CN111511399A - 制剂 - Google Patents

制剂 Download PDF

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Publication number
CN111511399A
CN111511399A CN201880075625.0A CN201880075625A CN111511399A CN 111511399 A CN111511399 A CN 111511399A CN 201880075625 A CN201880075625 A CN 201880075625A CN 111511399 A CN111511399 A CN 111511399A
Authority
CN
China
Prior art keywords
pharmaceutical composition
antibody
formulations
formulation
antigen
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
CN201880075625.0A
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English (en)
Chinese (zh)
Inventor
S·杜兰
A·J·耶茨
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.)
UCB Biopharma SRL
Original Assignee
UCB Biopharma SRL
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 UCB Biopharma SRL filed Critical UCB Biopharma SRL
Publication of CN111511399A publication Critical patent/CN111511399A/zh
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • 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
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
CN201880075625.0A 2017-11-23 2018-11-13 制剂 Pending CN111511399A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GBGB1719447.3A GB201719447D0 (en) 2017-11-23 2017-11-23 Pharmaceutical composition
GB1719447.3 2017-11-23
PCT/EP2018/081129 WO2019101582A1 (en) 2017-11-23 2018-11-13 Formulation

Publications (1)

Publication Number Publication Date
CN111511399A true CN111511399A (zh) 2020-08-07

Family

ID=60950516

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201880075625.0A Pending CN111511399A (zh) 2017-11-23 2018-11-13 制剂

Country Status (19)

Country Link
US (2) US11857625B2 (https=)
EP (1) EP3713602A1 (https=)
JP (1) JP6955632B2 (https=)
KR (1) KR102767553B1 (https=)
CN (1) CN111511399A (https=)
AR (1) AR113534A1 (https=)
AU (1) AU2018371056B2 (https=)
BR (1) BR112020009866A2 (https=)
CA (1) CA3082832C (https=)
CL (1) CL2020001307A1 (https=)
CO (1) CO2020006120A2 (https=)
EA (1) EA202091295A1 (https=)
GB (1) GB201719447D0 (https=)
IL (1) IL274719B2 (https=)
MX (1) MX2020004747A (https=)
MY (1) MY194682A (https=)
RU (1) RU2020120547A (https=)
SG (1) SG11202004601YA (https=)
WO (1) WO2019101582A1 (https=)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018119142A1 (en) 2016-12-21 2018-06-28 Amgen Inc. Anti-tnf alpha antibody formulations
KR102735988B1 (ko) 2019-02-18 2024-12-03 일라이 릴리 앤드 캄파니 치료 항체 제제
CN110585430B (zh) * 2019-09-29 2023-09-08 华博生物医药技术（上海）有限公司 一种人源化抗人il-17a单克隆抗体的药物组合物
CN112915201B (zh) * 2019-12-06 2023-06-27 珠海市丽珠单抗生物技术有限公司 包含抗il-17抗体的液体制剂
CN113769082A (zh) * 2020-06-10 2021-12-10 上海君实生物医药科技股份有限公司 抗il-17a抗体药物组合物及其用途

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010506580A (ja) * 2006-10-18 2010-03-04 ユセベ ファルマ ソシエテ アノニム Ｉｌ−１７ａ及びｉｌ−１７ｆに結合する抗体分子
CN103189074A (zh) * 2010-11-05 2013-07-03 诺华有限公司 使用il-17拮抗剂治疗类风湿性关节炎的方法
US20130202620A1 (en) * 2010-05-14 2013-08-08 Amgen Inc. High concentration antibody formulations
CN103384682A (zh) * 2011-01-14 2013-11-06 Ucb医药有限公司 结合il-17a和il-17f的抗体分子
US20150150979A1 (en) * 2012-06-21 2015-06-04 Ucb Pharma, S.A. Pharmaceutical formulation
WO2017072183A1 (en) * 2015-10-27 2017-05-04 Ucb Biopharma Sprl Methods of treatment using anti-il-17a/f antibodies
CN107148283A (zh) * 2014-10-31 2017-09-08 豪夫迈·罗氏有限公司 抗il‑17a和il‑17f交叉反应性抗体变体、包含其的组合物及其制备和使用方法
CN107257692A (zh) * 2014-12-22 2017-10-17 诺华股份有限公司 Il‑17抗体的药物产品和稳定液体组合物

