Comparative Research on the Properties of Nitrendipine Solid Dispersions Prepared by Different Techniques / 中国药学杂志

ABSTRACT

OBJECTIVE: To compare the properties of nitrendipine/PVP k25 solid dispersions prepared by three different technologies including spray drying, freeze-drying and co-precipitation technology. METHODS: The characteristics of nitrendipine solid dispersions including micromorphology, crystalline profile and intermolecular interactions were analyzed by scanning electron microscopy (SEM), differential scanning calorimetry (DSC), powder X-ray diffraction (PXRD) and Fourier transform infrared spectroscopy (FT-IR). The dissolution and solubility characteristics were investigated by dissolution apparatus and constant temperature shaker. The crystallization inhibition effect of polymers against the drug in a supersaturated state was investigated by supersaturation crystallization experiment. RESULTS: Nitrendipine existed in an amorphous form in the solid dispersion obtained by spray drying method. Compared with co-precipitation and freeze-drying method, the solid dispersion prepared by spray drying method significantly improved the dissolution and solubility of nitrendipine (P<0.05). The RESULTS: of supersaturation crystallization inhibition test showed that PVP k25 could obviously inhibit the crystallization of nitrendipine in supersaturated state. CONCLUSION: Based on the analysis of the above mentioned properties, nitrendipine solid dispersion prepared by spray drying technology displays the most optimal properties. Spray drying technology is more suitable for the practical production and industrial applications of nitrendipine solid dispersions.