DK3178481T3 - Formulering med rekonstitueret højdensitetslipoprotein og fremgangsmåde til fremstilling deraf - Google Patents
Formulering med rekonstitueret højdensitetslipoprotein og fremgangsmåde til fremstilling deraf Download PDFInfo
- Publication number
- DK3178481T3 DK3178481T3 DK16203579.4T DK16203579T DK3178481T3 DK 3178481 T3 DK3178481 T3 DK 3178481T3 DK 16203579 T DK16203579 T DK 16203579T DK 3178481 T3 DK3178481 T3 DK 3178481T3
- Authority
- DK
- Denmark
- Prior art keywords
- detergent
- formulation
- cholate
- rhdl
- apo
- Prior art date
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Classifications
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- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
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- A61K31/66—Phosphorus compounds
- A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
- A61K31/685—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin
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- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
- A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
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Landscapes
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Claims (16)
1. Rekonstitueret højdensitetslipoprotein (rHDL)-formulering, der omfatter et apolipoprotein eller et fragment deraf; et phospholipid; og et detergent ved et niveau, der er ca. 0,015-0,030 g/g apolipoprotein, hvor molforholdet for apolipoprotein phospholipid ligger i intervallet 1:20 til 1:100.
2. rHDL-formulering ifølge krav 1, hvor detergentet er et galdesalt eller en galdesyre.
3. rHDL-formulering ifølge krav 2, hvor detergentet er natriumcholat.
4. rHDL-formulering ifølge et hvilket som helst af ovennævnte krav, hvor apolipoproteinet er Apo-A1 eller et fragment deraf.
5. rHDL-formulering ifølge et hvilket som helst af ovennævnte krav, hvor phospholipidet er phosphatidylcholin.
6. rHDL-formulering ifølge et hvilket som helst af ovennævnte krav, hvor formuleringen yderligere omfatter en stabilisator.
7. Fremgangsmåde til fremstilling af en rHDL-formulering, der omfatter et apolipoprotein; et phospholipid; og et detergent, hvilken fremgangsmåde indbefatter trinet tilvejebringelse af detergentet ved et niveau, der er ca. 0,015-0,030 g/g apolipoprotein.
8. Fremgangsmåde ifølge krav 7, hvor detergentet er et galdesalt eller en galdesyre.
9. Fremgangsmåde ifølge krav 8, hvor detergentet er natriumcholat.
10. Fremgangsmåde ifølge et hvilket som helst af kravene 7-9, hvor apolipoproteinet er Apo-A1 eller et fragment deraf.
11. Fremgangsmåde ifølge et hvilket som helst af kravene 7-10, hvor phospholipidet er phosphatidylcholin.
12. Fremgangsmåde ifølge et hvilket som helst af kravene 7-11, der indbefatter trinene: (A) tilsætning af phosphatidylcholin uden organisk opløsningsmiddel og et cholatdetergent til en Apo-A1-opløsning; (B) reducering af niveauet af cholatdetergent i opløsningen, der er dannet i trin (I), til ca. 0,03 g/g Apo-A1; (C) tilsætning af en stabilisator til opløsningen i trin (B).
13. rHDL-formulering, der kan opnås ved anvendelse af fremgangsmåden ifølge et hvilket som helst af kravene 7-12.
14. rHDL-formulering ifølge et hvilket som helst af kravene 1-6 eller krav 13 til anvendelse til behandling af en sygdom, forstyrrelse eller tilstand hos et menneske.
15. rHDL-formulering til anvendelse ifølge krav 14, hvor sygdommen, forstyrrelsen eller tilstanden indbefatter kardiovaskulær sygdom, hyperkolesterolæmi eller hypokolesterolæmi.
16. rHDL-formulering til anvendelse ifølge krav 15, hvor sygdommen, forstyrrelsen eller tilstanden indbefatter akut koronart syndrom (ACS), aterosklerose og myokardieinfarkt.
