RU2001118162A - A TETRAHYDRATE SOLUTION OF N- [O- (P-PIVALOILOXYBENZENESULPHONYLAMINO) MONONATRIC SALT BENZENE] GLYCINE AND READY-BASED FORM ON BASIS - Google Patents

A TETRAHYDRATE SOLUTION OF N- [O- (P-PIVALOILOXYBENZENESULPHONYLAMINO) MONONATRIC SALT BENZENE] GLYCINE AND READY-BASED FORM ON BASIS

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Publication number
RU2001118162A
RU2001118162A RU2001118162/14A RU2001118162A RU2001118162A RU 2001118162 A RU2001118162 A RU 2001118162A RU 2001118162/14 A RU2001118162/14 A RU 2001118162/14A RU 2001118162 A RU2001118162 A RU 2001118162A RU 2001118162 A RU2001118162 A RU 2001118162A
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Russia
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solution according
solution
sodium hydroxide
organic solvent
dosage form
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RU2001118162/14A
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Russian (ru)
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RU2272623C2 (en
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Акира ТАКАДА
Масао Судох
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Оно Фармасьютикал Ко. Лтд.
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Claims (20)

1. Раствор тетрагидрата мононатриевой соли N-[0-(n-пивалоилоксибензолсульфониламино)бензоил] глицина формулы (I)
Figure 00000001

содержащий по меньшей мере один регулятор рН, выбранный из тринатрийфосфата, его гидрата, гидроксида натрия или гидроксида калия.1. A solution of the tetrahydrate monosodium salt of N- [0- (n-pivaloyloxybenzenesulfonylamino) benzoyl] glycine of formula (I)
Figure 00000001

containing at least one pH regulator selected from trisodium phosphate, its hydrate, sodium hydroxide or potassium hydroxide. 2. Раствор по п. 1, в котором растворителем является вода. 2. The solution according to claim 1, in which the solvent is water. 3. Раствор по п. 2, в котором рН раствора составляет от 7,0 до 8,5. 3. The solution according to claim 2, in which the pH of the solution is from 7.0 to 8.5. 4. Раствор по п. 2, в котором регулятор рН содержит гидроксид натрия. 4. The solution according to claim 2, in which the pH regulator contains sodium hydroxide. 5. Раствор по п. 1, в котором растворитель представляет собой смесь воды и органического растворителя. 5. The solution according to claim 1, in which the solvent is a mixture of water and an organic solvent. 6. Раствор по п. 5, в котором рН раствора составляет от 7,0 до 9,0. 6. The solution according to claim 5, in which the pH of the solution is from 7.0 to 9.0. 7. Раствор по п. 5, в котором регулятор рН представляет собой гидроксид натрия. 7. The solution according to claim 5, in which the pH regulator is sodium hydroxide. 8. Раствор по п. 7, в котором гидроксид натрия используют в количестве от 4,0 до 7,0 мас. /мас. % по отношению к соединению формулы (I). 8. The solution according to claim 7, in which sodium hydroxide is used in an amount of from 4.0 to 7.0 wt. / wt. % relative to the compound of formula (I). 9. Раствор по п. 5, в котором количество органического растворителя составляет от 1 до 40 об. /об. % по отношению к общему объему раствора. 9. The solution according to claim 5, in which the amount of organic solvent is from 1 to 40 vol. /about. % relative to the total volume of the solution. 10. Раствор по п. 9, в котором количество органического растворителя составляет от 10 до 40 об. /об. % по отношению к общему объему раствора. 10. The solution according to claim 9, in which the amount of organic solvent is from 10 to 40 vol. /about. % relative to the total volume of the solution. 11. Раствор по п. 10, в котором количество органического растворителя составляет от 20 до 35 об. /об. % по отношению к общему объему раствора. 11. The solution according to claim 10, in which the amount of organic solvent is from 20 to 35 vol. /about. % relative to the total volume of the solution. 12. Раствор по п. 5, в котором органический растворитель представляет собой спирт. 12. The solution according to claim 5, in which the organic solvent is an alcohol. 13. Раствор по п. 12, в котором спирт представляет собой этанол. 13. The solution according to claim 12, in which the alcohol is ethanol. 14. Готовая лекарственная форма, получаемая из раствора по п. 1. 14. The finished dosage form obtained from the solution under item 1. 15. Готовая лекарственная форма по п. 14, представляющая собой инъекционную форму. 15. The finished dosage form according to claim 14, which is an injectable form. 16. Готовая лекарственная форма по п. 15, полученная сушкой вымораживанием. 16. The finished dosage form under item 15, obtained by freeze-drying. 17. Высушенная вымораживанием готовая лекарственная форма, содержащая соединение формулы (I), как описано в п. 1, и по меньшей мере один регулятор рН, выбранный из тринатрийфосфата, его гидрата, гидроксида натрия или гидроксида калия. 17. Freeze-dried formulation containing the compound of formula (I) as described in claim 1, and at least one pH adjuster selected from trisodium phosphate, its hydrate, sodium hydroxide, or potassium hydroxide. 18. Готовая лекарственная форма по п. 17, в которой регулятор рН представляет собой гидроксид натрия. 18. The finished dosage form under item 17, in which the pH regulator is sodium hydroxide. 19. Раствор по п. 1 для изготовления лекарственного препарата для лечения состояния, которое улучшается при введении ингибитора эластазы. 19. The solution according to claim 1 for the manufacture of a medicinal product for the treatment of a condition that improves with the introduction of an elastase inhibitor. 20. Раствор по п. 1 для изготовления лекарственного препарата для лечения острых легочных заболеваний. 20. The solution according to claim 1 for the manufacture of a medicinal product for the treatment of acute pulmonary diseases.
RU2001118162/15A 2000-06-29 2001-06-28 N-[o-(para-pivaloyloxybenzenesulfonylamino)benzoyl]-glycine monosodium salt tetrahydrate solution and ready medicinal formulation based on thereof RU2272623C2 (en)

