BR9714434A - Formulações de interferon liquidas estáveis - Google Patents
Formulações de interferon liquidas estáveisInfo
- Publication number
- BR9714434A BR9714434A BR9714434-7A BR9714434A BR9714434A BR 9714434 A BR9714434 A BR 9714434A BR 9714434 A BR9714434 A BR 9714434A BR 9714434 A BR9714434 A BR 9714434A
- Authority
- BR
- Brazil
- Prior art keywords
- liquid
- interferon
- compositions
- stable liquid
- beta
- Prior art date
Links
- 239000007788 liquid Substances 0.000 title abstract 8
- 239000000203 mixture Substances 0.000 title abstract 7
- 102000014150 Interferons Human genes 0.000 title abstract 5
- 108010050904 Interferons Proteins 0.000 title abstract 5
- 229940079322 interferon Drugs 0.000 title abstract 5
- 238000009472 formulation Methods 0.000 title abstract 2
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 abstract 2
- 102000003996 Interferon-beta Human genes 0.000 abstract 2
- 108090000467 Interferon-beta Proteins 0.000 abstract 2
- 150000001413 amino acids Chemical class 0.000 abstract 2
- 229960001388 interferon-beta Drugs 0.000 abstract 2
- 239000004475 Arginine Substances 0.000 abstract 1
- 239000004471 Glycine Substances 0.000 abstract 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 abstract 1
- 230000002378 acidificating effect Effects 0.000 abstract 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 abstract 1
- 239000000463 material Substances 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 238000007911 parenteral administration Methods 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
- 238000001179 sorption measurement Methods 0.000 abstract 1
- 239000003381 stabilizer Substances 0.000 abstract 1
- 230000000087 stabilizing effect Effects 0.000 abstract 1
Classifications
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- 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
-
- 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
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/21—Interferons [IFN]
- A61K38/215—IFN-beta
-
- 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
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
- A61P31/18—Antivirals for RNA viruses for HIV
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/04—Antineoplastic agents specific for metastasis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Virology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Molecular Biology (AREA)
- Psychiatry (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Hospice & Palliative Care (AREA)
- Tropical Medicine & Parasitology (AREA)
- Dermatology (AREA)
- AIDS & HIV (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Abstract
Patente de Invenção: <B>"FORMULAçõES DE INTERFERON LìQUIDAS ESTáVEIS"<D>. São descritas composições de interferon líquidas tendo um pH entre 4,0 e 7,2. As composições compreendem interferon-beta e um agente de estabilização entre cerca de 0,3% e 5% em peso que é um aminoácido selecionado do grupo que consiste de aminoácidos ácidos, arginina e glicina. Se necessário, sal é adicionado para prover concentração iónica suficiente. A composição líquida não foi anteriormente liofilizada ou anteriormente cavitada. O líquido está de preferência contido dentro de um recipiente tendo pelo menos uma superfície em contato com o líquido que é revestido com um material inerte à adsorção de interferon-beta. São descritos um kit para a administração parenteral de uma formulação de interferon líquida e um método para a estabilização de composições de interferon líquidas.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US3435396P | 1996-12-24 | 1996-12-24 | |
PCT/US1997/023817 WO1998028007A1 (en) | 1996-12-24 | 1997-12-23 | Stable liquid interferon formulations |
Publications (1)
Publication Number | Publication Date |
---|---|
BR9714434A true BR9714434A (pt) | 2000-05-02 |
Family
ID=21875893
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BR9714434-7A BR9714434A (pt) | 1996-12-24 | 1997-12-23 | Formulações de interferon liquidas estáveis |
Country Status (28)
Country | Link |
---|---|
EP (1) | EP0948358B2 (pt) |
JP (5) | JP4878664B2 (pt) |
KR (2) | KR101042660B1 (pt) |
CN (2) | CN1222315C (pt) |
AT (1) | ATE270899T1 (pt) |
AU (1) | AU738362B2 (pt) |
BG (2) | BG65171B1 (pt) |
BR (1) | BR9714434A (pt) |
CA (1) | CA2275890C (pt) |
CZ (1) | CZ300636B6 (pt) |
DE (1) | DE69729880T3 (pt) |
DK (1) | DK0948358T4 (pt) |
EA (1) | EA002754B1 (pt) |
EE (2) | EE04266B1 (pt) |
ES (1) | ES2224290T5 (pt) |
HK (2) | HK1025040A1 (pt) |
