Pharmaceutical composition comprising 5-methoxy-n,n-dimethyltryptamine

Abstract

An intranasal composition comprising a dosage amount of 50-150 mg/ml 5-methoxy-N,N-dimethyltryptamine (5MeODMT) in a liquid medium, wherein the 5MeODMT is formulated as the chloride salt of 5MeODMT (5MeODMT hydrochloride) and wherein the 5MeODMT hydrochloride is crystalline and characterised by one or more of: peaks in an XRPD diffractogram; an endothermic event in a DSC thermograph; an onset of decomposition in a TGA thermograph; and a DVS isotherm profile.

1 - 48 . (canceled) 
     
     
         49 . A pharmaceutical composition comprising particles that comprise:
 (5-MeO-DMT) or a pharmaceutically acceptable salt thereof selected from benzoate, fumarate, citrate, acetate, succinate, halide, fluoride, chloride, bromide, iodide, oxalate, or triflate salts of 5-MeO-DMT; and   one or more pH-sensitive carriers or excipients.   
     
     
         50 . The pharmaceutical composition of  claim 49 , wherein the one or more pH-sensitive carriers or excipients are selected from chitosan or chitosan derivatives. 
     
     
         51 . The pharmaceutical composition of  claim 50 , wherein the composition comprises particles of the benzoate salt of 5-MeO-DMT. 
     
     
         52 . The pharmaceutical composition of  claim 50 , wherein the composition comprises particles of the chloride salt of 5-MeO-DMT. 
     
     
         53 . The pharmaceutical composition of  claim 50 , wherein the composition comprises particles of the bromide salt of 5-MeO-DMT. 
     
     
         54 . The pharmaceutical composition of  claim 51 , wherein the composition further comprises one or more of a mucoadhesive enhancer, a penetrating enhancer, a cationic polymer, a cyclodextrin, a Tight Junction Modulator, an enzyme inhibitor, a surfactant, a chelator, or a polysaccharide. 
     
     
         55 . The pharmaceutical composition of  claim 51 , wherein the composition is formulated for intranasal administration. 
     
     
         56 . The pharmaceutical composition of  claim 51 , wherein the particles have a median diameter of less than 2000 μm and greater than 0.5 μm. 
     
     
         57 . The pharmaceutical composition of  claim 52 , wherein the composition further comprises one or more of a mucoadhesive enhancer, a penetrating enhancer, a cationic polymer, a cyclodextrin, a Tight Junction Modulator, an enzyme inhibitor, a surfactant, a chelator, or a polysaccharide. 
     
     
         58 . The pharmaceutical composition of  claim 52 , wherein the composition is formulated for intranasal administration. 
     
     
         59 . The pharmaceutical composition of  claim 52 , wherein the particles have a median diameter of less than 2000 μm and greater than 0.5 μm. 
     
     
         60 . The pharmaceutical composition of  claim 53 , wherein the composition further comprises one or more of a mucoadhesive enhancer, a penetrating enhancer, a cationic polymer, a cyclodextrin, a Tight Junction Modulator, an enzyme inhibitor, a surfactant, a chelator, or a polysaccharide. 
     
     
         61 . The pharmaceutical composition of  claim 53 , wherein the composition is formulated for intranasal administration. 
     
     
         62 . The pharmaceutical composition of  claim 53 , wherein the particles have a median diameter of less than 2000 μm and greater than 0.5 μm. 
     
     
         63 . A pharmaceutical composition comprising particles that comprise:
 (5-MeO)-DMT) benzoate or 5-MeO)-DMT hydrochloride; and   one or more pH-sensitive carriers or excipients.   
     
     
         64 . The pharmaceutical composition of  claim 63 , wherein the composition further comprises a surfactant. 
     
     
         65 . The pharmaceutical composition of  claim 64 , wherein the composition further comprises an enzyme inhibitor. 
     
     
         66 . The pharmaceutical composition of  claim 65 , wherein the particles have a median diameter of less than 2000 μm and greater than 0.5 μm. 
     
     
         67 . The pharmaceutical composition of  claim 63 , wherein the 5-MeO-DMT benzoate or 5-MeO-DMT hydrochloride is crystalline. 
     
     
         68 . The pharmaceutical composition of  claim 63 , wherein the 5-MeO-DMT benzoate or 5-MeO-DMT hydrochloride is amorphous. 
     
     
         69 . A method of treating depression, anxiety, substance use disorder, addictive disorder, gambling disorder, eating disorder, obsessive-compulsive disorder, or body dysmorphic disorder in a subject, the method comprising administering a pharmaceutically effective amount of the pharmaceutical composition of  claim 63  to the subject to treat depression, anxiety, substance use disorder, addictive disorder, gambling disorder, eating disorder, obsessive-compulsive disorder, or body dysmorphic disorder.