US20240197758
2024-06-20
Human necessities
A61K31/661
Pharmaceutical compositions containing psilocybin are designed to provide a therapeutically effective amount alongside one or more acceptable excipients. These formulations aim to treat depressive disorders by ensuring stability and uniformity during storage and use.
Psilocybin is classified as a psychedelic compound, primarily affecting serotonin receptors. Initially derived from psilocybe mushrooms, it poses unique challenges in formulation due to its physical properties and potential chemical instability. There is a growing demand for stable psilocybin compositions that comply with regulatory standards.
Creating stable solid dosage forms of psilocybin is complex due to its crystalline structure and poor flow properties. Issues such as discoloration and potency loss during stability testing have been observed when using common excipients. Therefore, it is crucial to develop formulations that maintain potency and content uniformity over time.
The compositions should ensure that the potency of psilocybin decreases by less than 5% after one month under specific storage conditions. Additionally, the mass balance of psilocybin and related substances must exceed 97%, meeting the criteria set by recognized pharmacopeias.
A method for producing these compositions involves direct mixing of psilocybin with acceptable excipients, followed by encapsulation. This process is designed to ensure compliance with established content uniformity standards, facilitating effective treatment options for patients with depressive disorders.