AR099838A1 - Formulación de factor ix liofilizada, vial, kit y método para producir un polvo liofilizado - Google Patents
Formulación de factor ix liofilizada, vial, kit y método para producir un polvo liofilizadoInfo
- Publication number
- AR099838A1 AR099838A1 ARP150100880A ARP150100880A AR099838A1 AR 099838 A1 AR099838 A1 AR 099838A1 AR P150100880 A ARP150100880 A AR P150100880A AR P150100880 A ARP150100880 A AR P150100880A AR 099838 A1 AR099838 A1 AR 099838A1
- Authority
- AR
- Argentina
- Prior art keywords
- formulation
- hours
- temperature
- lyophilization
- lyophilization formulation
- Prior art date
Links
- 238000009472 formulation Methods 0.000 title abstract 15
- 239000000203 mixture Substances 0.000 title abstract 15
- 229960004222 factor ix Drugs 0.000 title abstract 2
- 238000000034 method Methods 0.000 title abstract 2
- 239000000843 powder Substances 0.000 title 1
- 238000004108 freeze drying Methods 0.000 abstract 12
- 238000007710 freezing Methods 0.000 abstract 4
- 230000008014 freezing Effects 0.000 abstract 4
- 229920001184 polypeptide Polymers 0.000 abstract 4
- 108090000765 processed proteins & peptides Proteins 0.000 abstract 4
- 102000004196 processed proteins & peptides Human genes 0.000 abstract 4
- 239000008176 lyophilized powder Substances 0.000 abstract 3
- 238000005496 tempering Methods 0.000 abstract 3
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 abstract 2
- 239000000945 filler Substances 0.000 abstract 2
- 102100022641 Coagulation factor IX Human genes 0.000 abstract 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 abstract 1
- 108010076282 Factor IX Proteins 0.000 abstract 1
- 229930195725 Mannitol Natural products 0.000 abstract 1
- 229920001213 Polysorbate 20 Polymers 0.000 abstract 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 abstract 1
- 229930006000 Sucrose Natural products 0.000 abstract 1
- 239000006172 buffering agent Substances 0.000 abstract 1
- 230000015271 coagulation Effects 0.000 abstract 1
- 238000005345 coagulation Methods 0.000 abstract 1
- 238000001035 drying Methods 0.000 abstract 1
- 230000000694 effects Effects 0.000 abstract 1
- 108700007283 factor IX Fc fusion Proteins 0.000 abstract 1
- 229960002885 histidine Drugs 0.000 abstract 1
- 239000000594 mannitol Substances 0.000 abstract 1
- 235000010355 mannitol Nutrition 0.000 abstract 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 abstract 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 abstract 1
- 229940068977 polysorbate 20 Drugs 0.000 abstract 1
- 239000003381 stabilizer Substances 0.000 abstract 1
- 239000005720 sucrose Substances 0.000 abstract 1
- 239000004094 surface-active agent Substances 0.000 abstract 1
- 239000002562 thickening agent Substances 0.000 abstract 1
Classifications
-
- 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
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
- A61K38/482—Serine endopeptidases (3.4.21)
- A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
-
- 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
- A61K47/22—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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
- C12Y304/21—Serine endopeptidases (3.4.21)
- C12Y304/21022—Coagulation factor IXa (3.4.21.22)
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- General Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Mechanical Engineering (AREA)
