Characterisation and sensory evaluation of placebo OrPhylloTM orodispersible films as a versatile paediatric drug delivery platform.

Abstract

Orodispersible films (ODFs) are a convenient form of paediatric 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. OrPhyllo^TM 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.This study focuses on characterising placebo OrPhyllo^TM films, including their morphological, mechanical, and textural properties, as well as physicochemical stability by thermal analysis and X-ray diffraction. After local ethical approval, healthy adults explored stickiness, mouthfeel, and disintegration of these 3 × 3cm ODFs following various modes of administration.OrPhyllo™ ODFs (185 ± 10µm 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 140s, 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.