Evaluation of a nanosuspension formulation prepared through microfluidic reactors for pulmonary delivery of budesonide using nebulizers

ABSTRACT

This study aimed to determine the aerosolization behavior of a nanodispersion of budesonide, prepared using microfluidic reactors. The size and morphology of budesonide nanoparticles were characterized by photon correlation spectroscopy [PCS] and transmission electron microscopy [TEM]. Processing/formulation parameters for formation of the nanoparticles were studied to determine their effects on the particle size. Results showed a narrow distribution for budesonide nanodispersion with spherical and smooth surfaced particles. To investigate the in-vitro aerosolization performance of the nanodispersion, the preparation was compared with a commercially available budesonide microsuspension using the Comite Europeen Normalization [CEN] methodology. Aerosolization results showed that the fine particle fraction [FPF] generated from the budesonide nanodispersion was significantly higher than that of the marketed budesonide [ie. mean [SD] 56.88 [3.37]% vs. 38.04 [7.82]%, respectively]. Additionally, mass median aerodynamic diameter [MMAD] of nano-budesonide dispersion was significantly smaller than the microsuspension [i.e. mean [SD] 3.91 [0.49] vs. 6.22 [1.09] microm, respectively], with nebulization time of nano-budesonide dispersion significantly shorter than the marketed budesonide microsuspension [i.e. 12.3 [0.37] vs. 14.85 [0.36] min, respectively]. The produced nanodispersion was found to be stable over a period of 10 days if stored at 4 °C