JPH11510170A - タンパク質の処方 - Google Patents
タンパク質の処方Info
- Publication number
- JPH11510170A JPH11510170A JP9507749A JP50774997A JPH11510170A JP H11510170 A JPH11510170 A JP H11510170A JP 9507749 A JP9507749 A JP 9507749A JP 50774997 A JP50774997 A JP 50774997A JP H11510170 A JPH11510170 A JP H11510170A
- Authority
- JP
- Japan
- Prior art keywords
- formulation
- protein
- antibody
- reconstituted
- lyophilized
- 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.)
- Withdrawn
Links
Classifications
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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
-
- 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
- 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
-
- 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
-
- 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
-
- 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
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/10—Drugs for disorders of the urinary system of the bladder
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- 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
-
- 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
- A61P37/08—Antiallergic agents
-
- 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
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.少なくとも約50mg/mLの量のタンパク質および希釈液を含む安定な等張性再 構成処方であり、その再構成処方はタンパク質およびリオプロテクタントの凍結 乾燥混合物から調製され、そこでは再構成処方内のタンパク質濃度が凍結乾燥前 の混合物中のタンパク質濃度の約2-40倍高い処方。 2.リオプロテクタントがスクロースまたはトレハロースである請求項1の処方 。 3.さらにバッファーを含む請求項1の処方。 4.バッファーがヒスチジンまたはコハク酸である請求項3の処方。 5.さらに界面活性剤を含む請求項1の処方。 6.少なくとも約50mg/mLの量の抗体および希釈液を含む安定な等張性再構成処 方であり、その再構成処方は抗体およびリオプロテクタントの凍結乾燥混合物か ら調製され、そこでは再構成処方内の抗体濃度が凍結乾燥前の混合物中の抗体濃 度の約2-40倍高い処方。 7.抗体が抗IgE抗体または抗HER2抗体である請求項6の処方。 8.等張性である請求項6の処方。 9.再構成処方におけるタンパク質の濃度が少なくとも50mg/mLであるように希 釈液中のタンパク質およびリオプロテクタントの凍結乾燥混合物を再構成するこ とを含む安定な等張性再構成処方の調製法で、そこでは再構成処方内のタンパク 質濃度が凍結乾燥前の混合物中のタンパク質濃度の約2-40倍高い処方。 10.(a) タンパク質およびリオプロテクタントの混合物の凍結乾燥: (b) 再構成処方が等張性で安定であり、少なくとも約50mg/mLのタンパク質 濃度であるような希釈液中で(a)工程の凍結乾燥混合物を再構成すること の各工程を含む処方の調製法。 11.再構成処方におけるタンパク質濃度が約80mg/mLから約300mg/mLである請求 項10の方法。 12.再構成処方におけるタンパク質濃度が凍結乾燥前の混合物中のタンパク質濃 度の約2-40倍高い請求項10の方法。 13.凍結乾燥が全体の凍結乾燥工程を通じて約15-30℃で維持された設定温度で 実施される請求項10の方法。 14.(a) タンパク質およびリオプロテクタントの凍結乾燥混合物が入っている容 器;および (b) 少なくとも約50mg/mLの再構成処方におけるタンパク質濃度にする希釈 液を用いて凍結乾燥混合物を再構成するための説明書 を含む製造品。 15.さらに希釈液が入っている第二の容器を含む請求項14の製造品。 16.希釈液が芳香族アルコールを含む注射のための静菌水(BWFI)である請求項15 の製造品。 17.リオプロテクタントおよび抗体の凍結乾燥混合物を含む処方で、そこではリ オプロテクタント:抗体のモル比が約100-1500モルリオプロテクタント:1モル抗 体である処方。 18.処方におけるタンパク質を用いた治療の必要がある疾患を持つ哺乳動物を治 療するための薬剤の調製における請求項1の処方の使用。 19.処方が皮下投与のためである請求項18記載の使用。 20.約5-40mg/mLの量の抗HER2抗体、約10-100mMの量のスクロースまたはトレハ ロース、バッファーおよび界面活性剤を含む処方。 21.さらに膨張試薬を含む請求項20の処方。 22.凍結乾燥され少なくとも6ヶ月30℃で安定な請求項20の処方。 23.再構成処方における抗HER2抗体濃度が約10-30mg/mLであるように希釈液を用 いて再構成され、そこでは再構成処方が少なくとも約30日間2-8℃で安定である 請求項20の処方。 24.約5-40mg/mLの量の抗IgE抗体、約80-300mMの量のスクロースまたはトレハロ ース、バッファーおよび界面活性剤を含む処方。 25.凍結乾燥され少なくとも1年約30℃で安定である請求項24の処方。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US50801495A | 1995-07-27 | 1995-07-27 | |
US08/508,014 | 1995-07-27 | ||
US08/615,369 | 1996-03-14 | ||
US08/615,369 US6267958B1 (en) | 1995-07-27 | 1996-03-14 | Protein formulation |
