N-N-DIMETHYLTRYPTAMINE (DMT) AND DMT ANALOG COMPOSITIONS, METHODS OF MAKING, AND METHODS OF USE THEREOF
Pharmaceutical compositions including an amorphous N—N-dimethyltryptamine (DMT) or a pharmaceutically acceptable salt or prodrug thereof, and a polymeric carrier are described. These compositions are suitable for buccal or sublingual administration to a patient. Methods of treating disorders, including neurological disorders, by administration of these compositions are described.
1 . A composition comprising a pharmaceutically effective amount of an amorphous N,N-dimethyltryptamine (DMT) incorporated within a polymeric carrier matrix.
2 . The composition of claim 1 , wherein the DMT is characterized by a powder x-ray diffractogram free of any discernable peaks.
3 . The composition of claim 1 , wherein the DMT is characterized by a differential scanning calorimetry (DSC) spectrum lacking a sharp melting endotherm of crystalline DMT and/or lacking an indication of phase change.
4 . The composition of claim 1 , wherein the polymeric carrier matrix is a mucoadhesive polymer.
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6 . The composition of claim 1 , wherein the pharmaceutical composition is capable of producing a T max between 10 min to 90 min upon administration.
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26 . A composition, comprising:
about 0.5% to about 60% by weight of an amorphous N—N-dimethyltryptamine or a pharmaceutically acceptable salt or prodrug thereof;
about 15% to about 80% by weight of a mucoadhesive polymer matrix; and
about 0.1% to about 30% by weight of a permeation enhancer.
27 . The composition of claim 26 , comprising about 20% to about 35% by weight of the N—N-dimethyltryptamine or a pharmaceutically acceptable salt or prodrug thereof.
28 . The composition of claim 26 , comprising about 50% to about 60% by weight of the mucoadhesive polymer matrix.
29 . The composition of claim 26 , further comprising about 0.5% to about 20% by weight of a plasticizer.
30 . The composition of claim 26 , comprising about 0.5% to about 5% by weight of the plasticizer.
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46 . The composition of claim 1 , wherein the DMT remains in an amorphous state after aging at 25° C. and 60% relative humidity for 6 months.
47 . The composition of claim 46 , characterized by a powder x-ray diffractogram free of any discernable peaks.
48 . The composition of claim 46 , characterized by a differential scanning calorimetry (DSC) spectrum for absence of sharp melting endotherm of crystalline DMT and/or indication of phase change (e.g., glass transition temperature).
49 . The composition of claim 1 , wherein the DMT is capable of remaining in an amorphous state after aging at 40° C. and 75% relative humidity for 6 months.
50 . The composition of claim 49 , characterized by a powder x-ray diffractogram free of any discernable peaks.
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54 . A method of making a pharmaceutical composition, comprising the steps of:
combining N—N-dimethyltryptamine or a pharmaceutically acceptable salt or prodrug thereof, and excipients in a solvent; and
removing the solvent to provide a polymeric matrix comprising an amorphous N—N-dimethyltryptamine or a pharmaceutically acceptable salt or prodrug thereof.
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65 . A composition prepared according to the method of claim 54 .
66 . The composition of claim 65 , wherein the DMT is capable of remaining in an amorphous state after aging at 25° C. and 60% relative humidity for 6 months.
67 . The composition of claim 66 , characterized by a powder x-ray diffractogram free of any discernable peaks.
68 . The composition of claim 66 , characterized by a differential scanning calorimetry (DSC) spectrum for absence of sharp melting endotherm of crystalline DMT and/or indication of phase change.
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