Two methods for the determination of the aerodynamic particle size distribution of budesonide inhalation aerosol
WANG Min
WANG Wen-ping
FANG Zhao-ying
LIU A-li
Abstract：Objective:To determine the in vitro particle size distribution of budesonide inhalation aerosol as a model drug and to assess the applicability of different impingers.Methods:The aerodynamic particle size distribution of budesonide inhalation aerosol was determined using Andersen cascade impactor(ACI)and new generation impactor(NGI).The mathematical models were developed to compare the results of different methods.Population bioequivalence(PBE)analyses were carried out using the results of selected cascade impingers.Results:There was differences between the results of two impingers.The curves of drug deposition at each level measured by NGI were better fitted to the distribution equations than those of ACI,and the particle separation of different particle sizes by NGI was better than by ACI.The results of the PBE analysis showed that there was consistency between the homemade formulation of budesonide inhalation aerosol and the reference formulation in the distribution of fine particles at the level.Conclusions:NGI has a high resolution across various layers and can obtain more comprehensive particle size distribution results.NGI may be more suitable for budesonide inhalation aerosol in vitro quality evaluation.
Keywords：budesonideinhalation aerosolaerodynamic particle size distributionAndersen cascade impactorthe next generation impactor
Publication Date：2025-05-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 986-993 )