PCT/US1996/012251 WO1997004801A1 (en) | 1995-07-27 | 1996-07-23 | Stabile isotonic lyophilized protein formulation |
Related Child Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2007135910A Division JP5043506B2 (ja) | 1995-07-27 | 2007-05-22 | タンパク質の処方 |
JP2007135911A Division JP5043507B2 (ja) | 1995-07-27 | 2007-05-22 | タンパク質の処方 |
Publications (1)
Publication Number | Publication Date |
---|---|
JPH11510170A true JPH11510170A (ja) | 1999-09-07 |
Family
ID=27056058
Family Applications (7)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP9507749A Withdrawn JPH11510170A (ja) | 1995-07-27 | 1996-07-23 | タンパク質の処方 |
JP2007135911A Expired - Lifetime JP5043507B2 (ja) | 1995-07-27 | 2007-05-22 | タンパク質の処方 |
JP2007135910A Expired - Lifetime JP5043506B2 (ja) | 1995-07-27 | 2007-05-22 | タンパク質の処方 |
JP2011202957A Withdrawn JP2011256205A (ja) | 1995-07-27 | 2011-09-16 | タンパク質の処方 |
JP2011202958A Withdrawn JP2011256206A (ja) | 1995-07-27 | 2011-09-16 | タンパク質の処方 |
JP2015231653A Pending JP2016033156A (ja) | 1995-07-27 | 2015-11-27 | タンパク質の処方 |
JP2016232371A Pending JP2017039778A (ja) | 1995-07-27 | 2016-11-30 | タンパク質の処方 |
Family Applications After (6)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2007135911A Expired - Lifetime JP5043507B2 (ja) | 1995-07-27 | 2007-05-22 | タンパク質の処方 |
JP2007135910A Expired - Lifetime JP5043506B2 (ja) | 1995-07-27 | 2007-05-22 | タンパク質の処方 |
JP2011202957A Withdrawn JP2011256205A (ja) | 1995-07-27 | 2011-09-16 | タンパク質の処方 |
JP2011202958A Withdrawn JP2011256206A (ja) | 1995-07-27 | 2011-09-16 | タンパク質の処方 |
JP2015231653A Pending JP2016033156A (ja) | 1995-07-27 | 2015-11-27 | タンパク質の処方 |
JP2016232371A Pending JP2017039778A (ja) | 1995-07-27 | 2016-11-30 | タンパク質の処方 |
Country Status (18)
Country | Link |
---|---|
EP (3) | EP2275119B1 (ja) |
JP (7) | JPH11510170A (ja) |
CN (3) | CN100360184C (ja) |
AR (2) | AR003969A1 (ja) |
AU (1) | AU716785B2 (ja) |
BR (1) | BR9609743A (ja) |
CA (2) | CA2226575C (ja) |
DK (2) | DK1516628T3 (ja) |
ES (2) | ES2434840T3 (ja) |
HK (2) | HK1117075A1 (ja) |
IL (1) | IL122910A (ja) |
MX (1) | MX9800684A (ja) |
NO (2) | NO323557B1 (ja) |
NZ (2) | NZ313503A (ja) |
PT (2) | PT2275119E (ja) |
RU (2) | RU2497500C2 (ja) |
SI (2) | SI1516628T1 (ja) |
WO (1) | WO1997004801A1 (ja) |
Cited By (37)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2000290179A (ja) * | 1999-03-31 | 2000-10-17 | Shimizu Pharmaceutical Co Ltd | 安定な6−アミジノ−2−ナフチル4−グアニジノベンゾエート酸付加塩製剤ならびにその製造方法 |
JP2001503781A (ja) * | 1996-11-19 | 2001-03-21 | ロシュ ダイアグノスティクス ゲゼルシャフト ミット ベシュレンクテル ハフツング | 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 |
JP2003510368A (ja) * | 1999-10-04 | 2003-03-18 | カイロン コーポレイション | 安定化された液体のポリペプチド含有薬学的組成物 |
JP2003516361A (ja) * | 1999-12-02 | 2003-05-13 | カイロン コーポレイション | 凍結乾燥の際に生物学的分子を安定化するための組成物および方法 |
JP2003519195A (ja) * | 1999-12-30 | 2003-06-17 | エヌピーエス アレリックス コーポレーション | Glp−2製剤 |
JP2003221345A (ja) * | 1998-03-26 | 2003-08-05 | Schering Plough Corp | PEG−インターフェロンα結合体の保護のための処方物 |
JP2004292455A (ja) * | 2002-02-14 | 2004-10-21 | Chugai Pharmaceut Co Ltd | 抗体含有溶液製剤 |
