Summary

Thirteen jet nebulisers were investigated in order to identify the biopharmaceutical constraints related to the quality attributes of the medicinal products. The aerosolization parameters, such as aerosol output, aerosol output rate and fine particle fraction were determined according to EN 13544-1 guideline, using sodium fluoride as reference formulation. The comparison between the aerosol output nebulization time and the fine particle fraction displaced a correlation of the nebulizer aerosol quality, i.e. the fine particle fraction, with the nebulization rate. The quality of the nebulization significantly increases when the rate of aerosol emission is slow down. Moreover, the performance of the nebulizers was analyzed in terms of respirable dose delivery rate and respirable delivered dose, which characterize the nebulization as rate and amount of respirable product that could be deposited into lung. Depending on which of these two parameters was used, the nebulizers showed different performance. The differences, in terms of rate and amount of delivered aerosol, could have relevance on the biopharmaceutical aspects of the drug delivery. Then, these data could provide relevant information for the appropriate choice of the nebulizer as a function of drug product, therapy and patient characteristics.

Key Message

The nebulization time of jet nebulizers affects the fine particle fraction. The quality of the nebulization significantly increases when the rate of aerosol emission is slow down.