HRP20120657T1 - Farmaceutski pripravak 271 - Google Patents
Farmaceutski pripravak 271 Download PDFInfo
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- HRP20120657T1 HRP20120657T1 HRP20120657AT HRP20120657T HRP20120657T1 HR P20120657 T1 HRP20120657 T1 HR P20120657T1 HR P20120657A T HRP20120657A T HR P20120657AT HR P20120657 T HRP20120657 T HR P20120657T HR P20120657 T1 HRP20120657 T1 HR P20120657T1
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- Croatia
- Prior art keywords
- pharmaceutical preparation
- preparation according
- benzoimidazole
- phenylamino
- bromo
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- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract 6
- 239000011159 matrix material Substances 0.000 claims abstract 15
- 229940113116 polyethylene glycol 1000 Drugs 0.000 claims abstract 7
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 claims abstract 7
- WWWTWPXKLJTKPM-UHFFFAOYSA-N 2-aminooxyethanol Chemical compound NOCCO WWWTWPXKLJTKPM-UHFFFAOYSA-N 0.000 claims abstract 6
- 125000005456 glyceride group Chemical group 0.000 claims abstract 6
- XAAPQRFIXGDKPZ-UHFFFAOYSA-N 6-(4-bromo-2-chloroanilino)-7-fluoro-3-methylbenzimidazole-5-carboxylic acid Chemical compound OC(=O)C=1C=C2N(C)C=NC2=C(F)C=1NC1=CC=C(Br)C=C1Cl XAAPQRFIXGDKPZ-UHFFFAOYSA-N 0.000 claims abstract 5
- 239000003937 drug carrier Substances 0.000 claims abstract 2
- 239000000825 pharmaceutical preparation Substances 0.000 claims 21
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical class OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 claims 14
- 238000002360 preparation method Methods 0.000 claims 11
- 239000007787 solid Substances 0.000 claims 10
- KWYWKYLYEIQRMF-UHFFFAOYSA-N CN1C(C=C(C(O)=O)C(NC(C=CC(Br)=C2)=C2Cl)=C2F)=C2N=C1.NOCCO Chemical compound CN1C(C=C(C(O)=O)C(NC(C=CC(Br)=C2)=C2Cl)=C2F)=C2N=C1.NOCCO KWYWKYLYEIQRMF-UHFFFAOYSA-N 0.000 claims 9
- AOBORMOPSGHCAX-UHFFFAOYSA-N Tocophersolan Chemical compound OCCOC(=O)CCC(=O)OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C AOBORMOPSGHCAX-UHFFFAOYSA-N 0.000 claims 6
- 239000003814 drug Substances 0.000 claims 6
- 239000002775 capsule Substances 0.000 claims 3
- 125000000400 lauroyl group Chemical group O=C([*])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 claims 3
- 239000000203 mixture Substances 0.000 claims 3
- 206010028980 Neoplasm Diseases 0.000 claims 2
- 208000024770 Thyroid neoplasm Diseases 0.000 claims 2
- 201000011510 cancer Diseases 0.000 claims 2
- 208000035250 cutaneous malignant susceptibility to 1 melanoma Diseases 0.000 claims 2
- 229940079593 drug Drugs 0.000 claims 2
- 201000001441 melanoma Diseases 0.000 claims 2
- 238000002156 mixing Methods 0.000 claims 2
- 229920001223 polyethylene glycol Polymers 0.000 claims 2
- 201000002510 thyroid cancer Diseases 0.000 claims 2
- 208000003174 Brain Neoplasms Diseases 0.000 claims 1
- 206010058467 Lung neoplasm malignant Diseases 0.000 claims 1
- ZDZOTLJHXYCWBA-VCVYQWHSSA-N N-debenzoyl-N-(tert-butoxycarbonyl)-10-deacetyltaxol Chemical compound O([C@H]1[C@H]2[C@@](C([C@H](O)C3=C(C)[C@@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)C=4C=CC=CC=4)C[C@]1(O)C3(C)C)=O)(C)[C@@H](O)C[C@H]1OC[C@]12OC(=O)C)C(=O)C1=CC=CC=C1 ZDZOTLJHXYCWBA-VCVYQWHSSA-N 0.000 claims 1
- 229940100198 alkylating agent Drugs 0.000 claims 1
- 239000002168 alkylating agent Substances 0.000 claims 1
- 210000000481 breast Anatomy 0.000 claims 1