- Immunology (AREA)
- Genetics & Genomics (AREA)
- Gastroenterology & Hepatology (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Monitoring And Testing Of Transmission In General (AREA)
- Mobile Radio Communication Systems (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201461969801P | 2014-03-24 | 2014-03-24 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR099838A1 true AR099838A1 (es) | 2016-08-24 |
Family
ID=54196282
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP150100880A AR099838A1 (es) | 2014-03-24 | 2015-03-25 | Formulación de factor ix liofilizada, vial, kit y método para producir un polvo liofilizado |
Country Status (16)
| Country | Link |
|---|---|
| US (3) | US10772942B2 (enExample) |
| EP (1) | EP3123090A4 (enExample) |
| JP (4) | JP7058940B2 (enExample) |
| KR (1) | KR102385372B1 (enExample) |
| AR (1) | AR099838A1 (enExample) |
| AU (3) | AU2015236340B2 (enExample) |
| CA (1) | CA2943034C (enExample) |
| CL (1) | CL2016002386A1 (enExample) |
| EA (2) | EA038573B1 (enExample) |
| IL (3) | IL247869B (enExample) |
| MA (1) | MA39779A (enExample) |
| MX (2) | MX387269B (enExample) |
| PH (1) | PH12016501877A1 (enExample) |
| SG (3) | SG11201607642RA (enExample) |
| TW (1) | TWI700101B (enExample) |
| WO (1) | WO2015148444A1 (enExample) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI788044B (zh) | 2013-03-15 | 2022-12-21 | 美商百歐維拉提夫治療公司 | 因子ｉｘ多肽調配物 |
| US10772942B2 (en) | 2014-03-24 | 2020-09-15 | Bioverativ Therapeutics Inc. | Lyophilized factor IX formulations |
| IL319473A (en) * | 2016-12-02 | 2025-05-01 | Bioverativ Therapeutics Inc | Methods for treating hemophilic arthritis using chimeric blood clotting factors |
| BR112020000592A2 (pt) * | 2017-07-11 | 2020-07-14 | Universal Stabilization Technologies, Inc. | método para conservar materiais biológicos |
| CN112175088B (zh) * | 2019-07-02 | 2023-03-28 | 江苏晟斯生物制药有限公司 | 改进的fix融合蛋白、缀合物及其应用 |
| WO2021158759A2 (en) | 2020-02-04 | 2021-08-12 | Regeneron Pharmaceuticals, Inc. | Target residual moisture content for lyophilized drug product |
| BR112022022869A2 (pt) * | 2020-05-11 | 2023-01-31 | Alkermes Pharma Ireland Ltd | Composições de polipeptídeo de fusão de il-2 e métodos de fabricação e uso destas |
| CN118557531B (zh) * | 2024-08-02 | 2024-10-18 | 成都蓉生药业有限责任公司 | 一种重组人凝血因子VIII-Fc融合蛋白冻干制剂的制备方法 |
Family Cites Families (58)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0154316B1 (en) | 1984-03-06 | 1989-09-13 | Takeda Chemical Industries, Ltd. | Chemically modified lymphokine and production thereof |
| JP2989002B2 (ja) | 1988-12-22 | 1999-12-13 | キリン―アムジエン・インコーポレーテツド | 化学修飾顆粒球コロニー刺激因子 |
| AU648020B2 (en) | 1989-02-21 | 1994-04-14 | Washington University | Modified forms of reproductive hormones |
| US6552170B1 (en) | 1990-04-06 | 2003-04-22 | Amgen Inc. | PEGylation reagents and compounds formed therewith |
| ATE240740T1 (de) | 1991-03-15 | 2003-06-15 | Amgen Inc | Pegylation von polypeptiden |
| FR2686899B1 (fr) | 1992-01-31 | 1995-09-01 | Rhone Poulenc Rorer Sa | Nouveaux polypeptides biologiquement actifs, leur preparation et compositions pharmaceutiques les contenant. |
| MX9306133A (es) * | 1992-10-02 | 1994-04-29 | Kabi Pharmacia Ab | Composicion que comprende una formulacion del factor de coagulacion viii, proceso para su preparacion y uso de un surfactante como estabilizador. |
