HRP20130108T1 - Farmaceutski sastav koji sadrži aleglitazar - Google Patents
Farmaceutski sastav koji sadrži aleglitazar Download PDFInfo
- Publication number
- HRP20130108T1 HRP20130108T1 HRP20130108AT HRP20130108T HRP20130108T1 HR P20130108 T1 HRP20130108 T1 HR P20130108T1 HR P20130108A T HRP20130108A T HR P20130108AT HR P20130108 T HRP20130108 T HR P20130108T HR P20130108 T1 HRP20130108 T1 HR P20130108T1
- Authority
- HR
- Croatia
- Prior art keywords
- pharmaceutical composition
- sodium
- aleglitazar
- salt
- solution
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title claims 18
- DAYKLWSKQJBGCS-NRFANRHFSA-N aleglitazar Chemical compound C1=2C=CSC=2C(C[C@H](OC)C(O)=O)=CC=C1OCCC(=C(O1)C)N=C1C1=CC=CC=C1 DAYKLWSKQJBGCS-NRFANRHFSA-N 0.000 title claims 7
- 229950010157 aleglitazar Drugs 0.000 title claims 7
- 238000000034 method Methods 0.000 claims 13
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 6
- 239000000243 solution Substances 0.000 claims 6
- 239000000203 mixture Substances 0.000 claims 5
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims 4
- 239000000314 lubricant Substances 0.000 claims 4
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 4
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 4
- 150000003839 salts Chemical class 0.000 claims 4
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 3
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 3
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims 3
- 229960001681 croscarmellose sodium Drugs 0.000 claims 3
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 3
- 239000003085 diluting agent Substances 0.000 claims 3
- 235000019359 magnesium stearate Nutrition 0.000 claims 3
- 229940069328 povidone Drugs 0.000 claims 3
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims 3
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 2
- 229920002472 Starch Polymers 0.000 claims 2
- 239000011230 binding agent Substances 0.000 claims 2
- 239000008101 lactose Substances 0.000 claims 2
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 2
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 2
- 239000008108 microcrystalline cellulose Substances 0.000 claims 2
- 159000000000 sodium salts Chemical class 0.000 claims 2
- 235000019698 starch Nutrition 0.000 claims 2
- 229940032147 starch Drugs 0.000 claims 2
- 239000008107 starch Substances 0.000 claims 2
- 239000004094 surface-active agent Substances 0.000 claims 2
- OKMWKBLSFKFYGZ-UHFFFAOYSA-N 1-behenoylglycerol Chemical compound CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(O)CO OKMWKBLSFKFYGZ-UHFFFAOYSA-N 0.000 claims 1
- 208000024172 Cardiovascular disease Diseases 0.000 claims 1
- 229920000881 Modified starch Polymers 0.000 claims 1
- 235000021355 Stearic acid Nutrition 0.000 claims 1
- 239000007864 aqueous solution Substances 0.000 claims 1
- 239000001768 carboxy methyl cellulose Substances 0.000 claims 1
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims 1
- 229910000397 disodium phosphate Inorganic materials 0.000 claims 1
- 235000019800 disodium phosphate Nutrition 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 claims 1
- 229940049654 glyceryl behenate Drugs 0.000 claims 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 1
- 229960001375 lactose Drugs 0.000 claims 1
- 229940057948 magnesium stearate Drugs 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 229910000403 monosodium phosphate Inorganic materials 0.000 claims 1
- 235000019799 monosodium phosphate Nutrition 0.000 claims 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical group CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims 1
- 239000008363 phosphate buffer Substances 0.000 claims 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 1
- 229920002503 polyoxyethylene-polyoxypropylene Polymers 0.000 claims 1
- 229920000053 polysorbate 80 Polymers 0.000 claims 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 1
- 238000011321 prophylaxis Methods 0.000 claims 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 claims 1
- 239000001488 sodium phosphate Substances 0.000 claims 1
- 239000008109 sodium starch glycolate Substances 0.000 claims 1
- 229920003109 sodium starch glycolate Polymers 0.000 claims 1
- 229940079832 sodium starch glycolate Drugs 0.000 claims 1
- 229940045902 sodium stearyl fumarate Drugs 0.000 claims 1
- 238000005507 spraying Methods 0.000 claims 1
- 239000008117 stearic acid Substances 0.000 claims 1
- 229960004274 stearic acid Drugs 0.000 claims 1
- 238000011282 treatment Methods 0.000 claims 1
- 208000001072 type 2 diabetes mellitus Diseases 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
- A61K31/41—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
- A61K31/42—Oxazoles
- A61K31/422—Oxazoles not condensed and containing further heterocyclic rings
-
- 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
-
- 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
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Diabetes (AREA)
- Heart & Thoracic Surgery (AREA)
- Biophysics (AREA)
- Cardiology (AREA)
- Molecular Biology (AREA)
- Endocrinology (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Urology & Nephrology (AREA)
- Emergency Medicine (AREA)
- Vascular Medicine (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
Claims (17)
1. Farmaceutski sastav, naznačen time, da sadrži 0,01 mg do 0,9 mg aleglitazara ili njegove soli, koji se dobiva pomoću:
(a) raspršivanja otopine, koja sadrži aleglitazar ili njegovu sol, na razrjeđivač i dezintegrator;
(b) miješanja s lubrikantom sastava dobivenog u koraku (a); i
(c) opcijski stlačivanja sastava dobivenog u koraku (b).
