卡里普拉辛口腔可分解片:卡里普拉辛的新配方
Viktória Meszár1, Gabriella Magyar1, Gabriella Mészárosné Pásztor1
1Research Directorate, Gedeon Richter Plc, Budapest, Hungary.
Pharmacopsychiatry
|May 6, 2024
概括
一个新的卡里普拉辛口腔可分散片与标准囊配方具有生物等价性. 这为精神分裂症治疗提供了替代的施用选择,特别是当吞困难时.
科学领域:
- 药理学 药理学是指药理学的学科.
- 临床药房 临床药房
- 药物开发 药物开发
背景情况:
- 卡里普拉辛是一种非典型的抗精神病药物,通常以囊形式使用.
- 对于患有吞困难或急性病情的患者,需要替代配方.
- 口腔可溶解片提供了一个方便的替代施用途径.
研究的目的:
- 为了评估与现有的硬凝囊相比,新型卡里普拉辛1.5毫克口腔可分散片的生物等价性.
- 为了确定可口 dispersible 片剂配方的安全性和耐受性.
主要方法:
- 第一阶段,开放标签,随机化,单剂量,交叉生物等价性研究.
- 43名健康志愿者接受了测试 (口腔可分解片) 和参考 (囊) 配方.
- 使用HPLC-MS/MS分析了药理动力学参数 (AUC0-72h,Cmax),通过几何平均比率和90%置信区间评估生物等价性.
主要成果:
- 对AUC0-72h和Cmax的几何平均比分分别为117.76%和100.88%.
- 两个参数的90%置信区间都在80.00%125.00%的生物等价性接受范围之内.
- 安全数据与 cariprazine 的产品特性摘要一致.
结论:
- 卡里普拉辛口腔可分散片的配方与硬凝囊具有生物等价性.
- 这种新配方为卡里普拉辛的使用提供了可行的替代方案.
- 这项研究支持在精神分裂症治疗中使用可口溶解片.
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