HRP20192026T1 - Formulacija tableta od neratinib maleata - Google Patents
Formulacija tableta od neratinib maleata Download PDFInfo
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- HRP20192026T1 HRP20192026T1 HRP20192026TT HRP20192026T HRP20192026T1 HR P20192026 T1 HRP20192026 T1 HR P20192026T1 HR P20192026T T HRP20192026T T HR P20192026TT HR P20192026 T HRP20192026 T HR P20192026T HR P20192026 T1 HRP20192026 T1 HR P20192026T1
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
-
- 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
- A61K31/435—Heterocyclic 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4709—Non-condensed quinolines and containing further heterocyclic rings
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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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
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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
-
- 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
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- Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Plural Heterocyclic Compounds (AREA)
Claims (16)
1. Farmaceutski prihvatljiv pripravak koji sadrži:
granulaciju koja sadrži intragranularne komponente:
(a) 10-70 masenih postotaka neratinib maleata;
(b) 15-65 masenih postotaka jednog ili više punila;
(c) 0-8 masenih postotaka jednog ili više sredstava za raspadanje;
(d) 0.2-8 masenih postotaka jednog ili više sredstava za klizanje;
(e) 5-15 masenih postotaka jednog ili više sredstava za modificiranje površine;
pri čemu se granulacija kombinira s ekstragranularnim komponentama:
(f) 1-25 masenih postotaka jednog ili više punila;
(g) 0-8 masenih postotaka jednog ili više sredstava za raspadanje;
(h) 0.1-3 masenih postotaka jednog ili više sredstava za podmazivanje.
2. Farmaceutski prihvatljiv pripravak koji sadrži 10-70 masenih postotaka neratinib maleata i 5-15 masenih postotaka povidona.
3. Farmaceutski prihvatljiv pripravak koji sadrži intragranularne komponente: 10-70 masenih postotaka neratinib maleata i 5-15 masenih postotaka povidona; i ekstragranularne komponente: mikrokristalnu celulozu, krospovidon i magnezijev stearat.
4. Farmaceutski prihvatljiv pripravak koji sadrži intragranularne komponente:
(a) 10-70 masenih postotaka neratinib maleata;
(b) 15-65 masenih postotaka manitola, mikrokristalne celuloze ili njihove kombinacije;
(c) 0.5-8 masenih postotaka krospovidona, kroskarmeloze natrija ili njihove kombinacije;
(d) 0.2-8 masenih postotaka koloidnog silicijevog dioksida; i
(e) 5-15 masenih postotaka povidona;
i ekstragranularne komponente:
(f) 1-25 masenih postotaka mikrokristalne celuloze;
(g) 1-8 masenih postotaka krospovidona; i
(h) 0.5-3 masenih postotaka magnezijevog stearata.
5. Tableta ili suho punjena kapsula koja sadrži pripravak u skladu s patentnim zahtjevom 4.
6. Pripravak u skladu s patentnim zahtjevom 4, pri čemu je količina neratinib maleata oko 41 masenih postotaka; ili pri čemu je količina neratinib maleata oko 35 masenih postotaka.
7. Pripravak u skladu s patentnim zahtjevom 4, pri čemu je količina manitola i mikrokristalne celuloze, kao intragranularne komponente, oko 50 masenih postotaka.
8. Pripravak u skladu s patentnim zahtjevom 4, pri čemu je količina krospovidona, kao intragranularne komponente, oko 3 masenih postotaka; i/ili pri čemu je količina povidona, kao intragranularne komponente, oko 5 masenih postotaka.
9. Pripravak u skladu s bilo kojim od patentnih zahtjeva 4 i 6-8, u obliku oralne doze od 40 mg, 80 mg ili 240 mg.
10. Pripravak u skladu s patentnim zahtjevom 4, pri čemu pripravak sadrži
(b) manitol i mikrokristalnu celulozu i
(c) krospovidon.
11. Pripravak u skladu s patentnim zahtjevom 4, pri čemu pripravak sadrži intragranularnu komponentu:
(a) 35.00 masenih postotaka neratinib maleata kao neratinib slobodna baza;
(b) 38.94 masenih postotaka manitola;
(c) 10.56 masenih postotaka mikrokristalne celuloze;
(d) 3.00 masenih postotaka krospovidona;
(e) 2.00 masenih postotaka koloidnog silicijevog dioksida; i
(f) 5.00 masenih postotaka povidona;
i kao ekstragranularne komponente:
(g) 1.50 masenih postotaka mikrokristalne celuloze;
(h) 2.00 masenih postotaka krospovidona; i
(i) 2.00 masenih postotaka magnezijevog stearata; i pri čemu pripravak nadalje sadrži filmski premaz.
