Formulation design of hydrocortisone films for the treatment of aphthous ulcers

Abstract

Objectives: Research and development in oral drug delivery has evolved to the changeover of solid dosage forms from tablets to oral films. These films offer an elegant route for systemic drug delivery, with an advantage for patients who are suffering from difficulty in swallowing larger oral dosage forms. Aphthous ulcers are the most common oral lesions and are round or oval, with a grayish yellow, crateriform base. For the treatment of aphthous ulcers various marketed product are available, such as vitamin B12 tablets, benzydamine hydrochloride mouthwash or spray, steroid lozenges, and local anesthetics. Hence hydrocortisone is selected as the drug of choice for the treatment of aphthous ulcers, exhibiting antiinflammatory and immunosuppressant properties that inhibit the clinical manifestations. The main aim of the present study was to develop a hydrocortisone film in order to improve the therapeutic efficacy and bioavailability of hydrocortisone for the treatment of aphthous ulcers. Materials and Methods: The hydrocortisone film was developed containing various concentrations of methylcellulose and propylene glycol (1.0- 2.0% w/v) by solvent casting. The prepared films were evaluated for various characterization studies like film forming capacity, visual appearance, thickness, weight variation, folding endurance, surface pH, drug content, disintegration time, tensile strength, in vitro release study, ex vivo study, and stability studies. Results: A total of five formulations were developed, out of which formulation F2 (1.25% w/v) is considered the optimized formulation as it showed the best results with respect to all characterization studies. A disintegration time of 44 s and maximum in vitro drug release, i.e. 97.55%, were observed. Further, no significant changes were observed during stability studies for the optimized formulation. Conclusion: Hydrocortisone oral films can be formulated as a potentially useful tool for effective treatment of aphthous ulcers with improved bioavailability, rapid onset of action, and increased patient compliance.