A Novel Submicron Formulation of Nebulized Budesonide Delivered by a Vibrating Mesh Nebulizer Significantly Improves Delivery Efficiency at One-Fifth of the Nominal Dose of both Pulmicort Respules® and a Generic Budesonide Suspensions Delivered via a Jet Nebulizer - A Potentially Important Advancement in Pediatric Asthma

Recent reports using a breathing simulator system have suggested that mesh nebulizers provide more effective medication delivery than jet nebulizers. In this study, the performances of jet and mesh nebulizers were evaluated by comparing their aerosol drug delivery efficiencies in mice. We compared four home nebulizers: two jet nebulizers (PARI BOY SX with red and blue nozzles), a static mesh nebulizer (NE-U22), and a vibrating mesh nebulizer (NE-SM1). After mice were exposed to salbutamol aerosol, the levels of salbutamol in serum and lung were estimated by ELISA. The residual volume of salbutamol was the largest at 34.6% in PARI BOY SX, while the values for NE-U22 and NE-SM1 mesh nebulizers were each less than 1%. The salbutamol delivery efficiencies of NE-U22 and NE-SM1 were higher than that of PARI BOY SX, as the total delivered amounts of lung and serum were 39.9% and 141.7% as compared to PARI BOY SX, respectively. The delivery efficiency of the mesh nebulizer was better than that of the jet nebulizer. Although the jet nebulizer can generate smaller aerosol particles than the mesh nebulizer used in this study, the output rate of the jet nebulizer is low, resulting in lower salbutamol delivery efficiency. Therefore, clinical validation of the drug delivery efficiency according to nebulizer type is necessary to avoid overdose and reduced drug wastage.

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Aerosol Delivery of Dornase Alfa Generated by Jet and Mesh Nebulizers

Pharmaceutics ◽

10.3390/pharmaceutics12080721 ◽

2020 ◽

Vol 12 (8) ◽

pp. 721 ◽

Cited By ~ 1

Author(s):

Kyung Hwa Chang ◽

Sang-Hyub Moon ◽

Sun Kook Yoo ◽

Bong Joo Park ◽

Ki Chang Nam

Keyword(s):

Enzymatic Activity ◽

Drug Stability ◽

Aerosol Delivery ◽

Clinical Safety ◽

Dornase Alfa ◽

Jet Nebulizer ◽

Jet Nebulizers ◽

In Vitro Performance ◽

Delivery Efficiency

Recent reports on mesh nebulizers suggest the possibility of stable nebulization of various therapeutic protein drugs. In this study, the in vitro performance and drug stability of jet and mesh nebulizers were examined for dornase alfa and compared with respect to their lung delivery efficiency in BALB/c mice. We compared four nebulizers: two jet nebulizers (PARI BOY SX with red and blue nozzles), a static mesh nebulizer (NE-U150), and a vibrating mesh nebulizer (NE-SM1). The enzymatic activity of dornase alfa was assessed using a kinetic fluorometric DNase activity assay. Both jet nebulizers had large residual volumes between 24% and 27%, while the volume of the NE-SM1 nebulizer was less than 2%. Evaluation of dornase alfa aerosols produced by the four nebulizers showed no overall loss of enzymatic activity or protein content and no increase in aggregation or degradation. The amount of dornase alfa delivered to the lungs was highest for the PARI BOY SX-red jet nebulizer. This result confirmed that aerosol droplet size is an important factor in determining the efficiency of dornase alfa delivery to the lungs. Further clinical studies and analysis are required before any conclusions can be drawn regarding the clinical safety and efficacy of these nebulizers.

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