HRP20192026T4 - Formulacija tableta od neratinib maleata - Google Patents
Formulacija tableta od neratinib maleata Download PDFInfo
- Publication number
- HRP20192026T4 HRP20192026T4 HRP20192026TT HRP20192026T HRP20192026T4 HR P20192026 T4 HRP20192026 T4 HR P20192026T4 HR P20192026T T HRP20192026T T HR P20192026TT HR P20192026 T HRP20192026 T HR P20192026T HR P20192026 T4 HRP20192026 T4 HR P20192026T4
- Authority
- HR
- Croatia
- Prior art keywords
- mass percent
- tablet according
- crospovidone
- microcrystalline cellulose
- mannitol
- Prior art date
Links
- VXZCUHNJXSIJIM-MEBGWEOYSA-N (z)-but-2-enedioic acid;(e)-n-[4-[3-chloro-4-(pyridin-2-ylmethoxy)anilino]-3-cyano-7-ethoxyquinolin-6-yl]-4-(dimethylamino)but-2-enamide Chemical compound OC(=O)\C=C/C(O)=O.C=12C=C(NC(=O)\C=C\CN(C)C)C(OCC)=CC2=NC=C(C#N)C=1NC(C=C1Cl)=CC=C1OCC1=CC=CC=N1 VXZCUHNJXSIJIM-MEBGWEOYSA-N 0.000 title claims 2
- 229950008835 neratinib Drugs 0.000 title claims 2
- 239000007916 tablet composition Substances 0.000 title 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 6
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 4
- 229960000913 crospovidone Drugs 0.000 claims 4
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 4
- 239000008108 microcrystalline cellulose Substances 0.000 claims 4
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 4
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 4
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 4
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 3
- 229930195725 Mannitol Natural products 0.000 claims 3
- 239000000594 mannitol Substances 0.000 claims 3
- 235000010355 mannitol Nutrition 0.000 claims 3
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 2
- 229940069328 povidone Drugs 0.000 claims 2
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 1
- 206010028980 Neoplasm Diseases 0.000 claims 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims 1
- 201000011510 cancer Diseases 0.000 claims 1
- 239000008119 colloidal silica Substances 0.000 claims 1
- 229960001681 croscarmellose sodium Drugs 0.000 claims 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 1
- 235000019359 magnesium stearate Nutrition 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
Classifications
-
- 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
- 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
-
- 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
-
- 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
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (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 (6)
1. Tableta koja sadrži farmaceutski prihvatljiv pripravak koji sadrži intragranularne komponente:
(a) 35 ili 41 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.
2. Tableta u skladu s patentnim zahtjevom 1, pri čemu je količina manitola i mikrokristalne celuloze, kao intragranularne komponente, oko 50 masenih postotaka.
3. Tableta u skladu s patentnim zahtjevom 1, 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.
4. Tableta u skladu s bilo kojim od patentnih zahtjeva 1 do 3, u obliku oralne doze od 40 mg, 80 mg, ili 240 mg.
5. Tableta u skladu s patentnim zahtjevom 1, pri čemu pripravak sadrži
(b) manitol i mikrokristalnu celulozu i
(c) krospovidon.
6. Tableta u skladu s bilo kojim od patentnih zahtjeva 1 do 5 za uporabu u načinu liječenja raka.
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 HRP20192026T1 (hr) | 2020-02-07 |
| HRP20192026T4 true HRP20192026T4 (hr) | 2023-03-31 |
Family
ID=43478191
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20192026TT HRP20192026T4 (hr) | 2009-11-09 | 2010-11-02 | Formulacija tableta od neratinib maleata |
Country Status (21)
| Country | Link |
|---|---|
| US (2) | US8518446B2 (hr) |
| EP (3) | 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 (1) | DK2498756T4 (hr) |
| ES (1) | ES2757882T5 (hr) |
| FI (1) | FI2498756T4 (hr) |
| HR (1) | HRP20192026T4 (hr) |
| HU (1) | HUE046606T2 (hr) |
| LT (1) | LT2498756T (hr) |
| NZ (1) | NZ599763A (hr) |
| PL (1) | PL2498756T5 (hr) |
| PT (1) | PT2498756T (hr) |
| RS (1) | RS59599B2 (hr) |
| SI (1) | SI2498756T2 (hr) |
| TW (1) | TWI466690B (hr) |
| WO (1) | WO2011055303A1 (hr) |
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| DE10351448A1 (de) * | 2003-11-04 | 2005-06-09 | Bayer Healthcare Ag | Geschmackstoffhaltige Arzneimittelformulierungen mit verbesserten pharmazeutischen Eigenschaften |
| KR101313702B1 (ko) | 2005-02-03 | 2013-10-04 | 와이어쓰 | 제피티니브 및/또는 에를로티니브 내성암 치료용 약제학적 조성물 |
| TW200803892A (en) | 2005-11-04 | 2008-01-16 | Wyeth Corp | Antineoplastic combinations with MTOR inhibitor, herceptin, and/or HKI-272 |
| US8022216B2 (en) | 2007-10-17 | 2011-09-20 | Wyeth Llc | Maleate salts of (E)-N-{4-[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof |
