Fabrication and Characterization of Betamethasone-loaded Oral Thin Films as a Novel Drug Delivery Platform for Oral Lichen Planus and Recurrent Mouth Ulcers

 Due to the existence of various issues and limitations associated with traditional buccal drug delivery systems such as the disability to consume food whilst using topical drugs in the mouth cavity, unpredictable drug release profile, undesirable taste, low patient adherence to therapy, and accelerated drug removal with saliva, these conventional methods are now rapidly becoming replaced with oral thin films as more precise and novel oral drug delivery platforms. The current study aims to discuss the design and characterization of betamethasone-loaded oral thin films with the aim of improved drug delivery in mouth cavity diseases.

 In this study, oral thin films with and without betamethasone were fabricated through the solvent casting method as a common, fast, and affordable technique prior to being evaluated for different physiochemical characteristics including weight, width, surface pH, disintegration period in vitro conditions, and swelling rates as well as drug release profiles at different intervals.

 Obtained oral films were demonstrated to possess adequate homogeneity, flexibility, and mechanical resistance. Accordingly, the average surface pH for films without and with betamethasone was equal to 6.75 and 6.66, respectively, which are in notable compatibility with the neutral pH of the oral cavity. Betamethasone-loaded films’ disintegration duration appeared to be superior to that of films without betamethasone and was in close correlation with their higher swelling rates. Further experiments revealed 25-30% drug release in the initial 20 minutes, followed by more than 90% betamethasone release in 360 minutes in a sustained manner.

 These results are indicative of betamethasone oral films’ satisfactory physiochemical properties and potential applicability as a sufficient oral drug delivery platform in mouth cavity diseases such as oral lichen planus or recurrent mouth sores. By sticking to the mouth mucosa, these films can significantly reduce drug removal with saliva and thus ameliorate sufficient delivery of therapeutic agents to specific mouth lesions. Moreover, they can alleviate some of the issues and limitations of traditional topical oral drug delivery and improve treatment or control of disease symptoms.