HRP20192026T1 - Formulacija tableta od neratinib maleata - Google Patents
Formulacija tableta od neratinib maleata Download PDFInfo
- Publication number
- 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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- HR
- Croatia
- Prior art keywords
- mass percent
- weight
- components
- intragranular
- crospovidone
- Prior art date
Links
- 229950008835 neratinib Drugs 0.000 title claims 10
- 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 9
- 239000007916 tablet composition Substances 0.000 title 1
- 238000002360 preparation method Methods 0.000 claims 15
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 13
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 7
- 229960000913 crospovidone Drugs 0.000 claims 7
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 7
- 239000008108 microcrystalline cellulose Substances 0.000 claims 7
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 7
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 7
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 7
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 6
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 6
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 6
- 229940069328 povidone Drugs 0.000 claims 6
- 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 4
- 229930195725 Mannitol Natural products 0.000 claims 4
- 239000007884 disintegrant Substances 0.000 claims 4
- 239000000945 filler Substances 0.000 claims 4
- 238000005469 granulation Methods 0.000 claims 4
- 230000003179 granulation Effects 0.000 claims 4
- 239000000594 mannitol Substances 0.000 claims 4
- 235000010355 mannitol Nutrition 0.000 claims 4
- 239000007888 film coating Substances 0.000 claims 3
- 238000009501 film coating Methods 0.000 claims 3
- 235000019359 magnesium stearate Nutrition 0.000 claims 3
- 238000000034 method Methods 0.000 claims 3
- 239000000203 mixture Substances 0.000 claims 3
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 2
- 239000002775 capsule Substances 0.000 claims 2
- 239000008119 colloidal silica Substances 0.000 claims 2
- 239000000314 lubricant Substances 0.000 claims 2
- 239000003607 modifier Substances 0.000 claims 2
- 239000012748 slip agent Substances 0.000 claims 2
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 1
- 206010028980 Neoplasm Diseases 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
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 229960001681 croscarmellose sodium Drugs 0.000 claims 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 1
- 239000012458 free base Substances 0.000 claims 1
- 229940057948 magnesium stearate Drugs 0.000 claims 1
- ZNHPZUKZSNBOSQ-BQYQJAHWSA-N neratinib Chemical compound C=12C=C(NC\C=C\CN(C)C)C(OCC)=CC2=NC=C(C#N)C=1NC(C=C1Cl)=CC=C1OCC1=CC=CC=N1 ZNHPZUKZSNBOSQ-BQYQJAHWSA-N 0.000 claims 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 1
- 238000005507 spraying Methods 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
- A61K9/20—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
- 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
-
- 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
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- 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 (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 | |
| EP10779339.0A EP2498756B2 (en) | 2009-11-09 | 2010-11-02 | Tablet formulations of neratinib maleate |
| PCT/IB2010/054964 WO2011055303A1 (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 (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) | EP4066821A1 (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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| 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 |
| EP3443961B1 (en) | 2008-06-17 | 2020-10-28 | Wyeth LLC | Antineoplastic combinations containing hki-272 and vinorelbine |