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| EP11799979.7A EP2588113B1 (en) | 2010-06-30 | 2011-06-30 | A reconstituted high density lipoprotein formulation and production method thereof |
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| DK16203579.4T DK3178481T3 (da) | 2010-06-30 | 2011-06-30 | Formulering med rekonstitueret højdensitetslipoprotein og fremgangsmåde til fremstilling deraf |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| TR201903209T4 (tr) | 2010-06-30 | 2019-03-21 | Csl Ltd | Yeniden yapılandırılan yüksek yoğunluğa sahip bir lipoprotein formülasyonu ve bunun üretim yöntemi. |
| US9125943B2 (en) | 2012-11-02 | 2015-09-08 | Csl Limited | Reconstituted HDL formulation |
| CN103833840A (zh) * | 2012-11-27 | 2014-06-04 | 上海复星医药（集团）股份有限公司 | 一种从人血浆中提取高密度脂蛋白及分离纯化载脂蛋白apoA-I的方法 |
| US9890203B2 (en) * | 2013-06-05 | 2018-02-13 | Csl Limited | Process for preparing apolipoprotein A-I (Apo A-I) |
| WO2015017888A1 (en) | 2013-08-08 | 2015-02-12 | Csl Limited | Contaminant removal method |
| EP2853259A1 (en) | 2013-09-30 | 2015-04-01 | Université Pierre et Marie Curie (Paris 6) | Reconstituted high density lipoproteins composition and uses thereof |
| KR101563403B1 (ko) * | 2013-11-05 | 2015-10-26 | 영남대학교 산학협력단 | 지방물질의 안전성 평가방법 |
| AU2015260929A1 (en) | 2014-05-02 | 2016-12-15 | Cerenis Therapeutics Holding Sa | HDL therapy markers |
| JP6818264B2 (ja) * | 2014-12-25 | 2021-01-20 | 国立大学法人京都大学 | 高密度リポタンパク質およびその細胞親和性ペプチドを融合した高密度リポタンパク質の点眼による後眼部薬物デリバリー |
| EP3490579B1 (en) | 2016-07-27 | 2025-09-10 | Hartis-Pharma SA | Therapeutic combinations to treat red blood cell disorders |
| CN109922810A (zh) * | 2016-11-10 | 2019-06-21 | 杰特有限公司 | 心肌梗塞的重构的高密度脂蛋白治疗 |
| SG11202003835PA (en) * | 2017-11-07 | 2020-05-28 | Alphacore Pharma Llc | Methods of treating and protecting against cardiac disease, cardiovascular disease and related conditions and symptoms |
| EP3731814A4 (en) * | 2017-12-28 | 2021-09-29 | HDL Therapeutics, Inc. | PROCESSES FOR THE STORAGE AND ADMINISTRATION OF HIGH DENSITY PRE-BETA LIPOPROTEINS EXTRACTED FROM HUMAN PLASMA |
| CN112546201A (zh) * | 2019-09-26 | 2021-03-26 | 中国科学院生物物理研究所 | 人工脂蛋白颗粒apoA-Ⅳ脂肪体在治疗和/或预防糖尿病中的应用 |
| KR102531293B1 (ko) * | 2021-12-06 | 2023-05-16 | (주) 멥스젠 | 신규한 재구축 고밀도 지단백 나노입자 |
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| CA1335077C (en) | 1988-02-08 | 1995-04-04 | Henri Isliker | Process for the manufacture of apolipoproteins from human blood plasma or serum |
| US5652339A (en) | 1993-12-31 | 1997-07-29 | Rotkreuzstiftung Zentrallaboratorium | Method of producing reconstituted lipoproteins |
| CN1283313C (zh) | 2001-09-28 | 2006-11-08 | 埃斯佩里安医疗公司 | α螺旋状载脂蛋白或HDL关联蛋白在制备局部给药预防和治疗再狭窄的药物中的用途 |
| CA2486127C (en) | 2002-05-17 | 2014-03-11 | Esperion Therapeutics, Inc. | Method of treating dyslipidemic disorders |
| EP1556413A4 (en) | 2002-05-17 | 2009-07-08 | Esperion Therapeutics Inc | METHODS AND COMPOSITIONS FOR TREATING ISCHEMIC REPERFUSION |
| PE20050438A1 (es) | 2003-10-20 | 2005-06-14 | Esperion Therapeutics Inc | Formulas farmaceuticas, metodos y regimenes de dosificacion para el tratamiento y la prevencion de sindromes coronarios agudos |
| US20070254832A1 (en) | 2006-02-17 | 2007-11-01 | Pressler Milton L | Methods for the treatment of macular degeneration and related eye conditions |
| CN100586958C (zh) * | 2006-12-20 | 2010-02-03 | 上海莱士血液制品股份有限公司 | 高纯度载脂蛋白a-i的制备方法 |
| KR100992488B1 (ko) | 2006-12-29 | 2010-11-05 | 주식회사 녹십자 | ＡｐｏＡ-Ｉ의 정제방법 및 정제된ＡｐｏＡ-Ｉ을 이용한재구축 ＨＤＬ의 생산 방법 |
| JP5600061B2 (ja) | 2007-08-17 | 2014-10-01 | ツェーエスエル ベーリンク ゲゼルシャフト ミット ベシュレンクテル ハフツング | α−１−抗トリプシンおよびアポリポタンパク質Ａ−Ｉを精製する方法 |
| US8734853B2 (en) * | 2008-11-17 | 2014-05-27 | University Of North Texas Health Science Center At Fort Worth | HDL particles for delivery of nucleic acids |
| TR201903209T4 (tr) * | 2010-06-30 | 2019-03-21 | Csl Ltd | Yeniden yapılandırılan yüksek yoğunluğa sahip bir lipoprotein formülasyonu ve bunun üretim yöntemi. |
| ES2717455T3 (es) | 2011-02-07 | 2019-06-21 | Cerenis Therapeutics Holding Sa | Complejos de lipoproteínas y fabricación y usos de los mismos |
| US9125943B2 (en) | 2012-11-02 | 2015-09-08 | Csl Limited | Reconstituted HDL formulation |
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