Formulation of a dry powder for inhalation combining ciclesonide and indacaterol maleate using spray drying

Dry powders for inhalation are evolving to address the challenge of maximizing lung deposition, with growing interest in carrier-free formulations shaping future therapies. This study focuses on developing an inhalation powder with optimal properties, combining ciclesonide and indacaterol, a combination treatment for asthma not yet available on the market. Using spray-drying technology with cyclodextrins, ultra-flying microparticles aim to be produced to enhance aerosolization and therapeutic efficacy. Cyclodextrin screening identified Crysmeb as the most effective for ciclesonide complexation, enabling stable solution atomization, while HPβCD was selected to create deflated particle shapes in a spray-dried suspension. The impact of active pharmaceutical ingredient solubilization state and solid content on powder properties was investigated, revealing that the solutions provided a more suitable particle size distribution for inhalation. Moreover, the atomized solutions led to fine particle fractions exceeding 60 % for both drugs, outperforming commercial products due to this enhanced distribution. Aerodynamic performance was further assessed under reduced flow rates using the Next Generation Impactor, showing no significant reduction in lung deposition at 60 L/min for atomized solutions. The optimized powders also demonstrated higher lung deposition of indacaterol maleate compared to Onbrez®, with findings confirmed using the PreciseInhale® system, providing comprehensive insights into aerosolization behavior. These results highlight the importance of advancing in vitro methods to better predict in vivo performance and support the development of more effective inhaled therapies. Overall, this work presents a stable, carrier-free inhalation powder with a novel drug combination that achieves efficient lung deposition and six-month stability.