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    Process for the preparation of shaped, compressed controlled-release unit-dosage forms, and the compressed unit-dosage forms thus obtained
    1.
    发明授权
    Process for the preparation of shaped, compressed controlled-release unit-dosage forms, and the compressed unit-dosage forms thus obtained 失效
    用于制备成形压缩的控释单元剂型的方法以及由此获得的压缩的单位剂型

    公开(公告)号：US5840330A

    公开(公告)日：1998-11-24

    申请号：US357143

    申请日：1994-12-15

    申请人： Berthold Stemmle ,  Klaus Budde ,  Alexander Wirl ,  Fritz Demmer

    发明人： Berthold Stemmle ,  Klaus Budde ,  Alexander Wirl ,  Fritz Demmer

    IPC分类号： A61K9/22 ,  A61K20060101 ,  A61K9/20 ,  A61K31/19 ,  A61K47/00 ,  A61P3/06

    CPC分类号： A61K9/2095 ,  A61K9/2077

    摘要： Process for the preparation of shaped, compressed controlled-release unit-dosage forms from a therapeutic active substance exhibiting a self-retarding release that depends on the magnitude of the force used for the compression. The process gives unit-dosage forms for which the release of the active substance is highly uniform, reproducibly identical and largely linear. To achieve this, the active substance and an additive charge that inhibits or compensates for the self-retardation of its release are processed into particles in the first stage of production, so that the preliminary compressed objects made from these particles without any further additives exhibit a rapid release (in comparison with the required controlled release) over the range of the force of compression envisaged for the production of the unit-dosage form in question, after which the particles are compressed in the second stage of production with a release-retarding agent to obtain the unit-dosage forms. The invention also relates to the unit-dosage forms thus obtained.

    摘要翻译： 从治疗活性物质制备成形的，压缩的控制释放单位剂型的方法，其表现出取决于用于压缩的力的大小的自我缓解释放。 该方法给出了单位剂型，其中活性物质的释放是高度均匀的，可重复地相同的并且在很大程度上是线性的。 为了达到这个目的，在生产的第一阶段，抑制或补偿其释放的自我延迟的活性物质和添加剂被加工成颗粒，使得由这些颗粒制成的预先压制的物体没有任何其它添加剂显示出 在生产所述单位剂量形式的压缩力的范围内快速释放（与所需的控制释放相比），然后在第二阶段用释放阻滞剂压缩颗粒 以获得单位剂型。 本发明还涉及由此获得的单位剂型。

    Carvedilol-galenics
    4.
    发明授权
    Carvedilol-galenics 失效
    卡维地洛

    公开(公告)号：US06852337B2

    公开(公告)日：2005-02-08

    申请号：US10278191

    申请日：2002-10-22

    申请人： Rolf-Dieter Gabel ,  Walter Preis ,  Alexander Wirl

    发明人： Rolf-Dieter Gabel ,  Walter Preis ,  Alexander Wirl

    IPC分类号： A61K9/14 ,  A61K9/16 ,  A61K31/403 ,  A61K31/454

    CPC分类号： A61K31/403 ,  A61K9/143 ,  A61K9/1617 ,  A61K9/1623 ,  A61K9/1635 ,  A61K9/1652 ,  A61K31/454

    摘要： The invention relates to a process for the preparation of fast-dissolving pharmaceutical preparations from difficultly soluble active substances, wherein an aqueous suspension is made from the active substance and one or more water-soluble adjuvants and then the resulting aqueous suspension is processed, with removal of the water, by methods conventional per se, to form solid pharmaceutical preparations. The invention also relates to fast-dissolving pharmaceutical preparations of active substances having a dissolution rate of at least 70% after 30 minutes, prepared in accordance with the process of the invention.

    摘要翻译： 本发明涉及从难溶性活性物质制备快速溶解药物制剂的方法，其中水性悬浮液由活性物质和一种或多种水溶性佐剂制成，然后将所得水性悬浮液加工，除去 的水，通过本身的方法形成固体药物制剂。 本发明还涉及根据本发明的方法制备的30分钟后溶解速率至少为70％的活性物质的快速溶解药物制剂。

    Method of stabilizing biologically active substances
    6.
    发明授权
    Method of stabilizing biologically active substances 有权
    稳定生物活性物质的方法

    公开(公告)号：US06689755B1

    公开(公告)日：2004-02-10

    申请号：US09184866

    申请日：1998-11-03

    申请人： Rolf-Dieter Gabel ,  Markus Mattern ,  Gerhard Winter ,  Alexander Wirl ,  Heinrich Woog

    发明人： Rolf-Dieter Gabel ,  Markus Mattern ,  Gerhard Winter ,  Alexander Wirl ,  Heinrich Woog

    IPC分类号： C08B3000

    CPC分类号： A61K9/1617 ,  A61K9/1623 ,  A61K47/183 ,  B01D1/18 ,  F26B3/02 ,  Y10S435/81 ,  Y10S514/911 ,  Y10S514/97

    摘要： The present invention relates to a rapid and readily reproducible process for stabilizing biologically active substances by combining the biologically active substance witha a stabilizingmixture and drying the resulting mixture into a dry, amorphous product by means of convection drying. The invention also relates to the amorphous, microscopically homogeneous products which are obtained by this process, are in the form of powders and have a uniform geometric, in particular spherical, shape. The invention furthermore relates to the use of substance mixtures for stabilizing biologically active material, in particular proteins by means of spray drying.

    摘要翻译： 本发明涉及通过将生物活性物质与稳定混合物组合并通过对流干燥将所得混合物干燥成干燥的无定形产物来稳定生物活性物质的快速和容易重现的方法。 本发明还涉及通过该方法获得的无定形，微观均匀的产品，其为粉末形式并且具有均匀的几何形状，特别是球形的形状。 本发明还涉及物质混合物用于通过喷雾干燥来稳定生物活性物质，特别是蛋白质的用途。