Exploring new buccal films based on hydroxyethyl cellulose and Linecaps® combination for the pediatric delivery of hydrophobic molecules

Polysaccharides and starch derivatives can play a role in the development of buccal films and patches. Buccal films are a valid approach to the transmucosal administration of drugs. These drug-delivery systems are adaptable to the mucosal surface, while being particularly suitable for the pediatric population. This study explores the combination of polysaccharide-based films for the buccal administration of the poorly soluble drug, ibuprofen. The films were obtained via the freeze-thaw technique using an innovative combination of two filmforming polymers of natural origin, i.e. hydroxyethylcellulose and a pea starch derivate (Linecaps (R)). Ibuprofen was selected as model drug to be loaded into the buccal formulation as a beta-cyclodextrin complex. The produced films showed good physico-chemical and functional properties including homogeneous drug content, thickness, mechanical strength, mucoadhesion, thus guaranteeing suitable drug loading and applicability. In vitro, permeation studies of Ibuprofen buccal films were carried out using a synthetic biomimetic membrane, and rabbit mucosae tissue exhibited values of permeability fluxes in the same order of magnitude for the two tested membranes (1.51 x 10- 2 +/- 0.33 x 10- 2 mu g/cm2*s vs 1.21 x 10- 2 +/- 0.18 x 10- 2 mu g/cm2*s). The release of the drug from the buccal film, the taste-masking and permeation properties suggested that the proposed combination of polysaccharides represent a potential formulation of mucoadhesive buccal films.