Formulation and Evaluation of Triamcinolone Acetonide-Loaded Oral Disintegrated Film with Different Polymers via Solvent Casting Method

Objectives: The study aimed to investigate the effect of different polymers and plasticizers on oral disintegrating films (ODFs) containing triamcinolone acetonide (TA), a glucocorticosteroid indicated for the treatment of oral wounds.

Materials and methods: Thirteen different formulations with the same amount of polymer and plasticizer were prepared by solvent casting. Briefly, the solutions containing polymer, plasticizer, and other ingredients were poured into Petri dishes and kept at room temperature for 20 hours to obtain ODFs. Physical properties of ODFs such as visual appearance, weight and thickness uniformity, pH, mechanical durability (tensile strength, elongation at break and folded insurance), and disintegration time were assessed and drug content analysis was performed on ODFs.

Results: Suitable ODFs were produced with hydroxypropyl methylcellulose (HPMC), polyvinyl alcohol, carboxymethylcellulose, gelatin, and pectin, while film integrity was not achieved with polyethyleneglycol 4000 (PEG 4000), chitosan and starch. Glycerin made ODFs more transparent, reduced their thickness, and improved their mechanical properties. On the other hand, PEG 400 reduced the weight variation. Regarding drug content, PEG-containing gelatin-based ODF (ODF10) and pectin-based ODF (ODF12) complied with pharmacopeial limits. In addition, all ODFs except HPMC-based ODFs had an appropriate pH range.

Conclusion: When all features were evaluated together in terms of the applicability of an ODF to the patient, the most convenient formulation was found to be gelatin-based with PEG 400 ODF (ODF10). In short, patients will benefit from ease of application and transportation and effective therapy with correct dosing with the development of ODF forms of TA for which there are no preparations except for cream, gel, and pomade forms for topical use in Türkiye.