HRP20140355T1 - Farmaceutska formulacija - Google Patents
Farmaceutska formulacija Download PDFInfo
- Publication number
- HRP20140355T1 HRP20140355T1 HRP20140355AT HRP20140355T HRP20140355T1 HR P20140355 T1 HRP20140355 T1 HR P20140355T1 HR P20140355A T HRP20140355A T HR P20140355AT HR P20140355 T HRP20140355 T HR P20140355T HR P20140355 T1 HRP20140355 T1 HR P20140355T1
- Authority
- HR
- Croatia
- Prior art keywords
- surfactant
- weight
- mixture
- ethanol
- range
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title claims 7
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 14
- 239000004094 surface-active agent Substances 0.000 claims 12
- 239000000203 mixture Substances 0.000 claims 11
- 150000001875 compounds Chemical class 0.000 claims 7
- 230000010412 perfusion Effects 0.000 claims 6
- 239000000243 solution Substances 0.000 claims 6
- 150000005690 diesters Chemical class 0.000 claims 4
- 239000002202 Polyethylene glycol Substances 0.000 claims 3
- 239000002253 acid Substances 0.000 claims 3
- 238000009472 formulation Methods 0.000 claims 3
- 239000000644 isotonic solution Substances 0.000 claims 3
- 238000000034 method Methods 0.000 claims 3
- 239000003186 pharmaceutical solution Substances 0.000 claims 3
- 229920001223 polyethylene glycol Polymers 0.000 claims 3
- 150000003839 salts Chemical class 0.000 claims 3
- ULQISTXYYBZJSJ-UHFFFAOYSA-N 12-hydroxyoctadecanoic acid Chemical compound CCCCCCC(O)CCCCCCCCCCC(O)=O ULQISTXYYBZJSJ-UHFFFAOYSA-N 0.000 claims 2
- 238000007865 diluting Methods 0.000 claims 2
- 239000013589 supplement Substances 0.000 claims 2
- 229940114072 12-hydroxystearic acid Drugs 0.000 claims 1
- BKVAAWMQOQLENB-UHFFFAOYSA-N 15-hydroxy stearic acid Chemical compound CCCC(O)CCCCCCCCCCCCCC(O)=O BKVAAWMQOQLENB-UHFFFAOYSA-N 0.000 claims 1
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims 1
- 238000001816 cooling Methods 0.000 claims 1
- 238000010790 dilution Methods 0.000 claims 1
- 239000012895 dilution Substances 0.000 claims 1
- 238000001914 filtration Methods 0.000 claims 1
- 238000010438 heat treatment Methods 0.000 claims 1
- 238000001802 infusion Methods 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 229960003511 macrogol Drugs 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- 230000001954 sterilising effect Effects 0.000 claims 1
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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
- 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
- A61P35/02—Antineoplastic agents specific for leukemia
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Dermatology (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oncology (AREA)
- Hematology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
Claims (16)
1. Farmaceutska formulacija, naznačena time što sadrži spoj formule (I):
[image]
,
u obliku baze, ili u obliku soli farmaceutski prihvatljive kiseline, solubilizirane u smjesi:
• etanola i
• surfaktanta koji sadrži smjesu polietoksiliranog mono- i diestera 12-hidroksistearinske kiseline, čije su odgovarajuće formule:
[image]
,
gdje je n cijeli broj, u rasponu od 15 do 16,
u smjesi surfaktant/etanol čiji je težinski omjer u rasponu od 25/75 do 80/20.
2. Farmaceutska formulacija u skladu s patentnim zahtjevom 1, naznačena time što je surfaktant surfaktantni makrogol 15-hidroksistearat.
3. Farmaceutska formulacija u skladu s patentnim zahtjevom 1 ili 2, naznačena time što smjesa surfaktant/etanol čiji je težinski omjer u rasponu od 73/27 do 77/23.
4. Formulacija u skladu s patentnim zahtjevom 2, naznačena time što surfaktant čini od 35 do 55%, težinski, mono- i diestera, te od 30 do 40%, težinski, polietilen-glikola H(OCH2CH2)n-OH.
5. Formulacija u skladu s patentnim zahtjevom 4, naznačena time što surfaktant kao glavne komponente sadrži od 35 do 55%, težinski, mono- i diestera, te od 30 do 40%, težinski, polietilen-glikola H(OCH2CH2)n-OH, kao i druge spojeve kao dopunu do 100%.
6. Formulacija u skladu s patentnim zahtjevom 1 ili 2, naznačena time što surfaktant čini od 10 do 20%, težinski, monoestera, od 25 do 35%, težinski, diestera, te od 30 do 40%, težinski, polietilen-glikola H(OCH2CH2)n-OH, kao i druge spojeve kao dopunu do 100%.
