Characterization and sensory evaluation of placebo OrPhyllo ^TM orodispersible films as a versatile pediatric drug delivery platform

Objective: Orodispersible films (ODFs) are a convenient form of pediatric drug delivery and for those with swallowing difficulties. They can be extemporaneously prepared in pharmacies using pre-formulated bases which simplify and fasten the process while reducing compounding errors. OrPhylloTM is a water-based commercial vehicle for preparing polymeric ODFs. It is chemically compatible with various clinically relevant active pharmaceutical ingredients (APIs) at different drug loadings. Methods: This study focuses on characterizing placebo OrPhylloTM films, including their morphological, mechanical, and textural properties, as well as physicochemical stability by thermal analysis and X-ray diffraction. Results: After local ethical approval, healthy adults explored stickiness, mouthfeel, and disintegration of these 3 × 3 cm ODFs following various modes of administration. OrPhyllo™ ODFs (185 ± 10 µm thick) exhibited distinct surface characteristics, one side (lower) smoother and the upper side rougher, as observed and shown by scanning electron and atomic force microscopy. However, both sides demonstrated similar mucoadhesive properties and rapid disintegration (between 60 and 140 s, depending on the method used). Both sides were well-accepted, whether administered on the tongue or in the cheeks, with minor differences in mouthfeel and fast disintegration perception. The hen’s egg chorioallantoic membrane test showed no irritancy, supporting the good acceptability of these placebo ODFs. The films remained structurally stable over 6 months, with low residual moisture. Conclusion: The comprehensive in vitro and in vivo characterisation confirmed the suitability of OrPhylloTM ODFs for pharmaceutical applications.