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    Multiple unit oral pharmaceutical formulations
    5.
    发明授权
    Multiple unit oral pharmaceutical formulations 失效
    多单位口服药物制剂

    公开(公告)号：US5955104A

    公开(公告)日：1999-09-21

    申请号：US896629

    申请日：1997-07-18

    申请人： Helmut Momberger ,  Marc Raber ,  Dieter Kuhn ,  Wolfgang Schmid

    发明人： Helmut Momberger ,  Marc Raber ,  Dieter Kuhn ,  Wolfgang Schmid

    IPC分类号： A61P25/04 ,  A61K9/22 ,  A61K9/50 ,  A61K9/52 ,  A61K9/54 ,  A61K9/60 ,  A61K9/62 ,  A61K31/135 ,  A61K31/137 ,  A61P29/00

    CPC分类号： A61K31/137 ,  A61K9/5078 ,  Y10S514/951

    摘要： A multiple unit oral pharmaceutical dosage form having a plurality of pellets in a water soluble capsule or in a tablet compressed from the pellets, wherein each pellet contains (a) a substantially inert core, (b) an active ingredient layer over the inert core, and containing (i) a pharmacologically active particulate active ingredient, (ii) a nonembedding amount of a binder for adhering the active ingredient over the inert core, and optionally (iii) a pharmaceutically acceptable, inert adjuvant, such as colloidal silica, and (c) a coating over the active ingredient layer for retarding the release of the active ingredient from the active ingredient layer into an aqueous body fluid solvent in situ, the nonembedding amount of the binder is suitably from about 1% wt. to about 10% wt. based on the active ingredient layer, the binder in the active ingredient layer is suitably a mixture of ethylcellulose and shellac, in a weight proportion suitably of from about 1:9 to about 9:1, the coating for retarding the release suitably contains from about 70% wt. to about 95% wt. based on the coating, of a substantially water-insoluble, pharmacologically inert, particulate material, and a binder; the pharmacologically inert, particulate material is suitably talcum, and the binder in the active ingredient layer is suitably identical to the binder in the coating.

    摘要翻译： 一种多单位口服药物剂型，其在水溶性胶囊中或在片剂中压制的片剂中具有多个丸粒，其中每个丸粒包含（a）基本上惰性的核心，（b）惰性核心上的活性成分层， 并且包含（i）药理学活性的颗粒活性成分，（ii）非固定量的用于将活性成分粘附在惰性核上的粘合剂，以及任选地（iii）药学上可接受的惰性佐剂，例如胶体二氧化硅和（ c）活性成分层上的涂层，用于阻止活性成分从活性成分层原位释放到体液溶剂中，非粘合剂量的粘合剂适宜为约1重量％ 至约10重量％ 基于活性成分层，活性成分层中的粘合剂适当地为乙基纤维素和虫胶的混合物，其重量比适当地为约1:9至约9:1，用于延缓释放的涂层适当地含有约 70％wt 至约95重量％ 基于涂层，基本上不溶于水的，药理惰性的颗粒材料和粘合剂; 药理学惰性的颗粒材料适当地是滑石粉，并且活性成分层中的粘合剂适当地与涂层中的粘合剂相同。