Preparation of Lamotrigine Orally Disintegrating Tablets based on the co-processed exicipient

ZHA Jing; WANG Tie-jie; WANG Si-ming; TU Jia-sheng

Abstract：Objective To prepare Lamotrigine Orally Disintegrating Tablets( ODTs)based on the co-processed ex-cipients. Methods Firstly,to prepare the co - processed excipient consisting of isomalt,microcrystalline cellulose and crospovidone by wet granulation method. Afterwards,Lamotrigine ODTs was directly compressed after mixing the co-pro-cessed excipient with a small amount of disintegrant,taste-masked agents and magnesium stearate,and the formula optimi-zation was conducted. Finally,the micromeritic properties of co-processed excipient and the disintegration time of Lam-otrigine ODTs with the optimal formula were investigated. Results The desirable co-processed excipient composed of iso-malt/microcrystalline cellulose at a ratio of 3:4 and 8% crospovidone. And the components of the optimal formula of Lam-otrigine ODTs(in 1 000)included 25 g lamotrigine,137 g co-processed excipient,14. 4 g low-substituted hydroxypropyl cellulose,1. 8 g magnesium stearate,1. 8 g taste-masked agents. From the in-vitro study,the disintegration and dissolu-tion time of Lmotrigine ODTs were within 35 seconds and 5 minutes,respectively. Conclusion According to the experi-ments,the micromeritic properties of co-processed excipients was good and the disintegration time,the dissolution time and the taste of ODTs were eligible.