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STABLE READY FOR USE CETRORELIX INJECTION SOLUTION
专利权人:
АСТРОН РИСЁРЧ ЛИМИТЕД (IN)
发明人:
ПАТЕЛ Панкадж (IN),ПАТЕЛ Бхавеш (IN),СЕХГАЛ Ашиш (IN),МАНДАЛ Джаянта Кумар (IN)
申请号:
RU2013128357/15
公开号:
RU2013128357A
申请日:
2011.12.05
申请国别(地区):
RU
年份:
2015
代理人:
摘要:
1. A stable ready-to-use aqueous pharmaceutical and parenteral cetrorelix preparation, wherein said preparation comprises cetrorelix or a pharmaceutically acceptable salt thereof in an amount of 0.025% w / v. or more, small amounts of glacial acetic acid, tonicity agent, optionally other pharmaceutically acceptable excipients, dissolved in water; wherein said preparation does not include any surfactant. 2. The pharmaceutical preparation of claim 1, wherein the pharmaceutically acceptable salt of cetrorelix is cetrorelix acetate. The pharmaceutical preparation according to claim 1 or claim 2, wherein the concentration of cetrorelix or a pharmaceutically acceptable salt thereof is 0.025-0.075% w / v, preferably 0.025-0.05% w / v. the specified drug. 4. The pharmaceutical preparation of claim 1, wherein small amounts of glacial acetic acid correspond to about 0.1-0.5% w / v. specified drug. 5. The pharmaceutical preparation according to claim 1, wherein the pH of the preparation is 2.5-5, preferably 2.8-3.5.6. The pharmaceutical preparation according to claim 1, wherein the tonicity regulating agent is selected from the group of mannitol, lactose, dextrose or the like, and the osmolality of the preparation is 290-330 mOsm / kg. A method of manufacturing a stable ready-to-use aqueous pharmaceutical preparation of cetrorelix for parenteral administration, where the steps include: a) dissolving glacial acetic acid, cetrorelix or a pharmaceutically acceptable salt and tonicity adjusting agent in water to obtain a solution; b) filtering the resulting solution through sterile filter and c) filling with sterile preparation1. Стабильный готовый к применению водный фармацевтический и препарат цетрореликса для парентерального введения, где указанный препарат включает цетрореликс или его фармацевтически приемлемую соль в количестве 0,025% вес./об. или больше, небольшие количества ледяной уксусной кислоты, средства, регулирующего тоничность, необязательно другие фармацевтически пр
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