使用体外释放盒进行皮下注射的胰岛素的评估:中等成分和结合白蛋白
Frederik Bock1, Nadia Zivlaei1, Anna Thu Hoai Nguyen1
1Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 2, DK-2100 Copenhagen, Denmark.
International journal of pharmaceutics
|July 8, 2024
概括
一种体外释放 (IVR) 有效地模仿生物治疗药物开发的皮下注射部位. 这个系统准确地预测了体内胰岛素的行为,并帮助优化配方.
科学领域:
- 药理学 药理学是指药理学的学科.
- 生物技术是生物技术.
- 药物运输 药物运输 药物运输
背景情况:
- 皮下注射的生物治疗药物是一种快速扩张的药物类别.
- 在体外释放测试对于配方开发和增强生物预测模型至关重要.
- 目前的方法缺乏皮下注射部位的生理相关性.
研究的目的:
- 为了评估一种在体外释放 (IVR) 卡特里奇与一个模拟皮下组织的阿加罗斯矩阵.
- 评估介质组成和人血清白蛋白 (HSA) 结合对药物释放的影响.
- 为了确定胰岛素产品的体外和体内相关性.
主要方法:
- 开发了一种使用多孔阿加罗斯矩阵的IVR弹.
- 测试了各种胰岛素配方 (溶液,悬浮剂,现场沉).
- 使用UV-Vis成像和光显微镜分析药物消失.
- 在释放介质和矩阵中研究双价和HSA的影响.
主要成果:
- 双价酸盐减缓了悬浮和现场沉配方中的胰岛素释放.
- 结合白蛋白的胰岛素类似物显示出快速释放,但与HSA合的矩阵持续保留.
- 对于非白蛋白结合性胰岛素,确立了可靠的体外-体内相关性.
- 这种IVR子成功地容纳了各种不同的胰岛素配方.
结论:
- IVR弹是生物治疗配方开发的多功能工具.
- 该系统有效地模拟了体内条件,包括介质组成和组织相互作用.
- 这种方法提高了皮下注射体外释放测试的生物预测能力.
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