Oral soft gel capsule containing psychedelic compound

Abstract

Provided is an oral soft gel capsule that includes a psychedelic compound. Also provided is a method of treating in a subject a disease or disorder ameliorated by a psychedelic compound, that includes orally administering to a subject an oral soft gel capsule that includes a therapeutically effective amount of the psychedelic compound. Also provided is a method of orally administering to a subject an oral soft gel capsule that includes a therapeutically effective amount of the psychedelic compound. Also provided is a method of orally administering to a subject an oral soft gel capsule that includes a low dose (e.g., microdose or sub-therapeutic dose) of the psychedelic compound.

1 . A method comprising orally administering to a subject an oral soft gel capsule comprising:
 (i) a capsule shell formed from the plasticizer glycerin, sorbitol, or combination thereof;   the solvent water, and at least one of gelatin, cellulose, hypromellose, 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 one or more oils;   
       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, Gymnopilis,  Inocybe , Micena, 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 , which is a method comprising improving creativity, boosting physical energy level, attaining emotional balance, increasing performance on problems-solving tasks, treating anxiety, treating depression, treating addiction, or any combination thereof. 
     
     
         3 . The method of  claim 1 , which is a method comprising treating 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. 
     
     
         4 . The method of  claim 1 , wherein 1-5 oral soft gel capsules are orally administered a day. 
     
     
         5 . The method of  claim 1 , wherein the psilocybin, psilocin, baeocystin, or combination thereof is delivered enterally. 
     
     
         6 . 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. 
     
     
         7 . The method of  claim 1 , wherein the psilocybin, psilocin, baeocystin, or combination thereof is present in a combined amount of 0.05 to 1 mg. 
     
     
         8 . The method of  claim 1 , wherein the psilocybin, psilocin, baeocystin, or combination thereof is present in a combined amount of 0.1 to 1 mg. 
     
     
         9 . The method of  claim 1 , wherein the liquid vehicle comprises at least one of vegetable oil, glycerin, hydrogenated vegetable oil, lecithin, beeswax, tochopherols, polyethylene glycols, polyoxyethylene—polyoxypropylene copolymers, propylene glycol, and Miglyol® 812. 
     
     
         10 . 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. 
     
     
         11 . 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 (RH) 75 ±5%, over a period of time of ≥ 3 months. 
     
     
         12 . The method of  claim 1 , wherein the oral soft gel capsule further comprises a preservative. 
     
     
         13 . The method of  claim 1 , wherein the oral soft gel capsule further comprises an opacifier. 
     
     
         14 . The method of  claim 1 , wherein the oral soft gel capsule further comprises a flavorant. 
     
     
         15 . The method of  claim 1 , wherein the oral soft gel capsule further comprises a colorant. 
     
     
         16 . The method of  claim 1 , wherein the oral soft gel capsule comprises a capsule shell that, when empty, blocks at least 99% of UV light from transmitting therethrough. 
     
     
         17 . An oral soft gel capsule comprising:
 (i) a capsule shell formed from a plasticizer glycerin, sorbitol, or combination thereof; a solvent water, and at least one of gelatin, cellulose, hypromellose, 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) a liquid vehicle comprising one or more oils;   
       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 genera Copelandia, Gynnwpilus,  Inocybe, Mycena , Panaeolus, Pholiolina, 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.