Applications Claiming Priority (4)

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JP2000195853 2000-06-29
JP2000-195853 2000-06-29
JP2000-195852 2000-06-29
JP2000195852 2000-06-29

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US (1) US6552082B2 (en)
EP (1) EP1166773B1 (en)
KR (1) KR100725076B1 (en)
CN (1) CN1263736C (en)
AT (1) ATE259218T1 (en)
AU (1) AU782838B2 (en)
BR (1) BR0102604B1 (en)
CA (1) CA2351273C (en)
DE (1) DE60101979T2 (en)
DK (1) DK1166773T3 (en)
ES (1) ES2215856T3 (en)
HU (1) HUP0102699A2 (en)
MX (1) MXPA01006698A (en)
NO (1) NO330296B1 (en)
NZ (1) NZ512486A (en)
PT (1) PT1166773E (en)
RU (1) RU2272623C2 (en)
TR (1) TR200400585T4 (en)
TW (1) TWI246925B (en)

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CA2416600A1 (en) * 2000-07-24 2003-01-20 Ono Pharmaceutical Co., Ltd. Freeze-dried preparation of n-¬o-(p-pivaloyloxybenzenesulfonylamino)benzoyl|glycine monosodium salt tetrahydrate and a process for the maufacture thereof
EP1393727B1 (en) * 2001-05-17 2007-04-18 Ono Pharmaceutical Co., Ltd. Remedial agent for myelopathic disease
CN1889942B (en) * 2003-10-03 2010-12-15 小野药品工业株式会社 Drug containing (2R)-2-propyloctanoic acid as the active ingredient
SI2868315T1 (en) 2007-12-04 2017-10-30 Biogen Chesapeake Llc Improved formulations and methods for lyophilization and lyophilates provided thereby
KR101247137B1 (en) * 2011-03-23 2013-04-01 주식회사 엠씨켐 Process for the preparation of N-[O-(P-Pivaloyloxybenzenesulfonylamino)-benzoyl]glycin and for the formulation of the lyophilization containing its mononatrium saltㆍ4 hydrate
KR101366706B1 (en) 2012-12-06 2014-02-24 상명대학교서울산학협력단 Process for the preparation of N-[O-(P-Pivaloyloxybenzenesulfonylamino)-benzoyl]glycin and for the formulation of the lyophilization containing its mononatrium saltㆍ4 hydrate
CN104107172B (en) * 2013-04-18 2017-11-28 上海汇伦生命科技有限公司 The preparation method of sivelestat sodium injection freeze-dried powder
CN114681435A (en) 2020-12-31 2022-07-01 上海汇伦生物科技有限公司 Pharmaceutical composition for inhalation

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KR0143565B1 (en) 1988-06-13 1998-07-15 사노 가즈오 Derivatives of p-substituted phenyl ester of pivalic acid
JPH0320253A (en) 1988-06-13 1991-01-29 Ono Pharmaceut Co Ltd Para-substituted phenyl pivalate derivatives, their production and elastase inhibitor containing the same
IT1242642B (en) * 1990-04-17 1994-05-16 Alfa Wassermann Spa INJECTABLE FORMULATIONS CONTAINING NAPROXEN SODIUM SALT.
JP3020253B2 (en) 1990-05-02 2000-03-15 松下電工株式会社 Mounting structure of wiring equipment to mounting frame
JPH05194366A (en) 1991-10-25 1993-08-03 Ono Pharmaceut Co Ltd Glycine derivative-monosodium salt-tetrahydrate, its production, medicine containing the same and production of intermediate for the same derivative
EP0539223A1 (en) 1991-10-25 1993-04-28 Ono Pharmaceutical Co., Ltd. Glycine derivative monosodium salt tetrahydrate having an inhibitory effect on elastase
JP3193597B2 (en) 1995-07-28 2001-07-30 小野薬品工業株式会社 Method for producing glycine derivative
WO2000015207A2 (en) 1998-09-15 2000-03-23 Naeja Pharmaceutical Inc. Combination for the treatment of inflammation using elastine inhibitor(s) and antibacterial agent(s)
WO2001017527A1 (en) * 1999-09-06 2001-03-15 Ono Pharmaceutical Co., Ltd. Preventive and therapeutic agents for eye diseases

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