TOBRAMYCIN INHALATION POWDER COMPARED TO TOBI IN CYSTIC FIBROSIS SUBJECTS

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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.