| US9439897B2 (en) | 2007-11-06 | 2016-09-13 | Immunolight, Llc | Use of psoralen derivatives and combination therapy for treatment of cell proliferation disorders |
| PT2310011E (pt) | 2008-06-17 | 2013-10-07 | Wyeth Llc | Combinações antineoplásicas contendo hki-272 e vinorelbina |
| KR20140069340A (ko) | 2008-08-04 | 2014-06-09 | 와이어쓰 엘엘씨 | 4-아닐리노-3-사이아노퀴놀린과 카페시타빈의 항신생물성 조합물 |
| HUE061640T2 (hu) | 2009-04-06 | 2023-07-28 | Wyeth Llc | Gyógykezelési rendszer mellrákhoz neratinib alkalmazásával |
| CN103893140B (zh) * | 2009-11-09 | 2016-06-01 | 惠氏有限责任公司 | 来那替尼马来酸盐的片剂制剂 |
| CN107308130B (zh) * | 2009-11-09 | 2021-06-15 | 惠氏有限责任公司 | 包衣药物球状体及消除或减少病症如呕吐和腹泻的用途 |
| ES2790358T3 (es) | 2011-12-28 | 2020-10-27 | Global Blood Therapeutics Inc | Compuestos de heteroaril aldehído sustituido y métodos para su uso en el aumento de la oxigenación tisular |
| AP2014007805A0 (en) | 2011-12-28 | 2014-07-31 | Cytokinetics Inc The Regents Of The University Of California | Substituted benzaldehyde compounds and methods fortheir use in increasing tissue oxygenation |
| US8952171B2 (en) | 2013-03-15 | 2015-02-10 | Global Blood Therapeutics, Inc. | Compounds and uses thereof for the modulation of hemoglobin |
| US10266551B2 (en) | 2013-03-15 | 2019-04-23 | Global Blood Therapeutics, Inc. | Compounds and uses thereof for the modulation of hemoglobin |
| ES2864707T3 (es) | 2013-03-15 | 2021-10-14 | Global Blood Therapeutics Inc | Compuestos y usos de los mismos para la modulación de la hemoglobina |
| EA034922B1 (ru) | 2013-03-15 | 2020-04-07 | Глобал Блад Терапьютикс, Инк. | Соединения и их применения для модуляции гемоглобина |
| ES2890077T3 (es) | 2013-03-15 | 2022-01-17 | Global Blood Therapeutics Inc | Compuestos y usos de los mismos para la modulación de la hemoglobina |
| US9458139B2 (en) | 2013-03-15 | 2016-10-04 | Global Blood Therapeutics, Inc. | Compounds and uses thereof for the modulation of hemoglobin |
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| CN104337782A (zh) * | 2013-08-02 | 2015-02-11 | 山东新时代药业有限公司 | 一种甲磺酸伊马替尼片剂 |
| EA201992707A1 (ru) | 2013-11-18 | 2020-06-30 | Глобал Блад Терапьютикс, Инк. | Соединения и их применения для модуляции гемоглобина |
| BR112015032160B1 (pt) | 2014-02-07 | 2021-11-30 | Global Blood Therapeutics, Inc | Ansolvato cristalino de composto, composição e composição farmacêutica |
| CA2939345C (en) | 2014-02-17 | 2022-05-31 | Children's National Medical Center | Method and system for providing recommendation for optimal execution of surgical procedures |
| PL3172209T3 (pl) * | 2014-07-25 | 2021-06-14 | Novartis Ag | Formulacja tabletkowa 2-fluoro-n-metylo-4-[7-(chinolin-6-ylometylo)imidazo[1,2-b][1,2,4]triazyn-2-ylo]benzamidu |
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-
2010
- 2010-11-02 CN CN201410082103.7A patent/CN103893140B/zh active Active
- 2010-11-02 SI SI201031952T patent/SI2498756T2/sl unknown
- 2010-11-02 PT PT107793390T patent/PT2498756T/pt unknown
- 2010-11-02 FI FIEP10779339.0T patent/FI2498756T4/fi active
- 2010-11-02 ES ES10779339T patent/ES2757882T5/es active Active
- 2010-11-02 WO PCT/IB2010/054964 patent/WO2011055303A1/en active Application Filing
- 2010-11-02 RS RS20191417A patent/RS59599B2/sr unknown
- 2010-11-02 PL PL10779339.0T patent/PL2498756T5/pl unknown
- 2010-11-02 CA CA2780428A patent/CA2780428C/en active Active
- 2010-11-02 HR HRP20192026TT patent/HRP20192026T4/hr unknown
- 2010-11-02 LT LT10779339T patent/LT2498756T/lt unknown
- 2010-11-02 AU AU2010316683A patent/AU2010316683B2/en active Active
- 2010-11-02 EP EP10779339.0A patent/EP2498756B2/en active Active
- 2010-11-02 CN CN201080060546.6A patent/CN102724970B/zh active Active
- 2010-11-02 EP EP19154710.8A patent/EP3566697B1/en active Active
- 2010-11-02 EP EP22169771.7A patent/EP4066821A1/en active Pending
- 2010-11-02 HU HUE10779339A patent/HUE046606T2/hu unknown
- 2010-11-02 NZ NZ599763A patent/NZ599763A/en unknown
- 2010-11-02 DK DK10779339.0T patent/DK2498756T4/da active
- 2010-11-05 US US12/940,808 patent/US8518446B2/en active Active
- 2010-11-08 TW TW99138396A patent/TWI466690B/zh active
- 2010-11-08 JP JP2010249385A patent/JP5835883B2/ja active Active
- 2010-11-09 AR ARP100104156A patent/AR078952A1/es not_active Application Discontinuation
-
2013
- 2013-08-21 US US13/972,764 patent/US8790708B2/en active Active
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2015
- 2015-02-06 JP JP2015021870A patent/JP2015091882A/ja not_active Withdrawn
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2017
- 2017-02-06 JP JP2017019429A patent/JP2017075192A/ja not_active Withdrawn
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2018
- 2018-11-14 AR ARP180103329A patent/AR114143A2/es not_active Application Discontinuation
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2019
- 2019-11-14 CY CY20191101200T patent/CY1122330T1/el unknown
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