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007019232A2 (en) 2005-08-03 2007-02-15 Immunogen, Inc. Immunoconjugate formulations
WO2009120684A1 (en) 2008-03-25 2009-10-01 Medimmune, Llc Antibody formulation
MX2012007676A (es) 2009-12-29 2012-08-03 Hoffmann La Roche Nueva formulacion de anticuerpo.
HRP20171939T1 (hr) 2010-01-15 2018-03-23 Kirin-Amgen, Inc. Formulacija protutijela i režimi terapije
US9956165B2 (en) 2010-03-01 2018-05-01 Cytodyn Inc. Concentrated protein formulations and uses thereof
FR2962650B1 (fr) 2010-07-19 2013-04-05 Lab Francais Du Fractionnement Composition d'immunoglobulines humaines concentrees
CA2995222C (en) 2015-08-19 2021-07-13 Medimmune, Llc Stable anti-ifnar1 formulation
GB201522391D0 (en) * 2015-12-18 2016-02-03 Ucb Biopharma Sprl Antibody molecules
US20190060241A1 (en) 2016-04-13 2019-02-28 Medimmune, Llc Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents
KR102329490B1 (ko) 2016-09-14 2021-11-23 베이징 한미 파마슈티컬 컴퍼니 리미티드 Ｉｌ-１７ａ에 특이적으로 결합하는 항체 및 그의 기능성 단편

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010506580A (ja) * 2006-10-18 2010-03-04 ユセベ ファルマ ソシエテ アノニム Ｉｌ−１７ａ及びｉｌ−１７ｆに結合する抗体分子
US20130202620A1 (en) * 2010-05-14 2013-08-08 Amgen Inc. High concentration antibody formulations
CN103189074A (zh) * 2010-11-05 2013-07-03 诺华有限公司 使用il-17拮抗剂治疗类风湿性关节炎的方法
CN103384682A (zh) * 2011-01-14 2013-11-06 Ucb医药有限公司 结合il-17a和il-17f的抗体分子
US20150150979A1 (en) * 2012-06-21 2015-06-04 Ucb Pharma, S.A. Pharmaceutical formulation
CN107148283A (zh) * 2014-10-31 2017-09-08 豪夫迈·罗氏有限公司 抗il‑17a和il‑17f交叉反应性抗体变体、包含其的组合物及其制备和使用方法
CN107257692A (zh) * 2014-12-22 2017-10-17 诺华股份有限公司 Il‑17抗体的药物产品和稳定液体组合物
WO2017072183A1 (en) * 2015-10-27 2017-05-04 Ucb Biopharma Sprl Methods of treatment using anti-il-17a/f antibodies

Non-Patent Citations (1)

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Title
梁文权: "《药剂学》", 北京：科学技术文献出版社, pages: 226 - 227 *

Also Published As

Publication number Publication date
BR112020009866A2 (pt) 2020-11-17
AU2018371056A1 (en) 2020-06-04
MY194682A (en) 2022-12-14
JP6955632B2 (ja) 2021-10-27
CA3082832A1 (en) 2019-05-31
JP2021504321A (ja) 2021-02-15
CA3082832C (en) 2023-07-18
EA202091295A1 (ru) 2020-09-03
EP3713602A1 (en) 2020-09-30
AR113534A1 (es) 2020-05-13
AU2018371056B2 (en) 2024-06-20
CO2020006120A2 (es) 2020-05-29
IL274719A (en) 2020-07-30
WO2019101582A1 (en) 2019-05-31
RU2020120547A (ru) 2021-12-23
GB201719447D0 (en) 2018-01-10
US11857625B2 (en) 2024-01-02
KR20200090829A (ko) 2020-07-29
MX2020004747A (es) 2020-08-20
US20210106683A1 (en) 2021-04-15
KR102767553B1 (ko) 2025-02-12
RU2020120547A3 (https=) 2021-12-23
CL2020001307A1 (es) 2020-10-16
IL274719B1 (en) 2024-06-01
US20240123065A1 (en) 2024-04-18
SG11202004601YA (en) 2020-06-29
IL274719B2 (en) 2024-10-01

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