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    • 2. 发明申请
    • PHARMACEUTICAL COMPOSITIONS FOR GLUCOCORTICOID REPLACEMENT THERAPY
    • 用于葡萄糖替代治疗的药物组合物
    • WO2005102271A2
    • 2005-11-03
    • PCT/EP2005/004400
    • 2005-04-21
    • DUOCORT ABSKRTIC, StankoJOHNSSON, JörgenLENNERNÄS, HansHEDNER, ThomasJOHANNSSON, Gudmundur
    • SKRTIC, StankoJOHNSSON, JörgenLENNERNÄS, HansHEDNER, ThomasJOHANNSSON, Gudmundur
    • A61K9/00
    • A61K31/573A61K9/2031A61K9/209A61K9/28
    • The invention relates to glucocorticoid replacement therapy and provides pharmaceutical compositions and kits designed to deliver one or more glucocorticoids to a subject in need thereof in a manner that results in serum levels of the glucocorticoid that essentially mimic that of a healthy subject for a clinically relevant period of time. The pharmaceutical composition comprises one or more glucocorticoids, wherein a first part of one or more glucocorticoids is substantially immediately released and a second part of one or more glucocorticoids is released over an extended period of time of at least about 8 hours, and the amount of the one or more glucocorticoids of the first part, expressed as hydrocortisone equivalents, is in a range of from about 15 to about 50% of the total hydrocortisone equivalents. The invention also relates to a kit comprising a first and a second component, the first component designed to release one or more glucocorticoids substantially immediately and the second component is designed to release one or more glucocorticoids over an extended period of time of at least 8 hours. The invention also relates to a method for treating diseases requiring glucocorticoid treatment such as in subjects having a glucocorticoid deficiency disorder. In another aspect the invention relates to the use of a first and a second amount of one or more glucocorticoids for the preparation of a pharmaceutical composition or kit for the treatment of a glucocorticoid deficiency disorder.
    • 本发明涉及糖皮质激素替代疗法,并且提供药物组合物和试剂盒,其设计用于将一种或多种糖皮质激素递送至有需要的受试者,其方式使得糖皮质激素的血清水平基本上模拟健康受试者在临床相关期间 的时间。 药物组合物包含一种或多种糖皮质激素,其中一种或多种糖皮质激素的第一部分基本上立即释放,并且一种或多种糖皮质激素的第二部分在至少约8小时的延长时间内释放, 表示为氢化可的松当量的第一部分的一种或多种糖皮质激素在总氢化可的松当量的约15至约50%的范围内。 本发明还涉及包含第一和第二组分的试剂盒,第一组分被设计成基本上立即释放一种或多种糖皮质激素,并且第二组分被设计成在至少8小时的延长的时间段内释放一种或多种糖皮质激素 。 本发明还涉及治疗需要糖皮质激素治疗的疾病的方法,例如具有糖皮质激素缺乏症的受试者。 在另一方面,本发明涉及第一和第二量的一种或多种糖皮质激素在制备用于治疗糖皮质激素缺乏症的药物组合物或试剂盒中的用途。