7. Farmaceutska formulacija u skladu s patentnim zahtjevom 1 do 6, naznačena time što je omjer surfaktant/etanol u rasponu od 73/27 do 77/23, a koncentracija spoja formule (I) je u rasponu od 5 do 25 mg/ml.
8. Farmaceutska formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačena time što je namijenjena za razrjeđivanje kojim se dobiva perfuzijska otopina.
9. Postupak priprave farmaceutske formulacije u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačen time što se sastoji u sljedećim koracima:
– grijanja surfaktanta dok ne postane tekuć;
– dodavanja etanola;
– hlađenja smjese surfaktant/etanol do temperature okoliša;
– dodavanja spoja formule (I) u ohlađenu smjesu;
– steriliziranja gotove smjese.
10. Postupak u skladu s patentnim zahtjevom 9, naznačen time što se smjesu sterilizira filtriranjem.
11. Perfuzijska otopina, naznačena time što sadrži spoj formule (I):
[image]
,
u obliku baze, ili u obliku soli farmaceutski prihvatljive kiseline,
dobivene razrjeđivanjem 1 volumena farmaceutske otopine u skladu s patentnim zahtjevom 1 do 8 u 20 do 500 volumena izotonične otopine.
12. Perfuzijska otopina, naznačena time što sadrži spoj formule (I):
[image]
,
u obliku baze, ili u obliku soli farmaceutski prihvatljive kiseline, u rasponu koncentracija od 0,01 do 1,2 mg/ml, surfaktant u skladu s bilo kojim od patentnih zahtjeva 1 do 7 u rasponu koncentracija od 0,48 do 37 mg/ml, te etanol u rasponu koncentracija od 0,35 do 35 mg/ml, razrijeđen u izotoničnoj otopini.
13. Perfuzijska otopina u skladu s patentnim zahtjevom 11 ili 12, naznačena time što je namijenjena primjeni na čovjeku.
14. Postupak priprave perfuzijske otopine, naznačen time što se sastoji u razrjeđivanju 1 volumena farmaceutske otopine u skladu s patentnim zahtjevom 1 do 8 u 20 do 500 volumena izotonične otopine.
15. Boca, naznačena time što sadrži farmaceutsku otopinu u skladu s bilo kojim od patentnih zahtjeva 1 do 8.
16. Vreća za polaganu infuziju, naznačena time što sadrži perfuzijsku otopinu u skladu s patentnim zahtjevom 11 do 13.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR0903742A FR2948568B1 (fr) | 2009-07-30 | 2009-07-30 | Formulation pharmaceutique |
PCT/FR2010/051611 WO2011012816A2 (fr) | 2009-07-30 | 2010-07-29 | Formulation pharmaceutique |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20140355T1 true HRP20140355T1 (hr) | 2014-06-20 |
Family
ID=41570922
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20140355AT HRP20140355T1 (hr) | 2009-07-30 | 2014-04-14 | Farmaceutska formulacija |
Country Status (40)
Country | Link |
---|---|
US (1) | US20120202831A1 (hr) |
EP (1) | EP2459221B1 (hr) |
JP (1) | JP5658754B2 (hr) |
KR (1) | KR20120052943A (hr) |
CN (1) | CN102470176B (hr) |
AR (1) | AR077338A1 (hr) |
AU (1) | AU2010277406B2 (hr) |
BR (1) | BR112012002105A2 (hr) |
CA (1) | CA2769477A1 (hr) |
CL (1) | CL2012000231A1 (hr) |
CO (1) | CO6491065A2 (hr) |
CR (1) | CR20120047A (hr) |
CY (1) | CY1115043T1 (hr) |
DK (1) | DK2459221T3 (hr) |
DO (1) | DOP2012000011A (hr) |
EA (1) | EA021059B1 (hr) |
ES (1) | ES2458419T3 (hr) |
FR (1) | FR2948568B1 (hr) |
HK (1) | HK1169960A1 (hr) |
HN (1) | HN2012000182A (hr) |
HR (1) | HRP20140355T1 (hr) |
IL (1) | IL217762A0 (hr) |
MA (1) | MA33462B1 (hr) |
MX (1) | MX2012001386A (hr) |
MY (1) | MY183312A (hr) |
NI (1) | NI201200017A (hr) |
NZ (1) | NZ597963A (hr) |
PE (1) | PE20120619A1 (hr) |
PL (1) | PL2459221T3 (hr) |
PT (1) | PT2459221E (hr) |
