CN101460151A - 药物制剂:8-[{1-(3,5-双-(三氟甲基)苯基)-乙氧基}-甲基]-8-苯基-1,7-二氮杂-螺[4.5]癸-2-酮的盐及用其治疗的方法 - Google Patents
药物制剂:8-[{1-(3,5-双-(三氟甲基)苯基)-乙氧基}-甲基]-8-苯基-1,7-二氮杂-螺[4.5]癸-2-酮的盐及用其治疗的方法 Download PDFInfo
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- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
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- 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
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
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- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
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- C07D207/02—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom
- C07D207/04—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having no double bonds between ring members or between ring members and non-ring members
- C07D207/10—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having no double bonds between ring members or between ring members and non-ring members with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
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Abstract
Description
时间(分钟) | 平均值(所释放的最初存在的活性成分的%) | n个样品的所释放活性成分的百分比范围 |
5 | 69% | 64%-74% |
15 | 88% | 83%-94% |
30 | 94% | 90%-100% |
45 | 97% | 93%-102% |
60 | 98% | 94%-103% |
时间(分钟) | 平均值(所释放的最初存在的活性成分的%) | n个样品的所释放活性成分的百分比范围 |
5 | 87% | 82%-91% |
15 | 95% | 91%-98% |
30 | 98% | 94%-100% |
45 | 98% | 95%-101% |
60 | 99% | 96%-100% |
时间(分钟) | 平均值(所释放的最初存在的活性成分的%) | n个样品的所释放活性成分的百分比范围 |
5 | 88% | 74%-96% |
15 | 97% | 91%-101% |
30 | 99% | 94%-102% |
45 | 100% | 95%-102% |
60 | 100% | 96%-103% |
剂量(mg) | Cmax*(ng/mL) | Tmax** | AUC*** | 半衰期T1/2(小时) |
5 | 27.3 | 2 | 931 | 未计算 |
10 | 52.7 | 2.5 | 1820 | 未计算 |
25 | 119 | 2.5 | 17200 | 183 |
50 | 276 | 3 | 33600 | 171 |
100 | 475 | 2 | 74400 | 181 |
200 | 944 | 4 | 148000 | 169 |
成分 | 2.5mg剂量 | 10mg剂量 | 50mg剂量 |
活性盐 | 100.0g | 400.0g | 1000.0g |
乳糖一水合物(预混合) | 1600.0g | 1600.0g | 1600.0g |
乳糖一水合物(主混合) | 5560.0g | 5260.0g | 1030.0g |
微晶纤维素 | 2400.0g | 2400.0g | 1200.0g |
预胶化淀粉 | 1800.0g | 1800.0g | 900.0g |
交联羧甲基纤维素钠(颗粒间) | 240.0g | 240.0g | 120.0g |
交联羧甲基纤维素钠(颗粒外) | 240.0g | 240.0g | 120.0g |
硬脂酸镁 | 60.0g | 60.0g | 30.0g |
时间(分钟) | 平均值(所释放的最初存在的活性成分的%) | n个样品的所释放活性成分的百分比范围 |
5 | 88% | 74%-96% |
15 | 97% | 91%-101% |
30 | 99% | 94%-102% |
45 | 100% | 95%-102% |
60 | 100% | 96%-103% |
剂量(mg) | Cmax*(ng/mL) | Tmax** | AUC*** | 半衰期T1/2(小时) |
5 | 27.3 | 2 | 931 | 未计算 |
10 | 52.7 | 2.5 | 1820 | 未计算 |
25 | 119 | 2.5 | 17200 | 183 |
50 | 276 | 3 | 33600 | 171 |
100 | 475 | 2 | 74400 | 181 |
200 | 944 | 4 | 148000 | 169 |
Claims (26)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201310495198.0A CN103751186B (zh) | 2006-04-05 | 2007-04-04 | 药物制剂:8-[{1-(3,5-双-(三氟甲基)苯基)-乙氧基}-甲基]-8-苯基-1,7-二氮杂-螺[4.5]癸-2-酮的盐及用其治疗的方法 |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US78951406P | 2006-04-05 | 2006-04-05 | |
US60/789,514 | 2006-04-05 | ||
PCT/US2007/008345 WO2007114921A2 (en) | 2006-04-05 | 2007-04-04 | Pharmaceutical formulations: salts of 8-[{1-(3,5-bis (trifluoromethy1)pheny1)-e thoxy}-methy1]-8-pheny1-1,7-diaza-spiro[4.5] decan-2-one and treatment methods using the same |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
