RU2007107368A - Композиция, содержащая десмопрессин - Google Patents
Композиция, содержащая десмопрессин Download PDFInfo
- Publication number
- RU2007107368A RU2007107368A RU2007107368/15A RU2007107368A RU2007107368A RU 2007107368 A RU2007107368 A RU 2007107368A RU 2007107368/15 A RU2007107368/15 A RU 2007107368/15A RU 2007107368 A RU2007107368 A RU 2007107368A RU 2007107368 A RU2007107368 A RU 2007107368A
- Authority
- RU
- Russia
- Prior art keywords
- pharmaceutical composition
- composition according
- specified
- oxidizing agent
- starch
- Prior art date
Links
- 108010000437 Deamino Arginine Vasopressin Proteins 0.000 title claims 4
- NFLWUMRGJYTJIN-NXBWRCJVSA-N desmopressin Chemical compound C([C@H]1C(=O)N[C@H](C(N[C@@H](CC(N)=O)C(=O)N[C@@H](CSSCCC(=O)N[C@@H](CC=2C=CC(O)=CC=2)C(=O)N1)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(N)=O)=O)CCC(=O)N)C1=CC=CC=C1 NFLWUMRGJYTJIN-NXBWRCJVSA-N 0.000 title claims 3
- 229960004281 desmopressin Drugs 0.000 title claims 3
- 239000000203 mixture Substances 0.000 title claims 3
- 239000008194 pharmaceutical composition Substances 0.000 claims 22
- 239000007800 oxidant agent Substances 0.000 claims 7
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 6
- 229920002472 Starch Polymers 0.000 claims 5
- 239000008107 starch Substances 0.000 claims 5
- 235000019698 starch Nutrition 0.000 claims 5
- 239000003085 diluting agent Substances 0.000 claims 3
- 239000000546 pharmaceutical excipient Substances 0.000 claims 3
- 239000000377 silicon dioxide Substances 0.000 claims 3
- 235000012239 silicon dioxide Nutrition 0.000 claims 3
- 239000007909 solid dosage form Substances 0.000 claims 3
- MHAJPDPJQMAIIY-UHFFFAOYSA-N Hydrogen peroxide Chemical compound OO MHAJPDPJQMAIIY-UHFFFAOYSA-N 0.000 claims 2
- 239000004480 active ingredient Substances 0.000 claims 2
- 150000002016 disaccharides Chemical class 0.000 claims 2
- 150000004676 glycans Chemical class 0.000 claims 2
- 229920001282 polysaccharide Polymers 0.000 claims 2
- 239000005017 polysaccharide Substances 0.000 claims 2
- 229920001592 potato starch Polymers 0.000 claims 2
- 150000003839 salts Chemical class 0.000 claims 2
- FIEYHAAMDAPVCH-UHFFFAOYSA-N 2-methyl-1h-quinazolin-4-one Chemical compound C1=CC=C2NC(C)=NC(=O)C2=C1 FIEYHAAMDAPVCH-UHFFFAOYSA-N 0.000 claims 1
- 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 1
- 229960002845 desmopressin acetate Drugs 0.000 claims 1
- 239000008187 granular material Substances 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- 150000002772 monosaccharides Chemical class 0.000 claims 1
- 229920001542 oligosaccharide Polymers 0.000 claims 1
- 150000002482 oligosaccharides Chemical class 0.000 claims 1
- 239000007935 oral tablet Substances 0.000 claims 1
- 229940096978 oral tablet Drugs 0.000 claims 1
- 125000002081 peroxide group Chemical group 0.000 claims 1
- 150000002978 peroxides Chemical class 0.000 claims 1
- 239000003755 preservative agent Substances 0.000 claims 1
- 230000002335 preservative effect Effects 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1611—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/08—Peptides having 5 to 11 amino acids
- A61K38/095—Oxytocins; Vasopressins; Related peptides
-
- 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
- A61K9/2009—Inorganic compounds
-
- 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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
-
- 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
- A61P7/12—Antidiuretics, e.g. drugs for diabetes insipidus
Claims (17)
1. Фармацевтическая композиция в виде твердой лекарственной формы, содержащая десмопрессин или его фармацевтически приемлемую соль в качестве терапевтически активного ингредиента вместе с фармацевтически приемлемым эксципиентом, разбавителем или носителем или их смесью, где указанная фармацевтическая композиция содержит диоксид кремния и где содержание окисляющего агента равно или менее 15 частей на миллион по массе от указанной фармацевтической композиции.
2. Фармацевтическая композиция по п.1, где содержание окисляющего агента составляет от 0,01 до менее 5 частей на миллион по массе от указанной фармацевтической композиции.
3. Фармацевтическая композиция по п.2, где содержание окисляющего агента составляет от 0,01 до 3 или менее частей на миллион по массе от указанной фармацевтической композиции.