RS (1) | RS53266B (hr) |
SG (1) | SG177754A1 (hr) |
SI (1) | SI2459221T1 (hr) |
SM (1) | SMT201400069B (hr) |
TN (1) | TN2011000659A1 (hr) |
TW (1) | TWI478921B (hr) |
UA (1) | UA105229C2 (hr) |
UY (1) | UY32816A (hr) |
WO (1) | WO2011012816A2 (hr) |
ZA (1) | ZA201200719B (hr) |
Families Citing this family (20)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2012088266A2 (en) | 2010-12-22 | 2012-06-28 | Incyte Corporation | Substituted imidazopyridazines and benzimidazoles as inhibitors of fgfr3 |
ME02651B (me) | 2012-06-13 | 2017-06-20 | Incyte Holdings Corp | Substituisana triciklična jedinjenja kao inhibitori fgfr |
US9388185B2 (en) | 2012-08-10 | 2016-07-12 | Incyte Holdings Corporation | Substituted pyrrolo[2,3-b]pyrazines as FGFR inhibitors |
US9266892B2 (en) | 2012-12-19 | 2016-02-23 | Incyte Holdings Corporation | Fused pyrazoles as FGFR inhibitors |
CA2909207C (en) | 2013-04-19 | 2021-11-02 | Incyte Corporation | Bicyclic heterocycles as fgfr inhibitors |
US10851105B2 (en) | 2014-10-22 | 2020-12-01 | Incyte Corporation | Bicyclic heterocycles as FGFR4 inhibitors |
WO2016134294A1 (en) | 2015-02-20 | 2016-08-25 | Incyte Corporation | Bicyclic heterocycles as fgfr4 inhibitors |
CR20170390A (es) | 2015-02-20 | 2017-10-23 | Incyte Holdings Corp | Heterociclos biciclicos como inhibidores de fgfr |
MA41551A (fr) | 2015-02-20 | 2017-12-26 | Incyte Corp | Hétérocycles bicycliques utilisés en tant qu'inhibiteurs de fgfr4 |
AR111960A1 (es) | 2017-05-26 | 2019-09-04 | Incyte Corp | Formas cristalinas de un inhibidor de fgfr y procesos para su preparación |
WO2019213544A2 (en) | 2018-05-04 | 2019-11-07 | Incyte Corporation | Solid forms of an fgfr inhibitor and processes for preparing the same |
BR112020022373A2 (pt) | 2018-05-04 | 2021-02-02 | Incyte Corporation | sais de um inibidor de fgfr |
WO2020185532A1 (en) | 2019-03-08 | 2020-09-17 | Incyte Corporation | Methods of treating cancer with an fgfr inhibitor |
US11591329B2 (en) | 2019-07-09 | 2023-02-28 | Incyte Corporation | Bicyclic heterocycles as FGFR inhibitors |
JOP20220083A1 (ar) | 2019-10-14 | 2023-01-30 | Incyte Corp | حلقات غير متجانسة ثنائية الحلقة كمثبطات لـ fgfr |
US11566028B2 (en) | 2019-10-16 | 2023-01-31 | Incyte Corporation | Bicyclic heterocycles as FGFR inhibitors |
JP2023505258A (ja) | 2019-12-04 | 2023-02-08 | インサイト・コーポレイション | Fgfr阻害剤としての三環式複素環 |
BR112022010664A2 (pt) | 2019-12-04 | 2022-08-16 | Incyte Corp | Derivados de um inibidor de fgfr |
WO2021146424A1 (en) | 2020-01-15 | 2021-07-22 | Incyte Corporation | Bicyclic heterocycles as fgfr inhibitors |
TW202313611A (zh) | 2021-06-09 | 2023-04-01 | 美商英塞特公司 | 作為fgfr抑制劑之三環雜環 |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE2911241A1 (de) | 1979-03-22 | 1980-10-02 | Basf Ag | Alkoxylierte fettsaeuren, verfahren zu deren herstellung und ihre anwendung als loesungsvermittler |
HU201567B (en) * | 1988-07-21 | 1990-11-28 | Gyogyszerkutato Intezet | Process for production of intravenous medical compositions containing cyclosphorin |
WO1996011007A1 (en) * | 1994-10-05 | 1996-04-18 | Glaxo Wellcome Inc. | Parenteral pharmaceutical compositions containing gf120918a |
US5922754A (en) * | 1998-10-02 | 1999-07-13 | Abbott Laboratories | Pharmaceutical compositions containing paclitaxel |
US8618085B2 (en) * | 2000-04-28 | 2013-12-31 | Koasn Biosciences Incorporated | Therapeutic formulations of desoxyepothilones |
KR100866728B1 (ko) * | 2004-11-12 | 2008-11-03 | 주식회사종근당 | 타크로리무스를 함유하는 주사제 |