- 210000004027 cell Anatomy 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 210000001072 colon Anatomy 0.000 claims 1
- 210000003238 esophagus Anatomy 0.000 claims 1
- 210000003128 head Anatomy 0.000 claims 1
- 239000008240 homogeneous mixture Substances 0.000 claims 1
- 210000003734 kidney Anatomy 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 210000004072 lung Anatomy 0.000 claims 1
- 201000005202 lung cancer Diseases 0.000 claims 1
- 208000020816 lung neoplasm Diseases 0.000 claims 1
- 238000002844 melting Methods 0.000 claims 1
- 230000008018 melting Effects 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 210000003739 neck Anatomy 0.000 claims 1
- 210000001672 ovary Anatomy 0.000 claims 1
- 210000000496 pancreas Anatomy 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 210000002307 prostate Anatomy 0.000 claims 1
- 210000002784 stomach Anatomy 0.000 claims 1
- 229940063683 taxotere Drugs 0.000 claims 1
- 210000001550 testis Anatomy 0.000 claims 1
- 210000003932 urinary bladder Anatomy 0.000 claims 1
- GRKFGZYYYYISDX-UHFFFAOYSA-N 6-(4-bromo-2-chloroanilino)-7-fluoro-n-(2-hydroxyethoxy)-3-methylbenzimidazole-5-carboxamide;sulfuric acid Chemical compound OS(O)(=O)=O.OCCONC(=O)C=1C=C2N(C)C=NC2=C(F)C=1NC1=CC=C(Br)C=C1Cl GRKFGZYYYYISDX-UHFFFAOYSA-N 0.000 abstract 1
- 150000002334 glycols Chemical class 0.000 abstract 1
- 229910052739 hydrogen Inorganic materials 0.000 abstract 1
- 239000001257 hydrogen Substances 0.000 abstract 1
- 125000004435 hydrogen atom Chemical class [H]* 0.000 abstract 1
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
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- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
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Abstract
Farmaceutski pripravak koji sadr·i hidrogen sulfatnu sol (2-hidroksi-etoksi)-amida 6-(4-bromo-2-kloro-fenilamino)-7-fluoro-3-metil-3H-benzoimidazol-5-karboksilne kiseline, te matricu nosača, naznačen time da se matrica nosača sastoji u osnovi od jednog ili vi®e farmaceutski prihvatljivih nosača koji su odabrani za slijedećih skupina: d-alfa-tokoferil polietilen glikol 1000 sukcinat; poliglikolizirani gliceridi; ipolietilen glikoli (PEG-ovi); i pri čemu je hidrogen sulfatna sol (2-hidroksi-etoksi)-amida 6-(4-bromo-2-kloro-fenilamino)-7-fluoro-3-metil-3H-benzoimidazol-5-karboksilne kiseline dispergirana unutar matrice nosača. Patent sadr·i jo® 24 patentna zahtjeva.
Claims (25)
1. Farmaceutski pripravak koji sadrži hidrogen sulfatnu sol (2-hidroksi-etoksi)-amida 6-(4-bromo-2-kloro-fenilamino)-7-fluoro-3-metil-3H-benzoimidazol-5-karboksilne kiseline, te matricu nosača, naznačen time da se matrica nosača sastoji u osnovi od jednog ili više farmaceutski prihvatljivih nosača koji su odabrani za slijedećih skupina:
a. d-alfa-tokoferil polietilen glikol 1000 sukcinat;
b. poliglikolizirani gliceridi; i
c. polietilen glikoli (PEG-ovi);
i pri čemu je hidrogen sulfatna sol (2-hidroksi-etoksi)-amida 6-(4-bromo-2-kloro-fenilamino)-7-fluoro-3-metil-3H-benzoimidazol-5-karboksilne kiseline dispergirana unutar matrice nosača.
2. Farmaceutski pripravak prema zahtjevu 1, naznačen time da matrica nosača sadrži u osnovi jedno ili oboje od slijedećeg:
a. d-alfa-tokoferil polietilen glikol 1000 sukcinat; te
b. poliglikolizirane gliceride.
3. Farmaceutski pripravak prema zahtjevu 1, naznačen time da je matrica nosača d-alfa-tokoferil polietilen glikol 1000 sukcinat ili Lauroil Makrogol-32 gliceridi.
