HIGH-AMYLOSE SODIUM CARBOXYMETHYL STARCH SUSTAINED RELEASE EXCIPIENT AND PROCESS FOR PREPARING THE SAME
    3.
    发明申请
    HIGH-AMYLOSE SODIUM CARBOXYMETHYL STARCH SUSTAINED RELEASE EXCIPIENT AND PROCESS FOR PREPARING THE SAME 审中-公开
    高分子量的羧甲基纤维素淀粉保留释放专利及其制备方法

    公开(公告)号:US20100113619A1

    公开(公告)日:2010-05-06

    申请号:US12451907

    申请日:2008-06-05

    IPC分类号: A61K47/36 C08B31/00 A61K9/20

    摘要: A process for obtaining a spray-dried high amylose sodium carboxymethyl starch comprising a major fraction of amorphous form and optionally a minor fraction of crystalline V form, is provided. The process comprises providing an amorphous pregelatinized high amylose sodium carboxymethyl starch (HASCA); dispersing the amorphous pregelatinized HASCA in a solution comprising water and at least one first pharmaceutically acceptable organic solvent miscible with water and suitable for spray-drying; and spray-drying the dispersion to obtain the spray-dried HASCA comprising a major fraction of amorphous form and optionally a minor fraction of crystalline V form, in the form of a powder. Also provided is a spray-dried HASCA sustained-release excipient. This excipient is useful for preparing a tablet for the sustained-release of at least one drug.

    摘要翻译: 提供了一种获得喷雾干燥的高直链淀粉钠羧甲基淀粉的方法,该方法包括非晶形式的主要部分和任选的微结晶V形式的少部分。 该方法包括提供无定形预胶化的高直链淀粉钠羧甲基淀粉(HASCA); 将无定形预胶化的HASCA分散在包含水和至少一种可与水混溶并适于喷雾干燥的至少一种药学上可接受的有机溶剂的溶液中; 并喷雾干燥该分散体以获得喷雾干燥的HASCA,其包含粉末形式的非晶形式的主要部分和任选的微晶V型的少部分。 还提供喷雾干燥的HASCA持续释放赋形剂。 该赋形剂可用于制备用于缓释至少一种药物的片剂。