IP Library › Patent Application 17537663
Patent Application
App. No. 17/537,663

ANALOGS OF DEUTETRABENAZINE, THEIR PREPARATION AND USE

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Patent No.
US None
App. No.
17/537,663
Abstract

The disclosure is directed to deutetrabenazine analogs, compositions comprising same and methods of detecting same in compositions comprising deutetrabenazine.

Claims (20)

1 . Deutetrabenazine drug substance comprising Compound 2 in an amount that is about 0.15 area-% or less of Compound 2, relative to the concentration of the deutetrabenazine, based on a determination by an HPLC method comprising a C18, 150×4.6 mm, 3.5 m column and a photodiode array/ultraviolet detector at 220 nm.

2 . The deutetrabenazine drug substance of claim 1 , comprising about 0.05 area-% to about 0.15 area-% of Compound 2, relative to the concentration of the deutetrabenazine.

3 . The deutetrabenazine drug substance of claim 1 , comprising about 0.05 area-% to about 0.1 area-% of Compound 2, relative to the concentration of the deutetrabenazine.

4 . The deutetrabenazine drug substance of claim 1 , comprising about 0.15 area-% of Compound 2, relative to the concentration of the deutetrabenazine.

5 . The deutetrabenazine drug substance of claim 1 , comprising about 0.1 area-% of Compound 2, relative to the concentration of the deutetrabenazine.

6 . The deutetrabenazine drug substance of claim 1 , comprising about 0.05 area-% of Compound 2, relative to the concentration of the deutetrabenazine.

7 . The deutetrabenazine drug substance claim 1 , wherein the deutetrabenazine has a deuterium enrichment of no less than about 50%.

8 . The deutetrabenazine drug substance of claim 1 , wherein the deutetrabenazine has a deuterium enrichment of no less than about 90%.

9 . The deutetrabenazine drug substance of claim 1 , wherein the deutetrabenazine has a deuterium enrichment of no less than about 95%.

10 . The deutetrabenazine drug substance of claim 1 , wherein the deutetrabenazine has a deuterium enrichment of no less than about 98%.

11 . The deutetrabenazine drug substance of claim 1 , wherein the Compound 2 has a deuterium enrichment of no less than about 50%.

12 . The deutetrabenazine drug substance of claim 1 , wherein the Compound 2 has a deuterium enrichment of no less than about 90%.

13 . The deutetrabenazine drug substance of claim 1 , wherein the Compound 2 has a deuterium enrichment of no less than about 95%.

14 . The deutetrabenazine drug substance of claim 1 , wherein the Compound 2 has a deuterium enrichment of no less than about 98%.

15 . A method of producing a deutetrabenazine drug product comprising:

a. obtaining the deutetrabenazine drug substance of claim 1 ;

b. admixing the deutetrabenazine drug substance with one or more suitable excipient.

16 . A process for determining the amount of Compound 2 in the deutetrabenazine drug substance of claim 1 comprising:

a. obtaining the deutetrabenazine drug substance;

b. determining the amount of the Compound 2 in the deutetrabenazine drug substance, based on a determination by the HPLC method.