Evaluation of orally disintegrating films containing ferulic acid inclusion complexes: Physical characteristics and release kinetics

Orally disintegrating films (ODFs) has gained significant attention as a nutrient delivery platform due to its ease of intake. But studies on delivering ferulic acid (FA) through ODFs are still scarce. The objective of this study was to assess the physical characteristics of ODFs containing FA/β-cyclodextrin (0.5:1) (FA/β-CD (0.5:1)) and FA/hydroxypropyl-β-cyclodextrin (0.5:1) (FA/HP-β-CD (0.5:1)) complexes, as well as analyze the release kinetics of FA in both ODFs. Confirmation of the FA/β-CD (0.5:1) and FA/HP-β-CD (0.5:1) inclusion complexes was achieved through the reduction or attenuation of FA’s distinctive peaks in FT-IR and XRD examinations. Both the ODFs containing FA/β-CD (0.5:1) and FA/HP-β-CD (0.5:1) had a thickness of 0.06 mm, a surface pH of 6.7, and a disintegration time of less than 30 s, all of which met the requirements of ODFs effectively. The release of FA in both ODF formulations exhibited a high degree of consistency with the first-order kinetic model. Furthermore, the FA/HP-β-CD (0.5:1) ODF exhibited a higher cumulative release rate compared to the FA/β-CD (0.5:1) ODF throughout the entire in-vitro digestion process, indicating that FA/HP-β-CD (0.5:1) was more suitable for ODF formulation.