Salts of sitagliptin, process for the preparation and pharmaceutical composition therefore
View Patent ↗The present invention relates to pharmaceutically acceptable acid addition salts of sitagliptin, in particular anti-oxidant acid addition salts of sitagliptin and a process for its preparation. The present invention also provides a pharmaceutical composition using the pharmaceutically acceptable acid addition salts of sitagliptin.
1. An anti-oxidant acid salt of sitagliptin, or solvates or hydrates thereof, wherein the anti-oxidant acid is selected from the group consisting of caffeic acid, ferulic acid, and p-coumaric acid, and wherein
the caffeic acid salt of sitagliptin is characterized by a X-ray diffraction (XRD) pattern in accordance with FIG. 1 , FIG. 2 , FIG. 3 , FIG. 4 , FIG. 5 , FIG. 6 , or FIG. 7 ,
the ferulic acid salt of sitagliptin is characterized by a XRD pattern in accordance with FIG. 8 , FIG. 9 , FIG. 10 , FIG. 11 , FIG. 12 , or FIG. 13 , and
the p-coumaric acid salt of sitagliptin is characterized by a XRD pattern in accordance with FIG. 14 , FIG. 15 , FIG. 16 , FIG. 17 , FIG. 18 , FIG. 19 , or FIG. 20 .
2. A composition comprising sitagliptin caffeate, sitagliptin ferulate, sitagliptin coumarate, or solvates or hydrates thereof, and at least one pharmaceutically acceptable carrier or excipient, wherein
the sitagliptin caffeate is characterized by a X-ray diffraction (XRD) pattern in accordance with FIG. 1 , FIG. 2 , FIG. 3 , FIG. 4 , FIG. 5 , FIG. 6 , or FIG. 7 ,
the sitagliptin ferulate is characterized by a XRD pattern in accordance with FIG. 8 , FIG. 9 , FIG. 10 , FIG. 11 , FIG. 12 , or FIG. 13 , and
the sitagliptin coumarate is characterized by a XRD pattern in accordance with FIG. 14 , FIG. 15 , FIG. 16 , FIG. 17 , FIG. 18 , FIG. 19 , or FIG. 20 .