Analogs of deutetrabenazine, their preparation and use
The disclosure is directed to deutetrabenazine analogs, compositions comprising same and methods of detecting same in compositions comprising deutetrabenazine.
1. A process for preparing a deutetrabenazine drug product in the form of a tablet, that has no more than 0.4 area-% of Compound 2 relative to the concentration of deutetrabenazine in the drug product after storage at room temperature for one month, comprising:
obtaining a deutetrabenazine drug substance comprising Compound 2 in an amount that is not more than 0.15 area-%, relative to the concentration of the deutetrabenazine in the deutetrabenazine drug substance;
wherein the amount of Compound 2 is determined by an HPLC method comprising a C18, 150×4.6 mm, 3.5 μm column and a photodiode array/ultraviolet detector at 220 nm; and
admixing the deutetrabenazine drug substance with an excipient to produce the deutetrabenazine drug product in the form of a tablet;
wherein the deutetrabenazine drug product has no more than 0.4 area-% of Compound 2, relative to the concentration of deutetrabenazine in the drug product, based on a determination by the HPLC method, after the storage at room temperature for one month.
2. A deutetrabenazine drug product in the form of a tablet produced according to the process of claim 1 .
3. The process of claim 1 , wherein the amount of Compound 2 in the deutetrabenazine drug substance is about 0.05 area-% to about 0.15 area-%, relative to the concentration of deutetrabenazine in the drug substance, based on a determination by the HPLC method.
4. The process of claim 1 , wherein the amount of Compound 2 in the deutetrabenazine drug substance is about 0.05 area-% to about 0.1 area-%, relative to the concentration of deutetrabenazine in the drug substance, based on a determination by the HPLC method.
5. The process of claim 1 , wherein the amount of Compound 2 in the deutetrabenazine drug product is 0.007 area-%, to 0.4 area-%, relative to the concentration of deutetrabenazine in the drug product, based on a determination by the HPLC method, after the storage at room temperature for one month.
6. The process of claim 1 , wherein the amount of Compound 2 in the deutetrabenazine drug product is 0.03 area-% to 0.4 area-%, relative to the concentration of deutetrabenazine in the drug product, based on a determination by the HPLC method, after the storage at room temperature for one month.
7. The process of claim 1 , wherein the amount of Compound 2 in the deutetrabenazine drug product is 0.1 area-% to 0.4 area-%, relative to the concentration of deutetrabenazine in the drug product, based on a determination by the HPLC method, after the storage at room temperature for one month.