HU (1) | HU224222B1 (pt) |
IL (1) | IL130524A (pt) |
IS (1) | IS2070B (pt) |
MX (1) | MX337876B (pt) |
NO (1) | NO327844B1 (pt) |
NZ (2) | NZ336548A (pt) |
PL (1) | PL193447B1 (pt) |
PT (1) | PT948358E (pt) |
SI (1) | SI0948358T2 (pt) |
SK (1) | SK284989B6 (pt) |
TR (1) | TR199901968T2 (pt) |
WO (1) | WO1998028007A1 (pt) |
Families Citing this family (69)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20030190307A1 (en) | 1996-12-24 | 2003-10-09 | Biogen, Inc. | Stable liquid interferon formulations |
HU224222B1 (hu) * | 1996-12-24 | 2005-06-28 | Biogen Inc. | Stabil folyékony interferon-készítményformák és eljárás interferon stabilizálására |
CA2304808C (en) | 1997-09-23 | 2011-03-22 | Michael Tschope | Liquid interferon-.beta. formulations |
CA2375779A1 (en) * | 1999-05-31 | 2000-12-07 | Mitsubishi Chemical Corporation | Lyophilized hgf preparation |
US6887462B2 (en) * | 2001-04-09 | 2005-05-03 | Chiron Corporation | HSA-free formulations of interferon-beta |
UY27373A1 (es) * | 2001-07-09 | 2003-02-28 | Schering Ag | Formulaciones de interferón beta-humano |
AU2002351756A1 (en) | 2001-12-21 | 2003-07-15 | Novo Nordisk Health Care Ag | Liquid composition of factor vii polypeptides |
JP4340540B2 (ja) * | 2002-01-18 | 2009-10-07 | 旭化成ファーマ株式会社 | 可溶性トロンボモジュリン高濃度含有製剤 |
AU2003240438A1 (en) | 2002-06-21 | 2004-01-06 | Novo Nordisk A/S | Stabilised solid compositions of factor vii polypeptides |
US7407955B2 (en) | 2002-08-21 | 2008-08-05 | Boehringer Ingelheim Pharma Gmbh & Co., Kg | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions |
US7897734B2 (en) | 2003-03-26 | 2011-03-01 | Novo Nordisk Healthcare Ag | Method for the production of proteins |
TWI272948B (en) * | 2003-05-01 | 2007-02-11 | Ares Trading Sa | HSA-free stabilized interferon liquid formulations |
AR044302A1 (es) * | 2003-05-13 | 2005-09-07 | Ares Trading Sa | Formulaciones con proteinas liquidas estabilizadas en recipientes farmaceuticos |
EP1628677B1 (en) | 2003-05-23 | 2010-01-13 | Novo Nordisk Health Care AG | Protein stabilization in solution |
CN1318087C (zh) * | 2003-06-06 | 2007-05-30 | 北京三诺佳邑生物技术有限责任公司 | 去白蛋白神经生长因子制剂 |
KR101293503B1 (ko) | 2003-08-14 | 2013-08-07 | 노보 노르디스크 헬스 케어 악티엔게젤샤프트 | 인자 vii 폴리펩티드의 액상 수성 약학적 조성물 |
WO2005051456A2 (en) * | 2003-11-13 | 2005-06-09 | Alza Corporation | Composition and apparatus for transdermal delivery |
EP1532983A1 (en) * | 2003-11-18 | 2005-05-25 | ZLB Bioplasma AG | Immunoglobulin preparations having increased stability |
PL2298287T3 (pl) | 2003-12-19 | 2019-02-28 | Novo Nordisk Health Care Ag | Stabilizowane kompozycje polipeptydów czynnika VII |
UA93349C2 (ru) * | 2004-06-01 | 2011-02-10 | Эйрэс Трейдинг C.A. | Способ стабилизации мономерного белка интерферона |
WO2006022301A1 (ja) * | 2004-08-24 | 2006-03-02 | Daiichi Asubio Pharma Co., Ltd. | 生理活性ペプチド液状製剤 |
DE102004054054A1 (de) | 2004-11-05 | 2006-05-11 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Verfahren zur Herstellung chiraler 8-(3-Amino-piperidin-1-yl)-xanthine |
PL1809662T3 (pl) * | 2004-11-10 | 2009-07-31 | Novartis Vaccines & Diagnostics Inc | Dezamidowany interferon-beta |
BRPI0606658B8 (pt) | 2005-01-12 | 2021-05-25 | Biogen Idec Inc | método para armazenar e distribuir interferon-beta, e dispositivo |
WO2006079019A2 (en) * | 2005-01-21 | 2006-07-27 | Alza Corporation | Therapeutic peptide formulations for coating microneedles with improved stabitity containing at least one counterion |
ATE501248T1 (de) | 2005-07-02 | 2011-03-15 | Arecor Ltd | Stabile wässrige systeme mit proteinen |
DE102005035891A1 (de) | 2005-07-30 | 2007-02-08 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | 8-(3-Amino-piperidin-1-yl)-xanthine, deren Herstellung und deren Verwendung als Arzneimittel |
CN103951667A (zh) | 2006-05-04 | 2014-07-30 | 勃林格殷格翰国际有限公司 | 多晶型 |
PE20080251A1 (es) | 2006-05-04 | 2008-04-25 | Boehringer Ingelheim Int | Usos de inhibidores de dpp iv |
EP1852108A1 (en) | 2006-05-04 | 2007-11-07 | Boehringer Ingelheim Pharma GmbH & Co.KG | DPP IV inhibitor formulations |
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EP2234645B1 (en) | 2007-12-20 | 2012-05-02 | Merck Serono S.A. | Peg-interferon-beta formulations |
AR071175A1 (es) | 2008-04-03 | 2010-06-02 | Boehringer Ingelheim Int | Composicion farmaceutica que comprende un inhibidor de la dipeptidil-peptidasa-4 (dpp4) y un farmaco acompanante |
CA2726824A1 (en) | 2008-05-01 | 2009-11-05 | Arecor Limited | Protein formulation |
