CN103582724A - 粘度降低的制剂 - Google Patents

粘度降低的制剂 Download PDF

Info

Publication number
CN103582724A
CN103582724A CN201280025770.0A CN201280025770A CN103582724A CN 103582724 A CN103582724 A CN 103582724A CN 201280025770 A CN201280025770 A CN 201280025770A CN 103582724 A CN103582724 A CN 103582724A
Authority
CN
China
Prior art keywords
formulation
viscosity
less
acetate
concentration
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.)
Pending
Application number
CN201280025770.0A
Other languages
English (en)
Chinese (zh)
Inventor
M.A.蒙克
M.Y.王
K.张
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SmithKline Beecham Corp
Original Assignee
SmithKline Beecham Corp
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by SmithKline Beecham Corp filed Critical SmithKline Beecham Corp
Publication of CN103582724A publication Critical patent/CN103582724A/zh
Pending legal-status Critical Current

Links

Images

Classifications

    • 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

Landscapes

  • 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)
  • Veterinary Medicine (AREA)
  • Public Health (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)
  • Mycology (AREA)
  • Endocrinology (AREA)
  • Microbiology (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)
CN201280025770.0A 2011-04-07 2012-04-06 粘度降低的制剂 Pending CN103582724A (zh)

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 (1)

Publication Number Publication Date
CN103582724A true CN103582724A (zh) 2014-02-12

Family

ID=47009919

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201280025770.0A Pending CN103582724A (zh) 2011-04-07 2012-04-06 粘度降低的制剂

Country Status (12)

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

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102821787A (zh) * 2010-01-15 2012-12-12 麒麟-安姆根有限公司 抗体制剂和治疗方案
CN105733250A (zh) * 2016-05-04 2016-07-06 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
CN112105343A (zh) * 2018-03-07 2020-12-18 辉瑞公司 抗-pd-1抗体组合物

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG193963A1 (en) * 2011-04-07 2013-11-29 Glaxosmithkline Llc Formulations with reduced viscosity
EA201590061A1 (ru) * 2012-06-21 2015-05-29 Юсб Фарма С.А. Фармацевтическая композиция
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
AU2015325055B2 (en) 2014-10-01 2021-02-25 Eagle Biologics, Inc. Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
KR20180037275A (ko) 2015-08-24 2018-04-11 글락소스미스클라인 인털렉츄얼 프로퍼티 (넘버 2) 리미티드 생물제약 조성물
ES2933808T3 (es) * 2017-01-11 2023-02-14 Celltrion Inc Fórmula líquida estable
SI4190355T1 (sl) * 2017-04-28 2025-02-28 Amgen Inc. Formulacije humanih protiteles proti-RANKL in postopki njihove uporabe
JP7382232B2 (ja) 2017-05-02 2023-11-16 メルク・シャープ・アンド・ドーム・エルエルシー 抗ｌａｇ３抗体の製剤および抗ｌａｇ３抗体と抗ｐｄ－１抗体との共製剤
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
US10646569B2 (en) 2017-05-16 2020-05-12 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity
BR112019025736A2 (pt) 2017-06-06 2020-06-30 Glaxosmithkline Llc uso de um anticorpo e composições para tratar uma doença e para diminuir uma contagem absoluta de eosinófilo no sangue
WO2020081408A1 (en) 2018-10-18 2020-04-23 Merck Sharp & Dohme Corp. Formulations of anti-rsv antibodies and methods of use thereof
MX2021004928A (es) 2018-10-31 2021-06-08 Merck Sharp & Dohme Llc Cristales de anticuerpo anti-pd-1 humano y metodos de uso de los mismos.
EP3876990A4 (en) 2018-11-07 2023-09-06 Merck Sharp & Dohme LLC CO-FORMULATIONS OF ANTI-LAG3 ANTIBODIES AND ANTI-PD-1 ANTIBODIES
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 (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060127414A1 (en) * 2002-11-01 2006-06-15 Glaxosmithkline Biologicals S.A. Immunogenic Composition
CN101378782A (zh) * 2005-12-21 2009-03-04 惠氏公司 粘度降低的蛋白质制剂及其用途
CN101820912A (zh) * 2007-07-06 2010-09-01 葛兰素史密斯克莱有限责任公司 抗体制剂
CN101883588A (zh) * 2007-12-27 2010-11-10 中外制药株式会社 含高浓度抗体的溶液制剂

