Development of an Infant Air-Jet Dry Powder Aerosol Delivery System (iDP-ADS) Including a New Multifunctional Bifurcating Two-Prong Nasal Interface.

IF 3.5 3区 医学 Q2 CHEMISTRY, MULTIDISCIPLINARY
Sarah C Strickler, Dale R Farkas, Mohammad A M Momin, Laura Vargas, Ghali Aladwani, Michael Hindle, Worth Longest
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引用次数: 0

Abstract

Purpose: To improve the quality of aerosol delivery to infants, the iDP-ADS was advanced to include dual-prong nose-to-lung aerosol administration with a bifurcating interface, consistently monitor lung pressures and control ventilatory parameters with a pressure monitoring and control (PMC) unit, and implement flexible nasal prongs for use across a range of subject sizes.

Methods: Four bifurcating flow pathways were integrated into the iDP-ADS and tested in vitro with a full-term infant nose-throat (NT) model for comparison to the performance of a single-prong interface. After selecting the best-performing flow pathway, flexible prong designs were evaluated in the same model and chosen for additional testing. Realistic pulmonary mechanics (PM) and age-appropriate tidal volumes were used to simulate ventilation with the PMC unit and aerosol delivery in full-term and 34-week gestational age preterm NT models.

Results: Three of the four bifurcating flow pathways matched the performance of the single-prong design (tracheal filter delivery of ~55%), and the FP4 design with co-flow was selected. A flexible prong version of FP4 produced similar performance to the rigid version. Measurements from the PMC unit demonstrated that consistent air volumes under safe operating pressures could be delivered with a PEEP between 4-6 cmH2O. Considering aerosol delivery, PM conditions resulted in ~4% decrease in filter deposition but high lung delivery efficiencies of ~45% and ~34% for the full-term and preterm models, respectively.

Conclusions: The best-performing interface with flexible prongs matched the lung delivery efficiency of a high-transmission single-prong interface and delivered high aerosol doses through late-preterm to full-term NT models.

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来源期刊
Pharmaceutical Research
Pharmaceutical Research 医学-化学综合
CiteScore
6.60
自引率
5.40%
发文量
276
审稿时长
3.4 months
期刊介绍: Pharmaceutical Research, an official journal of the American Association of Pharmaceutical Scientists, is committed to publishing novel research that is mechanism-based, hypothesis-driven and addresses significant issues in drug discovery, development and regulation. Current areas of interest include, but are not limited to: -(pre)formulation engineering and processing- computational biopharmaceutics- drug delivery and targeting- molecular biopharmaceutics and drug disposition (including cellular and molecular pharmacology)- pharmacokinetics, pharmacodynamics and pharmacogenetics. Research may involve nonclinical and clinical studies, and utilize both in vitro and in vivo approaches. Studies on small drug molecules, pharmaceutical solid materials (including biomaterials, polymers and nanoparticles) biotechnology products (including genes, peptides, proteins and vaccines), and genetically engineered cells are welcome.
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