JP2005527470A5 - - Google Patents
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- Publication number
- JP2005527470A5 JP2005527470A5 JP2003524606A JP2003524606A JP2005527470A5 JP 2005527470 A5 JP2005527470 A5 JP 2005527470A5 JP 2003524606 A JP2003524606 A JP 2003524606A JP 2003524606 A JP2003524606 A JP 2003524606A JP 2005527470 A5 JP2005527470 A5 JP 2005527470A5
- Authority
- JP
- Japan
- Prior art keywords
- composition
- nesp
- methionine
- concentration
- present
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 10
- 239000000203 mixture Substances 0.000 claims 10
- 108010019673 Darbepoetin alfa Proteins 0.000 claims 9
- 102000008100 Human Serum Albumin Human genes 0.000 claims 3
- 108091006822 Human Serum Albumin Proteins 0.000 claims 3
- WVDDGKGOMKODPV-UHFFFAOYSA-N benzyl alcohol Chemical group OCC1=CC=CC=C1 WVDDGKGOMKODPV-UHFFFAOYSA-N 0.000 claims 3
- 239000008194 pharmaceutical composition Substances 0.000 claims 3
- 230000000087 stabilizing Effects 0.000 claims 3
- JNYAEWCLZODPBN-CTQIIAAMSA-N Sorbitan Chemical compound OCC(O)C1OCC(O)[C@@H]1O JNYAEWCLZODPBN-CTQIIAAMSA-N 0.000 claims 2
- 150000001413 amino acids Chemical group 0.000 claims 2
- 230000001747 exhibiting Effects 0.000 claims 2
- 239000006174 pH buffer Substances 0.000 claims 2
- -1 poly (oxy-1,2-ethanediyl) Polymers 0.000 claims 2
- 230000002335 preservative Effects 0.000 claims 2
- 239000003755 preservative agent Substances 0.000 claims 2
- 235000019445 benzyl alcohol Nutrition 0.000 claims 1
- 230000003647 oxidation Effects 0.000 claims 1
- 238000007254 oxidation reaction Methods 0.000 claims 1
Claims (12)
- 新規の赤血球産生刺激タンパク質（NESP）とメチオニンとを含み、改善された安定性を示し、及びヒト血清アルブミンを含まない、医薬組成物。
- 前記メチオニンが約0.5mM〜50mMの濃度で存在する、請求項1に記載の組成物。
- 前記NESPが、配列番号2に示されるアミノ酸配列を有する、請求項1又は2に記載の組成物。
- 約5〜約7のpH範囲を提供するpH緩衝剤をさらに含む、請求項1〜3のいずれか1項に記載の組成物。
- 約0.001％〜0.1％（w/v）の濃度で存在する、安定化する量のソルビタンモノ-9-オクタデセノエートポリ（オキシ-1,2-エタンジイル）誘導体をさらに含む、請求項1〜4のいずれか1項に記載の組成物。
- 新規の赤血球産生刺激タンパク質（NESP）、保存剤及びメチオニンを含み、改善された安定性を示し、及びヒト血清アルブミンを含まない、頻回投与医薬組成物。
- 前記メチオニンが約0.5mM〜50mMの濃度で存在する、請求項6に記載の組成物。
- 前記NESPが配列番号2に示されるアミノ酸配列を有する、請求項6又は7に記載の組成物。
- 前記保存剤が、約0％から2％（w/v）の濃度で存在するベンジルアルコールである、請求項6に記載の組成物。
- 約5〜約7のpH範囲を提供するpH緩衝剤をさらに含む、請求項6〜9のいずれか1項に記載の組成物。
- 約0.001％〜0.1％（w/v）の濃度で存在する、安定化する量のソルビタンモノ-9-オクタデセノエートポリ（オキシ-1,2-エタンジイル）誘導体をさらに含む、請求項6〜10のいずれか1項に記載の組成物。
- 新規の赤血球産生刺激タンパク質（NESP）を含む医薬組成物を安定化する方法であって、前記NESPの酸化を抑制するのに十分な量のメチオニンを該組成物に加えることを含み、該組成物がヒト血清アルブミンを含まない、上記方法。
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US09/945,517 US20030104996A1 (en) | 2001-08-30 | 2001-08-30 | L-methionine as a stabilizer for NESP/EPO in HSA-free formulations |
| PCT/US2002/027855 WO2003020299A1 (en) | 2001-08-30 | 2002-08-29 | L-methionine as a stabilizer for nesp/epo in hsa-free formulations |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2010052203A Division JP2010138195A (ja) | 2001-08-30 | 2010-03-09 | Ｈｓａ非含有組成物中のｎｅｓｐ／ｅｐｏの安定化剤としてのｌ−メチオニン |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2005527470A JP2005527470A (ja) | 2005-09-15 |
| JP2005527470A5 true JP2005527470A5 (ja) | 2006-10-05 |
| JP4493334B2 JP4493334B2 (ja) | 2010-06-30 |
Family
ID=25483206
