HRP20230753T3 - Farmaceutski pripravci koji sadrže nilotinib - Google Patents
Farmaceutski pripravci koji sadrže nilotinibInfo
- 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
Links
- HHZIURLSWUIHRB-UHFFFAOYSA-N nilotinib Chemical compound C1=NC(C)=CN1C1=CC(NC(=O)C=2C=C(NC=3N=C(C=CN=3)C=3C=NC=CC=3)C(C)=CC=2)=CC(C(F)(F)F)=C1 HHZIURLSWUIHRB-UHFFFAOYSA-N 0.000 title claims 3
- 239000008194 pharmaceutical composition Substances 0.000 title claims 3
- 239000005536 L01XE08 - Nilotinib Substances 0.000 title 1
- 229960001346 nilotinib Drugs 0.000 title 1
- 239000008187 granular material Substances 0.000 claims 9
- 238000000034 method Methods 0.000 claims 7
- 239000000825 pharmaceutical preparation Substances 0.000 claims 6
- 239000000203 mixture Substances 0.000 claims 4
- 239000000843 powder Substances 0.000 claims 4
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims 3
- 150000001875 compounds Chemical class 0.000 claims 3
- 238000001035 drying Methods 0.000 claims 3
- 238000005469 granulation Methods 0.000 claims 3
- 230000003179 granulation Effects 0.000 claims 3
- 239000007788 liquid Substances 0.000 claims 3
- 229920001983 poloxamer Polymers 0.000 claims 3
- 229960000502 poloxamer Drugs 0.000 claims 3
- 239000004094 surface-active agent Substances 0.000 claims 3
- 230000001225 therapeutic effect Effects 0.000 claims 3
- CTKXFMQHOOWWEB-UHFFFAOYSA-N Ethylene oxide/propylene oxide copolymer Chemical group CCCOC(C)COCCO CTKXFMQHOOWWEB-UHFFFAOYSA-N 0.000 claims 2
- 239000002775 capsule Substances 0.000 claims 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims 2
- 229920001993 poloxamer 188 Polymers 0.000 claims 2
- 229940044519 poloxamer 188 Drugs 0.000 claims 2
- 238000002360 preparation method Methods 0.000 claims 2
- 150000003839 salts Chemical class 0.000 claims 2
- YCBPQSYLYYBPDW-UHFFFAOYSA-N 4-methyl-n-[3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]benzamide;hydrate;hydrochloride Chemical group O.Cl.C1=NC(C)=CN1C1=CC(NC(=O)C=2C=C(NC=3N=C(C=CN=3)C=3C=NC=CC=3)C(C)=CC=2)=CC(C(F)(F)F)=C1 YCBPQSYLYYBPDW-UHFFFAOYSA-N 0.000 claims 1
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 238000004898 kneading Methods 0.000 claims 1
- 229960001021 lactose monohydrate Drugs 0.000 claims 1
- 238000007873 sieving Methods 0.000 claims 1
- 239000008247 solid mixture Substances 0.000 claims 1
- 229940124597 therapeutic agent Drugs 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
Classifications
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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
- 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
- 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
- A61K31/495—Heterocyclic 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
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
-
- 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
-
- 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
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
-
- 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
-
- 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
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- 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
- A61K9/1635—Organic 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.
