JP2005527470A - 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 - Google Patents
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 Download PDFInfo
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- JP2005527470A JP2005527470A JP2003524606A JP2003524606A JP2005527470A JP 2005527470 A JP2005527470 A JP 2005527470A JP 2003524606 A JP2003524606 A JP 2003524606A JP 2003524606 A JP2003524606 A JP 2003524606A JP 2005527470 A JP2005527470 A JP 2005527470A
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- methionine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/18—Growth factors; Growth regulators
- A61K38/1816—Erythropoietin [EPO]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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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
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/06—Antianaemics
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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Abstract
Description
遺伝子及び細胞工学技術の最近の進歩により、in vivoで種々の薬理学的作用を示すことが知られるタンパク質を、医薬用途のために大量に製造することが可能である。そのようなタンパク質には、エリスロポエチン(EPO)、顆粒球コロニー刺激因子(G-CSF)、インターフェロン(アルファ、ベータ、ガンマ、コンセンサス)、腫瘍壊死因子結合タンパク質(TNFbp)、インターロイキン-1受容体アンタゴニスト(IL-1ra)、脳由来神経栄養因子(BDNF)、角質細胞成長因子(KGF)、幹細胞因子(SCF)、巨核球成長分化因子(MGDF)、オステオプロテゲリン(OPG)、グリア細胞系由来神経栄養因子(GDNF)、肥満タンパク質(OBプロテイン)、及び新規の赤血球産生刺激タンパク質(NESP)が含まれる。
本発明は、EPO及び/又はNESPの医薬組成物を提供する。この組成物では、メチオニンや他の安定化剤を組成物に取り込むと、光、熱、添加剤中の不純物、前もって充填された注射器中の浸出液、製造工程、保存、輸送及び処理によって誘導される重大な分解が起こりうる極度の条件でさえ、より安定な組成物を与える。
本明細書中、「賦形剤」は、所望の効果例えば安定性、等張性を付与するために医薬組成物に添加される非有効成分として定義される。
本発明で使用されるEPOは、参考として本明細書に取り入れる上記米国特許4,703,008(Lin)に従って製造できる。
Claims (27)
- 生物学的に活性な薬剤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。
- 前記活性薬剤が、ペプチド、小分子、炭水化物、核酸、脂質、タンパク質、及びそれらの類似体からなる群から選択される、請求項2に記載の組成物。
- 前記活性成分がタンパク質である、請求項3に記載の組成物。
- 前記タンパク質がエリスロポエチン(EPO)である、請求項4に記載の組成物。
- 前記EPOが、配列番号1に示されるアミノ酸配列を有する、請求項5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7に記載の組成物。
- 前記タンパク質が、新規の赤血球産生刺激タンパク質(NESP)又はその化学的改変体である、請求項4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9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10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11に記載の組成物。
- 生物学的に活性な薬剤、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13に記載の組成物。
- 前記活性薬剤が、ペプチド、小分子、炭水化物、核酸、脂質、タンパク質、及びそれらの類似体からなる群から選択される、請求項14に記載の組成物。
- 前記活性成分がタンパク質である、請求項15に記載の組成物。
- 前記タンパク質がエリスロポエチン(EPO)である、請求項16に記載の組成物。
- 前記EPOが、配列番号1に示されるアミノ酸配列を有する、請求項17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18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19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20に記載の組成物。
- 前記タンパク質が、新規の赤血球産生刺激タンパク質(NESP)又はその化学的改変体である、請求項16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22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23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24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25に記載の組成物。
- 生物学的に活性な薬剤の医薬組成物を安定化する方法であって、該生物学的に活性な薬剤のアミノ酸配列中のメチオニン残基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 true JP2005527470A (ja) | 2005-09-15 |
JP2005527470A5 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) |
Cited By (8)
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JP2009530380A (ja) * | 2006-03-20 | 2009-08-27 | ワイス | タンパク質凝集を減少させるための方法 |
JP2013519649A (ja) * | 2010-02-12 | 2013-05-30 | セントロ デ インヘニエリア ヘネティカ イ ビオテクノロヒア (セーイーヘベー) | 上皮増殖因子の経口投与可能薬学的ペレット |
JP2017088611A (ja) * | 2005-10-06 | 2017-05-25 | アラーガン、インコーポレイテッドAllergan,Incorporated | 非タンパク質安定化クロストリジウム毒素医薬組成物 |
JP6172880B1 (ja) * | 2017-02-01 | 2017-08-02 | 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 |
WO2019049967A1 (ja) | 2017-09-07 | 2019-03-14 | Jcrファーマ株式会社 | 水性医薬組成物 |
