KR102546471B1 - 액상의 약학 조성물 - Google Patents

액상의 약학 조성물 Download PDF

Info

Publication number
KR102546471B1
KR102546471B1 KR1020197010731A KR20197010731A KR102546471B1 KR 102546471 B1 KR102546471 B1 KR 102546471B1 KR 1020197010731 A KR1020197010731 A KR 1020197010731A KR 20197010731 A KR20197010731 A KR 20197010731A KR 102546471 B1 KR102546471 B1 KR 102546471B1
Authority
KR
South Korea
Prior art keywords
pharmaceutical composition
liquid pharmaceutical
ser
gly
antibody
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.)
Active
Application number
KR1020197010731A
Other languages
English (en)
Korean (ko)
Other versions
KR20190062440A (ko
Inventor
알레산드라 델 리오
카멜라 사비나
Original Assignee
프레제니우스 카비 도이치란트 게엠베하
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 프레제니우스 카비 도이치란트 게엠베하 filed Critical 프레제니우스 카비 도이치란트 게엠베하
Publication of KR20190062440A publication Critical patent/KR20190062440A/ko
Application granted granted Critical
Publication of KR102546471B1 publication Critical patent/KR102546471B1/ko
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • 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
    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/20—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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A61P21/02—Muscle relaxants, e.g. for tetanus or cramps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • 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
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/569—Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
    • 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)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Rheumatology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Neurology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
KR1020197010731A 2016-09-27 2017-09-26 액상의 약학 조성물 Active KR102546471B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP16190957 2016-09-27
EP16190957.7 2016-09-27
PCT/EP2017/074413 WO2018060210A1 (en) 2016-09-27 2017-09-26 Liquid pharmaceutical composition

Publications (2)

Publication Number Publication Date
KR20190062440A KR20190062440A (ko) 2019-06-05
KR102546471B1 true KR102546471B1 (ko) 2023-06-21

Family

ID=57047015

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020197010731A Active KR102546471B1 (ko) 2016-09-27 2017-09-26 액상의 약학 조성물

Country Status (12)

Country Link
US (3) US10961314B2 (https=)
EP (1) EP3518891A1 (https=)
JP (3) JP2019534863A (https=)
KR (1) KR102546471B1 (https=)
CN (1) CN109862880A (https=)
AU (1) AU2017333367A1 (https=)
BR (1) BR112019005328A2 (https=)
CA (1) CA3037440A1 (https=)
MA (1) MA46334A (https=)
RU (1) RU2019112680A (https=)
WO (1) WO2018060210A1 (https=)
ZA (1) ZA201901590B (https=)