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) |
Families Citing this family (31)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1923053A1 (en) | 2006-09-27 | 2008-05-21 | Novartis AG | Pharmaceutical compositions comprising nilotinib or its salt |
CA2775400A1 (en) | 2009-09-28 | 2011-03-31 | Medizinische Universitat Wien | New use of pdgfrbeta inhibitors |
US20120202836A1 (en) | 2009-10-23 | 2012-08-09 | Tomasz Szczudlo | Method of treating proliferative disorders and other pathological conditions mediated by bcr-abl, c-kit, ddr1, ddr2 or pdgf-r kinase activity |
JO3634B1 (ar) | 2009-11-17 | 2020-08-27 | Novartis Ag | طريقة لعلاج اضطرابات تكاثرية وحالات مرضية أخرى متوسطة بنشاط كيناز bcr-abl، c-kit، ddr1، ddr2، أو pdgf-r |
IN2011CH01887A (hr) * | 2011-06-02 | 2012-12-14 | ||
AR086913A1 (es) * | 2011-06-14 | 2014-01-29 | Novartis Ag | 4-metil-3-[[4-(3-piridinil)-2-pirimidinil]-amino]-n-[5-(4-metil-1h-imidazol-1-il)-3-(trifluoro-metil)-fenil]-benzamida amorfa, forma de dosificacion que la contiene y metodo para prepararlas |
CN102321073A (zh) * | 2011-08-12 | 2012-01-18 | 西安交通大学 | 一种尼罗替尼的制备方法 |
WO2013063003A1 (en) | 2011-10-28 | 2013-05-02 | Novartis Ag | Method of treating gastrointestinal stromal tumors |
AU2012328979B2 (en) | 2011-10-28 | 2016-04-21 | Novartis Ag | Method of treating gastrointestinal stromal tumors |
KR20140093230A (ko) * | 2011-11-14 | 2014-07-25 | 노파르티스 아게 | 즉시 방출 4-메틸-3-[[4-(3-피리디닐)-2-피리미디닐]아미노]-n-[5-(4-메틸-1h-이미다졸-1-일)-3-(트리플루오로메틸)페닐] 벤즈아미드 제제 |
US9301957B2 (en) | 2011-11-14 | 2016-04-05 | Novartis Ag | Immediate release 4-methyl-3-4[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-N-[5-(4-methyl-1H-imidazol-1-YL)-3-(trifluoromethyl)phenyl] benzamide formulation |
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US9682081B2 (en) | 2013-04-25 | 2017-06-20 | Sun Pharmaceutical Industries Limited | Pharmaceutical gastro-retentive solid oral dosage form of nilotinib |
US9636340B2 (en) | 2013-11-12 | 2017-05-02 | Ayyappan K. Rajasekaran | Kinase inhibitors |
PL3189045T3 (pl) | 2014-08-11 | 2022-04-04 | Sun Pharmaceutical Industries Limited | Nowe sole nilotynibu i jego polimorfy |
WO2016033304A1 (en) * | 2014-08-28 | 2016-03-03 | Codexis, Inc. | Imidazoyl anilide derivatives and methods of use |
WO2017158625A1 (en) * | 2016-03-17 | 2017-09-21 | Sun Pharmaceutical Industries Ltd. | Pharmaceutical composition of nilotinib |
CN107582531B (zh) * | 2016-07-06 | 2020-12-29 | 四川科伦药物研究院有限公司 | 一种利伐沙班固体制剂及其制备方法 |
CN107320460B (zh) * | 2017-08-04 | 2020-11-03 | 北京化工大学 | 一种尼罗替尼口服纳米制剂及其制备方法 |
CN107441094B (zh) * | 2017-08-08 | 2020-05-22 | 南方医科大学 | 尼罗替尼作为治疗登革病毒感染的药物及其制药用途 |
CZ2017821A3 (cs) | 2017-12-20 | 2019-07-03 | Zentiva, K.S. | Léková forma obsahující krystalický nilotinib |
CN113292537B (zh) | 2018-06-15 | 2024-04-05 | 汉达癌症医药责任有限公司 | 激酶抑制剂的盐类及其组合物 |
WO2021155254A1 (en) | 2020-01-31 | 2021-08-05 | Nanocopoeia, Llc | Amorphous nilotinib microparticles and uses thereof |
WO2021222739A1 (en) | 2020-04-30 | 2021-11-04 | Nanocopoeia, Llc | Orally disintegrating tablet comprising amorphous solid dispersion of nilotinib |
JP7489849B2 (ja) | 2020-07-20 | 2024-05-24 | 日本化薬株式会社 | ニロチニブ錠剤 |
AU2022292092A1 (en) | 2021-06-19 | 2024-02-01 | Helm Ag | Granulate composition comprising nilotinib |
WO2023285981A1 (en) * | 2021-07-15 | 2023-01-19 | Torrent Pharmaceuticals Limited | Stable pharmaceutical liquid composition of nilotinib |
EP4122452A1 (en) | 2021-07-23 | 2023-01-25 | KRKA, d.d., Novo mesto | Pharmaceutical composition comprising nilotinib and method of manufacturing the same |
EP4260848A1 (en) | 2022-04-11 | 2023-10-18 | Lotus Pharmaceutical Co., Ltd. | Pharmaceutical composition for solid dosage form containing nilotinib and process for its preparation |
WO2024142002A1 (en) | 2022-12-29 | 2024-07-04 | Renata Pharmaceuticals (Ireland) Limited | Pharmaceutical suspension of nilotinib |
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