| DE4405426A1 (de) | 1994-02-21 | 1995-08-24 | Boehringer Mannheim Gmbh | Pharmazeutisches Präparat enthaltend Plasminogenaktivator (t-PA) oder dessen Derivate |
| US6372716B1 (en) | 1994-04-26 | 2002-04-16 | Genetics Institute, Inc. | Formulations for factor IX |
| US6685940B2 (en) | 1995-07-27 | 2004-02-03 | Genentech, Inc. | Protein formulation |
| US5770700A (en) * | 1996-01-25 | 1998-06-23 | Genetics Institute, Inc. | Liquid factor IX formulations |
| IN184589B (enExample) * | 1996-10-16 | 2000-09-09 | Alza Corp | |
| US20010031721A1 (en) | 1999-05-05 | 2001-10-18 | Chandra Webb | Highly concentrated, lyophilized, and liquid factor IX formulations |
| AU7313400A (en) * | 1999-09-17 | 2001-04-24 | Takeda Chemical Industries Ltd. | Process for producing protein powder |
| JP2001151694A (ja) | 1999-09-17 | 2001-06-05 | Takeda Chem Ind Ltd | タンパク質粉体の製造法 |
| MXPA02007733A (es) | 2000-02-11 | 2004-09-10 | Merck Patent Gmbh | Mejoramiento de la vida media circulante de proteinas de fusion basadas en anticuerpos. |
| WO2002040544A2 (en) | 2000-11-14 | 2002-05-23 | Board Of Regents, University Of Texas Systems | Mutant human factor ix with an increased resistance to inhibition by heparin |
| PL369065A1 (en) | 2001-09-04 | 2005-04-18 | Merck Patent Gmbh | Modified factor ix |
| EP2277888A3 (en) | 2001-12-21 | 2011-04-27 | Human Genome Sciences, Inc. | Fusion proteins of albumin and erythropoietin |
| EP3002012A1 (en) | 2003-05-06 | 2016-04-06 | Biogen Hemophilia Inc. | Clotting factor-fc chimeric proteins to treat hemophilia |
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| JP2005060378A (ja) | 2003-07-28 | 2005-03-10 | Yamanouchi Pharmaceut Co Ltd | 生理活性蛋白質含有凍結乾燥製剤 |
| US20050152979A1 (en) | 2003-09-05 | 2005-07-14 | Cell Therapeutics, Inc. | Hydrophobic drug compositions containing reconstitution enhancer |
| ATE507822T1 (de) | 2003-12-19 | 2011-05-15 | Novo Nordisk Healthcare Ag | Stabilisierte zusammensetzungen von faktor-vii- polypeptiden |
| BRPI0509117A (pt) | 2004-03-04 | 2007-08-28 | Wyeth Corp | método de liofilização para melhorar a cristalização de excipientes |
| WO2006029467A1 (en) * | 2004-09-16 | 2006-03-23 | Btf Pty Ltd | Rapid freeze drying process |
| PT2371856T (pt) | 2004-11-12 | 2022-08-12 | Bayer Healthcare Llc | Modificação de fviii direcionada a sítio |
| US8367805B2 (en) | 2004-11-12 | 2013-02-05 | Xencor, Inc. | Fc variants with altered binding to FcRn |
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| PL2650305T3 (pl) | 2006-03-24 | 2024-09-16 | Bioverativ Therapeutics Inc. | PC5 jako enzym przetwarzający propeptyd czynnika IX |
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| TW200804416A (en) | 2006-06-19 | 2008-01-16 | Nautilus Technology Llc | Modified coagulation factor IX polypeptides and use thereof for treatment |
| US8015841B2 (en) * | 2006-09-08 | 2011-09-13 | Praxair Technology, Inc. | Cryogenic refrigeration system for lyophilization |
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| CN101970678B (zh) | 2007-06-21 | 2014-08-20 | 慕尼黑科技大学 | 具有增加的体内和/或体外稳定性的生物学活性蛋白 |
| AU2008311973B2 (en) | 2007-10-15 | 2013-10-03 | Cangene Corporation | Human Factor IX variants with an extended half life |
| BRPI0821591A2 (pt) | 2007-12-21 | 2016-05-03 | Inspiration Biopharmaceuticals Inc | composição liofilizada e métodos de preparação de composição seca estável do fator ix e de liofilização de formulação farmacêutica |
