Cheng Song, Huang Haozhou, Zhang Zhihao, Chen Mateng, Zhang Yulong, Lin Mengxing, Yang Gang, Kanye Lynda Thubelihle, Zhang Qingzhen, Xue Ning, Shi Kaiqi, Dong Bin, Li Hanhan
School of Engineering, China Pharmaceutical University, Nanjing, China.
Eastern Institute for Advanced Study, Eastern Institute of Technology, Ningbo, China.
Front Pharmacol. 2025 Jun 17;16:1528905. doi: 10.3389/fphar.2025.1528905. eCollection 2025.
infection has become a widespread problem in patients with cystic fibrosis (CF). A safe and effective manufacturing method is required to produce antibiotic dry powder inhalations (DPIs) which can be effectively delivered to treat lung infections. In this study, an excipient-free tobramycin inhalable powder was prepared using spray freeze-drying (SFD) method. The mass median aerodynamic diameters (MMAD) of optimized inhalable powder prepared by SFD was 1.30 µm, and the fine particle fractions (FPF) reached 83.31%. In both and safety and activity studies, the inhalable powder showed excellent safety performance at both animal and cellular levels, with a minimum inhibitory concentration (MIC) of 0.5 μg/mL. Compared with intravenous injection, inhalation of excipient-free tobramycin inhalable powder had a better effect in the infected mouse model because of its amorphous state. This study demonstrates that excipient-free tobramycin inhalable powder with good delivery and deposition performance can be successfully obtained using the SFD method. Inhalation of excipient-free tobramycin inhalable powder has the potential to be a promising strategy for treating pulmonary infections caused by in patients with CF.
感染已成为囊性纤维化（CF）患者中普遍存在的问题。需要一种安全有效的制造方法来生产可有效递送以治疗肺部感染的抗生素干粉吸入剂（DPI）。在本研究中，采用喷雾冷冻干燥（SFD）法制备了无辅料妥布霉素可吸入粉末。通过SFD制备的优化可吸入粉末的质量中值空气动力学直径（MMAD）为1.30 µm，细颗粒分数（FPF）达到83.31%。在安全性和活性研究中，该可吸入粉末在动物和细胞水平均表现出优异的安全性能，最低抑菌浓度（MIC）为0.5 μg/mL。与静脉注射相比，吸入无辅料妥布霉素可吸入粉末在感染小鼠模型中效果更好，因为其为无定形状态。本研究表明，使用SFD法可成功获得具有良好递送和沉积性能的无辅料妥布霉素可吸入粉末。吸入无辅料妥布霉素可吸入粉末有可能成为治疗CF患者由[原文此处缺失相关病菌名称]引起的肺部感染的一种有前景的策略。
