JP2019534863A - 液体医薬組成物 - Google Patents

液体医薬組成物 Download PDF

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Publication number
JP2019534863A
JP2019534863A JP2019515630A JP2019515630A JP2019534863A JP 2019534863 A JP2019534863 A JP 2019534863A JP 2019515630 A JP2019515630 A JP 2019515630A JP 2019515630 A JP2019515630 A JP 2019515630A JP 2019534863 A JP2019534863 A JP 2019534863A
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Japan
Prior art keywords
pharmaceutical composition
liquid pharmaceutical
antibody
concentration
buffer
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Pending
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JP2019515630A
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English (en)
Japanese (ja)
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JP2019534863A5 (enExample
Inventor
リオ，アレッサンドラ デル
リオ，アレッサンドラ デル
サビーナ，カルメラ
Original Assignee
フレゼニウス カービ ドイチュラント ゲーエムベーハー
フレゼニウス カービ ドイチュラント ゲーエムベーハー
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Application filed by フレゼニウス カービ ドイチュラント ゲーエムベーハー, フレゼニウス カービ ドイチュラント ゲーエムベーハー filed Critical フレゼニウス カービ ドイチュラント ゲーエムベーハー
Publication of JP2019534863A publication Critical patent/JP2019534863A/ja
Publication of JP2019534863A5 publication Critical patent/JP2019534863A5/ja
Priority to JP2022146770A priority Critical patent/JP2022188075A/ja
Priority to JP2024148123A priority patent/JP2024178197A/ja
Pending legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IGs], 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
    • 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
    • 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
    • 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
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (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)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Rheumatology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (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)
JP2019515630A 2016-09-27 2017-09-26 液体医薬組成物 Pending JP2019534863A (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2022146770A JP2022188075A (ja) 2016-09-27 2022-09-15 液体医薬組成物
JP2024148123A JP2024178197A (ja) 2016-09-27 2024-08-30 液体医薬組成物

Applications Claiming Priority (3)

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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2022146770A Division JP2022188075A (ja) 2016-09-27 2022-09-15 液体医薬組成物

Publications (2)

Publication Number Publication Date
JP2019534863A true JP2019534863A (ja) 2019-12-05
JP2019534863A5 JP2019534863A5 (enExample) 2020-08-20

Family

ID=57047015

Family Applications (3)

Application Number Title Priority Date Filing Date
JP2019515630A Pending JP2019534863A (ja) 2016-09-27 2017-09-26 液体医薬組成物
JP2022146770A Pending JP2022188075A (ja) 2016-09-27 2022-09-15 液体医薬組成物
JP2024148123A Pending JP2024178197A (ja) 2016-09-27 2024-08-30 液体医薬組成物

Family Applications After (2)

Application Number Title Priority Date Filing Date
JP2022146770A Pending JP2022188075A (ja) 2016-09-27 2022-09-15 液体医薬組成物
JP2024148123A Pending JP2024178197A (ja) 2016-09-27 2024-08-30 液体医薬組成物

Country Status (12)

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

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023540072A (ja) * 2020-08-31 2023-09-21 セルトリオン インク 安定した薬剤学的製剤
JP2024178197A (ja) * 2016-09-27 2024-12-24 フレゼニウス カービ ドイチュラント ゲーエムベーハー 液体医薬組成物

Families Citing this family (16)

* 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
EP4029881A1 (en) 2010-11-08 2022-07-20 F. Hoffmann-La Roche AG Subcutaneously administered anti-il-6 receptor antibody
EP3824906A1 (en) 2016-12-21 2021-05-26 Amgen Inc. Anti-tnf alpha antibody formulations
CA3083971A1 (en) * 2017-11-30 2019-06-06 Bio-Thera Solutions, Ltd. Liquid formulation of humanized antibody for treating il-6 related diseases
US11427639B2 (en) * 2018-04-02 2022-08-30 Richter Gedeon Nyrt. Antibody-containing aqueous formulation and use thereof
MA54095A (fr) * 2018-10-31 2022-02-09 Richter Gedeon Nyrt Formulations pharmaceutiques aqueuses
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
ES2987347T3 (es) * 2020-03-13 2024-11-14 Lek Pharmaceuticals Estabilización de composiciones farmacéuticas que comprenden polisorbato
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
WO2021228917A1 (en) * 2020-05-15 2021-11-18 F. Hoffmann-La Roche Ag Prevention of visible particle formation in parenteral protein solutions
US12281166B2 (en) 2020-05-26 2025-04-22 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
WO2022139457A1 (ko) * 2020-12-24 2022-06-30 이니스트에스티 주식회사 봉독 추출물로부터 bvPLA2를 50~99% 함량으로 포함하는 봉독 주사제 조성물 및 이의 제조방법
WO2024245170A1 (en) * 2023-05-26 2024-12-05 Bio-Thera Solutions, Ltd. Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases