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| CA2729972C (en) | 2008-08-05 | 2018-11-20 | Wyeth Llc | Lyophilization above collapse |
| CA2737407A1 (en) | 2008-09-24 | 2010-04-01 | Stabilitech Ltd. | Method for preserving polypeptides using a sugar and polyethyleneimine |
| MX2011013722A (es) | 2009-06-18 | 2012-05-08 | Wyeth Llc | Formulaciones liofilizadas para inmunofarmaceuticos modulares pequeños. |
| EP2458990B1 (en) | 2009-07-28 | 2016-03-30 | Merck Sharp & Dohme Corp. | Methods for producing high concentration lyophilized pharmaceutical formulations |
| CN103140237A (zh) * | 2010-07-09 | 2013-06-05 | 比奥根艾迪克依蒙菲利亚公司 | 因子ix多肽及其使用方法 |
| TWI507397B (zh) | 2010-09-30 | 2015-11-11 | Toyama Chemical Co Ltd | ６－氟－３－羥－２－吡羧醯胺之美洛明鹽 |
| EA029972B1 (ru) | 2011-02-09 | 2018-06-29 | ГЛЭКСОСМИТКЛАЙН ЭлЭлСи | Способы получения полипептидных композиций |
| AU2013270682A1 (en) | 2012-06-08 | 2014-12-11 | Biogen Ma Inc. | Procoagulant compounds |
| EP3542861A1 (en) * | 2012-09-25 | 2019-09-25 | Bioverativ Therapeutics Inc. | Methods of using fix polypeptides |
| TWI788044B (zh) | 2013-03-15 | 2022-12-21 | 美商百歐維拉提夫治療公司 | 因子ｉｘ多肽調配物 |
| US10772942B2 (en) | 2014-03-24 | 2020-09-15 | Bioverativ Therapeutics Inc. | Lyophilized factor IX formulations |
-
2015
- 2015-03-24 US US15/128,951 patent/US10772942B2/en active Active
- 2015-03-24 EA EA201691807A patent/EA038573B1/ru unknown
- 2015-03-24 CA CA2943034A patent/CA2943034C/en active Active
- 2015-03-24 KR KR1020167028692A patent/KR102385372B1/ko active Active
- 2015-03-24 SG SG11201607642RA patent/SG11201607642RA/en unknown
- 2015-03-24 EP EP15769411.8A patent/EP3123090A4/en active Pending
- 2015-03-24 SG SG10201913735SA patent/SG10201913735SA/en unknown
- 2015-03-24 JP JP2016558751A patent/JP7058940B2/ja active Active
- 2015-03-24 SG SG10201808249VA patent/SG10201808249VA/en unknown
- 2015-03-24 AU AU2015236340A patent/AU2015236340B2/en not_active Withdrawn - After Issue
- 2015-03-24 WO PCT/US2015/022141 patent/WO2015148444A1/en not_active Ceased
- 2015-03-24 EA EA202092926A patent/EA202092926A3/ru unknown
- 2015-03-24 TW TW104109389A patent/TWI700101B/zh active
- 2015-03-24 MX MX2016012447A patent/MX387269B/es unknown
- 2015-03-24 MA MA039779A patent/MA39779A/fr unknown
- 2015-03-25 AR ARP150100880A patent/AR099838A1/es unknown
-
2016
- 2016-09-18 IL IL247869A patent/IL247869B/en active IP Right Grant
- 2016-09-22 CL CL2016002386A patent/CL2016002386A1/es unknown
- 2016-09-23 PH PH12016501877A patent/PH12016501877A1/en unknown
- 2016-09-23 MX MX2021012939A patent/MX2021012939A/es unknown
-
2020
- 2020-01-26 IL IL272257A patent/IL272257B/en active IP Right Grant
- 2020-02-03 JP JP2020016131A patent/JP2020063313A/ja active Pending
- 2020-04-30 AU AU2020202863A patent/AU2020202863B2/en active Active
- 2020-08-17 US US16/995,173 patent/US12128092B2/en active Active
-
2021
- 2021-03-02 IL IL281197A patent/IL281197B/en unknown
-
2022
- 2022-01-20 JP JP2022007013A patent/JP7503583B2/ja active Active
- 2022-08-10 AU AU2022215218A patent/AU2022215218B2/en active Active
-
2024
- 2024-03-06 JP JP2024033771A patent/JP7759978B2/ja active Active
- 2024-09-24 US US18/894,851 patent/US20250121042A1/en active Pending
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