Therapeutic solid dosage forms
The present invention relates to a solid dosage form comprising two or more compounds selected from N,N-dimethyltryptamine and its deuterated analogues and pharmaceutically acceptable salts thereof, and methods of treatment (e.g., of a psychiatric disorder or a neurological disorder) comprising administering the solid dosage form to a patient in need thereof.
1. A solid dosage form comprising two or more compounds selected from N,N-dimethyltryptamine and its deuterated analogues and pharmaceutically acceptable salts thereof.
2. The solid dosage form of claim 1 , wherein the deuterated analogues are selected from α,α-dideutero-N,N-dimethyltryptamine compounds and α-protio, α-deutero-N,N-dimethyltryptamine compounds.
3. The solid dosage form of claim 2 , wherein the deuterated analogues are compounds of Formula I:
wherein:
each R 1 is independently selected from H and D;
R 2 is selected from CH 3 and CD 3 ;
R 3 is selected from CH 3 and CD 3 ;
each y H is independently selected from H and D; and
the ratio of deuterium:protium in a compound of Formula I is greater than that found naturally in hydrogen,
or pharmaceutically acceptable salts thereof.
4. The solid dosage form of claim 3 , wherein each R 1 is H.
5. The solid dosage form of claim 3 , wherein both y H are D.
6. The solid dosage form of claim 3 , wherein both R 2 and R 3 are CD 3 .
7. The solid dosage form of claim 3 , comprising one or more compounds selected from Compounds 1 to 5, or a pharmaceutically acceptable salt thereof:
8. The solid dosage form of claim 1 , comprising a combination of N,N-dimethyltryptamine and 2% or more by weight of one or more compounds selected from α,α-dideutero-N,N-dimethyltryptamine compounds, α-protio, α-deutero-N,N-dimethyltryptamine compounds and pharmaceutically acceptable salts of these compounds.
9. The solid dosage form of claim 1 , comprising up to 50% by weight, based on the total solid dosage form, of one or more compounds selected from α,α-dideutero-N,N-dimethyltryptamine compounds, α-protio, α-deutero-N,N-dimethyltryptamine compounds and pharmaceutically acceptable salts thereof.
10. The solid dosage form of claim 1 , comprising from 5% to 95% by weight of N,N-dimethyltryptamine or a pharmaceutically acceptable salt thereof.
11. The solid dosage form of claim 1 , comprising from 5% to 95% by weight of an α,α-dideutero-N,N-dimethyltryptamine, or a pharmaceutically acceptable salt thereof.
12. The solid dosage form of claim 1 , consisting essentially of two or more compounds selected from N,N-dimethyltryptamine, α-protio, α-deutero-N,N-dimethyltryptamine, and α,α-dideutero-N,N-dimethyltryptamine as biologically active agents, the solid dosage form optionally being in the form of a pharmaceutically acceptable salt, wherein the mean molecular weight of N,N-dimethyltryptamine, α-protio, α-deutero-N,N-dimethyltryptamine and α,α-dideutero-N,N-dimethyltryptamine present in the solid dosage form is less than or equal to 190.28 grams per mole.
13. The solid dosage form of claim 1 , comprising an N,N-dimethyltryptamine compound in the form of a pharmaceutically acceptable salt, wherein the pharmaceutically acceptable salt is a fumarate salt.
14. The solid dosage form of claim 1 , comprising an N,N-dimethyltryptamine compound in the form of a freebase.
15. A method of treating a psychiatric disorder or a neurological disorder, comprising:
administering to a patient in need thereof, the solid dosage form of claim 1 .
16. The method of claim 15 , wherein the psychiatric or neurological disorder is selected from the group consisting of (i) an obsessive compulsive disorder, (ii) a depressive disorder, (iii) a schizophrenia disorder, (iv) a schizotypal disorder, (v) an anxiety disorder, (vi) substance abuse, (vii) an avolition disorder, and (viii) a brain injury disorder.
17. The method of claim 15 , wherein the psychiatric or neurological disorder is major depressive disorder.
18. The method of claim 15 , wherein the psychiatric or neurological disorder is treatment resistant depression.
19. A method of treating a psychiatric disorder or a neurological disorder, comprising:
administering to a patient in need thereof, the solid dosage form of claim 10 .
20. A method of treating a psychiatric disorder or a neurological disorder, comprising:
administering to a patient in need thereof, the solid dosage form of claim 13 .
21. The solid dosage form of claim 1 , consisting essentially of two or more compounds selected from N,N-dimethyltryptamine and its deuterated analogues and pharmaceutically acceptable salts thereof as biologically active agents.