A review on the determination methods for the aerodynamic particle size distribution of the inhalation preparations
GAO Lei
WEI Ning-yi
ZHOU Ying
LIN Lan
CHEN Cui-cui
NING Bao-ming
Abstract：Particle size of the orally inhaled drug products(OIPs) is widely accepted as an important factor in determining the aerodynamic deposition of particles within the respiratory system.Methods used for the particle size determinationinclude cascade impactor (CI),laser diffraction (LD),and time of flight spectrometry.As an accurate compendium method,the CI-based methods for measuring the aerodynamic particle size distribution (APSD) properties of OIP-produced aerosols are recognized by the regulatory agencies worldwide and adopted by various pharmacopoeias,although CI method is characterized by complex devices and time-consuming operations.The purpose of this review is to discuss the roles of CI in determining the APSD of OIPs,including its principle and data interpretation,suitability and variability of the CI method for the characterization of inhalation preparations.
Keywords：inhalation administrationin vitro evaluationaerodynamic particle size distributioncascade impactor
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 1433-1438 )