RU2017112737A - Фармацевтическая композиция, включающая омега-3 жирную кислоту и гидрокси-производное статина и способы ее применения - Google Patents
Фармацевтическая композиция, включающая омега-3 жирную кислоту и гидрокси-производное статина и способы ее применения Download PDFInfo
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- RU2017112737A RU2017112737A RU2017112737A RU2017112737A RU2017112737A RU 2017112737 A RU2017112737 A RU 2017112737A RU 2017112737 A RU2017112737 A RU 2017112737A RU 2017112737 A RU2017112737 A RU 2017112737A RU 2017112737 A RU2017112737 A RU 2017112737A
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- Prior art keywords
- hydroxyatorvastatin
- pharmaceutical composition
- atorvastatin
- calcium
- pharmaceutically acceptable
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- 239000008194 pharmaceutical composition Substances 0.000 title claims 10
- CYQFCXCEBYINGO-IAGOWNOFSA-N delta1-THC Chemical compound C1=C(C)CC[C@H]2C(C)(C)OC3=CC(CCCCC)=CC(O)=C3[C@@H]21 CYQFCXCEBYINGO-IAGOWNOFSA-N 0.000 title claims 4
- 235000020660 omega-3 fatty acid Nutrition 0.000 title claims 4
- 229940012843 omega-3 fatty acid Drugs 0.000 title claims 4
- 229940121710 HMGCoA reductase inhibitor Drugs 0.000 title 1
- SOZOATLLFFVAPM-KAYWLYCHSA-N p-hydroxyatorvastatin Chemical compound C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CC[C@@H](O)C[C@@H](O)CC(O)=O)C(C(C)C)=C1C(=O)NC1=CC=C(O)C=C1 SOZOATLLFFVAPM-KAYWLYCHSA-N 0.000 claims 10
- CZBPKFICAYVHHM-JWQCQUIFSA-N (3r,5r)-7-[2-(4-fluorophenyl)-4-[(2-hydroxyphenyl)carbamoyl]-3-phenyl-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoic acid Chemical compound C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CC[C@@H](O)C[C@@H](O)CC(O)=O)C(C(C)C)=C1C(=O)NC1=CC=CC=C1O CZBPKFICAYVHHM-JWQCQUIFSA-N 0.000 claims 7
- XUKUURHRXDUEBC-UHFFFAOYSA-N Atorvastatin Natural products C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CCC(O)CC(O)CC(O)=O)C(C(C)C)=C1C(=O)NC1=CC=CC=C1 XUKUURHRXDUEBC-UHFFFAOYSA-N 0.000 claims 7
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims 7
- 229960005370 atorvastatin Drugs 0.000 claims 7
- 229910052791 calcium Inorganic materials 0.000 claims 7
- 239000011575 calcium Substances 0.000 claims 7
- 150000003839 salts Chemical class 0.000 claims 7
- 125000002887 hydroxy group Chemical group [H]O* 0.000 claims 6
- QXNVGIXVLWOKEQ-UHFFFAOYSA-N Disodium Chemical compound [Na][Na] QXNVGIXVLWOKEQ-UHFFFAOYSA-N 0.000 claims 5
- 235000014113 dietary fatty acids Nutrition 0.000 claims 4
- 229930195729 fatty acid Natural products 0.000 claims 4
- 239000000194 fatty acid Substances 0.000 claims 4
- 150000004665 fatty acids Chemical class 0.000 claims 4
- CLWMCOKPVIXYQL-UHFFFAOYSA-N 2-ethyldocosa-2,4,6,8,10,12-hexaenoic acid Chemical compound CCCCCCCCCC=CC=CC=CC=CC=CC=C(CC)C(O)=O CLWMCOKPVIXYQL-UHFFFAOYSA-N 0.000 claims 3
- 210000000170 cell membrane Anatomy 0.000 claims 3
- 150000002596 lactones Chemical class 0.000 claims 3
- -1 lipid hydroperoxides Chemical class 0.000 claims 3
- 201000001320 Atherosclerosis Diseases 0.000 claims 2
- 229920000064 Ethyl eicosapentaenoic acid Polymers 0.000 claims 2
- KDJMDZSAAFACAM-KAYWLYCHSA-N P-Hydroxyatorvastatin lactone Chemical compound C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CC[C@H]2OC(=O)C[C@H](O)C2)C(C(C)C)=C1C(=O)NC1=CC=C(O)C=C1 KDJMDZSAAFACAM-KAYWLYCHSA-N 0.000 claims 2