EP2328607A1 (en) | 2008-07-16 | 2011-06-08 | Arecor Limited | Stable formulation of a therapeutic protein |
BRPI0916997A2 (pt) | 2008-08-06 | 2020-12-15 | Boehringer Ingelheim International Gmbh | Inibidor de dpp-4 e seu uso |
UY32030A (es) | 2008-08-06 | 2010-03-26 | Boehringer Ingelheim Int | "tratamiento para diabetes en pacientes inapropiados para terapia con metformina" |
AU2009290911A1 (en) | 2008-09-10 | 2010-03-18 | Boehringer Ingelheim International Gmbh | Combination therapy for the treatment of diabetes and related conditions |
DE102008051574A1 (de) | 2008-10-14 | 2010-04-15 | Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. | Verfahren zur Herstellung von Interferon-beta und deren Varianten |
US20200155558A1 (en) | 2018-11-20 | 2020-05-21 | Boehringer Ingelheim International Gmbh | Treatment for diabetes in patients with insufficient glycemic control despite therapy with an oral antidiabetic drug |
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TW201036975A (en) | 2009-01-07 | 2010-10-16 | Boehringer Ingelheim Int | Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy |
DE102009032179A1 (de) | 2009-07-07 | 2011-01-13 | Biogenerix Ag | Verfahren zur Reinigung von Interferon beta |
AU2010323068B2 (en) | 2009-11-27 | 2015-09-03 | Boehringer Ingelheim International Gmbh | Treatment of genotyped diabetic patients with DPP-IV inhibitors such as linagliptin |
JP6078344B2 (ja) | 2010-02-04 | 2017-02-08 | ツェー・エス・エル・ベーリング・アクチエンゲゼルシャフト | 免疫グロブリン製剤 |
EP2361636A1 (en) | 2010-02-26 | 2011-08-31 | CSL Behring AG | Immunoglobulin preparation and storage system for an immunoglobulin preparation |
DE102010011430A1 (de) * | 2010-03-15 | 2011-09-15 | Kurt Koch | Verfahren für den Bau des Nullenergiehauses in Schalenbauweise durch Ausschäumen aller Wände, Decken und Bedachung |
EA033415B1 (ru) | 2010-05-05 | 2019-10-31 | Boehringer Ingelheim Int | Способы лечения ожирения, применение ингибитора dpp-4 в этих способах и способ лечения пациентов, страдающих диабетом типа 2 |
BR112012032579B1 (pt) | 2010-06-24 | 2021-05-11 | Boehringer Ingelheim International Gmbh | uso de linagliptina e composição farmacêutica compreendendo linagliptina e insulina basal de longa duração |
AR083878A1 (es) | 2010-11-15 | 2013-03-27 | Boehringer Ingelheim Int | Terapia antidiabetica vasoprotectora y cardioprotectora, linagliptina, metodo de tratamiento |
US9452216B2 (en) | 2010-12-09 | 2016-09-27 | Maruishi Pharmaceutical Co., Ltd. | Agent for stabilizing acetaminophen |
US9198955B2 (en) * | 2011-03-15 | 2015-12-01 | Biogen Inc. | Method for reducing flu-like symptoms associated with intramuscular administration of interferon using a fast titration escalating dosing regimen |
NZ618698A (en) | 2011-07-15 | 2015-08-28 | Boehringer Ingelheim Int | Substituted quinazolines, the preparation thereof and the use thereof in pharmaceutical compositions |
US9555001B2 (en) | 2012-03-07 | 2017-01-31 | Boehringer Ingelheim International Gmbh | Pharmaceutical composition and uses thereof |
US20130280346A1 (en) * | 2012-04-19 | 2013-10-24 | C. R. Bard, Inc. | Infusates with Enhanced pH Stability Under Ethylene Oxide Sterilization |
JP6224084B2 (ja) | 2012-05-14 | 2017-11-01 | ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング | 糸球体上皮細胞関連障害及び/又はネフローゼ症候群の治療に用いるdpp−4阻害薬としてのキサンチン誘導体 |
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TW249202B (pt) * | 1993-08-13 | 1995-06-11 | Ciba Gerigy Corp | |
US5545723A (en) * | 1994-03-15 | 1996-08-13 | Biogen Inc. | Muteins of IFN-β |
CA2185353A1 (en) * | 1994-04-08 | 1995-10-19 | David A. Hafler | Treatment of autoimmune disease using oral tolerization and/or type i interferon |
IT1272252B (it) * | 1994-05-16 | 1997-06-16 | Applied Research Systems | Formulazioni liquide di interferone beta |
TW426523B (en) * | 1995-04-06 | 2001-03-21 | Hoffmann La Roche | Interferon solution |
HU224222B1 (hu) * | 1996-12-24 | 2005-06-28 | Biogen Inc. | Stabil folyékony interferon-készítményformák és eljárás interferon stabilizálására |
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1997
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1999
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2000
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2001
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2006
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2007
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2011
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2014
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