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用于治疗阿尔茨海默病的纳米药物的开发:存在的理由、策略、挑战和监管方面。

Development of nanomedicines for the treatment of Alzheimer's disease: Raison d'être, strategies, challenges and regulatory aspects.

机构信息

Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Raebareli, India.

Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Raebareli, India.

出版信息

Ageing Res Rev. 2024 Jul;98:102318. doi: 10.1016/j.arr.2024.102318. Epub 2024 May 4.

DOI:10.1016/j.arr.2024.102318
PMID:38705362
Abstract

Alzheimer's disease (AD) is a chronic neurodegenerative disorder characterized by progressive loss of memory. Presently, AD is challenging to treat with current drug therapy as their delivery to the brain is restricted by the presence of the blood-brain barrier. Nanomedicines, due to their size, high surface volume ratio, and ease of tailoring drug release characteristics, showed their potential to treat AD. The nanotechnology-based formulations for brain targeting are expected to enter the market in the near future. So, regulatory frameworks are required to ensure the quality, safety, and effectiveness of the nanomedicines to treat AD. In this review, we discuss different strategies, in-vitro blood-brain permeation models, in-vivo permeation assessment, and regulatory aspects for the development of nanomedicine to treat AD.

摘要

阿尔茨海默病(AD)是一种慢性神经退行性疾病,其特征是记忆逐渐丧失。目前,由于血脑屏障的存在,药物治疗受到限制,因此 AD 难以治疗。由于纳米医学的尺寸、高表面积体积比以及易于定制药物释放特性,它们显示出治疗 AD 的潜力。基于纳米技术的脑部靶向制剂有望在不久的将来进入市场。因此,需要监管框架来确保用于治疗 AD 的纳米医学的质量、安全性和有效性。在这篇综述中,我们讨论了用于治疗 AD 的纳米医学的不同策略、体外血脑渗透模型、体内渗透评估和监管方面。

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