N,N-dimethyltryptamine compositions and methods
A composition including N,N-dimethyltryptamine (DMT) or a pharmaceutically acceptable salt thereof capable of exhibiting a therapeutically effective blood level of DMT from between about 20 and about 60 minutes when administered to a human. A method of treating a neurological disease or condition comprising administering buccally, sublingually, subcutaneously or intranasally to a subject in need thereof an effective amount of DMT or a pharmaceutically acceptable salt thereof, capable of exhibiting a therapeutically effective level of DMT from for between about 20 to about 60 minutes when administered to a human.
1. A composition comprising (i) an amorphous N,N-dimethyltryptamine (DMT) free base dispersed within a mucoadhesive polymer, wherein said film is capable of releasing DMT so as to maintain a therapeutically effective blood level of DMT for between about 20 and about 60 minutes when administered to a human.
2. The buccal film according to claim 1 , exhibiting a therapeutically effective level of DMT for between about 20 and about 45 minutes.
3. The buccal film according to claim 1 , exhibiting a therapeutically effective level of DMT for between about 30 and about 45 minutes.
4. The buccal film according to claim 1 , exhibiting a therapeutically effective level of DMT for about 45 minutes.
5. The buccal film according to claim 1 , having a Tmax less than or equal to 60 minutes.
6. The buccal film according to claim 1 , having a Tmax between 5 and 60 minutes.
7. The buccal film according to claim 1 , having a Tmax between 8 and 24 minutes.
8. The buccal film according to claim 1 , having a Tmax between 10 and 20 minutes.
9. The buccal film according to claim 5 , wherein, after Tmax is achieved, the concentration of DMT is maintained at about 50% or more of Cmax for between about 5 minutes to about 60 minutes.
10. The buccal film according to claim 5 , wherein, after Tmax is achieved, the concentration of DMT is maintained at about 80% or more of Cmax for between about 5 minutes to about 45 minutes.
11. The buccal film according to claim 10 , wherein the concentration of DMT is maintained at about 80% or more of Cmax for between about 10 minutes to about 30 minutes.
12. The buccal film according to claim 2 , wherein the concentration of DMT is reduced to about 10% or less of Cmax within about 20 minutes or less.
13. The buccal film according to claim 1 , capable of maintaining blood levels of DMT at a concentration of at least about 250 nmol/L for at least about 20 minutes.
14. The buccal film according to claim 1 , capable of maintaining blood levels of DMT at a concentration of at least about 250 nmol/L for between about 20 minutes to about 45 minutes.
15. The buccal film according to claim 1 , capable of releasing 100% of the DMT from the composition within about 20 minutes following administration to a subject.
16. The buccal film according to claim 1 , capable of releasing 100% of the from the composition within about 20 minutes to about 30 minutes following administration to a subject.
17. The buccal film according to claim 1 , comprising from about 0.1 mg/kg to about 1 mg/kg of DMT.
18. A method of treating a neurological disease or condition comprising administering to a subject in need thereof a buccal film comprising an effective amount of a N,N-dimethyltryptamine (DMT) free base dispersed within a mucoadhesive polymer, wherein said film is capable of releasing DMT so as to maintain a therapeutically effective blood level of DMT from for between about 20 to about 60 minutes when administered to a human.
19. The method of treatment according to claim 18 , wherein the neurological disease or condition is a neuropsychiatric disorder, premenstrual dysphoric disorder, or seasonal affective disorder, anxiety, anxiety disorder, social anxiety disorder, general anxiety disorder (GAD), avolition disorder, bipolar disorder, post-traumatic stress disorder, body dysmorphic disorder, abnormalities of mood or emotion, dysthymia, schizoaffective disorder, schizophrenia a, panic disorder, traumatic stress disorders, phobic disorders, and personality disorders with abnormal mood, addiction, addictive behavior, eating disorder, or pain.
20. The buccal film according to claim 1 , capable of maintaining blood levels of DMT at a concentration of at least about 250 nmol/L for between about 20 minutes to about 60 minutes.
21. The buccal film according to claim 1 , wherein said polymer film comprises a mucoadhesive polymer.
22. The buccal film according to claim 21 , wherein said mucoadhesive polymer comprises cellulose derivatives, polyacrylic acids, polyacrylates, polyethylene oxides, polyvinyl pyrrolidones, polyvinyl alcohols, tragacanth, alginates, gums, soluble starch, gelatin, lectin, pectin, or chitosan.
23. The buccal film according to claim 21 , wherein said mucoadhesive polymer comprises a hydrophilic polymer, a polysaccharide, a polysaccharide derivative, or a hydrogel.
24. The buccal film according to claim 21 , wherein said mucoadhesive polymer comprises polyacrylic acids, polyacrylates, celluloses, hydroxyalkyl celluloses, polyvinylpyrrolidones, or polyvinyl alcohols.
25. The buccal film according to claim 21 , wherein said mucoadhesive polymer comprises Copovidone, hydroxypropyl cellulose, and hydroxypropylmethyl cellulose.
26. The buccal film according to claim 21 , wherein said film comprises between about 15% to about 60% of said mucoadhesive polymer.
27. The buccal film according to claim 25 , further comprising citric acid.