Preparation and evaluation of oral disintegration tablets of clozapine/HP-β-cyclodextrin inclusion compound

Objective To prepare oral disintegration tablets of clozapine/HP-β-cyclodextrin inclusion compound, and to evaluate the quality of formula. Methods The clozapine HP-β-CD inclusion compound was prepared. The disintegration agent and the filling agent was optimized by orthogonal design method; the disintegration time, dissolution rate, and other indicators were inspected, and the tablet accessory was optimized. Results The encapsulation efficiency and drug loading capacity of clozapine HP-β-cyclodextrin inclusion compound were 71.12% and 18.52% respectively. With mannitol, microcrystalline cellulose and sodium carboxymethyl starch as excipients, the disintegration time of oral disintegration clozapine was less than 1 min, and the cumulative dissolution was 101.5%. ConclusionThe selected excipients can be used in the preparation of oral disintegration clozapine/HP-β-cyclodextrin inclusion complex and meet the quality standard.