TOBRAMYCIN INHALATION POWDER COMPARED TO TOBI IN CYSTIC FIBROSIS SUBJECTS

妥布霉素吸入粉与 Tobi 在囊性纤维化患者中的比较

• 批准号: 7604890
• 负责人: Jeffrey R. Smith
• 金额: $ 0.64万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604890
• 关键词: Adherence; Biological Preservation; Breathing; Calcium Chloride; Characteristics; Computer Retrieval of Information on Scientific Projects Database; Cystic Fibrosis; Devices; Dose; Drug Formulations; Electronics; Emulsions; Funding; Grant; Inhalators; Institution; Light; Lung; Patients; Perflubron; Persons; Pharmaceutical Preparations; Phospholipids; Powder dose form; Power Sources; Pseudomonas aeruginosa; Research; Research Personnel; Resources; Respiratory physiology; Source; Structure; System; Time; Tobramycin; Treatment Efficacy; United States National Institutes of Health; Water; base; capsule; compliance behavior; density; design; novel; particle

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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。列出的机构为 研究中心，而研究中心不一定是研究者所在的机构。 妥布霉素粉吸入剂（TIP）是一种新型药物-器械组合，旨在减少囊性纤维化（CF）患者的给药时间并增加其使用便利性，这些患者正在吸入妥布霉素以抑制铜绿假单胞菌（Pa）。 妥布霉素是通过喷雾干燥妥布霉素、DSPC、氯化钙和全氟辛基溴的乳剂的雾化液滴在TIP中配制的。 水和全氟辛烷磺酸在干燥过程中蒸发，产生具有多孔结构的球形磷脂颗粒。 当作为颗粒悬浮时，所得的低密度颗粒具有有利的空气动力学特性。 将粉末放入胶囊中，然后用T-326干粉吸入器（DPI）递送。 与TOBI制剂和给药系统相比，TIP药物-器械组合在设计上有所改进，同时保留了每次给药向肺递送的妥布霉素量相当。 T-326 DPI没有电子元件，不需要电源，轻便便携。 一个剂量（四个胶囊）可以在几分钟内给药。 鉴于CF患者与肺功能保护相关的治疗负担和依从性挑战，任何减少治疗给药时间或增加患者治疗便利性的现有疗法的改进都有可能增加患者的依从性，从而提高治疗效果。