SI3124018T1 - Peroralne formulacije deferasiroksa - Google Patents

Peroralne formulacije deferasiroksa Download PDF

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Publication number
SI3124018T1
SI3124018T1 SI201430621T SI201430621T SI3124018T1 SI 3124018 T1 SI3124018 T1 SI 3124018T1 SI 201430621 T SI201430621 T SI 201430621T SI 201430621 T SI201430621 T SI 201430621T SI 3124018 T1 SI3124018 T1 SI 3124018T1
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SI
Slovenia
Prior art keywords
tablet
deferasirox
film
oral administration
administration according
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SI201430621T
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English (en)
Inventor
Indrajit Ghosh
Jia-Ai Zhang
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Novartis Ag
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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=SI3124018(T1) "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 SI3124018T1 publication Critical patent/SI3124018T1/sl

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    • 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
    • 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
    • A61K9/2886—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

Claims (9)

  1. Peroralne formulacije deferasiroksa Patentni zahtevki
    1. Filmsko obložena tableta za peroralno dajanje, ki vsebuje deferasiroks ali njegovo farmacevtsko sprejemljivo sol v količini 45-60 mas. % glede na celotno maso tablete in kjer tableta vsebuje 90 mg, 180 mg ali 360 mg deferasiroksa ali njegove farmacevtsko sprejemljive soli, kjer tableta nadalje obsega: (i) vsaj eno polnilo v celotni količini 10^10 mas. % glede na celotno maso tablete, kjer je polnilo mikrokristalinična celuloza; (ii) vsaj eno razgrajevalo v celotni količini 1-10 mas.% glede na celotno maso tablete, kjer je razgrajevalo premrežen polivinilpirolidon (krospovidon); (iii) vsaj eno vezivo v celotni količini 1-5 mas. % glede na celotno maso tablete, kjer je vezivo polivinilpirolidon (PVP); (iv) po izbiri vsaj eno površinsko aktivno snov v celotni količini 0,0-2 mas. % glede na celotno maso tablete, kjer je površinsko aktivna snov poloksamer; (v) vsaj eno drsilo v celotni količini 0,1-1 mas. % glede na celotno maso tablete, kjer je drsilo koloidni silicijev dioksid; (vi) vsaj eno mazivo v celotni količini manj kot 0,1-2 mas. % glede na celotno maso tablete, kjer je mazivo magnezijev stearat, in (vii) oblogo.
  2. 2. Filmsko obložena tableta za peroralno dajanje po zahtevku 1, kjer tableta vsebuje 90 mg deferasiroksa ali njegove farmacevtsko sprejemljive soli.
  3. 3. Filmsko obložena tableta za peroralno dajanje po zahtevku 1, kjer tableta vsebuje 180 mg deferasiroksa ali njegove farmacevtsko sprejemljive soli.
  4. 4. Filmsko obložena tableta za peroralno dajanje po zahtevku 1, kjer tableta vsebuje 360 mg deferasiroksa ali njegove farmacevtsko sprejemljive soli.
  5. 5. Filmsko obložena tableta za peroralno dajanje po katerem koli od prejšnjih zahtevkov, kjer tableta izkazuje čas razpada 5-10 min pri merjenju s standardnim USP-preizkusom razpadnosti.
  6. 6. Filmsko obložena tableta za peroralno dajanje po zahtevku 1, ki sestoji iz 90 mg deferasiroksa; 53,61 mg mikrokristalinične celuloze; 3,65 mg polivinilpirolidona; 11,34 mg krospovidona; 0,16 mg poloksamera 188; 0,81 mg koloidnega silicijevega dioksida; 2,43 mg magnezijevega stearata in 4.86 mg obloge.
  7. 7. Filmsko obložena tableta za peroralno dajanje po zahtevku 1, ki sestoji iz 180 mg deferasiroksa; 107,23 mg mikrokristalinične celuloze; 7,29 mg polivinilpirolidona; 22,68 mg krospovidona; 0,32 mg poloksamera 188; 1,62 mg koloidnega silicijevega dioksida; 4.86 mg magnezijevega stearata in 9,72 mg obloge.
  8. 8. Filmsko obložena tableta za peroralno dajanje po zahtevku 1, ki sestoji iz 360 mg deferasiroksa; 215,45 mg mikrokristalinične celuloze; 14,58 mg polivinilpirolidona; 45,36 mg krospovidona; 0,65 mg poloksamera 188; 3,24 mg koloidnega silicijevega dioksida; 9,72 mg magnezijevega stearata in 19,44 mg obloge.
  9. 9. Filmsko obložena tableta za peroralno dajanje po zahtevku 1, ki obsega:
SI201430621T 2013-03-08 2014-03-06 Peroralne formulacije deferasiroksa SI3124018T1 (sl)

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
EP16188627.0A EP3124018B2 (en) 2013-03-08 2014-03-06 Oral formulations of deferasirox

Publications (1)

Publication Number Publication Date
SI3124018T1 true SI3124018T1 (sl) 2018-04-30

Family

ID=50288212

Family Applications (2)

Application Number Title Priority Date Filing Date
SI201431064T SI2964202T1 (sl) 2013-03-08 2014-03-06 Peroralne formulacije deferasiroksa
SI201430621T SI3124018T1 (sl) 2013-03-08 2014-03-06 Peroralne formulacije deferasiroksa

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SI201431064T SI2964202T1 (sl) 2013-03-08 2014-03-06 Peroralne formulacije deferasiroksa

Country Status (42)

