CU24348B1 - Formulaciones orales de deferasirox - Google Patents

Formulaciones orales de deferasirox

Info

Publication number
CU24348B1
CU24348B1 CUP2015000110A CU20150110A CU24348B1 CU 24348 B1 CU24348 B1 CU 24348B1 CU P2015000110 A CUP2015000110 A CU P2015000110A CU 20150110 A CU20150110 A CU 20150110A CU 24348 B1 CU24348 B1 CU 24348B1
Authority
CU
Cuba
Prior art keywords
formulations
deferasirox formulations
oral
oral deferasirox
neutral
Prior art date
Application number
CUP2015000110A
Other languages
English (en)
Other versions
CU20150110A7 (es
Inventor
Indrajit Ghosh
Jia-Ai Zhang
Original Assignee
Novartis Ag
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=50288212&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CU24348(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis Ag filed Critical Novartis Ag
Publication of CU20150110A7 publication Critical patent/CU20150110A7/es
Publication of CU24348B1 publication Critical patent/CU24348B1/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/12—Ketones
    • A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
    • A61K31/125—Camphor; Nuclear substituted derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4196—1,2,4-Triazoles
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/148—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with compounds of unknown constitution, e.g. material from plants or animals
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893—Tablet coating processes
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5089—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A61P39/04—Chelating agents
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Toxicology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Obesity (AREA)
  • Botany (AREA)
  • Zoology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

<p>Las formulaciones de deferasirox administrables por vía oral se describen por tener liberación reducida bajo condiciones gástricas y liberación rápida a pH casi neutro o a pH neutro.</p>
CUP2015000110A 2013-03-08 2014-03-06 Formulaciones orales de deferasirox CU24348B1 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361774893P 2013-03-08 2013-03-08
US201361824435P 2013-05-17 2013-05-17
PCT/IB2014/059494 WO2014136079A1 (en) 2013-03-08 2014-03-06 Oral formulations of deferasirox

Publications (2)

Publication Number Publication Date
CU20150110A7 CU20150110A7 (es) 2016-04-25
CU24348B1 true CU24348B1 (es) 2018-05-08

Family

ID=50288212

Family Applications (1)

Application Number Title Priority Date Filing Date
CUP2015000110A CU24348B1 (es) 2013-03-08 2014-03-06 Formulaciones orales de deferasirox

Country Status (42)