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US11033625B2 (en) | 2005-10-06 | 2021-06-15 | Allergan, Inc. | Method for stabilizing a toxin |
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BR112012017979B1 (pt) | 2010-01-19 | 2021-10-13 | Hanmi Science Co., Ltd. | Formulações líquidas para conjugado de g-csf de ação prolongada |
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-
2001
- 2001-08-30 US US09/945,517 patent/US20030104996A1/en not_active Abandoned
-
2002
- 2002-08-29 WO PCT/US2002/027855 patent/WO2003020299A1/en active Application Filing
- 2002-08-29 PL PL02374122A patent/PL374122A1/xx not_active Application Discontinuation
- 2002-08-29 EP EP02766203.0A patent/EP1439848B1/en not_active Expired - Lifetime
- 2002-08-29 JP JP2003524606A patent/JP4493334B2/ja not_active Expired - Lifetime
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2005
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US5272135A (en) * | 1991-03-01 | 1993-12-21 | Chiron Ophthalmics, Inc. | Method for the stabilization of methionine-containing polypeptides |
WO2000051629A1 (fr) * | 1999-03-01 | 2000-09-08 | Chugai Seiyaku Kabushiki Kaisha | Preparations stabilisees a longue conservation |
WO2001030320A1 (en) * | 1999-10-22 | 2001-05-03 | Amgen Inc. | Biodegradable microparticles with novel erythropoietin stimulating protein |
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US11147878B2 (en) | 2005-10-06 | 2021-10-19 | Allergan, Inc. | Animal protein-free pharmaceutical compositions |
US11285216B2 (en) | 2005-10-06 | 2022-03-29 | Allergan, Inc. | Animal protein-free pharmaceutical compositions |
JP2017088611A (ja) * | 2005-10-06 | 2017-05-25 | アラーガン、インコーポレイテッドAllergan,Incorporated | 非タンパク質安定化クロストリジウム毒素医薬組成物 |
US11524075B2 (en) | 2005-10-06 | 2022-12-13 | Allergan, Inc. | Animal protein-free pharmaceutical compositions |
US11033625B2 (en) | 2005-10-06 | 2021-06-15 | Allergan, Inc. | Method for stabilizing a toxin |
US11446382B2 (en) | 2005-10-06 | 2022-09-20 | Allergan, Inc. | Animal protein-free pharmaceutical compositions |
JP2009530380A (ja) * | 2006-03-20 | 2009-08-27 | ワイス | タンパク質凝集を減少させるための方法 |
US9205130B2 (en) | 2010-02-12 | 2015-12-08 | Centro De Ingenieria Genetica Y Biotecnologia | Orally administrable pharmaceutical pellet of epidermal growth factor |
JP2013519649A (ja) * | 2010-02-12 | 2013-05-30 | セントロ デ インヘニエリア ヘネティカ イ ビオテクノロヒア (セーイーヘベー) | 上皮増殖因子の経口投与可能薬学的ペレット |
US10973890B2 (en) | 2016-09-13 | 2021-04-13 | Allergan, Inc. | Non-protein clostridial toxin compositions |
JP6172880B1 (ja) * | 2017-02-01 | 2017-08-02 | 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 |
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 |
WO2019049967A1 (ja) | 2017-09-07 | 2019-03-14 | Jcrファーマ株式会社 | 水性医薬組成物 |
US11932699B2 (en) | 2017-09-07 | 2024-03-19 | Jcr Pharmaceuticals Co., Ltd. | Aqueous pharmaceutical composition |
JP2021533162A (ja) * | 2018-08-07 | 2021-12-02 | グラクソスミスクライン バイオロジカルズ ソシエテ アノニム | プロセス及びワクチン |
Also Published As
Publication number | Publication date |
---|---|
CN1592629A (zh) | 2005-03-09 |
MXPA04001774A (es) | 2004-11-22 |
HK1075198A1 (en) | 2005-12-09 |
EP1439848B1 (en) | 2014-11-26 |
CA2458386C (en) | 2012-05-08 |
PL374122A1 (en) | 2005-10-03 |
EP1439848A4 (en) | 2009-06-24 |
JP2010138195A (ja) | 2010-06-24 |
TWI327068B (en) | 2010-07-11 |
US20030104996A1 (en) | 2003-06-05 |
CA2458386A1 (en) | 2003-03-13 |
EP1439848A1 (en) | 2004-07-28 |
JP4493334B2 (ja) | 2010-06-30 |
CN100384468C (zh) | 2008-04-30 |
WO2003020299A1 (en) | 2003-03-13 |
KR100596610B1 (ko) | 2006-07-06 |
KR20040044194A (ko) | 2004-05-27 |
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