Preparation and Quality Evaluation of Olanzapine Oral Disintegrating Films / 中国药师

ABSTRACT

Objective:To prepare olanzapine oral disintegrating films and evaluate its quality .Methods:The formula of olanzap-ine oral disintegrating films was optimized by Box-Behnken response surface methodology , the effects of the amount of HPMC and PEG400 were selected as the independent variables , and the tensile strength ,the elongation rate and the drug dissolution at 10 min were used as the dependent variables .The tensile strength , elongation rate , folding endurance , disintegration time and drug dissolution of olanzapine oral disintegrating films were evaluated and the in vitro dissolution was compared with that of the marketed olanzapine oral disintegrating tablets .Results:The optimal formula of olanzapine oral disintegrating films was as follows the amount of HPMC was 11.0％and the amount of PEG400 was 2.3％.The oral disintegrating films had good film-forming performance, high hardness and flexibility, and could quickly disintegrate in 50 s with fast drug dissolution , and the in vitro dissolution was similar to the marketed olanzapine oral disintegrating tablets .Conclusion: The formula of olanzapine oral disintegrating films is reasonable , the preparation process is feasible , and the quality is stable and controlled , which is worthy of further development .