Orodispersible and Mucoadhesive Buccal Films: Advances, Formulation Challenges, and Future Perspectives in Oromucosal Drug Delivery

Abstract

Mucosal systems such as orally disintegrating films (ODFs) and mucoadhesive buccal films (MBFs) have gained attention and become a potential alternative to the conventional oral drug delivery systems, especially for patients who are geriatric or pediatric or those having difficulty in swallowing or drugs with extensive first-pass metabolism. Such films provide benefits, including a quick onset of action, increased bioavailability, and patient compliance. Successful development entails meticulous optimization of ingredients such as film-forming polymers, plasticizers, surfactants, taste maskers, and material selection for the corresponding manufacturing process, including solvent casting, hot-melt extrusion, 3D printing, and electrospinning. Limitations remain, with challenges including low drug loading capacity, no unified evaluation standard, stability problems, and regulatory vagueness of the liposome carrier. Emerging trends signal the promise of nanocarrier-based films, solid dispersions, and stimuli-responsive systems to circumvent these barriers. Personalization technologies, specifically 3D printing and natural and biodegradable polymers, are expected to broaden the clinical use of oromucosal films. This article provides an overview of the current state of development, along with formulation and manufacturing considerations of ODFs and MBFs, the role of which is significant in addressing translational and regulatory hurdles.