This study focuses on the preparation method and efficacy analysis of nifedipine self-micellized amorphous solid dispersions. Nifedipine is adopted as an antihypertensive drug, and self-micellized polymers are used as carrier materials to prepare amorphous solid dispersions. The preparation process and the influence of polymer concentration on the dissolution performance of nifedipine under supersaturated conditions are investigated and evaluated. The results show that the nifedipine self-micellized amorphous solid dispersions prepared by hot melt extrusion can significantly improve the dissolution rate and solubility of nifedipine, and exhibit enhanced crystallization inhibition with the increase of self-micellized polymer concentration in supersaturation tests. The solid dispersions prepared by hot melt extrusion have superior solubilization capacity, high dissolution rate and excellent stability. Compared with other preparation technologies, hot melt extrusion is more suitable for large-scale industrial production.

Area Code: CN

Application Number: CN202111218028.9