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2003524606A Expired - Lifetime JP4493334B2 (ja) | 2001-08-30 | 2002-08-29 | Ｈｓａ非含有組成物中のｎｅｓｐ／ｅｐｏの安定化剤としてのｌ−メチオニン |
| JP2010052203A Pending JP2010138195A (ja) | 2001-08-30 | 2010-03-09 | Ｈｓａ非含有組成物中のｎｅｓｐ／ｅｐｏの安定化剤としてのｌ−メチオニン |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2010052203A Pending JP2010138195A (ja) | 2001-08-30 | 2010-03-09 | Ｈｓａ非含有組成物中のｎｅｓｐ／ｅｐｏの安定化剤としてのｌ−メチオニン |
Country Status (11)
| Country | Link |
|---|---|
| US (1) | US20030104996A1 (ja) |
| EP (1) | EP1439848B1 (ja) |
| JP (2) | JP4493334B2 (ja) |
| KR (1) | KR100596610B1 (ja) |
| CN (1) | CN100384468C (ja) |
| CA (1) | CA2458386C (ja) |
| HK (1) | HK1075198A1 (ja) |
| MX (1) | MXPA04001774A (ja) |
| PL (1) | PL374122A1 (ja) |
| TW (1) | TWI327068B (ja) |
| WO (1) | WO2003020299A1 (ja) |
Families Citing this family (40)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ATE291436T2 (de) * | 2000-05-15 | 2005-04-15 | Hoffmann La Roche | Flüssige arzneizubereitung enthaltend ein erythropoietin derivat |
| US20030104996A1 (en) * | 2001-08-30 | 2003-06-05 | Tiansheng Li | L-methionine as a stabilizer for NESP/EPO in HSA-free formulations |
| US7141544B2 (en) | 2003-10-10 | 2006-11-28 | Baxter International, Inc. | Stabilization of pharmaceutical protein formulations with small peptides |
| CA2915270C (en) | 2005-08-05 | 2017-07-11 | Amgen Inc. | Stable aqueous protein or antibody pharmaceutical formulations and their preparation |
| US8168206B1 (en) | 2005-10-06 | 2012-05-01 | Allergan, Inc. | Animal protein-free pharmaceutical compositions |
| US8137677B2 (en) * | 2005-10-06 | 2012-03-20 | Allergan, Inc. | Non-protein stabilized clostridial toxin pharmaceutical compositions |
| TW200806317A (en) * | 2006-03-20 | 2008-02-01 | Wyeth Corp | Methods for reducing protein aggregation |
| CA2692165A1 (en) * | 2007-06-25 | 2008-12-31 | Amgen Inc. | Compositions of specific binding agents to hepatocyte growth factor |
| WO2009009406A1 (en) * | 2007-07-06 | 2009-01-15 | Smithkline Beecham Corporation | Antibody formulations |
| EP3381445B1 (en) | 2007-11-15 | 2023-10-25 | Amgen Inc. | Aqueous formulation of antibody stablised by antioxidants for parenteral administration |
| US20110060290A1 (en) * | 2008-02-07 | 2011-03-10 | Amgen Inc. | Stabilized protein compositions |
| LT2328601T (lt) | 2008-08-15 | 2020-04-27 | Ironwood Pharmaceuticals, Inc. | Linaklotidą turinčios vaisto formos, skirtos vartoti per burną |
| CN102209554A (zh) * | 2008-09-10 | 2011-10-05 | 弗·哈夫曼-拉罗切有限公司 | 用于防止蛋白质氧化降解的组合物和方法 |
| JP2012533548A (ja) * | 2009-07-14 | 2012-12-27 | バイオジェン・アイデック・エムエイ・インコーポレイテッド | 組成物における黄色形成および過酸化物形成を阻害する方法 |
| US8748573B2 (en) * | 2009-08-06 | 2014-06-10 | Ironwood Pharmaceuticals, Inc. | Formulations comprising linaclotide |
| FR2954325B1 (fr) | 2009-12-23 | 2012-02-03 | Flamel Tech Sa | Polymere amphiphile fonctionnalise par la methionine |
| US20110150837A1 (en) * | 2009-12-23 | 2011-06-23 | Flamel Technologies | Amphiphilic polymer functionalized by methionine |
| SG182304A1 (en) * | 2009-12-29 | 2012-08-30 | Hoffmann La Roche | Antibody formulation |
