TRIAZINE COMPOUND SALT, CRYSTAL FORM THEREOF, AND PRODUCTION METHOD THEREFOR
The present invention provides a salt of a triazine compound which has an inhibitory action against aldosterone synthase and is useful as a drug, and especially as a drug for preventing or treating primary aldosteronism and the like, a crystal thereof, and a method for producing the same. Specifically, the present invention provides a pharmaceutically acceptable salt of 3-[4-[[trans-4-(acetamino)cyclohexyl]carbamoylmethyl]piperazin-1-yl]-5-(p-tolyl)-1,2,4-triazine, wherein the salt is hydrobromide, sulfate, succinate, or tosilate, and the like.
1 . A method for preventing or treating a disease of which a pathological condition is expected to be improved by the inhibition of aldosterone synthase in a patient comprising administering to the patient an amount of a crystal of a hydrobromide, sulfate, succinate, or tosilate salt of 3-[4-[[trans-4-(acetamino)cyclohexyl]carbamoylmethyl]piperazin-1-yl]-5-(p-tolyl)-1,2,4-triazine effective to prevent or treat the disease in the patient.
2 . The method of claim 1 , comprising administering to the patient an effective amount of the crystal of the hydrobromide salt of 3-[4-[[trans-4-(acetamino)cyclohexyl]carbamoylmethyl]piperazin-1-yl]-5-(p-tolyl)-1,2,4-triazine.
3 . The method of claim 2 , wherein the crystal is characterized as having peaks at 8.8°±0.2°, 18.1°±0.2°, 20.9°±0.2°, and 25.6°±0.2° as diffraction angles expressed in 2θ in a powder X-ray diffraction spectrum.
4 . The method of claim 2 , wherein the crystal is characterized as having an endothermic peak at 265 to 275° C. in a differential scanning calorimetry analysis.
5 . The method of claim 2 , wherein the method comprises administering a pharmaceutical composition comprising the crystal and a pharmaceutically acceptable additive.
6 . The method of claim 2 , wherein the crystal is administered to the patient at a dosage of 0.01 to 500 mg/day.
7 . The method of claim 6 , wherein the crystal is administered orally.
8 . The method of claim 7 , wherein the disease is hypertension.
9 . The method of claim 8 , wherein the patient is a human.
10 . The method of claim 3 , wherein the method comprises administering a pharmaceutical composition comprising the crystal and a pharmaceutically acceptable additive.
11 . The method of claim 10 , wherein the crystal is administered to the patient at a dosage of 0.01 to 500 mg/day.
12 . The method of claim 11 , wherein the crystal is administered orally.
13 . The method of claim 12 , wherein the disease is hypertension.
14 . The method of claim 13 , wherein the patient is a human.