Effects of APIs, excipients, formulations and technologies on the dissolution profiles of solid oral preparations
XUE Jing
XU Ming-di
NAN Nan
LI Ya-ping
Abstract：In May 2016,CFDA issued the announcement according to the notice of quality and effect consistency evaluation of generic drugs issued by the State Council.In the announcement it was clearly proposed that the comparison study of dissolution profiles between the test preparation and the reference preparation for solid preparations was a part of the consistency evaluation.It was known that many factors such as APIs,excipients,formulations and technologies could affect the dissolution profiles of solid preparations.In this paper,based on a literature retrieval,the effects such as crystal forms and sizes of APIs,types and amounts of excipients,micro powder technologies of APIs and the preparation process of tablets on the dissolution profiles of solid oral preparations were reviewed.It would provide some assistance on the consistency evaluation of generic drugs in our country.
Keywords：active pharmaceutical ingredient and excipientformulation and technologysolid oral preparationdissolution profile
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( 1370-1375 )