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
TWI603738B (zh) 2010-11-08 2017-11-01 建南德克公司 皮下投予抗－ｉｌ－６受體抗體
US10961314B2 (en) * 2016-09-27 2021-03-30 Fresenius Kabi Deutschland Gmbh Liquid pharmaceutical composition comprising an anti-IL-6 receptor antibody
WO2018119142A1 (en) 2016-12-21 2018-06-28 Amgen Inc. Anti-tnf alpha antibody formulations
BR112020010761A2 (pt) * 2017-11-30 2020-11-24 Bio-Thera Solutions, Ltd. formulação líquida de anticorpo humanizado para o tratamento de doenças relacionadas à il-6
US11427639B2 (en) * 2018-04-02 2022-08-30 Richter Gedeon Nyrt. Antibody-containing aqueous formulation and use thereof
KR102917813B1 (ko) * 2018-10-31 2026-01-26 리히터 게데온 닐트. 수성 약학 제제
AU2020214796A1 (en) 2019-01-30 2021-07-29 Truebinding, Inc. Anti-Gal3 antibodies and uses thereof
CN110179746A (zh) * 2019-05-17 2019-08-30 通化东宝生物科技有限公司 一种稳定的苏金单抗注射剂及其制备方法
EP3714902B1 (en) * 2020-03-13 2024-08-28 LEK Pharmaceuticals d.d. Stabilization of pharmaceutical compositions comprising polysorbate
CN113456582B (zh) * 2020-03-30 2024-06-14 鲁南制药集团股份有限公司 重组人源化抗pd-1单克隆抗体的液体制剂
JP2023520249A (ja) * 2020-05-15 2023-05-16 エフ． ホフマン－ラ ロシュ アーゲー 非経口タンパク質溶液中の可視粒子形成の防止方法
WO2021242776A2 (en) * 2020-05-26 2021-12-02 Truebinding, Inc. Methods of treating inflammatory diseases by blocking galectin-3
RU2745814C1 (ru) * 2020-06-05 2021-04-01 Закрытое Акционерное Общество "Биокад" Водная фармацевтическая композиция левилимаба и ее применение
US11365248B2 (en) * 2020-06-29 2022-06-21 Anovent Pharmaceutical (U.S.), Llc Formulation of tocilizumab and method for treating COVID-19 by inhalation
CN116261448A (zh) * 2020-08-19 2023-06-13 百奥泰生物制药股份有限公司 用于治疗il-6相关疾病的包含高浓度人源化抗体的液体制剂
KR20220028972A (ko) * 2020-08-31 2022-03-08 (주)셀트리온 안정한 약제학적 제제
WO2022139457A1 (ko) * 2020-12-24 2022-06-30 이니스트에스티 주식회사 봉독 추출물로부터 bvPLA2를 50~99% 함량으로 포함하는 봉독 주사제 조성물 및 이의 제조방법
CN121240883A (zh) * 2023-05-26 2025-12-30 百奥泰生物制药股份有限公司 用于治疗il-6相关疾病的包含高浓度人源化抗体的液体制剂

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0628639B1 (en) 1991-04-25 1999-06-23 Chugai Seiyaku Kabushiki Kaisha Reconstituted human antibody against human interleukin 6 receptor
US8632778B2 (en) 2000-08-11 2014-01-21 Chugai Seiyaku Kabushiki Kaisha Stabilized anti-interleukin-6 antibody-containing preparations
AU2003211990A1 (en) 2002-02-14 2003-09-04 Chugai Seiyaku Kabushiki Kaisha Antibody-containing solution pharmaceuticals
PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
WO2010062896A1 (en) 2008-11-28 2010-06-03 Abbott Laboratories Stable antibody compositions and methods for stabilizing same
EP2196476A1 (en) * 2008-12-10 2010-06-16 Novartis Ag Antibody formulation
CN104119438A (zh) * 2009-01-29 2014-10-29 米迪缪尼有限公司 延长体内半衰期的人抗il-6抗体及其在治疗肿瘤、自身免疫性疾病和炎症性疾病中的应用
JP4885308B2 (ja) * 2009-03-19 2012-02-29 中外製薬株式会社 改良された抗体分子を含有する製剤
AU2010320515B2 (en) * 2009-11-20 2013-05-02 Biocon Limited Formulations of antibody
MX2012007676A (es) * 2009-12-29 2012-08-03 Hoffmann La Roche Nueva formulacion de anticuerpo.
JO3417B1 (ar) * 2010-01-08 2019-10-20 Regeneron Pharma الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r
TWI603738B (zh) * 2010-11-08 2017-11-01 建南德克公司 皮下投予抗－ｉｌ－６受體抗體
UY34105A (es) * 2011-06-03 2012-07-31 Lg Life Sciences Ltd Formulación líquida estable de etanercept
AU2012328524B2 (en) 2011-10-28 2017-05-18 Excelse Bio, Inc. Protein formulations containing amino acids
US20150239970A1 (en) 2012-10-25 2015-08-27 Medimmune, Llc Stable, Low Viscosity Antibody Formulation
US10961314B2 (en) * 2016-09-27 2021-03-30 Fresenius Kabi Deutschland Gmbh Liquid pharmaceutical composition comprising an anti-IL-6 receptor antibody
BR112020010761A2 (pt) * 2017-11-30 2020-11-24 Bio-Thera Solutions, Ltd. formulação líquida de anticorpo humanizado para o tratamento de doenças relacionadas à il-6
CN116261448A (zh) * 2020-08-19 2023-06-13 百奥泰生物制药股份有限公司 用于治疗il-6相关疾病的包含高浓度人源化抗体的液体制剂
CN117858722A (zh) * 2021-08-18 2024-04-09 百奥泰生物制药股份有限公司 用于治疗il-6相关疾病的包含高浓度人源化抗体的液体制剂

