Studies on Preparation of Diclofenac Sodium Sustained-release Capsules by High-shear Melt Agglomeration

OBJECTIVE To prepare diclofenac sodium sustained-release pellets by high-shear melt agglomeration technology and study its in vitro drug release. METHODS Drug-contained pellets were prepared in a high-shear granulator, and the influencing factors of formulation and technique on pellets releasing profile were investigated and the mechanism of drug releasing from pellets was also studied. RESULTS The release of the drug from pellet was in accordance with Higuchi equation: Y=35.43t1/2-16.152 3(r=0.998 8). The mechanism of diclofenac sodium releasing from pellets was matrix erosion and diffusion. CONCLUSION The diclofenac sodium sustained-release pellets made by this technique provided a rather good sustained-release profile.