Research on Dissolution Test of Extended Release Oral Dosage Forms
XU Zhen-yu
MA Yu-nan
Abstract:According to"Guidance for Pharmaceutical Researches on Extended Release Oral Dosage Forms",establishment of dissolution method,release performance of extended release drug and development of dissolution limit in specification were discussed.Establishment of dissolution method included apparatuses,dissolution medium and rotating speed etc,release performance of drug comprised release characteristics and release comparison with original drug product at different conditions,development of dissolution limit in specification consisted of selection of sampling time-points and release limit etc.
Keywords:extended releasedissolutionspecification
Publication Date:2010-01-01
Online Publishing Date:2026-08-14(First online date of this platform, not the publication date of the document)
