Crystalline form of the zoledronic acid, a process to obtain it and the pharmaceutical composition comprising it

摘要

A new crystalline form of the Zoledronic acid, characterized by its X-rays diffractogram as well as by its spatial atomic distribution in the red crystalline and its curves of thermal analysis. There is also included a method to obtain this crystalline form, which includes the synthesis of the corresponding acid and the pharmaceutical composition this crystalline form comprises.

主权项

1. A crystalline trihydrate of zoledronic acid characterized by:
an X- ray powder diffraction pattern with peaks in angles of 2θ at the following values: 9.2; 10.4; 10.8; 14.7; 16.4; 17.1; 18.4; 21.5; 21.8; 22.8; 25.0; 25.4; 27.8° ±0.2°, with the three major peak intensities in the following order of diminishing intensity: 16.4, 22.8, 27.8, a thermogravimetric analysis in which a loss of mass is seen, corresponding to a loss of water, of 16-17%; a Differential Scanning calorimetry curve showing an endotherm at 211-215° C., which corresponds to the melting process; and an Infrared Spectrum (KBr) Absorption with characteristic peaks at 3578-3011; 1643.6; 1579.9; 1549.1; 1443.0; 1414.0; 1387.0; 1294.4; 1155.5; 966.5 cm−1.