Patent ID: 7714158
Filing Date: 2010-05-11
Classification: A61P,C07F

Abstract:
1. A process for the preparation of a crystalline ibandronate polymorph form A having an X-ray powder diffraction pattern having characteristic peaks expressed in angle 2-theta at approximately comprising dissolving a member selected from the group consisting of 3-(N-methyl-N-pentyl) amino-1-hydroxypropane-1,1-diphosphonic acid monosodium salt, 3-(N-methyl-N-pentyl) amino-1-hydroxypropane-1,1-diphosphonic acid monosodium salt monohydrate, a polymorph form B of 3-(N-methyl-N-pentyl) amino-1-hydroxypropane-1,1-diphosphonic acid monosodium salt, and a polymorph mixture of form A and form B of 3-(N-methyl-N-pentyl) amino-1-hydroxypropane-1,1-diphosphonic acid monosodium salt thereof, and a polymorph mixture thereof in a polar solvent to form a solution; and adding a polar aprotic solvent to induce crystallization while maintaining the solution between 50° C. to 70° C.