A facile approach to manufacturing non-ionic surfactant nanodipsersions using proniosome technology and high-pressure homogenization.

In this study, a niosome nanodispersion was manufactured using high-pressure homogenization following the hydration of proniosomes. Using beclometasone dipropionate (BDP) as a model drug, the characteristics of the homogenized niosomes were compared with vesicles prepared via the conventional approach of probe-sonication. Particle size, zeta potential, and the drug entrapment efficiency were similar for both size reduction mechanisms. However, high-pressure homogenization was much more efficient than sonication in terms of homogenization output rate, avoidance of sample contamination, offering a greater potential for a large-scale manufacturing of noisome nanodispersions. For example, high-pressure homogenization was capable of producing small size niosomes (209 nm) using a short single-step of size reduction (6 min) as compared with the time-consuming process of sonication (237 nm in >18 min) and the BDP entrapment efficiency was 29.65% ± 4.04 and 36.4% ± 2.8. In addition, for homogenization, the output rate of the high-pressure homogenization was 10 ml/min compared with 0.83 ml/min using the sonication protocol. In conclusion, a facile, applicable, and highly efficient approach for preparing niosome nanodispersions has been established using proniosome technology and high-pressure homogenization.

Air-jet and vibrating-mesh nebulization of niosomes generated using a particulate-based proniosome technology.

The aerosol properties of niosomes were studied using Aeroneb Pro and Omron MicroAir vibrating-mesh nebulizers and Pari LC Sprint air-jet nebulizer. Proniosomes were prepared by coating sucrose particles with Span 60 (sorbitan monostearate), cholesterol and beclometasone dipropionate (BDP) (1:1:0.1). Nano-sized niosomes were produced by manual shaking of the proniosomes in deionized water followed by sonication (median size 236nm). The entrapment of BDP in proniosome-derived niosomes was higher than that in conventional thin film-made niosomes, being 36.4% and 27.5% respectively. All nebulizers generated aerosols with very high drug output, which was 83.6% using the Aeroneb Pro, 85.5% using the Pari and 72.4% using the Omron. The median droplet size was 3.32µm, 3.06µm and 4.86µm for the Aeroneb Pro, Pari and Omron nebulizers respectively and the "fine particle fraction" (FPF) of BDP was respectively 68.7%, 76.2% and 42.1%. The predicted extrathoracic deposition, based on size distribution of nebulized droplets was negligible for all devices, suggesting all of them are potentially suitable for pulmonary delivery of niosomes. The predicted drug deposition in the alveolar region was low using the Omron (3.2%), but greater using the Aeroneb Pro (17.4%) and the Pari (20.5%). Overall, noisome-BDP aerosols with high drug output and FPF can be generated from proniosomes and delivered using vibrating-mesh or air-jet nebulizers.