Discussion on the application of in vitro dissolution test method for oral solid dosage forms
LI Yan
WU Hengqian
WANG Zhengping
YAN Qiulin
HAN Jun
Abstract：Dissolution testing of oral solid dosage forms represents a critical component in pharmaceutical development and quality control.The selection of an appropriate dissolution method to accurately charac-terize drug release behavior is essential for ensuring the consistency of drug product quality and clinical ef-ficacy.In recent years,dissolution methodologies have undergone continuous refinement,with selection criteria increasingly prioritizing biological relevance to better simulate the in vivo environment.To com-prehensively investigate the characteristics of diverse dissolution testing approaches,this paper analyzes the features of methods for oral solid dosage forms based on the working principles and hydrodynamic characteristics of dissolution apparatuses.Building upon this foundation,the study focuses on factors in-fluencing dissolution outcomes and the assessment of dissolution curve similarity.Furthermore,it system-atically examines the application of dissolution testing methods and elucidates the principles underlying in vitro-in vivo correlation(IVIVC).
Keywords：dissolution testingoral solid dosage formsdissolution curvesimilarity evaluationhydrody-namic characteristics
Publication Date：2026-06-25
Online Publishing Date：2026-08-28(First online date of this platform, not the publication date of the document)
Pages：9( 438-446 )