Ondansetron Buccal Administration for Paediatric Use: A Comparison Between Films and Wafers

The objective of this study was the development of different solid formulations, such as wafers and films, for buccal administrationofondansetron,aselective andpotentantagonistof5-hydroxytryptamine 3receptorsused in children for the treatment of nausea and vomiting. Wafers and films have been prepared drying an aqueous solution of pectin, hydroxypropyl methylcellulose, sodium hyaluronate, sodium carboxymethylcellulose, chitosan or gelatin, through lyophilization or oven. Formulations were characterized in terms of morphology, drug solid state and ability to hydrate, adhere to mucosa, release and favour the permeation of the drug through porcine esophageal epithelium, used as model of human buccal epithelium. The most promising formulations were tested for in vitro biocompatibility in human pulp fibroblasts. Films showed greater hydration and mucoadhesion abilitiesand allowedthe release andthepermeation ofa greateramount ofondansetron withrespect to wafers. Chitosan or hyaluronate provided films with the best mucoadhesion properties and good biocompatibility profile. Moreover, chitosan based film allowed to obtain the highest amount of permeated drug and could represent a novel child-appropriate dosage form able to combine the advantages of solid dosage form with the possibility to avoid the swallowing.