JP2014510152A - 粘度が低減された処方物 - Google Patents

粘度が低減された処方物 Download PDF

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Publication number
JP2014510152A
JP2014510152A JP2014504014A JP2014504014A JP2014510152A JP 2014510152 A JP2014510152 A JP 2014510152A JP 2014504014 A JP2014504014 A JP 2014504014A JP 2014504014 A JP2014504014 A JP 2014504014A JP 2014510152 A JP2014510152 A JP 2014510152A
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Japan
Prior art keywords
formulation
viscosity
acetate
less
concentration
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Pending
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JP2014504014A
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English (en)
Japanese (ja)
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JP2014510152A5 (enExample
Inventor
マーナ、エイ．モンク
マン、イ、ウォン
カイ、ツァン
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GlaxoSmithKline LLC
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GlaxoSmithKline LLC
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Publication of JP2014510152A publication Critical patent/JP2014510152A/ja
Publication of JP2014510152A5 publication Critical patent/JP2014510152A5/ja
Pending legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K40/00—Cellular immunotherapy
    • 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
    • A61K47/20—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
    • 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
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Endocrinology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
JP2014504014A 2011-04-07 2012-04-06 粘度が低減された処方物 Pending JP2014510152A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161473123P 2011-04-07 2011-04-07
US61/473,123 2011-04-07
PCT/US2012/032464 WO2012141978A2 (en) 2011-04-07 2012-04-06 Formulations with reduced viscosity

Publications (2)

Publication Number Publication Date
JP2014510152A true JP2014510152A (ja) 2014-04-24
JP2014510152A5 JP2014510152A5 (enExample) 2015-05-21

Family

ID=47009919

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2014504014A Pending JP2014510152A (ja) 2011-04-07 2012-04-06 粘度が低減された処方物

Country Status (12)

Country Link
US (1) US20140044727A1 (enExample)
EP (1) EP2694708A4 (enExample)
JP (1) JP2014510152A (enExample)
KR (1) KR20140066124A (enExample)
CN (1) CN103582724A (enExample)
AU (1) AU2012243126A1 (enExample)
BR (1) BR112013025845A2 (enExample)
CA (1) CA2832560A1 (enExample)
EA (1) EA201391489A1 (enExample)
IL (1) IL228626A0 (enExample)
SG (1) SG193964A1 (enExample)
WO (1) WO2012141978A2 (enExample)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014516924A (ja) * 2011-04-07 2014-07-17 グラクソスミスクライン・リミテッド・ライアビリティ・カンパニー 粘度が低減された処方物
JP2018188430A (ja) * 2017-04-28 2018-11-29 アムジエン・インコーポレーテツド ヒト抗ｒａｎｋｌ抗体の製剤及びその使用方法
JP2021517129A (ja) * 2018-03-07 2021-07-15 ファイザー・インク 抗ｐｄ−１抗体組成物

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SI2523688T1 (en) * 2010-01-15 2018-03-30 Kirin-Amgen, Inc. Formulation of antibodies and therapeutic regimes
CN104520326A (zh) * 2012-06-21 2015-04-15 Ucb医药有限公司 药物制剂
FR2994390B1 (fr) 2012-08-10 2014-08-15 Adocia Procede d'abaissement de la viscosite de solutions de proteines a concentration elevee
UA117466C2 (uk) 2012-12-13 2018-08-10 Мерк Шарп Енд Доме Корп. СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19
IL312865B2 (en) 2013-09-11 2025-06-01 Eagle Biologics Inc Liquid protein formulations containing viscosity-lowering agents
SG11201702614SA (en) 2014-10-01 2017-04-27 Eagle Biolog Inc Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
ES3053874T3 (en) 2015-08-24 2026-01-27 Glaxosmithkline Ip No 2 Ltd Biopharmaceutical compositions
CN105733250B (zh) * 2016-05-04 2017-12-26 山东省药学科学院 一种交联聚谷氨酸悬浮液及其制备方法与应用
US10980881B2 (en) * 2017-01-11 2021-04-20 Celltrion Inc. Stable liquid formula having an anti-TNFalpha antibody, acetate buffer and glycine
US11603407B2 (en) 2017-04-06 2023-03-14 Regeneron Pharmaceuticals, Inc. Stable antibody formulation
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
CN110913906A (zh) 2017-05-02 2020-03-24 默沙东公司 抗lag3抗体的制剂和抗lag3抗体与抗pd-1抗体的共制剂
US10646569B2 (en) 2017-05-16 2020-05-12 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity
CN110913887A (zh) 2017-06-06 2020-03-24 葛兰素史克有限责任公司 用于儿科患者的生物药物组合物和方法
MX2021004356A (es) 2018-10-18 2021-05-31 Merck Sharp & Dohme Llc Formulaciones de anticuerpos anti-rsv y metodos de uso de las mismas.
MA54089A (fr) 2018-10-31 2022-02-09 Merck Sharp & Dohme Anticorps anti-pd-1 humain et procédés d'utilisation associés
JP7503056B6 (ja) 2018-11-07 2024-07-16 メルク・シャープ・アンド・ドーム・エルエルシー 抗ｌａｇ３抗体および抗ｐｄ－１抗体の共－製剤
CN113660927A (zh) * 2019-04-23 2021-11-16 安进公司 使用低分子量聚乙烯吡咯烷酮（pvp）降低高浓度蛋白质配制品的黏度
GB202102258D0 (en) * 2021-02-17 2021-03-31 Arecor Ltd Novel composition

