ABSTRACT
OBJECTIVE:To improve the original preparation technology,imitate Lamotrigine sustained-release tablets,and study its in vitro release behavior. METHODS:Hydroxypropylmethylcellulose (HPMC) E4M CR and HPMC K100LV CR were used to prepare the sustained-release matrix core. Using Eudragit? L30D-55 as enteric coating material,Lamotrigine sustained-re-lease tablets were prepared. Using the similar factor f2 of in vitro release rate of original preparation as index,single factor was used to screen the amount of lactose,mass ratio of HPMC E4M CR and HPMC K100LV CR,amount of HPMC and weight of coating layer in the formulation. RESULTS:The formulation of matrix core was as follow as lamotrigine 50 mg,HPMC K100LV CR 40 mg,HPMC E4M CR 61.4 mg,lactose 128 mg,and the optimal weight of coating layer of 3%. The in vitro release of self-made and original preparations were similar in pH 6.8 phosphate buffer containing 0.5% sodium dodecyl sulfate,pH 4.5 acetic acid sodi-um acetate buffer and water. CONCLUSIONS:Lamotrigine sustained-release tablets are successfully imitated,and the technology is more simple and feasible than original preparation.