Continuous preparation and evaluation of sirolimus albumin nanoparticles based on microchannel reactor
ZHOU Yong
GAO Hua
LI Ze-nan
JIN Yang-qiao
XU Xiao-jie
YANG Xiang-liang
Abstract：Objective:To develop a green and eco-friendly continuous-flow process for sirolimus albumin nanoparticles and evaluate the quality of the nanoparticles.Methods:Sirolimus albumin nanoparticles were prepared based on desolvation method utilizing a microchannel reactor.The nanoparticles were characterized for particle size,morphology,composition,disintegration kinetics,and in vivo pharmacokinetics.Results:Continuous manufacturing of sirolimus albumin nanoparticles was achieved using microchannel reactor.The prepared nanoparticles exhibited a spherical morphology with an average size of(120±43)nm.Rapid disintegration occurred in response to human serum albumin and the pharmacokinetic parameters in rats were consistent with the reference product.Conclusion:The desolvation method combined with a microchannel reactor enables continuous production of sirolimus albumin nanoparticles.The nanoparticles exhibit stable and controllable quality meeting pharmaceutical standards.
Keywords：sirolimusalbumin nanoparticlesdesolvation methodmicrochannel reactorcontinuous manufacturing
Publication Date：2026-03-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 632-637 )