2. Postupak za proizvodnju farmaceutskog sastava, koji sadrži 0,01 mg do 0,9 mg aleglitazara ili njegove soli, naznačen time, da obuhvaća:
(a) raspršivanje otopine, koja sadrži aleglitazar ili njegovu sol, na razrjeđivač i dezintegrator;
(b) miješanje s lubrikantom sastava dobivenog u koraku (a); i
(c) opcijski stlačivanje sastava dobivenog u koraku (b).
3. Farmaceutski sastav ili postupak prema zahtjevu 1 ili 2, naznačen time, da otopina iz koraka (a) je vodena otopina.
4. Farmaceutski sastav ili postupak prema bilo kojem od zahtjeva 1 do 3, naznačen time, da je otopina iz koraka (a) puferirana s fosfatnim puferom.
5. Farmaceutski sastav ili postupak prema bilo kojem od zahtjeva 1 do 4, naznačen time, da je razrjeđivač odabran između šećera, mikrokristalične celuloze, laktoze, škroba i njihovih mješavina.
6. Farmaceutski sastav ili postupak prema bilo kojem od zahtjeva 1 do 5, naznačen time, da otopina iz koraka (a) obuhvaća vezivo odabrano između povidona, HPMC-a i preželatiniziranog škroba.
7. Farmaceutski sastav ili postupak prema zahtjevu 6, naznačen time, da vezivo je povidon.
8. Farmaceutski sastav ili postupak prema bilo kojem od zahtjeva 1 do 7, naznačen time, da otopina iz koraka (a) obuhvaća tenzid odabran između tween 80, polioksietilen-polioksipropilen kopolimera i natrijevog lauril sulfata.
9. Farmaceutski sastav ili postupak prema zahtjevu 8, naznačen time, da tenzid je natrijev lauril sulfat.
10. Farmaceutski sastav ili postupak prema bilo kojem od zahtjeva 1 do 9, naznačen time, da je dezintegrator odabran između križno povezanog polivinil pirolidona, škroba, kroskarmeloze-natrij, natrijeve karboksimetil celuloze i natrijevog škrobnog glikolata.
11. Farmaceutski sastav ili postupak prema zahtjevu 10, naznačen time, da dezintegrator je kroskarmeloza-natrij.
12. Farmaceutski sastav ili postupak prema bilo kojem od zahtjeva 1 do 11, naznačen time, da je lubrikant odabran između stearinske kiseline, magnezijevog stearata, gliceril behenata i natrijevog stearil fumarata.
13. Farmaceutski sastav ili postupak prema zahtjevu 12, naznačen time, da lubrikant je magnezijev stearat.
14. Farmaceutski sastav ili postupak prema bilo kojem od zahtjeva 1 do 13, naznačen time, da obuhvaća natrijevu sol od aleglitazara.