| RU2519031C1 (ru) | 2010-01-19 | 2014-06-10 | Ханми Сайенс Ко., Лтд. | Жидкие препаративные формы для длительно действующего конъюгата g-csf |
| EP2364690A1 (en) | 2010-02-12 | 2011-09-14 | Centro De Ingenieria Genetica Y Biotecnologia | Orally administrable pharmaceutical pellet of epidermal growth factor |
| US8933030B2 (en) | 2010-02-17 | 2015-01-13 | Ironwwod Pharmaceuticals, Inc. | Treatments for gastrointestinal disorders |
| DK2603232T3 (da) | 2010-08-11 | 2019-12-09 | Ironwood Pharmaceuticals Inc | Stabile formuleringer af linaclotid |
| KR101303388B1 (ko) * | 2010-10-26 | 2013-09-03 | 한미사이언스 주식회사 | 지속형 인터페론 알파 결합체의 액상 제제 |
| MX347354B (es) | 2011-08-17 | 2017-04-24 | Ironwood Pharmaceuticals Inc | Tratamientos para trastornos gastrointestinales. |
| US9364542B2 (en) | 2011-10-28 | 2016-06-14 | Excelse Bio, Inc. | Protein formulations containing amino acids |
| AR092862A1 (es) * | 2012-07-25 | 2015-05-06 | Hanmi Pharm Ind Co Ltd | Formulacion liquida de insulina de accion prolongada y un peptido insulinotropico y metodo de preparacion |
| JP6294868B2 (ja) | 2013-03-12 | 2018-03-14 | 大日本住友製薬株式会社 | 液体水性組成物 |
| BR112015022587A2 (pt) * | 2013-03-13 | 2017-10-24 | Eleven Biotherapeutics Inc | formulações de citocina quimérica para entrega ocular |
| CA2902289A1 (en) | 2013-03-15 | 2014-09-18 | Glaxosmithkline Intellectual Property (No.2) Limited | Low concentration antibody formulations |
| SG11201605640UA (en) * | 2014-01-13 | 2016-08-30 | Amgen Inc | Regulating ornithine metabolism to manipulate the high mannose glycoform content of recombinant proteins |
| AR103173A1 (es) * | 2014-12-22 | 2017-04-19 | Novarits Ag | Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17 |
| RU2599031C1 (ru) * | 2015-08-11 | 2016-10-10 | Общество с ограниченной ответственностью "АйВиФарма" | Водная композиция рекомбинантного фолликулостимулирующего гормона человека (варианты) |
| CA3035473A1 (en) | 2016-09-13 | 2018-03-22 | Allergan, Inc. | Non-protein clostridial toxin compositions |
| US11338018B2 (en) | 2016-12-19 | 2022-05-24 | Harrow Ip, Llc | Adrenocorticotropic hormone-based pharmaceutical formulations and methods for fabricating and using thereof |
| WO2018142514A1 (ja) * | 2017-02-01 | 2018-08-09 | 協和発酵キリン株式会社 | ダルベポエチンを含む液体医薬組成物 |
| US11110063B2 (en) | 2017-08-25 | 2021-09-07 | MAIA Pharmaceuticals, Inc. | Storage stable sincalide formulations |
| CN111278453A (zh) | 2017-09-07 | 2020-06-12 | Jcr制药股份有限公司 | 水性药物组合物 |
| CN112601545A (zh) * | 2018-08-07 | 2021-04-02 | 葛兰素史密丝克莱恩生物有限公司 | 工艺和疫苗 |
| WO2023098844A1 (zh) * | 2021-12-03 | 2023-06-08 | 杰科（天津）生物医药有限公司 | 一种制剂及其制备方法和应用 |
| US11648247B1 (en) | 2021-12-16 | 2023-05-16 | Lenz Therapeutics, Inc. | Compositions and methods for the treatment of presbyopia |
Family Cites Families (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6936694B1 (en) * | 1982-05-06 | 2005-08-30 | Intermune, Inc. | Manufacture and expression of large structural genes |
| US4703008A (en) * | 1983-12-13 | 1987-10-27 | Kiren-Amgen, Inc. | DNA sequences encoding erythropoietin |
| KR850004274A (ko) * | 1983-12-13 | 1985-07-11 | 원본미기재 | 에리트로포이에틴의 제조방법 |
