NO871120L - Fremgangsmaate for fremstilling av et fast farmasoeytisk preparat. - Google Patents
Fremgangsmaate for fremstilling av et fast farmasoeytisk preparat. Download PDFInfo
- Publication number
- NO871120L NO871120L NO871120A NO871120A NO871120L NO 871120 L NO871120 L NO 871120L NO 871120 A NO871120 A NO 871120A NO 871120 A NO871120 A NO 871120A NO 871120 L NO871120 L NO 871120L
- Authority
- NO
- Norway
- Prior art keywords
- ibuprofen
- granules
- aggregate material
- crystalline ibuprofen
- crystalline
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims abstract description 28
- 239000007787 solid Substances 0.000 title claims abstract description 15
- 238000002360 preparation method Methods 0.000 title claims description 30
- 239000000825 pharmaceutical preparation Substances 0.000 title description 7
- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 claims abstract description 126
- 229960001680 ibuprofen Drugs 0.000 claims abstract description 125
- 239000008187 granular material Substances 0.000 claims abstract description 91
- 238000001125 extrusion Methods 0.000 claims abstract description 42
- 239000013078 crystal Substances 0.000 claims abstract description 16
- 239000000203 mixture Substances 0.000 claims abstract description 9
- 238000005469 granulation Methods 0.000 claims abstract description 8
- 230000003179 granulation Effects 0.000 claims abstract description 8
- 239000000463 material Substances 0.000 claims description 58
- 239000007788 liquid Substances 0.000 claims description 26
- 230000005484 gravity Effects 0.000 claims description 23
- 239000002245 particle Substances 0.000 claims description 22
- 238000004519 manufacturing process Methods 0.000 claims description 13
- 238000001035 drying Methods 0.000 claims description 10
- 238000007906 compression Methods 0.000 claims description 7
- 230000006835 compression Effects 0.000 claims description 7
- 238000010298 pulverizing process Methods 0.000 claims description 6
- 238000007873 sieving Methods 0.000 claims description 5
- 239000007909 solid dosage form Substances 0.000 claims description 4
- 239000004215 Carbon black (E152) Substances 0.000 claims description 2
- 229930195733 hydrocarbon Natural products 0.000 claims description 2
- 150000002430 hydrocarbons Chemical class 0.000 claims description 2
- 230000032258 transport Effects 0.000 claims 3
- 238000004220 aggregation Methods 0.000 claims 1
- 230000002776 aggregation Effects 0.000 claims 1
- 239000012265 solid product Substances 0.000 claims 1
- 238000005056 compaction Methods 0.000 abstract description 16
- 238000004090 dissolution Methods 0.000 abstract description 12
- 239000008194 pharmaceutical composition Substances 0.000 abstract 2
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 1
- VLKZOEOYAKHREP-UHFFFAOYSA-N n-Hexane Chemical compound CCCCCC VLKZOEOYAKHREP-UHFFFAOYSA-N 0.000 description 18
- 239000003826 tablet Substances 0.000 description 15
- 230000015556 catabolic process Effects 0.000 description 9
- 239000004744 fabric Substances 0.000 description 9
- 239000000654 additive Substances 0.000 description 8
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 description 6
- 238000006731 degradation reaction Methods 0.000 description 6
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 6
- 238000004525 petroleum distillation Methods 0.000 description 5
- 229920002785 Croscarmellose sodium Polymers 0.000 description 4
- 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 description 4
- 229960001681 croscarmellose sodium Drugs 0.000 description 4
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 description 4
- 239000011521 glass Substances 0.000 description 4
- 239000004615 ingredient Substances 0.000 description 4
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
- 239000011324 bead Substances 0.000 description 3
- 239000007853 buffer solution Substances 0.000 description 3
- 238000004898 kneading Methods 0.000 description 3
- 235000019359 magnesium stearate Nutrition 0.000 description 3
- QSHDDOUJBYECFT-UHFFFAOYSA-N mercury Chemical compound [Hg] QSHDDOUJBYECFT-UHFFFAOYSA-N 0.000 description 3
- 229910052753 mercury Inorganic materials 0.000 description 3
- 239000003209 petroleum derivative Substances 0.000 description 3
- 239000004094 surface-active agent Substances 0.000 description 3
- 230000001225 therapeutic effect Effects 0.000 description 3
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 2
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 2
- 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 description 2
- 230000000996 additive effect Effects 0.000 description 2
- 238000013019 agitation Methods 0.000 description 2