4. Farmaceutski pripravak prema zahtjevu 1, naznačen time da je matrica nosača smjesa d-alfa-tokoferil polietilen glikol 1000 sukcinata i Lauroil Makrogol-32 glicerida i pri čemu Lauroil Makrogol-32 glicerid je prisutan u količini da se dobije približno 30-55% težinski komponente matrice nosača u pripravku.
5. Farmaceutski pripravak prema zahtjevu 1, naznačen time da je matrica nosača d-alfa-tokoferil polietilen glikol 1000 sukcinat.
6. Farmaceutski pripravak prema zahtjevu 5, naznačen time da je d-alfa-tokoferil polietilen glikol 1000 sukcinat prisutan u količini da se dobije udio od približno 65 do 95% težinski u pripravku.
7. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 6, naznačen time da je više od 90% težinski ukupne količine hidrogen sulfatne soli (2-hidroksi-etoksi)-amida 6-(4-bromo-2-kloro-fenilamino)-7-fluoro-3-metil-3H-benzoimidazol-5-karboksilne kiseline koja se nalazi u pripravku dispergirano unutar matrice nosača.
8. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 7, naznačen time da pripravak sadrži između 5 do 30% težinski hidrogen sulfatne soli (2-hidroksi-etoksi)-amida 6-(4-bromo-2-kloro-fenilamino)-7-fluoro-3-metil-3H-benzoimidazol-5-karboksilne kiseline.
9. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 8, naznačen time da je pripravak kod temperature okoline u polu-krutom ili krutom stanju.
10. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 9, naznačen time da je hidrogen sulfatna sol (2-hidroksi-etoksi)-amida 6-(4-bromo-2-kloro-fenilamino)-7-fluoro-3-metil-3H-benzoimidazol-5-karboksilne kiseline dispergirana u obliku fino razdijeljenih čestica koji se raspodijeljene u fazi koja sadrži matricu nosača.
11. Farmaceutski pripravak prema zahtjevu 1, naznačen time da sadrži:
(i) od 15 do 25 dijelova hidrogen sulfatne soli (2-hidroksi-etoksi)-amida 6-(4-bromo-2-kloro-fenilamino)-7-fluoro-3-metil-3H-benzoimidazol-5-karboksilne kiseline; te
(ii) od 75 do 85 dijelova vitamina E TPGS;
pri čemu su oba dijela izraženi težinski i zbroj dijelova (i)+(ii) =100;
i pri čemu je hidrogen sulfatna sol (2-hidroksi-etoksi)-amida 6-(4-bromo-2-kloro-fenilamino)-7-fluoro-3-metil-3H-benzoimidazol-5-karboksilne kiseline dispergirana unutar vitamina E TPGS i pripravak je kod temperature okoline u polu-krutom ili krutom stanju.
12. Farmaceutski pripravak prema zahtjevu 1, naznačen time da sadrži:
(i) od 18 do 22 dijela hidrogen sulfatne soli (2-hidroksi-etoksi)-amida 6-(4-bromo-2-kloro-fenilamino)-7-fluoro-3-metil-3H-benzoimidazol-5-karboksilne kiseline; te
(ii) od 78 do 82 dijelova vitamina E TPGS;
pri čemu su oba dijela izraženi težinski i zbroj dijelova (i)+(ii) =100;
i pri čemu je hidrogen sulfatna sol (2-hidroksi-etoksi)-amida 6-(4-bromo-2-kloro-fenilamino)-7-fluoro-3-metil-3H-benzoimidazol-5-karboksilne kiseline dispergirana unutar vitamina E TPGS i pripravak je kod temperature okoline u polu-krutom ili krutom stanju.
13. Farmaceutski pripravak prema zahtjevu 1, naznačen time da sadrži:
(i) 19-21 dijelova hidrogen sulfatne soli (2-hidroksi-etoksi)-amida 6-(4-bromo-2-kloro-fenilamino)-7-fluoro-3-metil-3H-benzoimidazol-5-karboksilne kiseline; te
(ii) 79-81 dijelova vitamina E TPGS;
pri čemu su oba dijela izraženi težinski i zbroj dijelova (i)+(ii) =100;
te pri čemu je hidrogen sulfatna sol (2-hidroksi-etoksi)-amida 6-(4-bromo-2-kloro-fenilamino)-7-fluoro-3-metil-3H-benzoimidazol-5-karboksilne kiseline dispergirana unutar vitamina E TPGS i pripravak je kod temperature okoline u polu-krutom ili krutom stanju.
14. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 13, naznačen time da pripravak sadrži 30.25 +/- 2 mg hidrogen sulfatne soli (2-hidroksi-etoksi)-amida 6-(4-bromo-2-kloro-fenilamino)-7-fluoro-3-metil-3H-benzoimidazol-5-karboksilne kiseline.
15. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 13, naznačen time da pripravak sadrži 12.1 +/- 2 mg hidrogen sulfatne soli (2-hidroksi-etoksi)-amida 6-(4-bromo-2-kloro-fenilamino)-7-fluoro-3-metil-3H-benzoimidazol-5-karboksilne kiseline.
16. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 15, naznačen time da je pripravak oralni pripravak u obliku kapsule.
17. Postupak za dobivanje farmaceutskog pripravka prema zahtjevu 1 naznačen time da sadrži korake:
a. miješanja i taljenja komponenti matrice nosača;
b. miješanje Agensa u matricu nosača kako bi se dobila homogena smjesa; te
c. punjenje proizvoda iz koraka (b) u kapsulu i puštanja smjese da se ohladi i formira viskoznu tekućinu, polu-krutu ili krutu masu unutar kapsule.
18. Farmaceutski pripravak prema bilo kojem zahtjevu 1 do 16 naznačen time da je za uporabu kao lijek za liječenje stanja koje se liječi sa hidrogen sulfatnom soli (2-hidroksi-etoksi)-amida 6-(4-bromo-2-kloro-fenilamino)-7-fluoro-3-metil-3H-benzoimidazol-5-karboksilne kiseline.
19. Farmaceutski pripravak prema bilo kojem zahtjevu 1 do 16 naznačen time da je za uporabu kao lijek za liječenje raka.
20. Farmaceutski pripravak prema bilo kojem zahtjevu 1 do 16 naznačen time da je za uporabu kao lijek za liječenje malignog melanoma, karcinoma mozga, pluća, skvamoznih stanica, mokraćnog mjehura, želuca, gušterače, dojki, glave, vrata, renalnog, bubrega, jajnika, prostate, debelog crijeva, jednjaka, testisa, ginekoloških karcinoma ili karcinoma štitnjače.
21. Farmaceutski pripravak prema bilo kojem zahtjevu 1 do 16 naznačen time da je za uporabu kao lijek za liječenje karcinoma pluća.
22. Farmaceutski pripravak prema bilo kojem zahtjevu 1 do 16 naznačen time da je za uporabu kao lijek za liječenje karcinoma štitnjače.
23. Farmaceutski pripravak prema bilo kojem zahtjevu 1 do 16 naznačen time da je za uporabu kao lijek za liječenje malignog melanoma.
24. Farmaceutski pripravak prema bilo kojem zahtjevu 1 do 16 naznačen time da je za uporabu u kombinaciji s taksoterom.
25. Farmaceutski pripravak prema bilo kojem zahtjevu 1 do 16 naznačen time da je za uporabu u kombinaciji sa sredstvom za alkiliranje.
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| US4037208P | 2008-03-28 | 2008-03-28 | |
| PCT/GB2009/050293 WO2009118562A1 (en) | 2008-03-28 | 2009-03-26 | Pharmaceutical composition 271 |
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| HRP20120657AT HRP20120657T1 (hr) | 2008-03-28 | 2012-08-13 | Farmaceutski pripravak 271 |
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| TWI405756B (zh) * | 2005-12-21 | 2013-08-21 | Array Biopharma Inc | 新穎硫酸氫鹽 |
| SA109300195B1 (ar) | 2008-03-28 | 2013-04-20 | Astrazeneca Ab | تركيبة صيدلانية جديدة مضادة للسرطان |
| LT2903968T (lt) | 2012-10-02 | 2017-02-27 | Gilead Sciences, Inc. | Histondemetilazių inhibitoriai |
| AP2015008676A0 (en) | 2013-02-27 | 2015-08-31 | Epitherapeutics Aps | Inhibitors of histone demethylases |
| US20170369444A1 (en) | 2014-03-31 | 2017-12-28 | Marc Labelle | Inhibitors of histone demethylases |
| BR112017003442A2 (pt) | 2014-08-27 | 2017-11-28 | Gilead Sciences Inc | compostos e métodos para inibir histona desmetilases |