FR2879932B1 (fr) * | 2004-12-27 | 2007-03-23 | Aventis Pharma Sa | Formulations injectable ou administrable par voie orale de derives d'azetidine |
FR2887882B1 (fr) * | 2005-07-01 | 2007-09-07 | Sanofi Aventis Sa | Derives de pyrido[2,3-d] pyrimidine, leur preparation, leur application en therapeutique |
FR2910813B1 (fr) * | 2006-12-28 | 2009-02-06 | Sanofi Aventis Sa | Nouvelle utilisation therapeutique pour le traitement des leucemies |
DE102007021862A1 (de) * | 2007-05-10 | 2008-11-13 | Merck Patent Gmbh | Wässrige pharmazeutische Zubereitung |
-
2009
- 2009-07-30 FR FR0903742A patent/FR2948568B1/fr not_active Expired - Fee Related
-
2010
- 2010-07-29 PL PL10762950T patent/PL2459221T3/pl unknown
- 2010-07-29 PT PT107629503T patent/PT2459221E/pt unknown
- 2010-07-29 RS RS20140195A patent/RS53266B/en unknown
- 2010-07-29 DK DK10762950.3T patent/DK2459221T3/da active
- 2010-07-29 EP EP10762950.3A patent/EP2459221B1/fr active Active
- 2010-07-29 PE PE2012000117A patent/PE20120619A1/es not_active Application Discontinuation
- 2010-07-29 JP JP2012522231A patent/JP5658754B2/ja not_active Expired - Fee Related
- 2010-07-29 AR ARP100102748A patent/AR077338A1/es unknown
- 2010-07-29 BR BR112012002105A patent/BR112012002105A2/pt not_active IP Right Cessation
- 2010-07-29 SI SI201030587T patent/SI2459221T1/sl unknown
- 2010-07-29 SG SG2012005435A patent/SG177754A1/en unknown
- 2010-07-29 MY MYPI2012000425A patent/MY183312A/en unknown
- 2010-07-29 KR KR1020127002290A patent/KR20120052943A/ko not_active Application Discontinuation
- 2010-07-29 CN CN201080033686.4A patent/CN102470176B/zh not_active Expired - Fee Related
- 2010-07-29 NZ NZ597963A patent/NZ597963A/en not_active IP Right Cessation
- 2010-07-29 AU AU2010277406A patent/AU2010277406B2/en not_active Ceased
- 2010-07-29 CA CA2769477A patent/CA2769477A1/fr not_active Abandoned
- 2010-07-29 MX MX2012001386A patent/MX2012001386A/es active IP Right Grant
- 2010-07-29 WO PCT/FR2010/051611 patent/WO2011012816A2/fr active Application Filing
- 2010-07-29 EA EA201270216A patent/EA021059B1/ru not_active IP Right Cessation
- 2010-07-29 MA MA34577A patent/MA33462B1/fr unknown
- 2010-07-29 ES ES10762950.3T patent/ES2458419T3/es active Active
- 2010-07-29 UA UAA201202339A patent/UA105229C2/uk unknown
- 2010-07-30 UY UY0001032816A patent/UY32816A/es not_active Application Discontinuation
- 2010-07-30 TW TW099125517A patent/TWI478921B/zh not_active IP Right Cessation
-
2011
- 2011-12-22 TN TNP2011000659A patent/TN2011000659A1/fr unknown
-
2012
- 2012-01-19 DO DO2012000011A patent/DOP2012000011A/es unknown
- 2012-01-20 CO CO12008121A patent/CO6491065A2/es not_active Application Discontinuation
- 2012-01-24 CR CR20120047A patent/CR20120047A/es unknown
- 2012-01-26 CL CL2012000231A patent/CL2012000231A1/es unknown
- 2012-01-26 IL IL217762A patent/IL217762A0/en unknown
- 2012-01-27 HN HN2012000182A patent/HN2012000182A/es unknown
- 2012-01-27 NI NI201200017A patent/NI201200017A/es unknown
- 2012-01-30 US US13/361,309 patent/US20120202831A1/en not_active Abandoned
- 2012-01-30 ZA ZA2012/00719A patent/ZA201200719B/en unknown
- 2012-10-30 HK HK12110849.8A patent/HK1169960A1/xx not_active IP Right Cessation
-
2014
- 2014-04-14 HR HRP20140355AT patent/HRP20140355T1/hr unknown
- 2014-04-22 CY CY20141100298T patent/CY1115043T1/el unknown
- 2014-06-12 SM SM201400069T patent/SMT201400069B/xx unknown
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