Research on the quality control and development strategy of continuous manufacturing of chemical oral solid preparations
LI Xiang-yu
LIN Xiao-feng
LAN Yi-peng
HUANG Zhe
Abstract：Continuous manufacturing technology is an emerging technology that has been proven to have great advantages.Compared to traditional batch manufacturing,continuous manufacturing is characteristic of high integration,few unit operations,and small equipment footprint,but it is still in the early stages of application in the pharmaceutical field.As a pioneer experiment in the pharmaceutical field for continuous manufacturing,oral solid formulations of chemical drugs still face some challenges.Therefore,this study proposes some continuous manufacturing strategies based on quality control through comprehensive literature research and experimental data analysis to ensure the quality stability of chemical oral solid formulations.
Keywords：continuous manufacturingquality controlchemical oral solid preparationsdevelopment strategydrug regulatory science
Publication Date：2024-10-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 1976-1981 )