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2002213441B2 (en) * 2000-10-12 2006-10-26 Genentech, Inc. Reduced-viscosity concentrated protein formulations
US20050164929A1 (en) * 2000-11-06 2005-07-28 Lupine Logic, Inc. Methods of preventing and treating inflammatory bowel disease
WO2004060343A1 (en) * 2002-12-31 2004-07-22 Nektar Therapeutics Antibody-containing particles and compositions
AU2006296399B2 (en) * 2005-09-30 2011-01-20 Medimmune Limited Interleukin-13 antibody composition
WO2007074880A1 (ja) * 2005-12-28 2007-07-05 Chugai Seiyaku Kabushiki Kaisha 抗体含有安定化製剤
EP2173163A4 (en) * 2007-07-06 2010-12-08 Glaxosmithkline Llc ANTIBODY FORMULATIONS
EP2205280B1 (en) * 2007-09-27 2019-09-04 Amgen Inc. Pharmaceutical formulations
BR112012013093A2 (pt) * 2009-12-21 2017-12-12 Genentech Inc ''formulação farmacêutica aquosa estável, artigo, métodos para estabilizar um anticorpo, para tratamento de uma doença ou distúrbio em um indivíduo, para reduzir a agregação de um anticorpo monoclonal terapêutico e de fabricação de uma formulação farmaceutica, frasco e tanque de aço inoxidável
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 (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060127414A1 (en) * 2002-11-01 2006-06-15 Glaxosmithkline Biologicals S.A. Immunogenic Composition
CN101378782A (zh) * 2005-12-21 2009-03-04 惠氏公司 粘度降低的蛋白质制剂及其用途
CN101820912A (zh) * 2007-07-06 2010-09-01 葛兰素史密斯克莱有限责任公司 抗体制剂
CN101883588A (zh) * 2007-12-27 2010-11-10 中外制药株式会社 含高浓度抗体的溶液制剂

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102821787A (zh) * 2010-01-15 2012-12-12 麒麟-安姆根有限公司 抗体制剂和治疗方案
CN105733250A (zh) * 2016-05-04 2016-07-06 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
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
CN112105343A (zh) * 2018-03-07 2020-12-18 辉瑞公司 抗-pd-1抗体组合物

Also Published As

Publication number Publication date
BR112013025845A2 (pt) 2018-09-04
US20140044727A1 (en) 2014-02-13
WO2012141978A2 (en) 2012-10-18
SG193964A1 (en) 2013-11-29
EP2694708A2 (en) 2014-02-12
EP2694708A4 (en) 2014-10-01
IL228626A0 (en) 2013-12-31
CA2832560A1 (en) 2012-10-18
AU2012243126A1 (en) 2013-10-17
JP2014510152A (ja) 2014-04-24
WO2012141978A3 (en) 2012-12-27
KR20140066124A (ko) 2014-05-30
EA201391489A1 (ru) 2014-02-28

Similar Documents

Publication Publication Date Title
CN103582724A (zh) 粘度降低的制剂
CN103596585A (zh) 粘度降低的制剂
AU2014229282B2 (en) Low concentration antibody formulations
EP3143047B1 (en) Belimumab formulation
CN103492407A (zh) 冻干制剂
CN106659785A (zh) 包含gm‑csf中和化合物的液体制剂
WO2014141149A1 (en) Formulations with reduced viscosity
TW202011995A (zh) 高濃度液體抗體配製物
CN119095584A (zh) 抗gm-csf抗体的液体药物配制品及其用途
CN110536698A (zh) 重组单克隆抗TNFα抗体的水性药用组合物

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
C02 Deemed withdrawal of patent application after publication (patent law 2001)
WD01 Invention patent application deemed withdrawn after publication

Application publication date: 20140212