4. Фармацевтическая композиция по п.3, где содержание окисляющего агента составляет от 0,01 до 1 или менее части на миллион по массе от указанной фармацевтической композиции.
5. Фармацевтическая композиция по п.1, где указанный окисляющий агент представляет собой пероксид, такой, как перекись водорода, или смесь пероксидов.
6. Фармацевтическая композиция по п.1, содержащая диоксид кремния в количестве от 0,1 до 1,0, предпочтительно от 0,2 до 0,5% по массе от указанной фармацевтической композиции.
7. Фармацевтическая композиция по п.1, состоящая из прессованного гранулята.
8. Фармацевтическая композиция по п.1, где по меньшей мере один из указанных эксципиента, разбавителя и носителя представляет собой вещество, выбранное из моносахарида, дисахарида, олигосахарида и полисахарида.
9. Фармацевтическая композиция по п.8, содержащая дисахарид, предпочтительно лактозу, и полисахарид, предпочтительно крахмал.
10. Фармацевтическая композиция по п.9, где указанный крахмал представляет собой картофельный крахмал.
11. Фармацевтическая композиция по п.1, где суммарное объединенное количество указанных эксципиента, разбавителя или носителя составляет от 5 до 98, предпочтительно от 50 до 98% по массе от указанной фармацевтической композиции.
12. Фармацевтическая композиция по п.1, которая представляет собой таблетку для приема внутрь, которая возможно адаптирована для перорального, предпочтительно трансбуккального и/или сублингвального введения.
13. Фармацевтическая композиция по п.1, содержащая десмопрессина ацетат в количестве от 0,020 до 0,600 мг на единицу твердой лекарственной формы.
14. Фармацевтическая композиция по любому из пп.1-13, не содержащая консервант.
15. Применение крахмала, содержащего окисляющий агент в количестве, равном или меньшем 40 частей на миллион, для приготовления фармацевтической композиции в виде твердой лекарственной формы, содержащей десмопрессин или его фармацевтически приемлемую соль в качестве терапевтически активного ингредиента и диоксид кремния.
16. Применение по п.15, где крахмал представляет собой картофельный крахмал.
17. Применение по п.15 или 16, где крахмал содержит окисляющий агент в количестве от 0,03 до 8 или менее частей на миллион.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SE0600482-4 | 2006-03-02 | ||
| SE0600482A SE528446C2 (sv) | 2006-03-02 | 2006-03-02 | Farmaceutisk sammansättning innefattande desmopressin, kiseldioxid och stärkelse |
| EP06005326.1 | 2006-03-15 | ||
| EP06005326A EP1829532B1 (en) | 2006-03-02 | 2006-03-15 | Stable solid dosage form comprising desmopressin |
| DE202006004746 | 2006-03-24 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2007107368A true RU2007107368A (ru) | 2008-09-10 |
| RU2340351C1 RU2340351C1 (ru) | 2008-12-10 |
Family
ID=36218059
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2007107368/15A RU2340351C1 (ru) | 2006-03-02 | 2007-02-28 | Композиция, содержащая десмопрессин |
Country Status (16)
| Country | Link |
|---|---|
| US (1) | US20100273709A1 (ru) |
| EP (1) | EP1829532B1 (ru) |
| JP (1) | JP4976428B2 (ru) |
| AT (3) | ATE394095T1 (ru) |
| CY (1) | CY1108231T1 (ru) |
| DE (2) | DE602006001103D1 (ru) |
| DK (1) | DK1829532T3 (ru) |
| ES (1) | ES2304033T3 (ru) |
| IL (1) | IL193250A0 (ru) |
| NL (1) | NL1031397C2 (ru) |
| NO (1) | NO20083555L (ru) |
| PL (1) | PL1829532T3 (ru) |
| PT (1) | PT1829532E (ru) |
| RU (1) | RU2340351C1 (ru) |
| SE (1) | SE528446C2 (ru) |
| SI (1) | SI1829532T1 (ru) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB0210397D0 (en) | 2002-05-07 | 2002-06-12 | Ferring Bv | Pharmaceutical formulations |
| ES2260563T3 (es) * | 2003-11-13 | 2006-11-01 | Ferring B.V. | Paquete de blister y forma farmaceutica solida para ello. |
| CN103304639A (zh) * | 2013-06-08 | 2013-09-18 | 深圳翰宇药业股份有限公司 | 一种纯化去氨加压素中间体的方法 |
| US9744209B2 (en) | 2015-01-30 | 2017-08-29 | Par Pharmaceutical, Inc. | Vasopressin formulations for use in treatment of hypotension |
