IBANDRONATE SODIUM SOLID DISPERSION

摘要

The present invention provides a novel substantially amorphous solid dispersion of ibandronate sodium in combination with a pharmaceutically acceptable carrier, process for its preparation and pharmaceutical compositions comprising it. In a preferred embodiment the process for the preparation of amorphous solid dispersion of ibandronate sodium in combination with a pharmaceutically acceptable carrier comprises: preparing a solution comprising a mixture of ibandronate sodium and one or more pharmaceutically acceptable carriers selected from copovidone, ethyl cellulose, hydroxypropyl methylcellulose, polyethylene glycol, span 20 or soluplus in a solvent, water or mixture thereof; and removing the solvent or water to obtain substantially amorphous solid dispersion of ibandronate sodium in combination with a pharmaceutically acceptable carrier.