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    Solid formulation with improved solubility and stability, and method for producing said formulation
    1.
    发明申请
    Solid formulation with improved solubility and stability, and method for producing said formulation 审中-公开
    具有改进的溶解度和稳定性的固体制剂以及生产所述制剂的方法

    公开(公告)号：US20060153913A1

    公开(公告)日：2006-07-13

    申请号：US11256201

    申请日：2005-10-24

    申请人： Shogo Yamane ,  Hirofumi Yamane ,  Masaki Sunami

    发明人： Shogo Yamane ,  Hirofumi Yamane ,  Masaki Sunami

    IPC分类号： A61K31/47 ,  A61K31/454 ,  A61K9/20

    CPC分类号： A61K9/2027 ,  A61K9/0056 ,  A61K9/143 ,  A61K9/146 ,  A61K9/1635 ,  A61K9/1652 ,  A61K9/2009 ,  A61K9/2054 ,  A61K31/225 ,  A61K31/454 ,  A61K31/47

    摘要： The present invention relates to a solid formulation with improved solubility and maintained stability including a chemical substance poorly soluble in water as a pharmaceutically active ingredient formulated in an improved manner. More specifically, the present invention relates to a solid formulation having improved water-solubility which comprises a chemical substance poorly soluble in water as a pharmaceutically active ingredient, a water-soluble polymer substance and an inorganic porous substance, characterized in that (1) the chemical substance poorly soluble in water forms a solid dispersion together with the water-soluble polymer substance, (2) the water-soluble polymer substance forming the solid dispersion is in the form of fine pieces, and (3) the water-soluble polymer substance is in the form of fine pieces is maintained to be adsorbed on and/or adhered to the surface of the inorganic porous substance. The solid formulation can be produced by stirring and mixing a solution obtained by dissolving a chemical substance poorly soluble in water as a pharmaceutically active ingredient and a water-soluble polymer substance in an organic solvent with an inorganic porous substance and then granulating and drying the mixture.

    摘要翻译： 本发明涉及具有改善的溶解性和保持稳定性的固体制剂，包括以改进的方式配制的药物活性成分不溶于水的化学物质。 更具体地说，本发明涉及具有改善的水溶性的固体制剂，其包含难溶于水作为药物活性成分的化学物质，水溶性聚合物物质和无机多孔物质，其特征在于（1） 难溶于水的化学物质与水溶性聚合物物质一起形成固体分散体，（2）形成固体分散体的水溶性聚合物物质为细片，（3）水溶性聚合物物质 以细片的形式被保持吸附在无机多孔物质表面上和/或附着于无机多孔物质的表面上。 固体制剂可以通过将通过将难溶于水的化学物质作为药物活性成分和水溶性聚合物物质溶解在有机溶剂中而获得的溶液与无机多孔物质混合，然后将混合物制粒和干燥来制备 。