Country Link
US (4) US9283209B2 (es)
EP (2) EP2964202B2 (es)
JP (3) JP6434429B2 (es)
KR (2) KR20170045391A (es)
CN (1) CN105025886B (es)
AP (1) AP2015008668A0 (es)
AU (2) AU2014224198B2 (es)
BR (1) BR112015021254A2 (es)
CA (1) CA2890465A1 (es)
CL (1) CL2015002495A1 (es)
CR (1) CR20150467A (es)
CU (1) CU24348B1 (es)
CY (2) CY1120021T1 (es)
DK (2) DK2964202T3 (es)
DO (1) DOP2015000220A (es)
EA (1) EA031719B1 (es)
EC (1) ECSP15042897A (es)
ES (2) ES2663135T3 (es)
HK (1) HK1212242A1 (es)
HR (2) HRP20180387T1 (es)
HU (2) HUE036921T2 (es)
IL (1) IL240797B (es)
JO (1) JO3570B1 (es)
LT (2) LT2964202T (es)
ME (1) ME03297B (es)
MX (1) MX361055B (es)
MY (1) MY170303A (es)
NI (1) NI201500126A (es)
NZ (1) NZ711179A (es)
PE (1) PE20151600A1 (es)
PH (1) PH12015501981B1 (es)
PL (2) PL3124018T3 (es)
PT (2) PT3124018T (es)
RS (2) RS56890B1 (es)
SA (1) SA515360425B1 (es)
SG (2) SG10201807204YA (es)
SI (2) SI2964202T1 (es)
TN (1) TN2015000393A1 (es)
TW (2) TWI625136B (es)
UY (1) UY35367A (es)
WO (1) WO2014136079A1 (es)
ZA (1) ZA201506060B (es)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI625136B (zh) 2013-03-08 2018-06-01 諾華公司 祛鐵斯若（ｄｅｆｅｒａｓｉｒｏｘ）之口服配方
US9866684B2 (en) * 2015-02-16 2018-01-09 Microsoft Technology Licensing, Llc Process for real-time data exchange between users on a phone call
WO2016167729A1 (en) * 2015-04-16 2016-10-20 Öğün Yusuf Toktamiş Dispersible tablets comprising deferasirox
EP3310354A4 (en) * 2015-06-17 2018-12-12 Dispersol Technologies, LLC Improved formulations of deferasirox and methods of making the same
EP3429562A1 (en) 2016-03-17 2019-01-23 Lupin Limited Compositions of deferasirox
CA2937365C (en) 2016-03-29 2018-09-18 F. Hoffmann-La Roche Ag Granulate formulation of 5-methyl-1-phenyl-2-(1h)-pyridone and method of making the same
CA3029543C (en) * 2016-07-05 2021-11-23 Jubilant Generics Limited Immediate release pharmaceutical composition of iron chelating agents
EP3518904A1 (en) 2016-09-30 2019-08-07 Synthon B.V. Pharmaceutical composition comprising deferasirox
CZ2017255A3 (cs) 2017-05-04 2018-11-14 Zentiva, K.S. Filmem potažené tablety Deferasiroxu
TR201707764A2 (tr) * 2017-05-29 2018-12-21 Biofarma Ilac Sanayi Ve Ticaret Anonim Sirketi Deferasiroksun bölünebilir tablet formları.
WO2019108156A1 (en) * 2017-11-28 2019-06-06 Biofarma Ilac Sanayi Ve Ticaret A.S. A scored tablet formulation comprising deferasirox in a film tablet form
KR20200113116A (ko) 2019-03-22 2020-10-06 주식회사 한국팜비오 데페라시록스를 포함하는 필름코팅정제
WO2022186809A1 (en) * 2021-03-05 2022-09-09 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi The film coated tablet comprising deferasirox
CN115154428B (zh) * 2022-09-06 2023-01-10 上海奥科达医药科技股份有限公司 一种地拉罗司药物组合物及其制备方法

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MY129541A (en) * 1996-06-25 2007-04-30 Novartis Ag Substituded 3,5-diphenyl-1,2,4-triazoles and their use as pharmaceutical metal chelators
GB0223978D0 (en) 2002-10-15 2002-11-20 Novartis Ag Organic compound
GB0408078D0 (en) * 2004-04-08 2004-05-12 Novartis Ag Organic compounds
KR20070022243A (ko) * 2004-04-08 2007-02-26 노파르티스 아게 데페라시록스 분산성 정제
RU2008119410A (ru) 2005-10-19 2009-11-27 Новартис АГ (CH) Диспергируемые таблетки, включающие деферасирокс
WO2009067557A1 (en) 2007-11-19 2009-05-28 Teva Pharmaceutical Industries Ltd. Deferasirox pharmaceutical compositions
WO2009106824A2 (en) 2008-02-25 2009-09-03 Cipla Limited Pharmaceutical formulations
WO2009130604A2 (en) 2008-04-21 2009-10-29 Actavis Group Ptc Ehf Solid state forms of deferasirox salts and process for the preparation thereof
WO2010035282A1 (en) 2008-09-24 2010-04-01 Matrix Laboratories Limited Pharmaceutical compositions comprising deferasirox
WO2010143006A1 (en) * 2009-06-10 2010-12-16 Carlo Ghisalberti Orally bioavailable iron chelators in the treatment of an inflammatory bowel disease
US8703203B2 (en) * 2010-07-08 2014-04-22 Ratiopharm Gmbh Oral dosage form of deferasirox
EP2621471A2 (en) 2010-10-01 2013-08-07 Cipla Limited Pharmaceutical composition comprising deferasirox
TWI625136B (zh) 2013-03-08 2018-06-01 諾華公司 祛鐵斯若（ｄｅｆｅｒａｓｉｒｏｘ）之口服配方
EP3429562A1 (en) 2016-03-17 2019-01-23 Lupin Limited Compositions of deferasirox

