Preparation of Nifedipine Solid Dispersion by Hot-melt Extrusion Technology

OBJECTIVE Hot-melt extrusion technology was used to prepare solid dispersion of nifedipine for improving its dissolution, and moreover controlled-release tablets were prepared based on the solid dispersion. METHODS Acrylic resin Ⅳ, hydroxypropylmethylcellulose acetate succinate (HPMCAS), polyethylene pyrrole copolymer(PVP-VA64) and high replace hydroxypropyl cellulose(H-HPC) were selected as carriers. The homonymous double screw extrusion method was used for prepare nifedipine solid dispersion. The dissolution of various extrudates in different mediums were studied. Furthermore, nifedipine tablets were prepared. RESULTS The dissolution of nifedipine was improved significantly by solid dispersion technology and the tablets made by hydroxypropyl methyl cellulose matrix showed the zero order release controlled-release. CONCLUSION Solid dispersion using hot-melt extrusion technology can improve the dissolution of poorly water soluble drug nifedipine, and further form the controlled-release formulation.