1 (el) 2017-04-05
HUE063083T2 (hu) 2023-12-28
AR062980A1 (es) 2008-12-17
IL197496A0 (en) 2009-12-24
MX2009003184A (es) 2009-04-03
CY1126116T1 (el) 2023-11-15
US8501760B2 (en) 2013-08-06
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