Dissolution stability and IVIVC investigation of a buccal tablet

Using a recently developed bending point criterion to describe certain dissolution profiles, a physical stability screening study of a mucoadhesive buccal tablet was performed in order to obtain a fast and useful in-vitro testing system that allows the assessment of the physical stability of new formulations in a much faster way compared to the standard formal stability tests in which it takes months before conclusions can be drawn. The obtained dissolution results at normal, accelerated and stress conditions are correlated with each other, resulting in a rapid test system to evaluate the physical stability of the tablets. Last, a significant in-vivo in-vitro correlation (IVIVC) was established between the in-vivo residence time in the buccal cavity and the in-vitro bending point obtained from the dissolution data. For this particular case study, it is concluded that around 50% of the in-vivo variability of the residence time in the mouth is explained by the in-vitro bending point.