Citations (4)

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Publication number Priority date Publication date Assignee Title
JP2012510468A (ja) * 2008-11-28 2012-05-10 アボット・ラボラトリーズ 安定な抗体組成物およびこれを安定させるための方法
JP2013516481A (ja) * 2010-01-08 2013-05-13 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 抗インターロイキン６受容体（ｉｌ−６ｒ）抗体を含有する安定化製剤
JP2013541594A (ja) * 2010-11-08 2013-11-14 ジェネンテック， インコーポレイテッド 皮下投与される抗ｉｌ−６受容体抗体
JP2015536934A (ja) * 2012-10-25 2015-12-24 メディミューン，エルエルシー 安定した低粘度の抗体製剤

Family Cites Families (14)

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Publication number Priority date Publication date Assignee Title
US5795965A (en) 1991-04-25 1998-08-18 Chugai Seiyaku Kabushiki Kaisha Reshaped human to human interleukin-6 receptor
WO2002013860A1 (en) 2000-08-11 2002-02-21 Chugai Seiyaku Kabushiki Kaisha Stabilized antibody-containing preparations
WO2003068259A1 (fr) 2002-02-14 2003-08-21 Chugai Seiyaku Kabushiki Kaisha Produits pharmaceutiques en solution contenant des anticorps
PE20091174A1 (es) * 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
EP2196476A1 (en) * 2008-12-10 2010-06-16 Novartis Ag Antibody formulation
KR101468271B1 (ko) * 2009-03-19 2014-12-03 추가이 세이야쿠 가부시키가이샤 개량된 항체분자를 함유하는 의약 제제
WO2011061712A1 (en) * 2009-11-20 2011-05-26 Biocon Limited Formulations of antibody
CA2783715A1 (en) * 2009-12-29 2011-07-07 F. Hoffmann-La Roche Ag Novel antibody formulation
UY34105A (es) * 2011-06-03 2012-07-31 Lg Life Sciences Ltd Formulación líquida estable de etanercept
CA2951856A1 (en) 2011-10-28 2013-05-02 Integritybio Inc. Protein formulations containing amino acids
EP3518891A1 (en) * 2016-09-27 2019-08-07 Fresenius Kabi Deutschland GmbH Liquid pharmaceutical composition
CA3083971A1 (en) * 2017-11-30 2019-06-06 Bio-Thera Solutions, Ltd. Liquid formulation of humanized antibody for treating il-6 related diseases
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

Patent Citations (4)

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Publication number Priority date Publication date Assignee Title
JP2012510468A (ja) * 2008-11-28 2012-05-10 アボット・ラボラトリーズ 安定な抗体組成物およびこれを安定させるための方法
JP2013516481A (ja) * 2010-01-08 2013-05-13 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 抗インターロイキン６受容体（ｉｌ−６ｒ）抗体を含有する安定化製剤
JP2013541594A (ja) * 2010-11-08 2013-11-14 ジェネンテック， インコーポレイテッド 皮下投与される抗ｉｌ−６受容体抗体
JP2015536934A (ja) * 2012-10-25 2015-12-24 メディミューン，エルエルシー 安定した低粘度の抗体製剤

Non-Patent Citations (2)

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Title
ARTHRITIS RESEARCH & THERAPY, 2015, VOL.17, #135, JPN6021031255, ISSN: 0004771757 *
JPN. J. CLIN. IMMUNOL., 2015, VOL.38, NO.6, PP.433-442, JPN6021031247, ISSN: 0004771756 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2024178197A (ja) * 2016-09-27 2024-12-24 フレゼニウス カービ ドイチュラント ゲーエムベーハー 液体医薬組成物
JP2023540072A (ja) * 2020-08-31 2023-09-21 セルトリオン インク 安定した薬剤学的製剤

Also Published As

Publication number Publication date
BR112019005328A2 (pt) 2019-06-18
AU2017333367A1 (en) 2019-04-04
RU2019112680A (ru) 2020-10-29
US20210261673A1 (en) 2021-08-26
EP3518891A1 (en) 2019-08-07
KR20190062440A (ko) 2019-06-05
US10961314B2 (en) 2021-03-30
RU2019112680A3 (enExample) 2020-12-15
WO2018060210A1 (en) 2018-04-05
JP2024178197A (ja) 2024-12-24
KR102546471B1 (ko) 2023-06-21
CA3037440A1 (en) 2018-04-05
US20190218300A1 (en) 2019-07-18
JP2022188075A (ja) 2022-12-20
US20240150479A1 (en) 2024-05-09
CN109862880A (zh) 2019-06-07
MA46334A (fr) 2019-08-07
ZA201901590B (en) 2020-10-28

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