Study On Mizolastine Sustained-release Tablets

In this study, the sustained-release tablets of Mizolastine were prepared, and its release characteristics in vitro were observed. The sustained-release tablets of Mizolastine could rapidly effect in one hour and release completely in five hours. The factors influencing the release rate of Mizolastine from sustained-release tablets were examined.The sustained-release tablets were prepared with Mizolastine 10mg,HPMC 11.5mg,tartaric acid 40mg,lactose 110mg,microcrystalline cellulose 40mg,10%EC alcohol solution 0.068ml. Preparation technology: Mizolastine pass through 100 mesh sieve; HMPCK4MCR,lactose,microcrystalline cellulose,tartaric acid pass through 100 mesh sieve; add all the materials into rapid granulator , add 10%EC alcohol solution as adhesive, obtain roundness granules; Dry them at 50℃, control moisture between 2%~3%; granulation with 18 mesh sieve; add 1% magnesium stearate and admix homogenization; pressing, hardness10kg.Fitting the drug release mode by mathematical model according to the release data of Mizolastine sustained-release tablet, results show that drug release mode of Mizolastine sustained-release tablets meets Higuchi equation(C=42.722t1/2+3.5117,R=0.9969).Research the drug release mechanism theoretically. The release of Mizolastine is through the synergetic effect of the two mechanisms of dispersion of gel layer and gel framework corrosion.