| NZ210501A (en) * | 1983-12-13 | 1991-08-27 | Kirin Amgen Inc | Erythropoietin produced by procaryotic or eucaryotic expression of an exogenous dna sequence |
| US4667016A (en) * | 1985-06-20 | 1987-05-19 | Kirin-Amgen, Inc. | Erythropoietin purification |
| US4810643A (en) * | 1985-08-23 | 1989-03-07 | Kirin- Amgen Inc. | Production of pluripotent granulocyte colony-stimulating factor |
| JPS63500636A (ja) * | 1985-08-23 | 1988-03-10 | 麒麟麦酒株式会社 | 多分化能性顆粒球コロニー刺激因子をコードするｄｎａ |
| JPS6297229A (ja) * | 1985-10-21 | 1987-05-06 | Nec Kansai Ltd | 螢光膜の形成方法 |
| US4835260A (en) * | 1987-03-20 | 1989-05-30 | Genetics Institute, Inc. | Erythropoietin composition |
| US5075222A (en) * | 1988-05-27 | 1991-12-24 | Synergen, Inc. | Interleukin-1 inhibitors |
| US5372808A (en) * | 1990-10-17 | 1994-12-13 | Amgen Inc. | Methods and compositions for the treatment of diseases with consensus interferon while reducing side effect |
| US5272135A (en) * | 1991-03-01 | 1993-12-21 | Chiron Ophthalmics, Inc. | Method for the stabilization of methionine-containing polypeptides |
| US5581476A (en) * | 1993-01-28 | 1996-12-03 | Amgen Inc. | Computer-based methods and articles of manufacture for preparing G-CSF analogs |
| TW497972B (en) * | 1995-06-08 | 2002-08-11 | Kirin Brewery | Stable thrombopoietin (TPO)-containing lyophilized compositions |
| IL122732A0 (en) * | 1997-01-15 | 1998-08-16 | Akzo Nobel Nv | Liquid gonadotropin-containing formulation its preparation and a device containing same |
| JP2000247903A (ja) * | 1999-03-01 | 2000-09-12 | Chugai Pharmaceut Co Ltd | 長期安定化製剤 |
| AU1226901A (en) * | 1999-10-22 | 2001-05-08 | Amgen, Inc. | Biodegradable microparticles with novel erythropoietin stimulating protein |
| ATE291436T2 (de) * | 2000-05-15 | 2005-04-15 | Hoffmann La Roche | Flüssige arzneizubereitung enthaltend ein erythropoietin derivat |
| JP5490972B2 (ja) * | 2000-08-04 | 2014-05-14 | 中外製薬株式会社 | タンパク質注射製剤 |
| US20030104996A1 (en) * | 2001-08-30 | 2003-06-05 | Tiansheng Li | L-methionine as a stabilizer for NESP/EPO in HSA-free formulations |
-
2001
- 2001-08-30 US US09/945,517 patent/US20030104996A1/en not_active Abandoned
-
2002
- 2002-08-29 PL PL02374122A patent/PL374122A1/xx not_active Application Discontinuation
- 2002-08-29 WO PCT/US2002/027855 patent/WO2003020299A1/en active Application Filing
- 2002-08-29 MX MXPA04001774A patent/MXPA04001774A/es active IP Right Grant
- 2002-08-29 CA CA2458386A patent/CA2458386C/en not_active Expired - Lifetime
- 2002-08-29 CN CNB028217098A patent/CN100384468C/zh not_active Expired - Lifetime
- 2002-08-29 JP JP2003524606A patent/JP4493334B2/ja not_active Expired - Lifetime
- 2002-08-29 TW TW091119907A patent/TWI327068B/zh not_active IP Right Cessation
- 2002-08-29 KR KR1020047002971A patent/KR100596610B1/ko active IP Right Review Request
- 2002-08-29 EP EP02766203.0A patent/EP1439848B1/en not_active Expired - Lifetime
-
2005
- 2005-08-25 HK HK05107479A patent/HK1075198A1/xx not_active IP Right Cessation
-
2010
- 2010-03-09 JP JP2010052203A patent/JP2010138195A/ja active Pending
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