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吸入性菌体粉末配方的长期存储稳定性:为期四年的研究

Mengyu Li¹, Wei-Ren Ke², Rachel Yoon Kyung Chang³

¹Advanced Drug Delivery Group, Sydney Pharmacy School, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, 2006, Australia.

The AAPS journal

|August 5, 2025

概括

喷雾干燥的菌体 (菌体) 粉末显示出长期储存的潜力,用于治疗多药耐药性肺部感染. 更高的乳糖含量提高了菌体的稳定性,尽管气溶性能随着时间的推移而下降.

科学领域:

微生物学微生物学
制药科学制药科学
生物技术是生物技术.

背景情况:

菌体治疗是多药耐药细菌肺部感染的有希望的替代方案.
肺部药物输送需要稳定的配方才能有效治疗.
喷雾干燥菌体粉末的长期稳定性数据对于临床应用至关重要.

研究的目的:

为了评估喷雾干燥的菌体 (菌体) 粉末配方的长期稳定性,用于肺部输送.
评估配方成分 (乳糖,白糖) 对菌体生物活性和物理化学性质的影响.
为了确定存储条件对四年内菌体粉末稳定性的影响.

主要方法:

三种Pseudomonas aeruginosa菌体 (PEV1,PEV20,PEV61) 通过喷雾干燥与不同度的乳糖和氨酸制成.
配方在4°C/15%RH和20°C/15%RH下存储了四年.
随着时间的推移,分析了菌体活力 (标位),粒子形态和细粒子分数 (FPF).

主要成果:

菌体位数在四年内下降,下降幅度从0.97到2.49 log10.
含有70-80%乳糖的配方表现出对菌体生物活性的优越保存.
虽然粒子形态在很大程度上是稳定的,但在20°C/15%RH时出现了一些延长的特征. 细颗粒物分数 (FPF) 从50-60%显著下降到27-44%.

结论:

喷雾干燥的菌体粉末提供了长期储存的可行策略,保持了潜在的肺部输送的生物活性.
优化乳糖度是提高干粉配方菌体稳定性的关键.
需要进一步的研究来解决气溶性能 (FPF) 观察到的下降,以有效的肺部输送.

关键词:

细菌菌体是一种菌体.这是一种配方配方.吸入粉末的吸入方法肺部输送是通过肺部进行的.喷雾干燥喷雾干燥稳定的稳定性稳定的稳定性

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