US20260294939
2026-10-01
Human necessities
A61K31/661
Pharmaceutical compositions containing psilocybin are developed for treating depressive disorders. These compositions include a therapeutically effective amount of psilocybin and pharmaceutically acceptable excipients. The focus is on creating stable formulations that maintain potency and content uniformity under various storage conditions, meeting regulatory standards.
Psilocybin is a psychedelic drug, part of the serotonergic class, distinct from other tryptamines and phenethylamines. Initially isolated from mushrooms, it is now synthesized in labs. Given its therapeutic potential, there is a need for stable pharmaceutical compositions that comply with regulatory standards, particularly concerning stability and content uniformity.
Formulating psilocybin as an active pharmaceutical ingredient (API) presents challenges due to its chemical instability and poor flow properties. Issues like drug discoloration and potency loss were observed during stability testing. The compositions aim to accommodate low doses while ensuring content uniformity, crucial for psilocybin's therapeutic use.
The pharmaceutical compositions include psilocybin and excipients, maintaining potency and mass balance under industry-standard storage conditions. For instance, after one month at 40°C and 75% relative humidity, the psilocybin potency decreases by less than 5%, with a mass balance exceeding 97%. This ensures the compositions remain effective and safe.
The preparation involves directly mixing psilocybin with excipients to create a blend, which is then encapsulated. This method ensures the composition meets content uniformity standards as per European Pharmacopeia and USP guidelines, crucial for consistent therapeutic efficacy in treating depressive disorders.