Claims for Patent: 11,179,386

Summary for Patent: 11,179,386

Title:	Analogs of deutetrabenazine, their preparation and use
Abstract:	The disclosure is directed to deutetrabenazine analogs, compositions comprising same and methods of detecting same in compositions comprising deutetrabenazine.
Inventor(s):	Zhang; Chengzhi (San Diego, CA), Kerr; James (North Wales, PA)
Assignee:	AUSPEX PHARMACEUTICALS, INC. (Parsippany, NJ)
Application Number:	16/582,362
Patent Claims:	1. A pharmaceutical composition in the form of a tablet comprising an admixture of a deutetrabenazine drug substance and a pharmaceutically acceptable carrier, wherein the deutetrabenazine drug substance comprises 5 mg to 30 mg of deutetrabenazine; and Compound 2 in an amount that is not more than 0.15 area %, relative to the concentration of the deutetrabenazine in the tablet, based on a determination by an HPLC method comprising a C18, 150.times.4.6 mm, 3.5 .mu.m column and a photodiode array/ultraviolet detector at 220 nm ##STR00026## 2. The pharmaceutical composition of claim 1, wherein the concentration of the Compound 2 does not increase to more than 0.4 area-% relative to the concentration of the deutetrabenazine in the tablet, based on a determination by the HPLC method, after storage of the tablet at room temperature for twenty-four months. 3. The pharmaceutical composition of claim 1, wherein the concentration of the Compound 2 is 0.3 area-% or less, relative to the concentration of the deutetrabenazine in the tablet, based on a determination by the HPLC method, after storage of the tablet at room temperature for one month. 4. The pharmaceutical composition of claim 1, comprising 0.25 area-% or less of the Compound 2, relative to the concentration of the deutetrabenazine in the tablet, based on a determination by the HPLC method, after storage of the tablet at room temperature for one month. 5. The pharmaceutical composition of claim 1, wherein the concentration of the Compound 2 is 0.2 area-% or less, relative to the concentration of the deutetrabenazine in the tablet, based on a determination by the HPLC method, after storage of the tablet at room temperature for one month. 6. The pharmaceutical composition of claim 1, comprising 6-24 mg deutetrabenazine. 7. The pharmaceutical composition of claim 1, prepared for once daily administration. 8. The pharmaceutical composition of claim 1, prepared for more than once daily administration. 9. A method of treating a subject afflicted with a hyperkinetic movement disorder comprising administering to the subject the pharmaceutical composition of claim 1. 10. The method of claim 9, wherein the hyperkinetic movement disorder is Huntington's disease. 11. The method of claim 9, wherein the hyperkinetic movement disorder is chorea related to Huntington's disease. 12. The method of claim 9, wherein the hyperkinetic movement disorder is tardive dyskinesia. 13. The method of claim 9, wherein the hyperkinetic movement disorder is a tic associated with Tourette syndrome. 14. The pharmaceutical composition of claim 1, comprising 6 mg of deutetrabenazine. 15. The pharmaceutical composition of claim 1, comprising 9 mg of deutetrabenazine. 16. The pharmaceutical composition of claim 1, comprising 12 mg of deutetrabenazine. 17. The pharmaceutical composition of claim 1, comprising 24 mg of deutetrabenazine. 18. The pharmaceutical composition of claim 1, wherein the concentration of the Compound 2 does not increase to more than 0.4 area-% relative to the concentration of the deutetrabenazine in the tablet, based on a determination by the HPLC method, after storage of the tablet at room temperature for two months. 19. The pharmaceutical composition of claim 1, wherein the concentration of the Compound 2 does not increase to more than 0.4 area-% relative to the concentration of the deutetrabenazine, based on a determination by the HPLC method, after storage at room temperature for three months. 20. The pharmaceutical composition of claim 1, wherein the concentration of the Compound 2 does not increase to more than 0.4 area-% relative to the concentration of the deutetrabenazine, based on a determination by the HPLC method, after storage at room temperature for six months. 21. The pharmaceutical composition of claim 1, wherein the concentration of the Compound 2 is 0.4 area-% or less, relative to the concentration of the deutetrabenazine, based on a determination by the HPLC method, after storage at room temperature for one month. 22. The pharmaceutical composition of claim 1, comprising 18 mg of deutetrabenazine.