JP2004532262A (ja) * | 2001-05-31 | 2004-10-21 | ノバルティス アクチエンゲゼルシャフト | 安定な抗体液体製剤 |
JP2004532798A (ja) * | 2000-10-12 | 2004-10-28 | ジェネンテック・インコーポレーテッド | 粘度の減少した濃縮タンパク質製剤 |
JP2004538287A (ja) * | 2001-07-25 | 2004-12-24 | プロテイン デザイン ラブス インコーポレイティド | IgG抗体の安定な凍結乾燥医薬製剤 |
JP2005532395A (ja) * | 2002-07-02 | 2005-10-27 | スミスクライン・ビーチャム・コーポレイション | 新規な安定処方 |
JP2006522780A (ja) * | 2003-04-09 | 2006-10-05 | ラボラトワール フランセ デュ フラクショヌマン エ デ ビオテクノロジ.グループメント ディンテレット パブリック | 液状形態及び凍結乾燥形態の免疫ブロブリンg組成物用安定化配合物 |
JP2008524229A (ja) * | 2004-12-15 | 2008-07-10 | アムジエン・インコーポレーテツド | ケラチノサイト増殖因子の治療用製剤 |
JP2008535819A (ja) * | 2005-03-25 | 2008-09-04 | リジェネロン・ファーマシューティカルズ・インコーポレイテッド | Vegfアンタゴニスト製剤 |
JP2009534392A (ja) * | 2006-04-21 | 2009-09-24 | アムジエン・インコーポレーテツド | 凍結乾燥された治療用ペプチボディ製剤 |
JP2009540001A (ja) * | 2006-06-16 | 2009-11-19 | リジェネロン・ファーマシューティカルズ・インコーポレイテッド | 硝子体内投与に適したvegfアンタゴニスト製剤 |
JP2010515742A (ja) * | 2007-01-09 | 2010-05-13 | ワイス エルエルシー | 抗il−13抗体製剤およびその使用 |
JP2012507553A (ja) * | 2008-10-29 | 2012-03-29 | ワイス・エルエルシー | 単一ドメイン抗原結合分子の製剤 |
JP2012072173A (ja) * | 2000-08-11 | 2012-04-12 | Chugai Pharmaceut Co Ltd | 抗体含有安定化製剤 |
US8318161B2 (en) | 2009-03-06 | 2012-11-27 | Genentech, Inc. | Anti-oxidized LDL antibody formulation |
JP2013511510A (ja) * | 2009-11-20 | 2013-04-04 | バイオコン リミテッド | 抗体製剤 |
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JP2013525406A (ja) * | 2010-04-27 | 2013-06-20 | スキル テクノロジー ゲーエムベーハー | 安定mia/cd−rap製剤 |
JP2013533244A (ja) * | 2010-06-24 | 2013-08-22 | ジェネンテック, インコーポレイテッド | タンパク質含有製剤の安定化のためのアルキルグリコシドを含む組成物及び方法 |
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JP2015061839A (ja) * | 2009-09-11 | 2015-04-02 | エフ・ホフマン−ラ・ロシュ・アクチェンゲゼルシャフト | 高度に濃縮された薬学的製剤 |
JP2015536932A (ja) * | 2012-10-31 | 2015-12-24 | タケダ・ゲー・エム・ベー・ハーTakeda GmbH | Gm−csf中和化合物を含む凍結乾燥製剤 |
JP2016508973A (ja) * | 2012-12-21 | 2016-03-24 | グレンマーク ファーマシューティカルズ, エセ.アー. | 抗her2抗体製剤 |
JP2016196512A (ja) * | 2006-02-07 | 2016-11-24 | シャイアー ヒューマン ジェネティック セラピーズ インコーポレイテッド | 遊離チオール部分を有するタンパク質の安定化された組成物 |
JP2017514868A (ja) * | 2014-05-07 | 2017-06-08 | タケダ・ゲー・エム・ベー・ハーTakeda GmbH | Gm−csf中和化合物を含む液体製剤 |
JP2017517517A (ja) * | 2014-05-28 | 2017-06-29 | ノノ インコーポレイテッド | Tat−NR2B9cの塩化物塩 |
US10034940B2 (en) | 2003-04-04 | 2018-07-31 | Genentech, Inc. | High concentration antibody and protein formulations |
US10118962B2 (en) | 2008-10-29 | 2018-11-06 | Ablynx N.V. | Methods for purification of single domain antigen binding molecules |
JP2018184478A (ja) * | 2011-10-25 | 2018-11-22 | プロシーナ バイオサイエンシーズ リミテッド | 抗体製剤および方法 |
JP2019534263A (ja) * | 2016-10-07 | 2019-11-28 | リジェネロン・ファーマシューティカルズ・インコーポレイテッドRegeneron Pharmaceuticals, Inc. | 室温で安定な凍結乾燥タンパク質 |
US10745475B2 (en) | 2013-08-30 | 2020-08-18 | Takeda Gmbh | Antibodies neutralizing GM-CSF for use in the treatment of rheumatoid arthritis or as analgesics |
US11571466B2 (en) | 2009-07-28 | 2023-02-07 | Takeda Pharmaceutical Company Limited | Compositions and methods for treating Gaucher disease |
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- 1996-07-23 RU RU98103237/15K patent/RU2497500C2/ru not_active IP Right Cessation
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