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| US6022852A (en) | 1993-10-22 | 2000-02-08 | Hexal Ag | Pharmaceutical composition containing cyclosporin A |
| JPH09512794A (ja) | 1994-04-07 | 1997-12-22 | スミスクライン・ビーチャム・パブリック・リミテッド・カンパニー | マラリアの治療用のハロファントリン遊離塩基および組成物 |
| EP0825849A1 (en) | 1995-05-19 | 1998-03-04 | Abbott Laboratories | Self-emulsifying formulations of lipophilic drugs |
| FR2736550B1 (fr) | 1995-07-14 | 1998-07-24 | Sandoz Sa | Composition pharmaceutique sous la forme d'une dispersion solide comprenant un macrolide et un vehicule |
| MY126358A (en) * | 1996-03-22 | 2006-09-29 | Glaxo Group Ltd | Compositions comprising vx478 and a water soluble tocopherol derivative such as vitamin e-tpgs |
| US5891469A (en) | 1997-04-02 | 1999-04-06 | Pharmos Corporation | Solid Coprecipitates for enhanced bioavailability of lipophilic substances |
| DE29824679U1 (de) | 1997-01-30 | 2002-03-28 | Novartis Ag | Pharmazeutische Zusammensetzungen |
| US5891845A (en) * | 1997-11-21 | 1999-04-06 | Fuisz Technologies Ltd. | Drug delivery systems utilizing liquid crystal structures |
| US7374779B2 (en) * | 1999-02-26 | 2008-05-20 | Lipocine, Inc. | Pharmaceutical formulations and systems for improved absorption and multistage release of active agents |
| US20030104048A1 (en) | 1999-02-26 | 2003-06-05 | Lipocine, Inc. | Pharmaceutical dosage forms for highly hydrophilic materials |
| US6372251B2 (en) | 1999-06-11 | 2002-04-16 | Abbott Laboratories | Formulations comprising lipid-regulating agents |
| US20030236236A1 (en) | 1999-06-30 | 2003-12-25 | Feng-Jing Chen | Pharmaceutical compositions and dosage forms for administration of hydrophobic drugs |
| EP2275102B1 (en) | 2002-03-13 | 2015-07-29 | Array Biopharma, Inc. | N3 alkylated benzimidazole derivatives as MEK inhibitors |
| EP1515703A1 (en) * | 2002-06-21 | 2005-03-23 | Transform Pharmaceuticals, Inc. | Pharmaceutical compositions with improved dissolution |
| AU2003267231A1 (en) | 2002-09-20 | 2004-04-08 | Transform Pharmaceuticals, Inc. | Pharmaceutical compositions with improved dissolution |
| US20040127551A1 (en) | 2002-12-27 | 2004-07-01 | Kai Zhang | Taxane-based compositions and methods of use |
| KR20060115350A (ko) * | 2003-09-02 | 2006-11-08 | 화이자 프로덕츠 인크. | 지프라시돈의 지속 방출형 투여 형태 |
| US20050096365A1 (en) | 2003-11-03 | 2005-05-05 | David Fikstad | Pharmaceutical compositions with synchronized solubilizer release |
| US20060003002A1 (en) | 2003-11-03 | 2006-01-05 | Lipocine, Inc. | Pharmaceutical compositions with synchronized solubilizer release |
| AR046773A1 (es) | 2003-12-23 | 2005-12-21 | Novartis Ag | Formulaciones farmaceuticas de bisfosfonatos |
| CA2552925A1 (en) | 2004-01-30 | 2005-08-18 | Pfizer Italia S.R.L. | Semisolid matrix pharmaceutical formulations |
| KR20050104152A (ko) * | 2004-04-28 | 2005-11-02 | 최승호 | 경구용 약물의 흡수를 증진하는 약제학적 조성물 |
| WO2006138431A2 (en) | 2005-06-16 | 2006-12-28 | Eastman Chemical Company | Methods and pharmaceutical formulations for increasing bioavailability |
| TWI405756B (zh) * | 2005-12-21 | 2013-08-21 | Array Biopharma Inc | 新穎硫酸氫鹽 |
| US9561178B2 (en) | 2006-07-25 | 2017-02-07 | Allergan, Inc. | Cyclosporin compositions |
| CA2715018C (en) | 2008-03-20 | 2012-11-13 | Virun, Inc. | Vitamin e derivatives and their uses |
| SA109300195B1 (ar) | 2008-03-28 | 2013-04-20 | Astrazeneca Ab | تركيبة صيدلانية جديدة مضادة للسرطان |
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