Composition comprising a benzoate salt of 5-methoxy-n,n-dimethyltryptamine

Abstract

A composition comprising a pharmaceutically effective amount of a pharmaceutically acceptable benzoate salt of 5-methoxy-N,N-dimethyltryptamine (5MeODMT).

1 - 80 . (canceled) 
     
     
         81 . 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) benzoate. 
     
     
         82 . The 5-MeO-DMT benzoate of  claim 81  in crystalline form. 
     
     
         83 . The 5-MeO-DMT benzoate of  claim 82 , wherein the crystalline form is Pattern B. 
     
     
         84 . The 5-MeO-DMT benzoate of  claim 83 , wherein the crystalline form Pattern B is characterised by one or more of:
 a peak in an X-ray powder diffraction (XRPD) diffractogram at a 20 value of 18.3°2θ±0.1° as measured by x-ray powder diffraction using an x-ray wavelength of 1.5406 Å;   peaks in an XRPD diffractogram at 2θ values of 17.2°2θ±0.1°, 18.3°2θ±0.1° and 19.5°2θ±0.1° as measured by x-ray powder diffraction using an x-ray wavelength of 1.5406 Å;   peaks in an XRPD diffractogram at 2θ values of 18.5°2θ±0.1° and 20°2θ±0.1° as measured by x-ray powder diffraction using an x-ray wavelength of 1.5406 Å;   an XRPD diffractogram as substantially illustrated in Figure 24 (lots P1, R1, Q1), Figure 28 (lot R2), Figures 38 (lots A1, B1) or 39 (lots A1, B1); and/or   Fourier transform infrared (FTIR) spectra as substantially illustrated in Figure 93 (lot C2).   
     
     
         85 . The 5-MeO-DMT benzoate of  claim 82 , wherein the crystalline form is Pattern C. 
     
     
         86 . The 5-MeO-DMT benzoate of  claim 85 , wherein the crystalline form Pattern C is characterised by one or more of:
 a minor broad endotherm with a peak temperature of 108° C. in a differential scanning calorimetry (DSC) thermograph;   a DSC thermograph as substantially illustrated in Figure 65 or Figure 66;   a peak in an X-ray powder diffraction (XRPD) diffractogram at a 2θ value of 10.3° 2θ±0.1° as measured by x-ray powder diffraction using an x-ray wavelength of 1.5406 Å;   an XRPD diffractogram as substantially illustrated in Figure 68 (lot A1); and/or   Fourier transform infrared (FTIR) spectra as substantially illustrated in Figure 93 (lot C1).   
     
     
         87 . The 5-MeO-DMT benzoate of  claim 82 , wherein the crystalline form is Pattern D. 
     
     
         88 . The 5-MeO-DMT benzoate of  claim 87 , wherein the crystalline form Pattern D is characterised by one or more of:
 an X-ray powder diffraction (XRPD) diffractogram as substantially illustrated in Figure 73 or Figure 74;   an endothermic event in a differential scanning calorimetry (DSC) thermograph at 118° C.; and/or   an endothermic event in a DSC thermograph at 119° C.   
     
     
         89 . The 5-MeO-DMT benzoate of  claim 82 , wherein the crystalline form is Pattern E. 
     
     
         90 . The 5-MeO-DMT benzoate of  claim 89 , wherein the crystalline form Pattern E is characterised by one or more of:
 an X-ray powder diffraction (XRPD) diffractogram as substantially illustrated in Figure 77 or Figure 78 (lot D);   a major bimodal endothermic event with peak temperatures of 110.31° C. and 113.13° C. in a differential scanning calorimetry (DSC) thermograph;   a minor endothermic event with a peak temperature of 119.09° C. in a DSC thermograph;   a DSC thermograph as substantially illustrated in Figure 79; and/or   an XRPD diffractogram as substantially illustrated in Figure 80.   
     
     
         91 . A pharmaceutical composition comprising the 5-MeO-DMT benzoate of  claim 81  and one or more pharmaceutically acceptable carriers or excipients formulated for administration one or more times a day. 
     
     
         92 . A pharmaceutical composition comprising the 5-MeO-DMT benzoate of  claim 81  and one or more pharmaceutically acceptable carriers or excipients formulated for administration more than one time a day. 
     
     
         93 . A pharmaceutical composition comprising the 5-MeO-DMT benzoate of  claim 81  and one or more pharmaceutically acceptable carriers or excipients formulated for administration twice daily. 
     
     
         94 . The pharmaceutical composition of  claim 93  formulated for nasal administration. 
     
     
         95 . An antidepressant pharmaceutical composition comprising the 5-MeO-DMT benzoate of  claim 81  and one or more pharmaceutically acceptable carriers or excipients. 
     
     
         96 . The pharmaceutical composition of  claim 95  formulated for nasal administration. 
     
     
         97 . An antianxiety pharmaceutical composition comprising the 5-MeO-DMT benzoate of  claim 81  and one or more pharmaceutically acceptable carriers or excipients. 
     
     
         98 . The pharmaceutical composition of  claim 97  formulated for nasal administration. 
     
     
         99 . An anti-addiction pharmaceutical composition comprising the 5-MeO-DMT benzoate of  claim 81  and one or more pharmaceutically acceptable carriers or excipients. 
     
     
         100 . The pharmaceutical composition of  claim 99  formulated for nasal administration.