Also Published As

Publication number Publication date
JP2024178197A (ja) 2024-12-24
US20240150479A1 (en) 2024-05-09
MA46334A (fr) 2019-08-07
CN109862880A (zh) 2019-06-07
EP3518891A1 (en) 2019-08-07
CA3037440A1 (en) 2018-04-05
WO2018060210A1 (en) 2018-04-05
ZA201901590B (en) 2020-10-28
RU2019112680A3 (https=) 2020-12-15
KR20190062440A (ko) 2019-06-05
US20210261673A1 (en) 2021-08-26
BR112019005328A2 (pt) 2019-06-18
AU2017333367A1 (en) 2019-04-04
JP2022188075A (ja) 2022-12-20
RU2019112680A (ru) 2020-10-29
JP2019534863A (ja) 2019-12-05
US20190218300A1 (en) 2019-07-18
US10961314B2 (en) 2021-03-30

Similar Documents

Publication Publication Date Title
KR102546471B1 (ko) 액상의 약학 조성물
JP7473603B2 (ja) 液体医薬組成物
US20240058263A1 (en) Formulations of antibody
EP1409018B1 (en) Stable lyophilized pharmaceutical formulation the igg antibody daclizumab
RU2664736C2 (ru) Фармацевтическая композиция, содержащая адалимумаб
US12577297B2 (en) Anti-IL-23p19 antibody formulations
JP2025024067A (ja) 治療用タンパク質の凍結乾燥医薬配合物のためのプロセス
AU2019407063B2 (en) Protein solution formulation containing high concentration of an anti-VEGF antibody
WO2020173431A2 (zh) 包含抗cd47抗体的制剂及其制备方法和用途
HK40005809B (en) Liquid pharmaceutical composition

Legal Events

Date Code Title Description
PA0105 International application

St.27 status event code: A-0-1-A10-A15-nap-PA0105

PG1501 Laying open of application

St.27 status event code: A-1-1-Q10-Q12-nap-PG1501

A201 Request for examination
AMND Amendment
P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

PA0201 Request for examination

St.27 status event code: A-1-2-D10-D11-exm-PA0201

E902 Notification of reason for refusal
PE0902 Notice of grounds for rejection

St.27 status event code: A-1-2-D10-D21-exm-PE0902

T11-X000 Administrative time limit extension requested

St.27 status event code: U-3-3-T10-T11-oth-X000

AMND Amendment
P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

E601 Decision to refuse application
PE0601 Decision on rejection of patent

St.27 status event code: N-2-6-B10-B15-exm-PE0601

T11-X000 Administrative time limit extension requested

St.27 status event code: U-3-3-T10-T11-oth-X000

T13-X000 Administrative time limit extension granted

St.27 status event code: U-3-3-T10-T13-oth-X000

AMND Amendment
P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

PX0901 Re-examination

St.27 status event code: A-2-3-E10-E12-rex-PX0901

PX0701 Decision of registration after re-examination

St.27 status event code: A-3-4-F10-F13-rex-PX0701

X701 Decision to grant (after re-examination)
GRNT Written decision to grant
PR0701 Registration of establishment

St.27 status event code: A-2-4-F10-F11-exm-PR0701

PR1002 Payment of registration fee

St.27 status event code: A-2-2-U10-U12-oth-PR1002

Fee payment year number: 1

PG1601 Publication of registration

St.27 status event code: A-4-4-Q10-Q13-nap-PG1601