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ADMINISTRATIVE FACTORS PREPARED FOR DISPOSAL IN THE FIELD OF THE STANDARD TREATY UNDER CONCLUSION OF A CLOSURE MEDICINAL PRODUCT LEGISLATION

机译:根据结束药品立法,在标准条约的领域准备出售的行政因素

摘要

Embodiments provide devices, preparations and methods for delivering therapeutic agents (TAs) such as clotting factors (CFs, e.g., Factor 8) within the GI tract. Many embodiments provide a swallowable device e.g., a capsule for delivering TAs into the intestinal wall (IW). Embodiments also provide TA preparations configured to be contained within the capsule, advanced from the capsule into the IW and/or surrounding tissue (ST) and degrade to release the TA into the bloodstream to produce a therapeutic effect (e.g., improved clotting). The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the IW or ST (e.g., the peritoneal cavity). Embodiments are particularly useful for delivery of CFs for treatment of clotting disorders (e.g., hemophilia) where such CFs are poorly absorbed and/or degraded within the GI tract.
机译:实施方案提供用于递送治疗剂(TAS)的装置,制剂和方法,例如GI在GI的凝血因子(CFS,例如,因子8)中。 许多实施例提供了一种可吞咽的装置,例如,用于将TA输送到肠壁(IW)中的胶囊。 实施例还提供配置成含有的TA制剂,其含有胶囊内,从胶囊进入IW和/或周围组织(ST)并降解以将TA释放到血液中以产生治疗效果(例如,改进的凝血)。 制剂可以可操作地联接到具有第一构型的递送装置,其中制剂包含在胶囊中的制剂和第二构型,其中将制剂从胶囊中提出到IW或ST(例如,腹膜腔)中。 实施方案特别适用于递送CFS以治疗凝血性疾病(例如,血友病),其中这种CFS在GI道内较差和/或降解。

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