15. Farmaceutski sastav, naznačen time, da obuhvaća:
aleglitazar ili njegovu natrijevu sol 0,01 – 0,9 mg
dinatrijev fosfat 1 – 1,5 mg
natrijev dihidrogen fosfat 0,01 – 0,3 mg
natrijev lauril sulfat 0,1 – 2 mg
povidon 0,1 – 20 mg
laktoza 20 – 110 mg
mikrokristalična celuloza 5 – 100 mg
kroskarmeloza-natrij 0,5 – 20 mg
magnezijev stearat 0,5 – 3 mg.
16. Farmaceutski sastav prema bilo kojem od zahtjeva 1 ili 3 do 15, naznačen time, da je u obliku tablete.
17. Farmaceutski sastav prema bilo kojem od zahtjeva 1 ili 3 do 16, naznačen time, da se upotrebljava kao lijek za liječenje ili profilaksu dijabetesa tipa II ili kardiovaskularnih bolesti.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP09151254 | 2009-01-23 | ||
PCT/EP2010/050343 WO2010084066A1 (en) | 2009-01-23 | 2010-01-13 | Pharmaceutical composition comprising aleglitazar |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20130108T1 true HRP20130108T1 (hr) | 2013-03-31 |
Family
ID=42112184
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20130108AT HRP20130108T1 (hr) | 2009-01-23 | 2013-02-07 | Farmaceutski sastav koji sadrži aleglitazar |
Country Status (25)
Country | Link |
---|---|
US (2) | US20100190835A1 (hr) |
EP (1) | EP2389166B1 (hr) |
JP (1) | JP5619027B2 (hr) |
KR (2) | KR20110105798A (hr) |
CN (1) | CN102292074B (hr) |
AR (1) | AR075041A1 (hr) |
AU (1) | AU2010206249B2 (hr) |
BR (1) | BRPI1007237B1 (hr) |
CA (1) | CA2748896C (hr) |
CL (1) | CL2011001777A1 (hr) |
CY (1) | CY1113641T1 (hr) |
DK (1) | DK2389166T3 (hr) |
ES (1) | ES2397558T3 (hr) |
HR (1) | HRP20130108T1 (hr) |
IL (1) | IL213671A (hr) |
MX (1) | MX2011007381A (hr) |
PE (2) | PE20160746A1 (hr) |
PL (1) | PL2389166T3 (hr) |
PT (1) | PT2389166E (hr) |
RU (1) | RU2537224C2 (hr) |
SG (1) | SG173058A1 (hr) |
SI (1) | SI2389166T1 (hr) |
TW (1) | TWI406861B (hr) |
WO (1) | WO2010084066A1 (hr) |
ZA (1) | ZA201104670B (hr) |
Families Citing this family (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2013181384A1 (en) | 2012-05-31 | 2013-12-05 | Ratiopharm Gmbh | Solid state forms of aleglitazar sodium |
WO2014016369A1 (en) | 2012-07-27 | 2014-01-30 | Ratiopharm Gmbh | Pharmaceutical formulation comprising aleglitazar and complexing agent |
WO2014016371A1 (en) | 2012-07-27 | 2014-01-30 | Ratiopharm Gmbh | Micronized aleglitazar |
WO2014016370A1 (en) * | 2012-07-27 | 2014-01-30 | Ratiopharm Gmbh | Amorphous aleglitazar |
CA2879500A1 (en) * | 2012-09-12 | 2014-03-20 | F. Hoffmann-La Roche Ag | Solid forms of (s)-2-methoxy-3-{4-[2-(5-methyl-2-phenyl-oxazol-4-yl)-ethoxy]-benzo[b]thiophen-7-yl}-propionic acid and of salts thereof |
IL293480B2 (en) * | 2016-08-10 | 2024-02-01 | Hoffmann La Roche | Medical preparations containing AKT protein kinase inhibitors |
CN114404375B (zh) * | 2022-01-21 | 2023-06-27 | 武汉九珑人福药业有限责任公司 | 一种叶酸固体制剂及其原料组合物、制备方法和应用 |
Family Cites Families (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2772615B1 (fr) * | 1997-12-23 | 2002-06-14 | Lipha | Comprime multicouche pour la liberation instantanee puis prolongee de substances actives |
MXPA03010435A (es) * | 2001-05-15 | 2004-03-09 | Hoffmann La Roche | Derivados de oxazol acido carboxilico sustituidos para uso como activadores de proliferacion del peroximosa(ppar-alfa y gama) en el tratamiento de diabetes. |
