Impact of Formulation Variables on the Quality Attributes of Psilocybin-Loaded Oral Thin Films for Early-Phase Development
Journal of Drug Delivery Science and Technology March 1, 2026 Vorawut Wongumpornpinit, K Ingkaninan, Prapapan Temkitthawon et al.
Psilocybin, an investigational compound for neuropsychiatric disorders, was successfully incorporated into oral thin film (OTF) formulations using a solvent casting process. The films disintegrated and dissolved within 180 seconds, with drug loading ranging from 6.73% to 24.07% and recovery between 89.78% and 99.56%. The maximum amorphous psilocybin loading without detectable crystallinity was 11.75%. Stability studies over three months at 25°C/60% RH and 40°C/75% RH showed no significant changes in film appearance or drug content. The OTF platform enables flexible dose adjustment and broad dose exploration within a single stability program, supporting efficient formulation development for early-phase clinical trials.