- 239000002775 capsule Substances 0.000 claims 2
- 210000000748 cardiovascular system Anatomy 0.000 claims 2
- 201000010099 disease Diseases 0.000 claims 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 2
- ITNKVODZACVXDS-YATCGRJWSA-N ethyl (4e,7e,10e,13e,16e,19e)-docosa-4,7,10,13,16,19-hexaenoate Chemical compound CCOC(=O)CC\C=C\C\C=C\C\C=C\C\C=C\C\C=C\C\C=C\CC ITNKVODZACVXDS-YATCGRJWSA-N 0.000 claims 2
- SSQPWTVBQMWLSZ-AAQCHOMXSA-N ethyl (5Z,8Z,11Z,14Z,17Z)-icosapentaenoate Chemical compound CCOC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/C\C=C/CC SSQPWTVBQMWLSZ-AAQCHOMXSA-N 0.000 claims 2
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 claims 2
- 229960002600 icosapent ethyl Drugs 0.000 claims 2
- XUKUURHRXDUEBC-KAYWLYCHSA-N Atorvastatin Chemical compound C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CC[C@@H](O)C[C@@H](O)CC(O)=O)C(C(C)C)=C1C(=O)NC1=CC=CC=C1 XUKUURHRXDUEBC-KAYWLYCHSA-N 0.000 claims 1
- 208000032928 Dyslipidaemia Diseases 0.000 claims 1
- 208000035150 Hypercholesterolemia Diseases 0.000 claims 1
- 206010020772 Hypertension Diseases 0.000 claims 1
- JVTAAEKCZFNVCJ-UHFFFAOYSA-M Lactate Chemical compound CC(O)C([O-])=O JVTAAEKCZFNVCJ-UHFFFAOYSA-M 0.000 claims 1
- 208000017170 Lipid metabolism disease Diseases 0.000 claims 1
- MNECBMZJZFGTIK-JWQCQUIFSA-N O-Hydroxyatorvastatin lactone Chemical compound C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CC[C@H]2OC(=O)C[C@H](O)C2)C(C(C)C)=C1C(=O)NC1=CC=CC=C1O MNECBMZJZFGTIK-JWQCQUIFSA-N 0.000 claims 1
- 208000006011 Stroke Diseases 0.000 claims 1
- 206010003119 arrhythmia Diseases 0.000 claims 1
- 230000006793 arrhythmia Effects 0.000 claims 1
- 208000029078 coronary artery disease Diseases 0.000 claims 1
- GVJHHUAWPYXKBD-UHFFFAOYSA-N d-alpha-tocopherol Natural products OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims 1
- 208000006575 hypertriglyceridemia Diseases 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 208000010125 myocardial infarction Diseases 0.000 claims 1
- 229960001295 tocopherol Drugs 0.000 claims 1
- 229930003799 tocopherol Natural products 0.000 claims 1
- 235000010384 tocopherol Nutrition 0.000 claims 1
- 239000011732 tocopherol Substances 0.000 claims 1
- 208000019553 vascular disease Diseases 0.000 claims 1
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 claims 1
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- A61K31/19—Carboxylic acids, e.g. valproic acid
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- A61K31/404—Indoles, e.g. pindolol
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Claims (16)
1. Фармацевтическая композиция для перорального введения для снижения гидроперекисей липидов в клеточных мембранах, включающая (a) от 2,5 мг до 100 мг гидрокси-производного аторвастатина или его фармацевтически приемлемой соли и (b) масло, включающее омега-3 жирную кислоту, при этом омега-3 жирная кислота включает по меньшей мере 95 масс.% этилэйкозапентаеноата от всех присутствующих жирных кислот, или по меньшей мере 95 масс.% этилдокозагексаеноата от всех присутствующих жирных кислот.
2. Фармацевтическая композиция по п.1, где масло включает, по меньшей мере, 95 масс.% этилэйкозапентаеноата.
