Oral mucoadhesive systems, such as polymer films, are among innovative pharmaceutical products. These systems can be applied in swallowing problems and can also be used in geriatrics and paediatrics. In our earlier work, we successfully formulated buccal mucoadhesive polymer films, which contained cetirizine-hydrochloride (CTZ) as the API. The present study focused on investigating the stability and permeability of the prepared films. The stability of the films was studied with an accelerated stability test. During the stability test, thickness, breaking hardness and in vitro mucoadhesivity were analysed. Furthermore, the interactions were studied with FT-IR spectroscopy, and the changes in the amount of the API were also monitored. Cytotoxicity and cell line permeability studies were carried out on TR 146 buccal cells. Compositions that can preserve more than 85% of the API after 6 months were found. Most of the compositions had a high cell viability of more than 50%. Citric acid (CA) decreased the stability and reduced every physical parameter of the films. However, cell line studies showed that the permeability of the films was enhanced. In our work, we successfully formulated CTZ-containing buccal films with adequate stability, high cell viability and appropriate absorption properties.
Keywords: alginate; antihistamine; buccal films; cetirizine; cytotoxicity; drug delivery; mucoadhesive; permeability; stability.