Application US20220062237

INJECTABLE FORMULATION
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US20220062237

1. An injectable pharmaceutical formulation, comprising: (9) (4)

a salt of a dimethyltryptamine compound, wherein the dimethyltryptamine compound is optionally substituted with one or more of deuterium, acetoxy, methoxy, or monohydrogen phosphate;

a buffer which is other than the salt; and

water,

wherein the formulation has a pH of about 3.5 to about 6.5 and an osmolality of about 250 to about 350 mOsm/Kg.

2. The formulation of claim 1, wherein the dimethyltryptamine compound is unsubstituted dimethyltryptamine. (0)

3. The formulation of claim 1, wherein the dimethyltryptamine compound is substituted with deuterium. (0)

4. The formulation of claim 1, wherein the dimethyltryptamine compound is substituted at position 4 or 5 with acetoxy or methoxy. (0)

5. The formulation of claim 1, wherein the dimethyltryptamine compound is substituted at position 4 with monohydrogen phosphate. (0)

6. The formulation of claim 1, wherein the salt comprises a Brønsted acid having a pKa of from about 3 to about 5, and a compound of Formula I: (4) (3)

R⁴and R⁵are both H and each ^xH and each ^YH is independently selected from H and D, or

one of R⁴and R⁵is H and the other is acetoxy or methoxy, each ^YH is H and each ^xH is independently selected from H and D, or

the salt comprises a compound of Formula I wherein R⁴is monohydrogen phosphate, R⁵is H and each ^YH and each ^xH is H.

7. The formulation of claim 6, wherein R⁴and R⁵are both H. (0)

8. The formulation of claim 6, wherein R⁴is acetoxy and R⁵is H. (0)

9. The formulation of claim 6, wherein R⁴is H and R⁵is methoxy. (0)

17. A kit, comprising: (0) (2)

10. The formulation of claim 1, wherein the salt formed by an acid selected from the group consisting of fumaric acid, tartaric acid, citric acid, acetic acid, lactic acid, and gluconic acid. (0)

11. The formulation of claim 1, wherein the concentration of the optionally substituted dimethyltryptamine is about 2.5 mg/mL. (1) (0)

12. The formulation of claim 1, wherein the buffer comprises an acetate salt and acetic acid, sodium acetate and acetic acid, or potassium acetate and acetic acid. (1) (0)

16. The formulation of claim 1, wherein the formulation has an oxygen content of less than 2 ppm. (0)

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Application US20220062237

INJECTABLE FORMULATION

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