Oral soft gel capsule containing psychedelic compound

1. A method of treating anxiety in a subject, the method comprising orally administering to a subject in need or at risk thereof an oral soft gel capsule comprising:

(i) a capsule shell formed from gelatin and at least one of vegetable starch, tapioca starch, carrageenan, potato starch, cassava starch, cornstarch, and arrowroot;

(ii) a psychedelic compound comprising at least one of psilocybin, psilocin, and baeocystin; and

(iii) liquid vehicle comprising at least one of glycerin, beeswax, tocopherols, polyoxyethylene-polyoxypropylene copolymers, and Caprylic/Capric Triglyceride;

wherein,

the psilocybin, psilocin baeocystin, or combination thereof is present in a combined amount of 0.01 to 5 mg,

the psilocybin, psilocin, baeocystin, or combination thereof has a purity of at least 99 wt. % pure,

the psilocybin, psilocin, baeocystin, or combination thereof is obtained from the genera Copelandia, Gymnopilus, Inocybe, Mycena, Panaeolus, Pholiotina, Pluteus , or Psilocybe,

the liquid vehicle is compatible with the capsule shell;

the liquid vehicle effectively dissolves and/or suspends the psychedelic compound; and

the psychedelic compound and the liquid vehicle are contained within the capsule shell.

2. The method of claim 1 , wherein the anxiety is associated with at least one of obsessive compulsive disorder (OCD), pain, irritability, fibromyalgia, post-traumatic stress disorder (PTSD), cluster headaches, paranoia, psychosis, anxiety, panic attacks, flashbacks, smoking addiction, alcohol addiction, and cocaine addiction.

3. The method of claim 1 , wherein 1-5 oral soft gel capsules are orally administered a day.

4. The method of claim 1 , wherein the psilocybin, psilocin, baeocystin, or combination thereof is delivered enterally.

5. The method of claim 1 , wherein the psilocybin, psilocin, baeocystin, or combination thereof is present in a combined amount of 0.05 to 2.5 mg.

6. The method of claim 1 , wherein the psilocybin, baeocystin, or combination thereof is present in a combined amount of 0.05 to 1 mg.

7. The method of claim 1 , wherein the psilocybin, baeocystin, or combination thereof is present in a combined amount of 0.1 to 1 mg.

8. The method of claim 1 , wherein the liquid vehicle further comprises at least one of vegetable oil, hydrogenated vegetable oil, lecithin, polyethylene glycols, and propylene glycol.

9. The method of claim 1 , wherein the liquid vehicle comprises less than 0.1 wt. % of each of dimethyl isosorbide, surfactants, diethylene glycol monoethyl ether, water, and alcohol.

10. The method of claim 1 , wherein the oral soft gel capsule exhibits a high stability such that at least 90 wt. % of the psilocybin, psilocin, baeocystin, or combination thereof remains in the oral soft gel capsule, under accelerated stability conditions of ≥40° C., relative humidity (RE) 75±5%, over a period of time of ≥3 months.

11. The method of claim 1 , wherein the oral soft gel capsule further comprises a preservative.

12. The method of claim 1 , wherein the oral soft gel capsule further comprises an opacifier.

13. The method of claim 1 , wherein the oral soft gel capsule further comprises a flavorant.

14. The method of claim 1 , wherein the oral soft gel capsule further comprises a colorant.

15. The method of claim 1 , wherein the oral soft gel capsule comprises a capsule shell that, when empty, blocks at least 99% of U light from transmitting therethrough.

16. The method of claim 1 , wherein the capsule shell is further formed from a plasticizer glycerin, or sorbitol, or combination thereof.

17. The method of claim 1 , wherein the capsule shell is further formed from the solvent water.

18. The method of claim 1 , wherein the capsule shell is further formed from cellulose, hypromellose, or combination thereof.

19. The method of claim 1 , wherein the the gelatin of capsule shell is further formed from collagen of animal skin and/or bone.

20. A method of treating anxiety in a subject, the method comprising orally administering to a subject in need or at risk thereof an oral soft gel capsule comprising:

(i) a capsule shell formed from gelatin and at least one of vegetable starch, tapioca starch, carrageenan, potato starch, cassava starch, cornstarch, and arrowroot;

(ii) a psychedelic compound comprising at least one of psilocybin, psilocin and baeocystin; and

(iii) liquid vehicle comprising at least one of glycerin, beeswax, tocopherols, polyoxyethylene-polyoxypropylene copolymers, and Caprylic/Capric Triglyceride;

wherein,

the psychedelic compound has a purity of at least 90 wt. % pure,

the liquid vehicle is compatible with the capsule shell;

the liquid vehicle effectively dissolves and/or suspends the psychedelic compound; and

the psychedelic compound and the liquid vehicle are contained within the capsule shell.

21. The method of claim 20 , wherein the psychedelic compound is present in up to 250 mg.

22. The method of claim 20 , wherein the psychedelic compound comprises at least one of psilocybin, psilocin, and baeocystin and is present in a combined amount of up to 100 mg.

23. The method of claim 22 , wherein the psychedelic compound is present in up to 35 wt. % of the liquid vehicle.

24. The method of claim 20 , wherein the psychedelic compound is present in up to 5 wt. % of the liquid vehicle.

25. The method of claim 20 , wherein t the psychedelic compound has a purity of at least 95 wt. % pure.

26. The method of claim 20 , wherein t the psychedelic compound has a purity of at least 97.5 wt. % pure.