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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Prior art keywords
formulation
viscosity
acetate
less
concentration
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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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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K40/00Cellular immunotherapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins 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)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (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)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (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 (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK2523688T3 (en) * 2010-01-15 2017-12-04 Kirin-Amgen Inc ANTIBODY FORMULATION AND THERAPEUTIC REGIMENS
KR20150032941A (ko) * 2012-06-21 2015-03-31 유씨비 파마, 에스.에이. 약학 제제
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
SG10201902915VA (en) 2014-10-01 2019-04-29 Eagle Biologics Inc Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
TWI780988B (zh) 2015-08-24 2022-10-11 英商葛蘭素史密斯克藍智慧財產權有限公司 生藥組成物
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
CA3049857A1 (en) * 2017-01-11 2018-07-19 Celltrion Inc. Stable liquid formulation
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
AU2018263868A1 (en) 2017-05-02 2019-12-12 Merck Sharp & Dohme Llc Formulations of anti-LAG3 antibodies and co-formulations of anti-LAG3 antibodies and anti-PD-1 antibodies
SG11202003754YA (en) 2017-05-16 2020-05-28 Bhamis Research Laboratory Pvt Ltd High concentration protein formulations with reduced viscosity
JP7295038B2 (ja) 2017-06-06 2023-06-20 グラクソスミスクライン エルエルシー 小児患者のための生物薬剤組成物及び方法
CA3118144A1 (en) 2018-11-07 2020-05-14 Merck Sharp & Dohme Corp. Co-formulations of anti-lag3 antibodies and anti-pd-1 antibodies
AU2020263318B2 (en) * 2019-04-23 2025-10-23 Amgen Inc. The use of low molecular weight polyvinylpyrrolidone (PVP) to reduce viscosity of high concentration protein formulations
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
AU2003287980B2 (en) * 2002-11-01 2009-06-25 Glaxosmithkline Biologicals S.A. Drying process
JP2006514954A (ja) * 2002-12-31 2006-05-18 ネクター セラピューティクス 抗体含有粒子及び組成物
UA107557C2 (xx) * 2007-07-06 2015-01-26 Композиція антитіла офатумумабу
CA2701032C (en) * 2007-09-27 2021-01-26 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
EP2515941B1 (en) * 2009-12-21 2019-11-13 F.Hoffmann-La Roche Ag Pharmaceutical formulation of bevacizumab
JP2013525484A (ja) * 2010-05-03 2013-06-20 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粘度を低減させるために有用な組成物及び方法

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 (8)

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

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