Abstract

This study aims to explore the stability of lipo-polymeric niosomes/niosome-based pCMS-EGFP complexes under different storage temperatures (25 °C, 4 °C, and −20 °C). To date, the question of nucleic acid-complex stability is one of the most vital issues in gene delivery applications. The need for stable vaccines during the COVID-19 pandemic has merely highlighted it. In the case of niosomes as gene carriers, the scientific literature still lacks comprehensive stability studies. In this study, the physicochemical features of niosomes/nioplexes in terms of size, surface charge, and polydispersity index (PDI), along with transfection efficiency, and cytotoxicity in NT2 cells were evaluated for 8 weeks. Compared to day 0, the physicochemical features of the niosomes stored at 25 °C and −20 °C changed dramatically in terms of size, zeta potential, and PDI, while remaining in reasonable values when stored at 4 °C. However, niosomes and nioplexes stored at 4 °C and −20 °C showed nearly stable transfection efficiency values, yet an obvious decrease at 25 °C. This article provides a proof of concept into the stability of polymeric cationic niosomes and their nioplexes as promising gene delivery vehicles. Moreover, it highlights the practical possibility of storing nioplexes at 4 °C for up to 2 months, as an alternative to niosomes, for gene delivery purposes.

 抽象的

本研究旨在探讨脂聚合物niosomes/基于niosome的pCMS-EGFP复合物在不同储存温度（25℃、4℃和-20℃）下的稳定性。迄今为止，核酸复合物的稳定性问题是基因递送应用中最重要的问题之一。 COVID-19 大流行期间对稳定疫苗的需求只是凸显了这一点。就囊泡作为基因载体而言，科学文献仍缺乏全面的稳定性研究。在这项研究中，评估了niosomes/nioplexes的尺寸、表面电荷和多分散指数（PDI）方面的物理化学特征，以及转染效率和NT2细胞中的细胞毒性，为期8周。与第0天相比，在25°C和-20°C下储存的脂质体的理化特征在尺寸、zeta电位和PDI方面发生了显着变化，而在4°C下储存时仍保持在合理的值。然而，在4℃和-20℃储存的niosomes和nioplexes表现出几乎稳定的转染效率值，但在25℃时明显下降。本文提供了聚合阳离子类脂质体及其作为有前途的基因递送载体的氮氧化物复合物的稳定性的概念证明。此外，它还强调了将 nioplex 在 4°C 下储存长达 2 个月的实际可能性，作为 niosome 的替代品，用于基因传递目的。