Alginate-magnesium aluminum silicate films for buccal delivery of nicotine.

Sodium alginate-magnesium aluminum silicate (SA-MAS) dispersions with nicotine (NCT) were prepared at different pHs and characterized for the particle size and zeta potential, NCT adsorbed by MAS, and flow behavior before film casting. The physicochemical properties, NCT content, in vitro bioadhesive property, and NCT release and permeation of the NCT-loaded SA-MAS films were investigated. This study showed that incorporation of NCT into the SA-MAS dispersions caused a change in particle size and flow behavior and that NCT could be adsorbed by MAS. The formation of protonated NCT at acidic and neutral pHs could interact with negatively charged MAS via an electrostatic force, resulting in the formation of NCT-MAS flocculates/complexes that could act as microreservoirs in the films. The NCT-loaded SA-MAS films prepared at pH 5 yielded the highest NCT content due to non-significant loss of NCT during drying. Moreover, pH of the preparation also affected the crystallinity and thermal properties of the films. The NCT release and permeation across the mucosal membrane of the films could be described using a matrix diffusion controlled mechanism. In addition, the NCT-loaded SA-MAS films also possessed a bioadhesive property for adhesion to the mucosal membrane. This finding suggests that the NCT-loaded SA-MAS films composed of numerous NCT-MAS complexes as microreservoirs demonstrated a strong potential for use as a buccal delivery system.