3. Фармацевтическая композиция по п.1, где масло включает, по меньшей мере, 95 масс.% этилдокозагексаеновой кислоты.
4. Фармацевтическая композиция по п.1, где масло включает этилэйкозапентаеноат и этилдокозагексаеновую кислоту.
5. Фармацевтическая композиция по п.1, где гидрокси-производное аторвастатина выбирают из орто- или пара-гидроксиаторвастатина и его фармацевтически приемлемых солей.
6. Фармацевтическая композиция по п.5, где гидрокси-производное аторвастатина или его фармацевтически приемлемую соль выбирают из o-гидроксиаторвастатина, п-гидроксиаторвастатина, п-гидроксиаторвастатина кальция, п-гидроксиаторвастатина динатрия, o-гидроксиаторвастатина кальция, o-гидроксиаторвастатина лактона, o-гидроксиаторвастатин-d5 кальция, o-гидроксиаторвастатин-d5 динатрия, o-гидроксиаторвастатин-d5 лактона, 2-гидроксиаторвастатина бинатрия, п-гидроксиаторвастатина лактона, п-гидроксиаторвастатин-d5 кальция, п-гидроксиаторвастатин-d5 лактона, и 4-гидроксиаторвастатина бинатрия.
7. Фармацевтическая композиция по п.1, дополнительно включающая токоферол в количестве от около 0,1 масс.% до около 0,3 масс.%.
8. Капсула для снижения гидроперекисей липидов в клеточных мембранах, включающая фармацевтическую композицию по любому из пп. 1-7.
9. Капсула по п.8, включающая от около 0,5 г до около 2 г фармацевтической композиции.
10. Способ снижения гидроперекисей липидов в клеточных мембранах у субъекта, нуждающегося в этом, включающий пероральное введение пациенту композиции, включающей (a) от 2,5 мг до 100 мг гидрокси-производного аторвастатина или его фармацевтически приемлемой соли и (b) масло, включающее омега-3 жирную кислоту, включающее по меньшей мере 95 масс.% этилэйкозапентаеноата от всех присутствующих жирных кислот или по меньшей мере 95 масс.% этилдокозагексаеноата от всех присутствующих жирных кислот.
11. Способ по п.10, где масло включает, по меньшей мере, 95 масс.% этилэйкозапентаеноата.
12. Способ по п.10, где масло включает по меньшей мере 95 масс.% этилдокозагексаеновой кислоты.
13. Способ по п.10, где гидрокси-производное аторвастатина или его фармацевтически приемлемой соли выбирают из орто- или пара-гидроксиаторвастатина и его фармацевтически приемлемых солей.
14. Способ по п.10, где гидрокси-производное аторвастатина или его фармацевтически приемлемую соль выбирают из o-гидроксиаторвастатина, п-гидроксиаторвастатина, п-гидроксиаторвастатина кальция, п-гидроксиаторвастатина динатрия, o-гидроксиаторвастатина кальция, o-гидроксиаторвастатина лактона, o-гидроксиаторвастатин-d5 кальция, o-гидроксиаторвастатин-d5 динатрия, o-гидроксиаторвастатин-d5 лактона, 2-гидроксиаторвастатина бинатрия, п-гидроксиаторвастатина лактона, п-гидроксиаторвастатин-d5 кальция, п-гидроксиаторвастатин-d5 лактона, и 4-гидроксиаторвастатина бинатрия.
15. Способ по п.10, где заболевание, связанное с сердечно-сосудистой системой, выбирают из гипертриглицеридемии, гиперхолестеринемии, смешанной дислипидемии, ишемической болезни сердца, сосудистых заболеваний, удара, атеросклероза, аритмии, гипертонии и инфаркта миокарда.
16. Способ по п.10, где заболеванием, связанным с сердечно-сосудистой системой, является атеросклероз.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US24508609P | 2009-09-23 | 2009-09-23 | |
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| NZ599061A (en) | 2014-05-30 |
| EP2480248B1 (en) | 2015-09-02 |
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| US20150265574A1 (en) | 2015-09-24 |
| RU2012116079A (ru) | 2013-10-27 |
| MX2012003555A (es) | 2012-07-03 |
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