In Vitro Oral Cavity Model for Screening the Disintegration Behavior of Orodispersible Films: A Bespoke Design.

The availability of biorelevant methods for the disintegration study of pharmaceutical orodispersible dosage forms is required. The disintegration of orodispersibles should be assessed using in vitro methods that can combine biorelevant volumes of disintegration medium and mechanical stresses mimicking in vivo conditions. This study proposes an adaptation of a mechanical oral cavity model for the disintegration study of orodispersible films. A periodic compression is applied to the sample in the presence of a biorelevant volume of artificial salivary fluid. Four orodispersible film samples (P1, C1, P2, and C2), differing in polymer type and molecular weight, and Listerine were tested and filmed during disintegration. An image analysis program was developed for the determination of the volume reduction of the film matrix over time, as a descriptor of film disintegration behavior. Samples P1 and Listerine showed a volume reduction at 180 s of >90%, C1, P2, and C2 were 85%, 48%, and 37%, respectively. The model was able to detect differences in the disintegration behavior of the 4 samples, and results were comparable with the benchmark product. The concept of disintegration behavior of orodispersible films was introduced for the first time as an informative method for the study of orodispersible dosage form.