| KR20140069340A (ko) | 2008-08-04 | 2014-06-09 | 와이어쓰 엘엘씨 | 4-아닐리노-3-사이아노퀴놀린과 카페시타빈의 항신생물성 조합물 |
| KR20160106211A (ko) | 2009-04-06 | 2016-09-09 | 와이어쓰 엘엘씨 | 네라티닙을 이용한 유방암의 치료법 |
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| NZ599762A (en) | 2009-11-09 | 2014-07-25 | Wyeth Llc | Coated drug spheroids and uses thereof for eliminating or reducing conditions such as emesis and diarrhea |
| EP2797597B1 (en) | 2011-12-28 | 2020-02-26 | Global Blood Therapeutics, Inc. | Substituted heteroaryl aldehyde compounds and methods for their use in increasing tissue oxygenation |
| PE20142454A1 (es) | 2011-12-28 | 2015-02-07 | Global Blood Therapeutics Inc | Compuestos de benzaldehido sustituidos y metodos para su uso en incrementar la oxigenacion del tejido |
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| CN111454200A (zh) | 2013-03-15 | 2020-07-28 | 全球血液疗法股份有限公司 | 化合物及其用于调节血红蛋白的用途 |
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| CA3181361A1 (en) * | 2020-04-30 | 2021-11-04 | Nanocopoeia, Llc | Orally disintegrating tablet comprising amorphous solid dispersion of nilotinib |
| AU2021291437B2 (en) * | 2020-06-19 | 2024-07-04 | Acerta Pharma B.V. | Acalabrutinib maleate dosage forms |
| WO2023172958A1 (en) * | 2022-03-08 | 2023-09-14 | Onkosxcel Therapeutics, Llc | Stable formulations of talabostat |
| WO2024187321A1 (zh) * | 2023-03-10 | 2024-09-19 | 甫康（上海）健康科技有限责任公司 | 含有egfr抑制剂的药物组合物及其制备方法和应用 |
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| TW442301B (en) * | 1995-06-07 | 2001-06-23 | Sanofi Synthelabo | Pharmaceutical compositions containing irbesartan |
| US6002008A (en) | 1997-04-03 | 1999-12-14 | American Cyanamid Company | Substituted 3-cyano quinolines |
| US6297258B1 (en) | 1998-09-29 | 2001-10-02 | American Cyanamid Company | Substituted 3-cyanoquinolines |
| US6288082B1 (en) | 1998-09-29 | 2001-09-11 | American Cyanamid Company | Substituted 3-cyanoquinolines |
| US6384051B1 (en) | 2000-03-13 | 2002-05-07 | American Cyanamid Company | Method of treating or inhibiting colonic polyps |
| US7399865B2 (en) † | 2003-09-15 | 2008-07-15 | Wyeth | Protein tyrosine kinase enzyme inhibitors |
| AR046544A1 (es) * | 2003-10-15 | 2005-12-14 | Wyeth Corp | Administracion oral de acido [2- (8,9 - dioxo - 2,6 - diazabiciclo [5.2.0] non -1 (7) - en - 2 - il ) alquil] fosfonico yderivados |
| US20050142192A1 (en) * | 2003-10-15 | 2005-06-30 | Wyeth | Oral administration of [2-(8,9-dioxo-2,6-diazabicyclo[5.2.0]non-1(7)-en-2-yl)alkyl] phosphonic acid and derivatives |
| AU2005295859A1 (en) * | 2004-10-13 | 2006-04-27 | Wyeth | Analogs of 17-hydroxywortmannin as PI3K inhibitors |
| WO2006085168A2 (en) * | 2005-01-07 | 2006-08-17 | Ranbaxy Laboratories Limited | Solid oral dosage forms of ziprasidone containing colloidal silicone dioxide |
| ATE460937T1 (de) * | 2005-04-28 | 2010-04-15 | Wyeth Corp | Mikronisierte tanaproget zusammensetzungen und verfahren zu ihrer herstellung |
| EP2340837B1 (en) * | 2005-11-11 | 2017-03-15 | Boehringer Ingelheim International GmbH | Combination treatment of cancer comprising egfr/her2 inhibitors |
| JP2007169273A (ja) * | 2005-11-28 | 2007-07-05 | Takeda Chem Ind Ltd | 杵付着を改善した医薬製剤 |
| JP2007211005A (ja) * | 2006-01-16 | 2007-08-23 | Ono Pharmaceut Co Ltd | 固形製剤用組成物および固形製剤 |
| TW200806282A (en) * | 2006-05-05 | 2008-02-01 | Wyeth Corp | Solid dosage formulations |
| AU2008206476A1 (en) * | 2007-01-12 | 2008-07-24 | Wyeth | Tablet-in-tablet compositions |
| TW200836774A (en) * | 2007-02-01 | 2008-09-16 | Takeda Pharmaceutical | Solid preparation |
| 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 |
| MX2012000048A (es) * | 2009-07-02 | 2012-01-27 | Wyeth Llc | Formulaciones de comprimidos de 3-cianoquinolina y usos de los mismos. |
| DK2498756T4 (da) * | 2009-11-09 | 2023-03-20 | Wyeth Llc | Tabletformuleringer af neratinibmaleat |
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