Determination of aerodynamic particle size distribution of revefenacin inhalation solution
CAO Ting
WANG Xue
YUAN Dan
ZHAO Wen-jie
WANG Min
LIU A-li
Abstract：Objective:To establish a method for determining the aerodynamic particle size distribution(APSD)of revefenacin inhalation solution and to provide a reference for subsequent quality studies on this generic drug.Methods:The APSD of revefenacin inhalation solution was determined by the next generation impactor method.The aerosol content was determined by HPLC,and the in vitro nebulization characteristics of revefenacin inhalation solution was evaluated by fine particle dose,fine particle fraction,mass median aerodynamic diameter and geometric standard deviation.Results:The method has good precision and robustness,and the loss rate at different stages was negligible.The nebulization can be completed in 10 min.There was no significant difference in the determination results in the range of flow rate 15 L·min-1(±5%).The results also showed no significant variation under the test conditions(20～25℃、35%RH～55%RH).There are differences in the results of the APSD measurements obtained by using three compression nebulizers of different brands and models.The PARI BOY nebulizer is suitable for the APSD measurement of this variety.Conclusion:This study established a method for determining the APSD of revefenacin inhalation solution,which was validated.An appropriate nebulizer was also identified.These findings can provide a basis for future quality research of this drug,and offer a reference for developing nebulization characteristics of inhalation solutions in vitro.
Keywords：revefenacin inhalation solutionaerodynamic particle size distributionnebulizernext generation impactorHigh performance liquid chromatography
Publication Date：2025-10-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 2087-2093 )