Development of Duloxetine hydrochloride Orodispersible Films for Rapid Onset of Antidepressant Action

Abstract

This study aimed to formulate fast-dissolving orodispersible films (ODFs) containing Duloxetine HCl to expedite beginning of action and augment patient adherence, especially in individuals with dysphagia. Films were fabricated by the solvent-casting method, employing HPMC E15 as the principal film-forming polymer, with sodium starch glycolate (SSG) and croscarmellose sodium (CCS) integrated as superdisintegrants to enhance wetting and disintegration. Seven formulations (DL1–DL7) were assessed for physicomechanical characteristics, content uniformity, FTIR compatibility, and in vitro dissolution. All films demonstrated sufficient flexibility, satisfactory surface pH, consistent thickness, and assay results within the range of 95–105%. Dissolution studies revealed swift drug release, with DL4 (9% SSG) and DL6 (4% CCS) attaining approximately 80–85% release in 10 minutes and nearly total release within 20 minutes. Kinetic modeling aligns most effectively with the Korsmeyer–Peppas model, suggesting the presence of anomalous diffusion. Stability testing verified the absence of substantial alterations in assay or performance. Ultimately, DL4 and DL6 were identified as optimal formulations.