Also Published As

Publication number Publication date
AU2014224198B2 (en) 2017-06-15
TN2015000393A1 (en) 2017-01-03
PT2964202T (pt) 2019-02-06
US20180221285A1 (en) 2018-08-09
RS58317B1 (sr) 2019-03-29
AP2015008668A0 (en) 2015-08-31
CN105025886B (zh) 2019-01-15
HRP20180387T1 (hr) 2018-04-20
HK1212242A1 (en) 2016-06-10
EP2964202B2 (en) 2023-05-31
UY35367A (es) 2014-10-31
KR20150126900A (ko) 2015-11-13
EP2964202B1 (en) 2018-10-31
IL240797A0 (en) 2015-10-29
KR20170045391A (ko) 2017-04-26
SG10201807204YA (en) 2018-09-27
PL2964202T3 (pl) 2019-04-30
LT3124018T (lt) 2018-03-12
US9283209B2 (en) 2016-03-15
ES2663135T3 (es) 2018-04-11
HUE036921T2 (hu) 2018-08-28
RS56890B1 (sr) 2018-04-30
EP2964202A1 (en) 2016-01-13
CY1121315T1 (el) 2020-05-29
BR112015021254A2 (pt) 2017-07-18
DOP2015000220A (es) 2015-11-30
PT3124018T (pt) 2018-03-22
IL240797B (en) 2022-01-01
AU2017203897A1 (en) 2017-06-29
SI2964202T1 (sl) 2019-02-28
CA2890465A1 (en) 2014-09-12
ES2708955T3 (es) 2019-04-12
JO3570B1 (ar) 2020-07-05
CN105025886A (zh) 2015-11-04
EP3124018A1 (en) 2017-02-01
KR101925671B1 (ko) 2019-02-27
PH12015501981A1 (en) 2016-01-11
TW201838623A (zh) 2018-11-01
CY1120021T1 (el) 2018-12-12
AU2014224198A1 (en) 2015-09-10
HUE041224T2 (hu) 2019-05-28
US20170290811A1 (en) 2017-10-12
EP3124018B2 (en) 2024-04-24
ECSP15042897A (es) 2019-03-29
EA201591665A1 (ru) 2015-12-30
TW201442742A (zh) 2014-11-16
CL2015002495A1 (es) 2016-03-04
JP2020180123A (ja) 2020-11-05
EP3124018B1 (en) 2017-12-20
NI201500126A (es) 2015-11-18
LT2964202T (lt) 2019-02-11
SA515360425B1 (ar) 2018-01-21
MY170303A (en) 2019-07-17
JP6434429B2 (ja) 2018-12-05
WO2014136079A1 (en) 2014-09-12
ME03297B (me) 2019-07-20
CU20150110A7 (es) 2016-04-25
PE20151600A1 (es) 2015-11-26
US20150017241A1 (en) 2015-01-15
DK3124018T3 (en) 2018-03-26
JP6739470B2 (ja) 2020-08-12
SG11201506491RA (en) 2015-09-29
US20160220493A1 (en) 2016-08-04
JP2018162255A (ja) 2018-10-18
JP2016510068A (ja) 2016-04-04
ES2708955T5 (es) 2023-11-10
TWI686215B (zh) 2020-03-01
AU2017203897B2 (en) 2019-02-14
SI3124018T1 (en) 2018-04-30
ZA201506060B (en) 2016-12-21
NZ711179A (en) 2018-07-27
PH12015501981B1 (en) 2016-01-11
HRP20190173T1 (hr) 2019-03-22
MX2015011962A (es) 2016-07-07
MX361055B (es) 2018-11-26
PL3124018T3 (pl) 2018-05-30
EA031719B1 (ru) 2019-02-28
TWI625136B (zh) 2018-06-01
CR20150467A (es) 2015-10-27
DK2964202T3 (en) 2019-02-25

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