GB0303600D0 (en) * | 2003-02-17 | 2003-03-19 | Glaxo Group Ltd | Novel therapeutic method and compositions |
US7262303B2 (en) * | 2003-09-29 | 2007-08-28 | Hoffman-La Roche Inc. | Process for the production of chiral propionic acid derivatives |
US20060051413A1 (en) * | 2004-09-08 | 2006-03-09 | Chow Sing S M | Method of enhancing absorptions of transmucosal administration formulations |
BRPI0606187A2 (pt) * | 2005-02-25 | 2009-06-09 | Hoffmann La Roche | comprimidos com capacidade de dispersão da substáncia do fármaco melhorada |
US20060270722A1 (en) * | 2005-05-31 | 2006-11-30 | Thornberry Nancy A | Combination of a dipeptidyl peptidase-IV inhibitor and a dual PPAR agonist for the treatment of diabetes and obesity |
FR2894477A1 (fr) * | 2005-12-13 | 2007-06-15 | Galderma Res & Dev | Utilisation du naveglitazar pour la preparation d'une composition pharmaceutique destinee au traitement des affections dermatologiques |
US20100210692A1 (en) * | 2007-03-28 | 2010-08-19 | Farmer Stephen R | Methods of treatment using sirt modulators and compositions containing sirt1 modulators |
-
2010
- 2010-01-13 AU AU2010206249A patent/AU2010206249B2/en not_active Ceased
- 2010-01-13 CA CA2748896A patent/CA2748896C/en not_active Expired - Fee Related
- 2010-01-13 EP EP10701340A patent/EP2389166B1/en not_active Not-in-force
- 2010-01-13 ES ES10701340T patent/ES2397558T3/es active Active
- 2010-01-13 JP JP2011546748A patent/JP5619027B2/ja not_active Expired - Fee Related
- 2010-01-13 WO PCT/EP2010/050343 patent/WO2010084066A1/en active Application Filing
- 2010-01-13 MX MX2011007381A patent/MX2011007381A/es active IP Right Grant
- 2010-01-13 CN CN2010800050015A patent/CN102292074B/zh not_active Expired - Fee Related
- 2010-01-13 PT PT107013401T patent/PT2389166E/pt unknown
- 2010-01-13 BR BRPI1007237-3A patent/BRPI1007237B1/pt not_active IP Right Cessation
- 2010-01-13 KR KR1020117016128A patent/KR20110105798A/ko active Application Filing
- 2010-01-13 PE PE2016000386A patent/PE20160746A1/es unknown
- 2010-01-13 SI SI201030129T patent/SI2389166T1/sl unknown
- 2010-01-13 SG SG2011052305A patent/SG173058A1/en unknown
- 2010-01-13 PE PE2011001309A patent/PE20120421A1/es not_active Application Discontinuation
- 2010-01-13 RU RU2011134964/15A patent/RU2537224C2/ru not_active IP Right Cessation
- 2010-01-13 PL PL10701340T patent/PL2389166T3/pl unknown
- 2010-01-13 KR KR1020137032602A patent/KR20140002812A/ko not_active Application Discontinuation
- 2010-01-13 DK DK10701340.1T patent/DK2389166T3/da active
- 2010-01-19 US US12/689,296 patent/US20100190835A1/en not_active Abandoned
- 2010-01-21 AR ARP100100131A patent/AR075041A1/es not_active Application Discontinuation
- 2010-01-22 TW TW099101817A patent/TWI406861B/zh not_active IP Right Cessation
-
2011
- 2011-06-20 IL IL213671A patent/IL213671A/en unknown
- 2011-06-23 ZA ZA2011/04670A patent/ZA201104670B/en unknown
- 2011-07-22 CL CL2011001777A patent/CL2011001777A1/es unknown
-
2012
- 2012-11-12 US US13/674,310 patent/US20130072529A1/en not_active Abandoned
- 2012-12-03 CY CY20121101181T patent/CY1113641T1/el unknown
-
2013
- 2013-02-07 HR HRP20130108AT patent/HRP20130108T1/hr unknown
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