JP2001503781A - モノクローナル抗体又はポリクローナル抗体の安定な凍結乾燥された医薬製剤 - Google Patents
モノクローナル抗体又はポリクローナル抗体の安定な凍結乾燥された医薬製剤Info
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- JP2001503781A JP2001503781A JP52321098A JP52321098A JP2001503781A JP 2001503781 A JP2001503781 A JP 2001503781A JP 52321098 A JP52321098 A JP 52321098A JP 52321098 A JP52321098 A JP 52321098A JP 2001503781 A JP2001503781 A JP 2001503781A
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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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
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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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
- C07K16/081—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from DNA viruses
- C07K16/082—Hepadnaviridae, e.g. hepatitis B virus
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.糖又はアミノ糖、アミノ酸、及び界面活性剤を含有する、モノクローナル 抗体又はポリクローナル抗体の安定な凍結乾燥された医薬製剤。 2.前記製剤が、ポリエチレングリコール及び/又は蛋白質−様標準的医薬補 助剤を実質上含有しない、請求項1に記載の製剤。 3.a)モノクローナル抗体又はポリクローナル抗体、 b)糖又はアミノ糖、 c)アミノ酸、 d)緩衝物質として作用する無機酸、及び e)界面活性剤、 から実質的に形成される請求項1又は2に記載の製剤。 4.前記糖がモノサッカライド、ジサッカライド又はトリサッカライドであり 、好ましくはシュークロース、マルトース、トレハロース又はラフィノースであ る、請求項1〜3のいずれか1項に記載の製剤。 5.前記アミノ糖がグルコサミン、N−メチル−グルコサミン、ガラクトサミ ン又はニューラミン酸である、請求項1〜4のいずれか1項に記載の製剤。 6.前記アミノ酸が、塩基性アミノ酸、酸性アミノ酸又は中性アミノ酸であり 、好ましくはアルギニン、リジン、ヒスチジン、オルニチン、イソロイシン、ロ イシン、アラニン、グルタミン酸又はアスパラギン酸である、請求項1〜5のい ずれか1項に記載の製剤。 7.前記界面活性剤がポリソルベート、又はポリオキシエチレン−ポリオキシ プロピレンポリマーである、請求項1〜6のいずれか1項に記載の製剤。 8.酸、塩基、緩衝剤、及び/又は等張化剤から成る群から選択された医薬と して許容される補助物質を含有する、請求項1〜7のいずれか1項に記載の製剤 。 9.請求項1〜8のいずれか1項に記載の凍結乾燥物を再溶解することにより 得られる、モノクローナル抗体又はポリクローナル抗体の水性医薬製剤。 10.溶液が5〜8、好ましくは6〜7.4のpH値を有する、請求項9に記載の水 性医薬製剤。 11.請求項1〜8のいずれか1項に記載の凍結乾燥された医薬製剤の製造方法 において、活性成分としてのモノクローナル抗体又はポリクローナル抗体、並び に添加剤としての糖又はアミノ糖、アミノ酸及び界面活性剤、並びに所望により さらに医薬補助物質を含有する水性溶液を製造し、そして次にこの溶液を凍結乾 燥する、ことを特徴とする方法。 12.a)糖又はアミノ糖、b)アミノ酸及びc)界面活性剤の、抗体を含有す る安定な療法剤又は診断剤の製造のための使用。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP96118489A EP0852951A1 (de) | 1996-11-19 | 1996-11-19 | Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern |
EP96118489.2 | 1996-11-19 | ||
PCT/EP1997/006452 WO1998022136A2 (de) | 1996-11-19 | 1997-11-19 | Stabile lyophilisierte pharmazeutische zubereitungen von mono- oder polyklonalen antikörpern |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2008233138A Division JP5153532B2 (ja) | 1996-11-19 | 2008-09-11 | モノクローナル抗体又はポリクローナル抗体の安定な凍結乾燥された医薬製剤 |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2001503781A true JP2001503781A (ja) | 2001-03-21 |
JP4536829B2 JP4536829B2 (ja) | 2010-09-01 |
Family
ID=8223412
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP52321098A Expired - Lifetime JP4536829B2 (ja) | 1996-11-19 | 1997-11-19 | モノクローナル抗体又はポリクローナル抗体の安定な凍結乾燥された医薬製剤 |
JP2008233138A Expired - Lifetime JP5153532B2 (ja) | 1996-11-19 | 2008-09-11 | モノクローナル抗体又はポリクローナル抗体の安定な凍結乾燥された医薬製剤 |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2008233138A Expired - Lifetime JP5153532B2 (ja) | 1996-11-19 | 2008-09-11 | モノクローナル抗体又はポリクローナル抗体の安定な凍結乾燥された医薬製剤 |
Country Status (19)
Country | Link |
---|---|
US (2) | US8758747B2 (ja) |
EP (2) | EP0852951A1 (ja) |
JP (2) | JP4536829B2 (ja) |
KR (1) | KR100514207B1 (ja) |