| US9925233B2 (en) | 2015-01-30 | 2018-03-27 | Par Pharmaceutical, Inc. | Vasopressin formulations for use in treatment of hypotension |
| US9750785B2 (en) | 2015-01-30 | 2017-09-05 | Par Pharmaceutical, Inc. | Vasopressin formulations for use in treatment of hypotension |
| US9937223B2 (en) | 2015-01-30 | 2018-04-10 | Par Pharmaceutical, Inc. | Vasopressin formulations for use in treatment of hypotension |
| US9744239B2 (en) | 2015-01-30 | 2017-08-29 | Par Pharmaceutical, Inc. | Vasopressin formulations for use in treatment of hypotension |
| US9687526B2 (en) | 2015-01-30 | 2017-06-27 | Par Pharmaceutical, Inc. | Vasopressin formulations for use in treatment of hypotension |
Family Cites Families (42)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4285858A (en) * | 1979-10-30 | 1981-08-25 | Mt. Sinai School Of Medicine Of The City University Of N.Y. | Vasopressin analogs |
| US4263283A (en) * | 1980-05-16 | 1981-04-21 | Ferring Pharmaceuticals, Inc. | Method for prophylaxis and/or treatment of sickle cell disease |
| SE8306367L (sv) * | 1983-11-18 | 1985-05-19 | Ferring Ab | Antidiuretiskt verkande farmaceutiskt preparat |
| US4863737A (en) * | 1985-05-01 | 1989-09-05 | University Of Utah | Compositions and methods of manufacture of compressed powder medicaments |
| US4764378A (en) * | 1986-02-10 | 1988-08-16 | Zetachron, Inc. | Buccal drug dosage form |
| US6746678B1 (en) * | 1991-02-22 | 2004-06-08 | Howard K. Shapiro | Method of treating neurological diseases and etiologically related symptomology using carbonyl trapping agents in combination with medicaments |
| US7074871B2 (en) * | 1992-05-29 | 2006-07-11 | Basell Poliolefine Italia S.R.L. | Crystalline polymers of propylene having improved processability in the molten state and process for their preparation |
| SE9300937L (sv) * | 1993-03-19 | 1994-09-20 | Anne Fjellestad Paulsen | Komposition för oral administrering av peptider |
| SE501677C2 (sv) * | 1993-06-18 | 1995-04-10 | Ferring Bv | Biologiskt aktiva vasopressinanaloger, farmaceutiska preparat innehållande dem samt deras användning för framställning av läkemedel |
| HU221617B1 (hu) * | 1993-06-29 | 2002-12-28 | Ferring B.V. | Vizes készítmény dezmopresszin nazális adagolására |
| US5482931A (en) * | 1993-06-29 | 1996-01-09 | Ferring Ab | Stabilized pharmaceutical peptide compositions |
| US5985835A (en) * | 1993-12-23 | 1999-11-16 | Ferring B.V. | Desmopressin for nocturia, incontinence and enuresis |
| US5500413A (en) * | 1993-06-29 | 1996-03-19 | Ferring Ab | Process for manufacture of 1-deamino-8-D-arginine vasopressin |
| WO1995001368A1 (en) * | 1993-06-29 | 1995-01-12 | Ferring B.V. | Improved synthesis of cyclic peptides |
| US5674850A (en) * | 1993-12-23 | 1997-10-07 | Ferring Ab | High purity desmopressin produced in large single batches |
| US5849322A (en) * | 1995-10-23 | 1998-12-15 | Theratech, Inc. | Compositions and methods for buccal delivery of pharmaceutical agents |
| US5763398A (en) * | 1996-06-20 | 1998-06-09 | Ferring B.V. | Nasal administration of desmopressin |
| US5922680A (en) * | 1996-10-23 | 1999-07-13 | Ferring, B.V. | Stabilized composition for oral administration of peptides |
| SE9604341D0 (sv) * | 1996-11-26 | 1996-11-26 | Ferring Bv | Hepta-peptide oxytocin analogue |
| US7153845B2 (en) * | 1998-08-25 | 2006-12-26 | Columbia Laboratories, Inc. | Bioadhesive progressive hydration tablets |
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| AR014640A1 (es) * | 1999-02-23 | 2001-03-28 | Univ Nac Quilmes | UNA COMPOSICíoN FARMACÉUTICA INHIBIDORA DE LA DISEMINACIoN METASTÁSICA DURANTE LA CIRUGíA DE UN TUMOR CANCEROSO, UN PROCEDIMENTO DE PREPARACIoN Y UN KIT PARA UNA FORMULACIoN INYECTABLE. |
| US6248363B1 (en) * | 1999-11-23 | 2001-06-19 | Lipocine, Inc. | Solid carriers for improved delivery of active ingredients in pharmaceutical compositions |
