Formulation Design of Hydrocortisone Films for The Treatment of Aphthous Ulcer

INTRODUCTION: Research and developments in oral drug delivery has evolved to changeover of solid dosage forms from tablets to oral films. These films offer an elegant route for systemic drug delivery, with the advantage for the patients who are suffering from the difficulty of swallowing larger oral dosage forms. Aphthous ulcers are the most common oral lesions which occurs as a round or oval, with a greyish yellow, crateriform base. For the treatment of aphthous ulcer various marketed product are available such as vitamin B12 tablet, benzydomine hydrochloride mouth wash or spray, steroid lozenges and local anaesthathatics. Hence hydrocortisone is selected as choice of drug for the treatment of aphthous ulcer which exhibits anti-inflammatory and immunosuppressant properties inhibiting the clinical manifestations.
METHODS: The main aim of the present study is to develop a hydrocortisone film in order to improve the therapeutic efficacy and bioavailability of hydrocortisone for the treatment of aphthous ulcer. The hydrocortisone film was developed containing various concentrations of methylcellulose and propylene glycol (0.25 - 2.0 %w/v) by solvent casting method. 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: Total eight formulations were developed out of that, formulation F2 (1.25%w/v) is considered as the optimized formulation as it showed the best results with respect to all characterization studies. The disintegration time (44sec) and maximum in vitro drug release i.e., 97.55% was observed. Further, no significant changes were observed during stability studies for the optimized formulation.
DISCUSSION AND CONCLUSION: From the study, it was concluded that hydrocortisone oral films can be formulated as a potentially useful tool for an effective treatment of aphthous ulcer with improved bioavailability, rapid onset of action and with increased patient compliance