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REGIMEN FOR SUPPRESSING ORGAN REJECTION

机译:制止器官拒绝制度

摘要

The present invention relates to a method of suppressing organ rejection in a patient receiving an organ transplant by initiating oral treatment with a once-daily extended release tacrolimus dosage form, for example, at an initial dose of from about 0.15 to about 0.20 mg/kg/day within 24 or 48 hours following transplantation. The once-daily extended release tacrolimus dosage form (i) provides low fluctuation and/or swing of tacrolimus, (ii) provides a significantly lower Cmax than an immediate release formulation of tacrolimus while providing the same or greater area under the curve (AUC), (iii) releases the tacrolimus substantially in the colon and/or the lower ileum, (iv) releases at most 63.5% of the tacrolimus in the dosage form at the 12 hour time point, or (v) any combination of any of the foregoing.
机译:本发明涉及一种通过接受每日一次延长释放他克莫司剂型的口服治疗,例如初始剂量为约0.15至约0.20mg / kg的口服治疗,来抑制接受器官移植的患者的器官排斥的方法。 /天在移植后24或48小时内。每天一次的他克莫司缓释剂型(i)提供他克莫司的低波动和/或摆动,(ii)提供比他克莫司的速释制剂低得多的C max ,同时提供他克莫司或曲线下的更大面积(AUC),(iii)在结肠和/或回肠下部释放他克莫司,(iv)在12小时时点释放剂型中他克莫司的至多63.5%,或( v)上述任何内容的任何组合。

著录项

  • 公开/公告号US2020268721A1

    专利类型

  • 公开/公告日2020-08-27

    原文格式PDF

  • 申请/专利权人 VELOXIS PHARMACEUTICALS A/S;

    申请/专利号US201916678527

  • 发明设计人 WILLIAM J POLVINO;

    申请日2019-11-08

  • 分类号A61K31/436;A61K31/5377;A61K39/395;A61P43;A61K9/20;A61K9;A61K45/06;

  • 国家 US

  • 入库时间 2022-08-21 11:23:52

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