- 230000003110 anti-inflammatory effect Effects 0.000 description 2
- 239000000872 buffer Substances 0.000 description 2
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 238000001816 cooling Methods 0.000 description 2
- 238000005520 cutting process Methods 0.000 description 2
- 239000002552 dosage form Substances 0.000 description 2
- 239000008101 lactose Substances 0.000 description 2
- 239000000314 lubricant Substances 0.000 description 2
- 238000005259 measurement Methods 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 238000002459 porosimetry Methods 0.000 description 2
- 238000005096 rolling process Methods 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 230000004580 weight loss Effects 0.000 description 2
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- NTIZESTWPVYFNL-UHFFFAOYSA-N Methyl isobutyl ketone Chemical compound CC(C)CC(C)=O NTIZESTWPVYFNL-UHFFFAOYSA-N 0.000 description 1
- UIHCLUNTQKBZGK-UHFFFAOYSA-N Methyl isobutyl ketone Natural products CCC(C)C(C)=O UIHCLUNTQKBZGK-UHFFFAOYSA-N 0.000 description 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 1
- 235000021355 Stearic acid Nutrition 0.000 description 1
- 235000010724 Wisteria floribunda Nutrition 0.000 description 1
- 230000004931 aggregating effect Effects 0.000 description 1
- 230000000202 analgesic effect Effects 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 239000008116 calcium stearate Substances 0.000 description 1
- 235000013539 calcium stearate Nutrition 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 229940075614 colloidal silicon dioxide Drugs 0.000 description 1
- 238000010960 commercial process Methods 0.000 description 1
- 239000002178 crystalline material Substances 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- 239000007884 disintegrant Substances 0.000 description 1
- 239000010419 fine particle Substances 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 150000002576 ketones Chemical class 0.000 description 1
- 239000007937 lozenge Substances 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 1
- 239000008108 microcrystalline cellulose Substances 0.000 description 1
- 229940016286 microcrystalline cellulose Drugs 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
- 201000008482 osteoarthritis Diseases 0.000 description 1
- 239000003208 petroleum Substances 0.000 description 1
- 229940127557 pharmaceutical product Drugs 0.000 description 1
- 239000011148 porous material Substances 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 206010039073 rheumatoid arthritis Diseases 0.000 description 1
- 238000009490 roller compaction Methods 0.000 description 1
- 238000004062 sedimentation Methods 0.000 description 1
- 238000005204 segregation Methods 0.000 description 1
- 238000007493 shaping process Methods 0.000 description 1
- 235000019333 sodium laurylsulphate Nutrition 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000000829 suppository Substances 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
Classifications
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Landscapes
- Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Pain & Pain Management (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Rheumatology (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
- Steroid Compounds (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
- Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
- Polyurethanes Or Polyureas (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB868606762A GB8606762D0 (en) | 1986-03-19 | 1986-03-19 | Therapeutic agents |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| NO871120D0 NO871120D0 (no) | 1987-03-18 |
| NO871120L true NO871120L (no) | 1987-09-21 |
Family
ID=10594868
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| NO871120A NO871120L (no) | 1986-03-19 | 1987-03-18 | Fremgangsmaate for fremstilling av et fast farmasoeytisk preparat. |
Country Status (21)
| Country | Link |
|---|---|
| EP (1) | EP0241126B1 (pt) |
| JP (1) | JPS62230723A (pt) |
| KR (1) | KR870008582A (pt) |
| CN (1) | CN87101974A (pt) |
| AT (1) | ATE65393T1 (pt) |
| AU (1) | AU7017787A (pt) |
| CS (1) | CS182787A2 (pt) |
| DD (1) | DD263232A5 (pt) |
| DE (1) | DE3771544D1 (pt) |
| DK (1) | DK136487A (pt) |
| FI (1) | FI871112A (pt) |
| GB (2) | GB8606762D0 (pt) |
| HU (1) | HU195422B (pt) |
| IL (1) | IL81884A0 (pt) |
| IN (1) | IN163939B (pt) |
| NO (1) | NO871120L (pt) |
| NZ (1) | NZ219560A (pt) |
| PL (1) | PL264695A1 (pt) |
| PT (1) | PT84526B (pt) |
| YU (1) | YU47087A (pt) |
| ZA (1) | ZA871836B (pt) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3833448A1 (de) * | 1988-10-01 | 1990-04-12 | Hoechst Ag | Verfahren zur gewinnung von ibuprofen fuer die direkttablettierung |