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US (4) US9283209B2 (sl)
EP (2) EP3124018B2 (sl)
JP (3) JP6434429B2 (sl)
KR (2) KR20170045391A (sl)
CN (1) CN105025886B (sl)
AP (1) AP2015008668A0 (sl)
AU (2) AU2014224198B2 (sl)
BR (1) BR112015021254A2 (sl)
CA (1) CA2890465A1 (sl)
CL (1) CL2015002495A1 (sl)
CR (1) CR20150467A (sl)
CU (1) CU24348B1 (sl)
CY (2) CY1120021T1 (sl)
DK (2) DK3124018T3 (sl)
DO (1) DOP2015000220A (sl)
EA (1) EA031719B1 (sl)
EC (1) ECSP15042897A (sl)
ES (2) ES2708955T5 (sl)
HK (1) HK1212242A1 (sl)
HR (2) HRP20180387T1 (sl)
HU (2) HUE041224T2 (sl)
IL (1) IL240797B (sl)
JO (1) JO3570B1 (sl)
LT (2) LT3124018T (sl)
ME (1) ME03297B (sl)
MX (1) MX361055B (sl)
MY (1) MY170303A (sl)
NI (1) NI201500126A (sl)
NZ (1) NZ711179A (sl)
PE (1) PE20151600A1 (sl)
PH (1) PH12015501981A1 (sl)
PL (2) PL3124018T3 (sl)
PT (2) PT3124018T (sl)
RS (2) RS58317B1 (sl)
SA (1) SA515360425B1 (sl)
SG (2) SG10201807204YA (sl)
SI (2) SI2964202T1 (sl)
TN (1) TN2015000393A1 (sl)
TW (2) TWI625136B (sl)
UY (1) UY35367A (sl)
WO (1) WO2014136079A1 (sl)
ZA (1) ZA201506060B (sl)

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WO2018059922A1 (en) 2016-09-30 2018-04-05 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
EP4052698A1 (en) * 2021-03-05 2022-09-07 Sanovel Ilac Sanayi Ve Ticaret A.S. 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

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GB0223978D0 (en) * 2002-10-15 2002-11-20 Novartis Ag Organic compound
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CU20150110A7 (es) 2016-04-25
SI2964202T1 (sl) 2019-02-28
TWI625136B (zh) 2018-06-01
NZ711179A (en) 2018-07-27
HK1212242A1 (en) 2016-06-10
TW201838623A (zh) 2018-11-01
EP3124018A1 (en) 2017-02-01
AP2015008668A0 (en) 2015-08-31
KR20150126900A (ko) 2015-11-13
CR20150467A (es) 2015-10-27
DK2964202T3 (en) 2019-02-25
IL240797A0 (en) 2015-10-29
ME03297B (me) 2019-07-20
JP2020180123A (ja) 2020-11-05
US20160220493A1 (en) 2016-08-04
BR112015021254A2 (pt) 2017-07-18
JP6739470B2 (ja) 2020-08-12
CY1120021T1 (el) 2018-12-12
CY1121315T1 (el) 2020-05-29
PT2964202T (pt) 2019-02-06
HUE036921T2 (hu) 2018-08-28
CU24348B1 (es) 2018-05-08
EP3124018B1 (en) 2017-12-20
EA201591665A1 (ru) 2015-12-30
EP2964202B2 (en) 2023-05-31
TWI686215B (zh) 2020-03-01
JP6434429B2 (ja) 2018-12-05
SG10201807204YA (en) 2018-09-27
LT2964202T (lt) 2019-02-11
AU2014224198A1 (en) 2015-09-10
US9283209B2 (en) 2016-03-15
IL240797B (en) 2022-01-01
RS56890B1 (sr) 2018-04-30
WO2014136079A1 (en) 2014-09-12
CN105025886A (zh) 2015-11-04
AU2014224198B2 (en) 2017-06-15
UY35367A (es) 2014-10-31
ECSP15042897A (es) 2019-03-29
NI201500126A (es) 2015-11-18
KR20170045391A (ko) 2017-04-26
PH12015501981B1 (en) 2016-01-11
EP2964202B1 (en) 2018-10-31
HRP20180387T1 (hr) 2018-04-20
EP3124018B2 (en) 2024-04-24
ES2708955T5 (es) 2023-11-10
US20180221285A1 (en) 2018-08-09
HRP20190173T1 (hr) 2019-03-22
CA2890465A1 (en) 2014-09-12
US20150017241A1 (en) 2015-01-15
KR101925671B1 (ko) 2019-02-27
PE20151600A1 (es) 2015-11-26
PL3124018T3 (pl) 2018-05-30
US20170290811A1 (en) 2017-10-12
ES2708955T3 (es) 2019-04-12
JP2018162255A (ja) 2018-10-18
DOP2015000220A (es) 2015-11-30
LT3124018T (lt) 2018-03-12
ES2663135T3 (es) 2018-04-11
PH12015501981A1 (en) 2016-01-11
EA031719B1 (ru) 2019-02-28
MY170303A (en) 2019-07-17
JO3570B1 (ar) 2020-07-05
EP2964202A1 (en) 2016-01-13
TN2015000393A1 (en) 2017-01-03
MX361055B (es) 2018-11-26
PL2964202T3 (pl) 2019-04-30
ZA201506060B (en) 2016-12-21
SA515360425B1 (ar) 2018-01-21
MX2015011962A (es) 2016-07-07
AU2017203897B2 (en) 2019-02-14
PT3124018T (pt) 2018-03-22
AU2017203897A1 (en) 2017-06-29
CL2015002495A1 (es) 2016-03-04
SG11201506491RA (en) 2015-09-29
HUE041224T2 (hu) 2019-05-28
DK3124018T3 (en) 2018-03-26
JP2016510068A (ja) 2016-04-04
CN105025886B (zh) 2019-01-15
TW201442742A (zh) 2014-11-16
RS58317B1 (sr) 2019-03-29

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