Formulation and In vitro Evaluation of a Fast-dissolving Oral Film of Triamcinolone Acetonide for Recurrent Aphthous Stomatitis

Background: Patient non-compliance with traditional oral solid dosage forms has driven the development of innovative drug delivery systems aimed at improving therapeutic efficacy and adherence. Oral fast-dissolving films (OFDFs) are intended for placement on the tongue or oral mucosa, where they rapidly hydrate and dissolve upon contact with saliva. Triamcinolone acetonide is a synthetic glucocorticoid with long-acting anti-inflammatory and immunosuppressive properties. It is commonly utilized to treat conditions, such as allergies, dermatological disorders, and inflammatory diseases. Depending on the formulation, it can be administered via oral, topical, injectable, or inhalation routes. Objective: This study aimed to formulate and evaluate an oral fast-dissolving film containing triamcinolone acetonide, with a focus on achieving rapid disintegration and adequate mechanical strength to enhance the treatment of recurrent aphthous stomatitis. Methods: The OFDFs were prepared using the solvent casting technique, incorporating hydroxypropyl methylcellulose (HPMC) as the film-forming polymer. Polyethylene glycol 400 (PEG 400) was utilized as a plasticizer, while sucrose and citric acid acted as saliva-stimulating agents. The films were assessed for various physicochemical properties, including disintegration time, folding endurance, surface pH, weight uniformity, thickness, surface morphology (via scanning electron microscopy), drug content, transparency, tensile strength, dissolution profile, content uniformity, loss of moisture, and moisture absorption. Additionally, drug-excipient compatibility was analyzed using differential scanning calorimetry (DSC) and Fourier-transform infrared spectroscopy (FT-IR). Results: The optimized formulations exhibited rapid disintegration within 23 seconds and demonstrated excellent mechanical properties, with folding endurance values exceeding 100. The films displayed uniform weight, thickness, and drug content, while the surface pH remained within the physiologically acceptable range (4.74-4.77). Scanning electron microscopy confirmed a smooth surface morphology, and DSC and FT-IR analyses verified compatibility between the drug and excipients. in vitro dissolution testing, conducted under simulated oral cavity conditions, revealed that over 79% of the drug was released within the first minute. Conclusion: This study successfully developed an oral fast-dissolving film of triamcinolone acetonide using the solvent casting method. The formulated film exhibited rapid disintegration and dissolution in vitro, suggesting its potential to improve patient convenience. However, further in vivo and clinical studies are required to confirm its therapeutic utility in the management of recurrent aphthous stomatitis.