Objectives:

The aim of the study was to investigate the effect of different polymers and plasticizers on oral disintegrating films (ODFs) containing triamcinolone acetonide, which is a glucocorticosteroid indicated for the treatment of oral wounds.

Materials and Methods:

13 different formulations which have same amount of polymer and plasticizer were prepared by solvent casting method. 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 ensurance), disintegration time were assessed and drug content analysis were performed on ODFs.

Results:

Suitable ODFs were produced with HPMC, PVA, CMC, gelatin, and pectin, while film integrity was not achieved with 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. In terms of 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 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 triamcinolone acetonide for which there are no preparations except for cream, gel and pomade forms for topical use in Türkiye.

Keywords: Triamcinolone acetonide, Oral disintegrating films, Solvent casting method, PEG 400, Glycerin