| US7060708B2 (en) * | 1999-03-10 | 2006-06-13 | New River Pharmaceuticals Inc. | Active agent delivery systems and methods for protecting and administering active agents |
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| AT409081B (de) * | 2000-02-16 | 2002-05-27 | Gebro Pharma Gmbh | Stabile, nasal, oral oder sublingual anwendbare pharmazeutische zubereitung |
| GB0015601D0 (en) * | 2000-06-26 | 2000-08-16 | Ferring Bv | Novel antidiuretic agents |
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| WO2003094886A2 (en) * | 2002-05-07 | 2003-11-20 | Ferring Bv | Desmopressin in an orodispersible dosage form |
| GB0210397D0 (en) * | 2002-05-07 | 2002-06-12 | Ferring Bv | Pharmaceutical formulations |
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| US7022340B2 (en) * | 2003-07-25 | 2006-04-04 | Ferring B.V. | Pharmaceutical composition as solid dosage form and method for manufacturing thereof |
| EP2322195A2 (en) * | 2003-11-10 | 2011-05-18 | Reprise Biopharmaceutics, LLC | Pharmaceutical compositions including low dosages of desmopressin |
| ES2260563T3 (es) * | 2003-11-13 | 2006-11-01 | Ferring B.V. | Paquete de blister y forma farmaceutica solida para ello. |
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| US7018653B2 (en) * | 2003-12-29 | 2006-03-28 | Ferring B.V. | Method for preparing solid dosage form of desmopressin |
| SI1550439T1 (sl) * | 2003-12-29 | 2006-08-31 | Ferring Bv | Postopek za pripravo trdne dozirne oblike dezmopresina |
| BRPI0610046A2 (pt) * | 2005-04-22 | 2010-05-25 | Wyeth Corp | derivados de benzodioxano e benzodioxolano e usos destes |
-
2006
- 2006-03-02 SE SE0600482A patent/SE528446C2/sv unknown
- 2006-03-15 DK DK06005326T patent/DK1829532T3/da active
- 2006-03-15 AT AT06005326T patent/ATE394095T1/de active
- 2006-03-15 PT PT06005326T patent/PT1829532E/pt unknown
- 2006-03-15 PL PL06005326T patent/PL1829532T3/pl unknown
- 2006-03-15 SI SI200630038T patent/SI1829532T1/sl unknown
- 2006-03-15 DE DE602006001103T patent/DE602006001103D1/de active Active
- 2006-03-15 ES ES06005326T patent/ES2304033T3/es active Active
- 2006-03-15 EP EP06005326A patent/EP1829532B1/en not_active Revoked
- 2006-03-16 AT AT0020406U patent/AT8372U3/de not_active IP Right Cessation
- 2006-03-16 AT AT0043906A patent/AT503320A1/de not_active Application Discontinuation
- 2006-03-17 NL NL1031397A patent/NL1031397C2/nl not_active IP Right Cessation
- 2006-03-24 DE DE202006004746U patent/DE202006004746U1/de not_active Ceased
-
2007
- 2007-02-28 RU RU2007107368/15A patent/RU2340351C1/ru not_active IP Right Cessation
- 2007-03-01 JP JP2008556715A patent/JP4976428B2/ja not_active Expired - Fee Related
- 2007-03-01 US US12/224,437 patent/US20100273709A1/en not_active Abandoned
-
2008
- 2008-07-31 CY CY20081100802T patent/CY1108231T1/el unknown
- 2008-08-05 IL IL193250A patent/IL193250A0/en unknown
- 2008-08-18 NO NO20083555A patent/NO20083555L/no not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| CY1108231T1 (el) | 2014-02-12 |
| NO20083555L (no) | 2008-08-18 |
| US20100273709A1 (en) | 2010-10-28 |
| AT503320A1 (de) | 2007-09-15 |
| PL1829532T3 (pl) | 2008-09-30 |
| JP2009528312A (ja) | 2009-08-06 |
| DE602006001103D1 (de) | 2008-06-19 |
| EP1829532A1 (en) | 2007-09-05 |
| SE0600482L (sv) | 2006-11-14 |
| DK1829532T3 (da) | 2008-08-04 |
| EP1829532B1 (en) | 2008-05-07 |
| IL193250A0 (en) | 2011-08-01 |
| ES2304033T3 (es) | 2008-09-01 |
| SI1829532T1 (sl) | 2008-08-31 |
| DE202006004746U1 (de) | 2006-06-29 |
| ATE394095T1 (de) | 2008-05-15 |
| NL1031397C2 (nl) | 2006-09-18 |
| AT8372U3 (de) | 2007-03-15 |
| RU2340351C1 (ru) | 2008-12-10 |
| AT8372U2 (de) | 2006-07-15 |
| JP4976428B2 (ja) | 2012-07-18 |
| PT1829532E (pt) | 2009-02-13 |
| NL1031397A1 (nl) | 2006-05-08 |
| SE528446C2 (sv) | 2006-11-14 |
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