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
WO2007074880A1 (ja) * 2005-12-28 2007-07-05 Chugai Seiyaku Kabushiki Kaisha 抗体含有安定化製剤
JP2009510046A (ja) * 2005-09-30 2009-03-12 メドイミューン・リミテッド インターロイキン−１３抗体組成物
JP2009521482A (ja) * 2005-12-21 2009-06-04 ワイス 低粘度のタンパク質製剤およびその用途
JP2010532790A (ja) * 2007-07-06 2010-10-14 グラクソスミスクライン・リミテッド・ライアビリティ・カンパニー 抗体処方

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050164929A1 (en) * 2000-11-06 2005-07-28 Lupine Logic, Inc. Methods of preventing and treating inflammatory bowel disease
CA2503871C (en) * 2002-11-01 2012-12-11 Glaxosmithkline Biologicals S.A. An immunogenic composition for generating an immune response against polio virus
WO2004060343A1 (en) * 2002-12-31 2004-07-22 Nektar Therapeutics Antibody-containing particles and compositions
UA107557C2 (xx) * 2007-07-06 2015-01-26 Композиція антитіла офатумумабу
AU2008304111B2 (en) * 2007-09-27 2014-04-24 Amgen Inc. Pharmaceutical formulations
PE20091174A1 (es) * 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
CN107095846A (zh) * 2009-12-21 2017-08-29 霍夫曼-拉罗奇有限公司 抗体配制剂
BR112012027828A2 (pt) * 2010-05-03 2016-08-09 Genentech Inc composição de matéria, artigo de fabricação e método de redução da viscosidade de uma formulação contendo proteína e de preparação de uma formulação aquosa contendo proteína

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
JP2009510046A (ja) * 2005-09-30 2009-03-12 メドイミューン・リミテッド インターロイキン−１３抗体組成物
JP2009521482A (ja) * 2005-12-21 2009-06-04 ワイス 低粘度のタンパク質製剤およびその用途
WO2007074880A1 (ja) * 2005-12-28 2007-07-05 Chugai Seiyaku Kabushiki Kaisha 抗体含有安定化製剤
JP2010532790A (ja) * 2007-07-06 2010-10-14 グラクソスミスクライン・リミテッド・ライアビリティ・カンパニー 抗体処方

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014516924A (ja) * 2011-04-07 2014-07-17 グラクソスミスクライン・リミテッド・ライアビリティ・カンパニー 粘度が低減された処方物
JP2018188430A (ja) * 2017-04-28 2018-11-29 アムジエン・インコーポレーテツド ヒト抗ｒａｎｋｌ抗体の製剤及びその使用方法
JP2022062059A (ja) * 2017-04-28 2022-04-19 アムジエン・インコーポレーテツド ヒト抗ｒａｎｋｌ抗体の製剤及びその使用方法
JP7190822B2 (ja) 2017-04-28 2022-12-16 アムジエン・インコーポレーテツド ヒト抗ｒａｎｋｌ抗体の製剤及びその使用方法
JP7356525B2 (ja) 2017-04-28 2023-10-04 アムジエン・インコーポレーテツド ヒト抗ｒａｎｋｌ抗体の製剤及びその使用方法
JP2023166396A (ja) * 2017-04-28 2023-11-21 アムジエン・インコーポレーテツド ヒト抗ｒａｎｋｌ抗体の製剤及びその使用方法
JP2025093923A (ja) * 2017-04-28 2025-06-24 アムジエン・インコーポレーテツド ヒト抗ｒａｎｋｌ抗体の製剤及びその使用方法
JP7851438B2 (ja) 2017-04-28 2026-04-24 アムジエン・インコーポレーテツド ヒト抗ｒａｎｋｌ抗体の製剤及びその使用方法
JP2021517129A (ja) * 2018-03-07 2021-07-15 ファイザー・インク 抗ｐｄ−１抗体組成物
JP7312188B2 (ja) 2018-03-07 2023-07-20 ファイザー・インク 抗ｐｄ－１抗体組成物

Also Published As

Publication number Publication date
BR112013025845A2 (pt) 2018-09-04
WO2012141978A2 (en) 2012-10-18
IL228626A0 (en) 2013-12-31
CA2832560A1 (en) 2012-10-18
US20140044727A1 (en) 2014-02-13
EP2694708A4 (en) 2014-10-01
CN103582724A (zh) 2014-02-12
WO2012141978A3 (en) 2012-12-27
EA201391489A1 (ru) 2014-02-28
KR20140066124A (ko) 2014-05-30
AU2012243126A1 (en) 2013-10-17
EP2694708A2 (en) 2014-02-12
SG193964A1 (en) 2013-11-29

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