| NZ234587A (en) * | 1989-08-04 | 1991-11-26 | Mcneil Ppc Inc | A chewable pharmaceutical tablet of compressed coated granules |
| CA2063141C (en) * | 1989-08-04 | 1997-03-04 | Edward J. Roche | Rotogranulations and taste masking coatings for preparation of chewable pharmaceutical tablets |
| US5191114A (en) * | 1991-10-09 | 1993-03-02 | Sage Pharmaceuticals, Inc. | Process for enhancing the flow characteristics of ibuprofen |
| US5605930A (en) * | 1991-10-21 | 1997-02-25 | The United States Of America As Represented By The Department Of Health And Human Services | Compositions and methods for treating and preventing pathologies including cancer |
| US5534262A (en) * | 1992-01-10 | 1996-07-09 | Dobrotvorsky; Anatoly E. | Pharmaceutical granulated composition and method for preparing same |
| IS1736B (is) | 1993-10-01 | 1999-12-30 | Astra Ab | Aðferð og tæki sem stuðla að aukinni samloðun agna |
| IL111080A (en) * | 1993-10-01 | 1999-08-17 | Astra Ab | Method for treating a finely divided powder medicament |
| TWI225402B (en) | 1996-03-13 | 2004-12-21 | Biochemie Gmbh | Auxiliary-free agglomerates |
| FR2804603B1 (fr) * | 2000-02-04 | 2004-01-23 | Rhodia Chimie Sa | Procede continu pour formuler sous forme de granules une ou plusieurs matieres actives pharmaceutiques |
| DE102005037630A1 (de) | 2005-08-09 | 2007-02-15 | Glatt Gmbh | Verfahren zur Herstellung von Teilchen aus pharmazeutischen Substanzen, Teilchen aus pharmazeutischen Substanzen sowie deren Verwendung |
| HUE051406T2 (hu) | 2012-11-14 | 2021-03-01 | Grace W R & Co | Biológiailag aktív anyagot és rendezetlen szervetlen oxidot tartalmazó kompozíciók |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4476248A (en) * | 1983-02-28 | 1984-10-09 | The Upjohn Company | Crystallization of ibuprofen |
| JPS60120616A (ja) * | 1983-12-05 | 1985-06-28 | Yaskawa Electric Mfg Co Ltd | プリセット型可逆カウンタ装置 |
| US4609675A (en) * | 1984-08-17 | 1986-09-02 | The Upjohn Company | Stable, high dose, high bulk density ibuprofen granulations for tablet and capsule manufacturing |
-
1986
- 1986-03-19 GB GB868606762A patent/GB8606762D0/en active Pending
-
1987
- 1987-03-03 AT AT87301825T patent/ATE65393T1/de active
- 1987-03-03 GB GB8704987A patent/GB2187952B/en not_active Revoked
- 1987-03-03 EP EP87301825A patent/EP0241126B1/en not_active Expired - Lifetime
- 1987-03-03 DE DE8787301825T patent/DE3771544D1/de not_active Expired - Fee Related
- 1987-03-10 NZ NZ219560A patent/NZ219560A/xx unknown
- 1987-03-12 IN IN174/MAS/87A patent/IN163939B/en unknown
- 1987-03-13 ZA ZA871836A patent/ZA871836B/xx unknown
- 1987-03-13 IL IL81884A patent/IL81884A0/xx unknown
- 1987-03-13 FI FI871112A patent/FI871112A/fi not_active IP Right Cessation
- 1987-03-17 DK DK136487A patent/DK136487A/da not_active Application Discontinuation
- 1987-03-17 DD DD87300859A patent/DD263232A5/de not_active IP Right Cessation
- 1987-03-18 HU HU871184A patent/HU195422B/hu not_active IP Right Cessation
- 1987-03-18 CS CS871827A patent/CS182787A2/cs unknown
- 1987-03-18 JP JP62063658A patent/JPS62230723A/ja active Pending
- 1987-03-18 PL PL1987264695A patent/PL264695A1/xx unknown
- 1987-03-18 KR KR870002431A patent/KR870008582A/ko not_active Application Discontinuation
- 1987-03-18 NO NO871120A patent/NO871120L/no unknown
- 1987-03-19 AU AU70177/87A patent/AU7017787A/en not_active Abandoned
- 1987-03-19 YU YU00470/87A patent/YU47087A/xx unknown
- 1987-03-19 PT PT84526A patent/PT84526B/pt not_active IP Right Cessation
- 1987-03-19 CN CN198787101974A patent/CN87101974A/zh active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| GB8606762D0 (en) | 1986-04-23 |
| GB8704987D0 (en) | 1987-04-08 |
| GB2187952A (en) | 1987-09-23 |
| HU195422B (en) | 1988-05-30 |
| YU47087A (en) | 1988-04-30 |
| DD263232A5 (de) | 1988-12-28 |
| FI871112A (fi) | 1987-09-20 |
| NZ219560A (en) | 1989-05-29 |
| PL264695A1 (en) | 1988-05-12 |
| AU7017787A (en) | 1987-09-24 |
| CS182787A2 (en) | 1991-05-14 |
| HUT42939A (en) | 1987-09-28 |
| NO871120D0 (no) | 1987-03-18 |
| KR870008582A (ko) | 1987-10-19 |
| IL81884A0 (en) | 1987-10-20 |
| IN163939B (pt) | 1988-12-10 |
| DE3771544D1 (de) | 1991-08-29 |
| GB2187952B (en) | 1990-05-09 |
| DK136487D0 (da) | 1987-03-17 |
| CN87101974A (zh) | 1987-10-21 |
| JPS62230723A (ja) | 1987-10-09 |
| ATE65393T1 (de) | 1991-08-15 |
| DK136487A (da) | 1987-09-20 |
| PT84526B (pt) | 1989-11-10 |
| ZA871836B (en) | 1987-09-02 |
| FI871112A0 (fi) | 1987-03-13 |
| EP0241126A1 (en) | 1987-10-14 |
| EP0241126B1 (en) | 1991-07-24 |
| PT84526A (en) | 1987-04-01 |
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