12. Način za pripremu farmaceutski prihvatljivog pripravka sadrži: prskanje 5-15 masenih postotaka jednog ili više sredstava za modificiranje površine na intragranularne komponente granulacije, navedene intragranularne komponente sadrže:
(a) 10-70 masenih postotaka neratinib maleata;
(b) 15-65 masenih postotaka jednog ili više punila;
(c) 0-8 masenih postotaka jednog ili više sredstava za raspadanje;
(d) 0.2-8 masenih postotaka jednog ili više sredstava za klizanje; i
(e) 5-15 masenih postotaka jednog ili više sredstava za modificiranje površine;
pri čemu su navedene obložene intragranularne komponente kombinirane s ekstragranularnim komponentama granulacije, navedene ekstragranularne komponente sadrže:
(f) 1-25 masenih postotaka jednog ili više punila;
(g) 0-8 masenih postotaka jednog ili više sredstava za raspadanje; i
(h) 0.1-3 masenih postotaka jednog ili više sredstava za podmazivanje.
13. Način u skladu s patentnim zahtjevom 12, pri čemu je sredstvo za modificiranje površine povidon.
14. Farmaceutski prihvatljiv pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 4 i 6 do 11 ili tableta ili suho punjena kapsula u skladu s patentnim zahtjevom 5 za uporabu u načinu liječenja karcinoma.
15. Pripravak u skladu s patentnim zahtjevom 11, pri čemu je količina filmskog premaza oko 3 masena postotka.
16. Farmaceutski pripravak u skladu s patentnim zahtjevom 15, pri čemu je filmski premaz crven, žut ili ružičast.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US25940309P | 2009-11-09 | 2009-11-09 | |
| PCT/IB2010/054964 WO2011055303A1 (en) | 2009-11-09 | 2010-11-02 | Tablet formulations of neratinib maleate |
| EP10779339.0A EP2498756B2 (en) | 2009-11-09 | 2010-11-02 | Tablet formulations of neratinib maleate |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| HRP20192026T1 true HRP20192026T1 (hr) | 2020-02-07 |
| HRP20192026T4 HRP20192026T4 (hr) | 2023-03-31 |
Family
ID=43478191
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20250604TT HRP20250604T1 (hr) | 2009-11-09 | 2010-11-02 | Formulacije tableta neratinib maleata |
| HRP20192026TT HRP20192026T4 (hr) | 2009-11-09 | 2010-11-02 | Formulacija tableta od neratinib maleata |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20250604TT HRP20250604T1 (hr) | 2009-11-09 | 2010-11-02 | Formulacije tableta neratinib maleata |
Country Status (22)
| Country | Link |
|---|---|
| US (2) | US8518446B2 (hr) |
| EP (4) | EP2498756B2 (hr) |
| JP (3) | JP5835883B2 (hr) |
| CN (2) | CN103893140B (hr) |
| AR (2) | AR078952A1 (hr) |
| AU (1) | AU2010316683B2 (hr) |
| CA (1) | CA2780428C (hr) |
| CY (1) | CY1122330T1 (hr) |
| DK (2) | DK2498756T4 (hr) |
| ES (3) | ES2757882T5 (hr) |
| FI (2) | FI4066821T3 (hr) |
| HR (2) | HRP20250604T1 (hr) |
| HU (1) | HUE046606T2 (hr) |
| LT (2) | LT2498756T (hr) |
| NZ (1) | NZ599763A (hr) |
| PL (1) | PL2498756T5 (hr) |
| PT (2) | PT4066821T (hr) |
| RS (2) | RS66797B1 (hr) |
| SI (2) | SI4066821T1 (hr) |
| SM (2) | SMT202500153T1 (hr) |
| TW (1) | TWI466690B (hr) |
| WO (1) | WO2011055303A1 (hr) |
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| JP2009089982A (ja) * | 2007-10-11 | 2009-04-30 | Ohara Yakuhin Kogyo Kk | 打錠用造粒物の造粒方法 |
| US20090203709A1 (en) * | 2008-02-07 | 2009-08-13 | Abbott Laboratories | Pharmaceutical Dosage Form For Oral Administration Of Tyrosine Kinase Inhibitor |
| EP2448563A2 (en) * | 2009-07-02 | 2012-05-09 | Wyeth LLC | 3-cyanoquinoline tablet formulations and uses thereof |
| ES2757882T5 (es) * | 2009-11-09 | 2023-05-10 | Wyeth Llc | Formulaciones de comprimidos de maleato de neratinib |
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2010
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