New Therapeutic Possibilities of Budesonide Administered in Suspension for Nebulisation Using a Pulsating Nebuliser in the Treatment of Upper Respiratory Tract Diseases

<b>Introduction:</b> The primary treatment method for T2 immune response-related airway inflammations, such as eosinophilic inflammation, is topical glucocorticosteroid therapy. However, its effectiveness is limited by the challenge of drug penetration into the perinasal cavity. The introduction of a new generation of pulsating nebulizers has partially addressed this issue. Pulsating nebulizers (vibrating aerosol) enhance the penetration of nebulized medication into the paranasal sinuses, thereby opening a new therapeutic option for the treatment of chronic sinusitis. Consequently, a new regulatory indication has been approved for the use of budesonide in chronic rhinosinusitis with nasal polyps. <br><br><b>Aim:</b> The aim of the study was to compare the aerodynamic particle size distribution (APSD) of the dispersed suspensions of the test drug (TD) and the reference drug (RD) administered using the PARI SINUS2 nebulizer system, consisting of the PARI LC SPRINT SINUS nebulizer and the PARI SINUS2 compressor <br><br><b>Material and methods:</b> Comparison of the APSD of the dispersed suspensions of the TD and the RD administered using the PARI SINUS2 nebulizer system. Twelve nebulizations of each formulation were tested using six PARI SINUS2 nebulizer systems, with two repetitions per system. The methods were review of studies and own research. The APSD study was conducted using a next-generation impactor (NGI) and a laser diffraction spectrometer after nebulization of 2 mL suspensions of TD and RD via the PARI SINUS2 nebulizer system. Statistical analyses included descriptive statistics as well as 90% and 95% confidence intervals for the difference in means and the ratio of means of the examined parameters. <br><br><b>Results:</b> The TD was well-suited to the nebulization procedure. Both formulations (TD and RD) exhibited significant variability in the aerosol droplet distribution at different levels of the NGI cascade impactor. In the case of TD, larger droplets were more easily generated, which promoted deposition of the drug at the upper levels of the impactor. The equivalence of the two forms of budesonide, RD and TD, in the treatment of chronic rhinosinusitis with nasal polyps using a pulsating nebulizer was demonstrated. These indications were acknowledged by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB) and added to the Product Information of TD. <br><br><b>Conclusions:</b> Both budesonide formulations were effective. Budesonide administered via vibrational nebulization is effective in the treatment of chronic rhinosinusitis with nasal polyps.