Preparation and Quality Evaluation of Vardenafil Hydrochloride Orally Disintegrating Tablets / 医药导报

ABSTRACT

Objective To prepare vardenafil hydrochloride orally disintegrating tablets and evaluate their quality. Methods The tablets were prepared by direct power compression method, using crosslinking povidone ( PVPP ) as disintegrants. The preparation method was optimized by response surface test using amount of PVPP, menthol and taste-masking agents as factors with disintegrating time and distance of bitterness as index. The results of taste of orally disintegrating tablets were determined by electronic tongue, comparing to the results of taste tests. At the same time, the properties of the tablets were evaluated using appearance, content uniformity, disintegrating time, et al. as index. Results The optimal formula was as followsPVPP 13. 26%, menthol 0. 43%, taste-masking agent SGxj 1. 26%. The results on evaluation of electronic tongue were consistent with the results of taste tests. The quality of the prepared tablets was in line with standard. The disintegrating time was (22. 34 ± 0. 34 ) s. Conclusion The preparation technology of orally disintegrating tablets is simple, and controllable in quality.