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Impact of Formulation Variables on the Quality Attributes of Psilocybin-Loaded Oral Thin Films for Early-Phase Development

Vorawut Wongumpornpinit, K Ingkaninan, Prapapan Temkitthawon, Neti Waranuch, Rhannanda Copetti Pivetta, Jieyu Zuo, Gabriel Lima Barros de Araújo, Nádia Bou-Charcra, Vijay Somayaji, Raimar Loebenberg

Journal of Drug Delivery Science and Technology March 1, 2026 DOI: 10.1016/j.jddst.2026.108228 (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Experimental study Peer reviewed
Intervention Psilocybin-loaded oral thin film
Duration Three months
Topics Psilocybin
Keywords Dissolution Thin film Crystallinity Amorphous solid Solvent Drug Chemical engineering Casting Nanotechnology Phase matter Chemical stability Solubility
Key findings Psilocybin-loaded oral thin films with acceptable short-term physical and chemical stability were successfully developed, supporting their suitability for early-phase pharmaceutical development.

Abstract

Psilocybin is an emerging investigational compound with therapeutic potential in neuropsychiatric disorders, creating a need for flexible and scalable dosage forms suitable for early clinical development. This study aimed to develop and evaluate psilocybin-loaded oral thin film (OTF) formulations as a dose-proportional platform for early-phase clinical use. OTFs were prepared using a solvent casting process and characterized with respect to physicochemical properties, drug loading, content uniformity, disintegration, dissolution behavior, and short-term stability. Psilocybin was fully solubilized in the aqueous phase and successfully incorporated into the polymeric film matrix. All formulations disintegrated and dissolved within 180 s. Drug loading ranged from 6.73% to 24.07%, with recovery between 89.78% and 99.56%. The maximum amorphous psilocybin loading without detectable crystallinity was 11.75%. Stability studies conducted at 25 ± 2 °C / 60 ± 5% RH and 40 ± 2 °C / 75 ± 5% RH over three months demonstrated no significant changes in film appearance or drug content. A psilocybin-loaded oral thin film formulation with acceptable short-term physical and chemical stability was successfully developed, supporting its suitability for early-phase pharmaceutical development. Owing to their inherent dose proportionality based on film size, OTFs enable flexible dose adjustment and broad dose exploration within a single bracketed stability program, supporting efficient formulation development for early-phase clinical trials.

Comparable studies

Other experimental studies on psilocybin, most cited first.

Study Year Design Participants
Psilocybin induces schizophrenia-like psychosis in humans via a serotonin-2 agonist action Healthy human volunteers 1998 Experimental study
Validation of the revised Mystical Experience Questionnaire in experimental sessions with psilocybin Participants in controlled laboratory experiments receiving a moderate to high oral... 2015 Validation study using pooled data from five laboratory experiments n = 184
Broadband Cortical Desynchronization Underlies the Human Psychedelic State Healthy human participants 2013 Experimental study
Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer Participants with cancer-related psychiatric distress who completed a parent randomized... 2020 Long-term within-subjects follow-up analysis n = 15
Enzymatic Synthesis of Psilocybin 2017 Laboratory study

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