Stable pharmaceutical solution preparation for pressure-type quantitative inhalator
    8.
    发明专利
    Stable pharmaceutical solution preparation for pressure-type quantitative inhalator 有权
    用于压力式定量吸入器的稳定的药物溶液制备

    公开(公告)号:JP2011093915A

    公开(公告)日:2011-05-12

    申请号:JP2010286171

    申请日:2010-12-22

    Abstract: PROBLEM TO BE SOLVED: To provide an aerosol composition using a hydrofluoroalkane (HFA) as a propellant and having sufficient storage life.
    SOLUTION: The aerosol composition includes an amino-type pharmaceutical having functional group(s) sensitive to oxidation and/or hydrolysis and an auxiliary solvent selected from pharmaceutically acceptable alcohols, in a solution of a liquefied HFA propellant (wherein, the pH of the solution has been adjusted to 2.5-5.0 by adding a small amount of an inorganic acid such as hydrochloric acid, nitric acid or phosphoric acid). In the composition, it is preferable that the solution contains a low-volatile component having vapor pressure of not higher than 0.1 kPa at 25°C, preferably not higher than 0.05 kPa; the low-volatile component is preferably isopropyl myristate; the auxiliary solvent is preferably ethanol; and the pharmaceutical as the active ingredient is preferably e.g. salbutamol, or salmeterol.
    COPYRIGHT: (C)2011,JPO&INPIT

    Abstract translation: 要解决的问题:提供使用氢氟烷烃(HFA)作为推进剂并具有足够的储存寿命的气溶胶组合物。 解决方案:气溶胶组合物包含在液化HFA推进剂的溶液中具有对氧化和/或水解敏感的官能团的氨基型药物和选自药学上可接受的醇的辅助溶剂(其中,pH 的溶液通过加入少量的无机酸如盐酸,硝酸或磷酸调节至2.5-5.0)。 在该组合物中,优选该溶液含有在25℃,优选为0.05kPa以下蒸气压不高于0.1kPa的低挥发性成分; 低挥发性成分优选为肉豆蔻酸异丙酯; 辅助溶剂优选为乙醇; 并且作为活性成分的药物优选为例如。 沙丁胺醇或沙美特罗。 版权所有(C)2011,JPO&INPIT

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