par Bui, Le ;Vukanovic, Tamara ;Fiaschi, Tommaso;Merlos, Romain;Sebti, Thami;Vander Heyden, Yvan;Amighi, Karim ;Wauthoz, Nathalie
Référence International Journal of Pharmaceutics: X, 12, page (100581)
Publication Publié, 2026-06-05
Article révisé par les pairs
Résumé : Chronic obstructive inflammatory respiratory diseases are among the most common non communicable respiratory diseases worldwide. Although inhaled corticosteroids are effective, inadequate inspiratory flow through an inhaler can still result in poor asthma and COPD control. The patient's inhalation pattern directly determines the Fine Particle Dose (FPD) delivered to the lungs. This study evaluates which internal resistance of the RS01 inhaler, (low, medium-low, medium, or medium-high resistance) provides the most consistent FPD, of controlled-release budesonide dry powder, across inspiratory profiles typical in asthmatic and COPD patients. Inspiratory profiles were defined by peak inspiratory flow rates (PIFR) from 30 to 100 L/min, inhaled volumes (Vi) from 1 to 5 L and times to inhale (Ti) from 1 to 5 s. They were generated using a Breath-Simulator (BRS300i) coupled to a Next Generation Impactor connected to Alberta Idealized Throat, for strong in vitro/in vivo correlations. The FPD was measured for each combination of PIFR, Vi, and Ti for the four different RS01 inhalers, using a central composite Design of Experiment setup. Results indicate that the medium-low and medium-high resistance RS01 inhalers provide the most stable FPD across the full range of inspiratory profiles. Among the both, the medium-low RS01 inhaler delivered the most stable drug amount. On the other hand, the FPD delivered with the low resistance and medium resistance RS01 inhalers was significantly influenced by PIFR. The applied approach may help to select more adequately a device for a developed dry powder formulation taking account of the patient's inspiratory profiles.

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