Keywords : MG apparatus
karbala journal of pharmaceutical sciences,
Volume 3, Issue 3, Pages 117-128
Many patients who have problems in swallowing of solid dosage forms may benefit the Orodispersible tablets,where they rapidly disintegrate and dissolve in the oral cavity. Yet, there is no official and reproducible in vitro test that can predict the disintegration time. The present study was designed to evaluate a novel in vitro model for evaluation of disintegration time of the orodipersible tablets.A novel simple apparatus was prepared to simulate the oral cavity known as MG apparatus; it consists mainly of adult dental set with saliva input reservoir and digital monitoring. To validate the MG apparatus, nine blank orodispersible tablets were prepared using different concentrations of four superdisintegrants, in addition one of them prepared under different compression forces as well as subjected to stress storage condition (50°C/75%RH for 2weeks). Also, five commercial orodispersible tablets were used to comparebetween the saliva and buffer as disintegration media. Moreover, sixteen volunteers were participated in human sensory tests for disintegration. The results indicate that there is a very high correlation between the novel in vitro disintegration test using the new method (MG apparatus) and the in vivo disintegration using human sensory test; while poor correlation was reported with the conventional method. In conclusion, thenovelMG method is simple and highly correlated with the in vivo method and might be of value to predict disintegration time for orodispersible solid dosage forms.