Controlled release formulation of tamsulosin hydrochloride and preparation process thereof
    1.
    发明申请
    Controlled release formulation of tamsulosin hydrochloride and preparation process thereof 审中-公开
    盐酸坦洛新的控制释放制剂及其制备方法

    公开(公告)号:US20050100606A1

    公开(公告)日:2005-05-12

    申请号:US10747044

    申请日:2003-12-30

    IPC分类号: A61K9/16 A61K9/26

    CPC分类号: A61K9/1676 A61K9/1635

    摘要: Provided is a controlled-release formulation of tamsulosin hydrochloride, which includes a granular core, and a drug-coating layer coated on the granular core, including the tamsulosin hydrochloride and a release-controlling agent selected from the group consisting of (a) a first copolymer of 1 part by weight of ethylacrylate, 2 parts by weight of methylmethacrylate, and 0.1 parts by weight of trimethylammonioethyl methacrylate chloride, (b) a mixture of the first copolymer and a second copolymer of 1 part by weight of ethylacrylate, 2 parts by weight of methylmethacrylate, and 0.2 parts by weight of trimethylammonioethyl methacrylate chloride, the weight ratio between the first copolymer and the second copolymer being 1: 0.05 to 0.2, and (c) polyvinylacetate. A process for preparing the controlled-release formulation of the tamsulosin hydrochloride is also provided.

    摘要翻译: 本发明提供一种盐酸坦索罗辛的控释制剂,其包含粒状核,涂覆在粒状核上的药物包衣层,包括盐酸坦洛新,以及选自下述的释放控制剂:(a)第一 共聚物,1重量份丙烯酸乙酯,2重量份甲基丙烯酸甲酯和0.1重量份甲基丙烯酸三甲基铵乙酯氯化物,(b)第一共聚物和第二共聚物的混合物,1重量份丙烯酸乙酯,2份 重量的甲基丙烯酸甲酯和0.2重量份的甲基丙烯酸三甲基铵乙酯氯化物,第一共聚物和第二共聚物之间的重量比为1:0.05至0.2,和(c)聚乙酸乙烯酯。 还提供了制备盐酸坦洛新的控释制剂的方法。

    Enteric Coated Pharmaceutical Oral Formulations Comprising Acid-Labile Active Substances, and a Method Thereof
    2.
    发明申请
    Enteric Coated Pharmaceutical Oral Formulations Comprising Acid-Labile Active Substances, and a Method Thereof 审中-公开
    包含酸不稳定活性物质的肠溶性药物口服制剂及其方法

    公开(公告)号:US20070269509A1

    公开(公告)日:2007-11-22

    申请号:US10596187

    申请日:2006-02-08

    IPC分类号: A61K9/30 A61K31/4436 A61K9/20

    CPC分类号: A61K9/2846

    摘要: This invention relates to an oral pharmaceutical formulation formed by a direct coating of an enteric layer containing polyethylene glycol as a plasticizer on a core containing an acid-labile pantoprazole, and its manufacturing method. The enteric-coated oral pharmaceutical formulation of this invention, which combines directly a core containing an acid-labile pantoprazole and an enteric layer in the absence of an inert intermediate layer, is able to improve the storage stability of the acid-labile pantoprazole and maximize the bioavailability and oral absorption rates via preventing related substances from increasing.

    摘要翻译: 本发明涉及通过在包含酸不稳定泮托拉唑的核心上直接包衣含有聚乙二醇作为增塑剂的肠溶层形成的口服药物制剂及其制造方法。 本发明的肠溶包衣口服药物制剂在不存在惰性中间层的情况下直接结合含有酸不稳定泮托拉唑和肠溶层的核心能够提高酸不稳定泮托拉唑的储存稳定性, 通过防止相关物质增加的生物利用度和口服吸收率。