Dissolution stability and IVIVC investigation of a buccal tablet

Using a recently developed bending point criterion to describe certain diss olution profiles, a physical stability screening study of a mucoadhesive bu ccal tablet was performed in order to obtain a fast and useful in-vitro tes ting system that allows the assessment of the physical stability of new for mulations in a much faster way compared to the standard formal stability te sts in which it takes months before conclusions can be drawn. The obtained dissolution results at normal, accelerated and stress conditio ns are correlated with each other, resulting in a rapid test system to eval uate the physical stability of the tablets. Last, a significant in-vivo in- vitro correlation (IVIVC) was established between the in-vivo residence tim e in the buccal cavity and the in-vitro bending point obtained from the dis solution 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 explai ned by the in-vitro bending point. (C) 2001 Elsevier Science B.V. All right s reserved.