使用薄膜冷干燥技术开发了可吸入的D29菌菌体干粉
Benjamin Southard1, Kyoka Melton1, Michael A Sandoval1
1Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, Austin, TX 78712, USA.
International journal of pharmaceutics
|July 7, 2025
概括
这项研究开发了一种稳定的抗结核菌体D29的干粉配方,用于使用薄膜冷干燥 (TFFD) 进行肺部输送. 通过TFFD方法,成功地产生了可吸入的菌体粉末,具有很高的活力和稳定性,可用于潜在的结核病治疗.
科学领域:
- 制药科学 制药科学
- 生物技术是生物技术.
- 微生物学 微生物学
背景情况:
- 菌体D29是一种菌体,准结核病引起的细菌,对剪切敏感,需要特定的配方来进行肺部输送.
- 肺部输送提供了对肺部感染的菌体治疗的直接途径,但需要稳定,可喷雾的配方.
研究的目的:
- 使用薄膜冷干燥 (TFFD) 开发一种稳定的mycobacteriophage D29干粉配方,用于肺部输送.
- 为了优化菌体生存能力,气溶性能和长期稳定性的配方和工艺参数.
主要方法:
- 实验设计 (DOE) 方法,包括选和Box-Behnken设计,以确定最佳的配方辅助剂 (三糖,白素,聚烯酸-K25) 和工艺参数 (鼓温度).
- 薄膜冷干燥 (TFFD) 技术用于产生可喷雾的菌体粉末.
- 使用X射线衍射 (XRD) 和差分扫描热量计 (DSC) 进行粉末性能的表征.
- 在各种温度和湿度条件下的稳定性研究.
- 使用干粉吸入器 (DPI) 和雾化,评估菌体活力和气溶性能.
主要成果:
- 高度的三糖和白素,以及增加的鼓温度,在TFFD期间保护了菌体的活力.
- 优化的配方实现了高菌体位回收 (>10^8 PFU/剂量) 和微粒分数高达70%的气溶输送.
- 菌体粉在4°C下6个月以无形形式 (三糖,PVP-K25) 呈现出良好的稳定性,而配方在4°C和22°C下9个月的位降低<0.5日志.
- 与雾化液体配方 (>2日志损失) 相比,TFFD输送的菌体粉具有显著更好的生存能力 (0.33日志损失).
结论:
- 薄膜冷干燥 (TFFD) 是一种有前途的方法,用于生产稳定,可吸入的菌体粉末.
- 开发的配方和TFFD过程为制造用于肺部输送的保质性菌体粉末提供了一个框架.
- 这种方法有可能促进肺结核等呼吸道感染的菌体治疗.
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