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对可溶性微阵列贴片的临床前评估的见解

Maja Railic¹, Sonja Vucen¹, Abina Crean¹

¹SSPC Centre for Pharmaceutical Research, School of Pharmacy, University College Cork, Ireland.

International journal of pharmaceutics

|February 19, 2025

概括

可溶性微阵列贴片 (MAP) 提供了患者友好的药物输送. 本综述强调了临床前研究中的关键实验因素,以改善MAP性能和推进临床转化.

科学领域:

制药科学制药科学
生物材料工程生物材料工程
药物输送系统药物输送系统

背景情况:

含有药物的可溶性微阵列贴片 (MAP) 正因其对患者友好,经济和环保的优势而受到关注.
尽管在制造和设计方面进行了大量研究,MAP的临床翻译仍然有限.
在了解临床前实验设计方面仍然存在差距,这对于将MAP推向临床试验至关重要.

研究的目的:

在临床前评估期间全面审查影响药物负载MAP性能的实验因素.
确定体外,体内和体内MAP测试的关键考虑因素.
提出优化方案,以提高临床前MAP方法的有效性和生物相关性.

主要方法:

深入分析皮肤环境对体外MAP表现的影响.
对MAP临床前评估当前研究趋势的批判性评估.
对影响MAP表现的因素的审查,强调计算方法.

主要成果:

皮肤插入方法,释放/透测试介质,皮肤模型和皮肤代谢对于体外MAP性能至关重要.
在形方法显示有希望的潜力预测MAP的表现.
目前的体外试验方法需要优化,以提高生物相关性和预测能力.

结论:

可靠的临床前方法的标准化对于成功的药物载荷MAP开发至关重要.
解决已识别的实验因素将促进微阵列贴片技术的临床转化.
本综述为旨在优化MAP临床前研究的研究人员提供了关键的见解.

关键词:

临床翻译临床翻译可以溶解的微阵列贴片.在体外表现的表现.临床前研究临床前研究

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