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CN201310495198.0A Division CN103751186B (zh) | 2006-04-05 | 2007-04-04 | 药物制剂:8-[{1-(3,5-双-(三氟甲基)苯基)-乙氧基}-甲基]-8-苯基-1,7-二氮杂-螺[4.5]癸-2-酮的盐及用其治疗的方法 |
Publications (2)
Publication Number | Publication Date |
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CN101460151A true CN101460151A (zh) | 2009-06-17 |
CN101460151B CN101460151B (zh) | 2013-11-20 |
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CN201310495198.0A Expired - Fee Related CN103751186B (zh) | 2006-04-05 | 2007-04-04 | 药物制剂:8-[{1-(3,5-双-(三氟甲基)苯基)-乙氧基}-甲基]-8-苯基-1,7-二氮杂-螺[4.5]癸-2-酮的盐及用其治疗的方法 |
CN2007800206407A Expired - Fee Related CN101460151B (zh) | 2006-04-05 | 2007-04-04 | 药物制剂:8-[{1-(3,5-双-(三氟甲基)苯基)-乙氧基}-甲基]-8-苯基-1,7-二氮杂-螺[4.5]癸-2-酮的盐 |
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CN201310495198.0A Expired - Fee Related CN103751186B (zh) | 2006-04-05 | 2007-04-04 | 药物制剂:8-[{1-(3,5-双-(三氟甲基)苯基)-乙氧基}-甲基]-8-苯基-1,7-二氮杂-螺[4.5]癸-2-酮的盐及用其治疗的方法 |
Country Status (20)
Country | Link |
---|---|
US (4) | US7563801B2 (zh) |
EP (2) | EP2004148B1 (zh) |
JP (4) | JP5155998B2 (zh) |
KR (1) | KR20080108319A (zh) |
CN (2) | CN103751186B (zh) |
AR (1) | AR060303A1 (zh) |
AU (1) | AU2007233389C1 (zh) |
BR (1) | BRPI0710577A2 (zh) |
CA (2) | CA2861281A1 (zh) |
CL (1) | CL2007000945A1 (zh) |
ES (1) | ES2553805T3 (zh) |
HK (1) | HK1133387A1 (zh) |
MX (1) | MX2008012936A (zh) |
NO (1) | NO342810B1 (zh) |
NZ (1) | NZ571693A (zh) |
PE (2) | PE20080054A1 (zh) |
SG (1) | SG10201500028RA (zh) |
TW (1) | TWI332836B (zh) |
WO (1) | WO2007114921A2 (zh) |
ZA (1) | ZA200808465B (zh) |
Cited By (1)
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CN104473887A (zh) * | 2014-11-12 | 2015-04-01 | 广东东阳光药业有限公司 | 一种提高利伐沙班片溶出曲线重现性的方法 |
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CN103751186B (zh) * | 2006-04-05 | 2016-08-24 | 欧科生医股份有限公司 | 药物制剂:8-[{1-(3,5-双-(三氟甲基)苯基)-乙氧基}-甲基]-8-苯基-1,7-二氮杂-螺[4.5]癸-2-酮的盐及用其治疗的方法 |
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KR101719004B1 (ko) | 2008-09-05 | 2017-03-22 | 옵코 헬스, 인크. | 8-[{1-(3,5-비스-(트리플루오로메틸)페닐)-에톡시}-메틸]-8-페닐-1,7-디아자-스피로[4.5]데칸-2-온 화합물의 합성 방법 및 중간체 |
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AR066191A1 (es) | 2007-03-22 | 2009-08-05 | Schering Corp | Proceso e intermediarios para la sintesis de compuestos 8- [ ( 1- (3,5- bis- ( trifluorometil) fenil) - etoxi ) - metil]- 8 fenil - 1,7- diaza - espiro (4, 5) decan -2 ona |
PE20081891A1 (es) | 2007-03-22 | 2008-12-27 | Opko Health Inc | Formulaciones de comprimidos que contienen sales de 8-[{1-(3,5-bis-(trifluorometil)fenil)-etoxi}-metil]-8-fenil-1,7-diaza-spiro[4.5]decan-2-ona y comprimidos elaborados a partir de estas |
KR101719004B1 (ko) | 2008-09-05 | 2017-03-22 | 옵코 헬스, 인크. | 8-[{1-(3,5-비스-(트리플루오로메틸)페닐)-에톡시}-메틸]-8-페닐-1,7-디아자-스피로[4.5]데칸-2-온 화합물의 합성 방법 및 중간체 |
EP3143996A1 (en) | 2009-08-14 | 2017-03-22 | OPKO Health, Inc. | Intravenous formulations of neurokinin 1-antagonists |
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Publication number | Priority date | Publication date | Assignee | Title |
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CN104473887A (zh) * | 2014-11-12 | 2015-04-01 | 广东东阳光药业有限公司 | 一种提高利伐沙班片溶出曲线重现性的方法 |
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