TOBRAMYCIN INHALATION POWDER COMPARED TO TOBI IN CYSTIC FIBROSIS SUBJECTS

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 妥布霉素吸入粉(TIP)是一种新型的药物-设备组合，旨在减少囊性纤维化(CF)患者吸入妥布霉素抑制铜绿假单胞菌(PA)的时间和便利性。妥布霉素是通过喷雾干燥妥布霉素、二氯丙烷、氯化钙和全氟辛基溴乳剂的雾化液滴在喷嘴中制成的。水和PFOB在干燥过程中蒸发，产生具有多孔结构的球形磷脂颗粒。当悬浮为颗粒时，生成的低密度颗粒具有良好的空气动力学特性。粉末被装在胶囊中，然后用T-326干粉吸入器(DPI)运送。与TOBI配方和给药系统相比，TIP药物-装置组合在设计上有了改进，同时保留了每次给药向肺部输送同等数量的妥布霉素。T-326 DPI没有电子元件，不需要电源，重量轻，携带方便。一剂(四粒胶囊)可以在几分钟内给药。鉴于CF患者的治疗负担和与肺功能保护相关的依从性挑战，现有疗法中任何减少给药时间或增加患者治疗便利性的改进都有可能增加患者的依从性，从而提高治疗效果。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Tobramycin Inhalation Powder (TIP) is a novel drug-device combination intended to reduce administration time and increase convenience for persons with cystic fibrosis (CF) that are on inhaled tobramycin for suppression of Pseudomonas aeruginosa (Pa). Tobramycin is formulated in TIP by spray-drying atomized droplets of an emulsion of tobramycin, DSPC, calcium chloride, and perfluorooctyl bromide. Water and PFOB evaporate during drying, yielding spherical phospholipid-based particles with porous structure. The resulting low-density particles possess favorable aerodynamic characteristics when suspended as particles. The powder is put in capsules that are then delivered with a T-326 Dry Powder Inhaler (DPI). The TIP drug-device combination is an imporvement in design compared to the TOBI formulation and delivery system, while retaining the delivery of a comparable quantity of tobramycin to the lung per administration. The T-326 DPI has no electronic components, does not require a power source, is light and portable. A dose (four capsules) can be administered in a few minutes. Given the treatment burden and adherence challenges associated with preservation of lung function in persons with CF, any improvement in existing therapies that reduce treatment administration time or increase convenience of treatment for patients have the potential to increase patient adherence and thereby increasing therapeutic efficacy.