Ibandronate sodium polymorphs

摘要

A crystalline form of ibandronate sodium having an X-ray powder diffraction pattern with peaks at about 5.5, 10.9, 19.3, 23.1, and 33.2, ±0.2 degrees two theta; and a process for preparing said crystalline form of ibandronate sodium is disclosed, wherein the process comprises the steps of: (a) providing a solution of ibandronate sodium in formic acid, optionally in a mixture with methyl tertiary-butyl ether;(b) heating the solution to temperatures of 45 Deg. C to about 65 Deg. C;(c) adding methyl tertiary-butyl ether;(d) separating a solid; and (e) converting the solid of step (d) into the crystalline form of ibandronate sodium.