CN (1) | CN1155408C (ja) |
AR (2) | AR012540A1 (ja) |
AT (1) | ATE276762T1 (ja) |
AU (2) | AU735411C (ja) |
BR (1) | BR9713521A (ja) |
CA (1) | CA2272245C (ja) |
DE (1) | DE59711959D1 (ja) |
DK (1) | DK0941121T3 (ja) |
ES (1) | ES2227727T3 (ja) |
ID (1) | ID19029A (ja) |
PT (1) | PT941121E (ja) |
TR (1) | TR199901696T2 (ja) |
TW (1) | TW520291B (ja) |
WO (1) | WO1998022136A2 (ja) |
ZA (1) | ZA9710409B (ja) |
Cited By (31)
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WO2003068259A1 (en) | 2002-02-14 | 2003-08-21 | Chugai Seiyaku Kabushiki Kaisha | Antibody-containing solution pharmaceuticals |
WO2004075913A1 (ja) * | 2003-02-28 | 2004-09-10 | Chugai Seiyaku Kabushiki Kaisha | タンパク質含有安定化製剤 |
JPWO2003007967A1 (ja) * | 2001-07-17 | 2004-11-04 | 塩野義製薬株式会社 | 注射用医薬製剤 |
JP2005513110A (ja) * | 2001-12-21 | 2005-05-12 | メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフトング | Egf受容体に対する抗体を含む凍結乾燥製剤 |
JP2005516998A (ja) * | 2002-02-06 | 2005-06-09 | メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフトング | 免疫サイトカイン含有凍結乾燥製剤 |
WO2006001240A1 (ja) * | 2004-06-29 | 2006-01-05 | Juridical Foundation The Chemo-Sero-Therapeutic Research Institute | 安定化改変ダニ主要アレルゲン含有医薬組成物 |
JPWO2004028557A1 (ja) * | 2002-09-26 | 2006-01-19 | 塩野義製薬株式会社 | 安定化されたタンパク組成物 |
JP2006511457A (ja) * | 2002-08-16 | 2006-04-06 | アボツト・バイオテクノロジー・リミテツド | Tnf−アルファ関連疾患の治療用ヒト抗体の製剤 |
JP2006517233A (ja) * | 2003-02-10 | 2006-07-20 | エラン ファーマシューティカルズ,インコーポレイテッド | 免疫グロブリン製剤およびその調製の方法 |
JP2007511539A (ja) * | 2003-11-14 | 2007-05-10 | バクスター・インターナショナル・インコーポレイテッド | α1−抗トリプシン組成物およびこのような組成物を用いた処置方法 |
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JP2007512266A (ja) * | 2003-11-26 | 2007-05-17 | メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフトング | Egf受容体に対する抗体を含む医薬製剤 |
WO2008029908A1 (fr) * | 2006-09-07 | 2008-03-13 | Kyowa Hakko Kirin Co., Ltd. | Préparation pharmaceutique lyophilisée stable comprenant un anticorps |
JP2008536917A (ja) * | 2005-04-18 | 2008-09-11 | イエダ リサーチ アンド ディベロップメント カンパニー リミテッド | 安定化抗b型肝炎ウイルス(hbv)抗体製剤 |
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AR012540A1 (es) | 2000-11-08 |
KR20000053328A (ko) | 2000-08-25 |
US20140248274A1 (en) | 2014-09-04 |
AU7824201A (en) | 2001-11-22 |
US8758747B2 (en) | 2014-06-24 |
JP2009046494A (ja) | 2009-03-05 |
BR9713521A (ja) | 2000-03-21 |
EP0852951A1 (de) | 1998-07-15 |
CN1244805A (zh) | 2000-02-16 |
TR199901696T2 (xx) | 1999-09-21 |
DK0941121T3 (da) | 2005-01-31 |
AU735411C (en) | 2004-08-05 |
KR100514207B1 (ko) | 2005-09-13 |
CA2272245A1 (en) | 1998-05-28 |
DE59711959D1 (de) | 2004-10-28 |
JP5153532B2 (ja) | 2013-02-27 |
JP4536829B2 (ja) | 2010-09-01 |
AU735411B2 (en) | 2001-07-05 |
EP0941121A2 (de) | 1999-09-15 |
AR074958A2 (es) | 2011-02-23 |
PT941121E (pt) | 2005-01-31 |
ATE276762T1 (de) | 2004-10-15 |
CN1155408C (zh) | 2004-06-30 |
ES2227727T3 (es) | 2005-04-01 |
AU772940B2 (en) | 2004-05-13 |
WO1998022136A3 (de) | 1998-08-20 |
EP0941121B1 (de) | 2004-09-22 |
ZA9710409B (en) | 1999-05-19 |
US20080286280A1 (en) | 2008-11-20 |
AU5484198A (en) | 1998-06-10 |
CA2272245C (en) | 2013-09-10 |
TW520291B (en) | 2003-02-11 |
WO1998022136A2 (de) | 1998-05-28 |
ID19029A (id) | 1998-06-04 |
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