Abstract:
OBJECTIVE To evaluate the correlation between the solid dispersion(SD) powder properties and the relative crystallinity(RC) during SD recrystallization.
METHODS Andrographolide was used as model drug, polyvinylpyrrolidone K30, polyethylene glycol 8000, Poloxam 188, Soluplus
® as carrier materials, 12 SD powders were prepared by three preparation processes, and then the SD powder properties were determined. Afterwards, the principle component analysis and partial least squares analysis(PLS) were used to evaluate the correlation between the SD powder properties and RC during SD recrystallization.
RESULTS The correlation model was successfully established by partial least square method between the SD powder properties and the RC. The VIP value of particle size parameter D(0.5) was >1.2, which indicated that the particle size was the key factor affecting the recrystallization of SD powder.
CONCLUSION In practical work, SD powder with different particle size parameters can be obtained by different preparation methods or by adjusting the process parameters of the selected preparation method, so as to improve the recrystallization stability of SD.