Patent Number: 7,824,710

Title: Crystalline and stable form of andolast

Abstract: Described is a new crystalline Form A of Andolast disodium salt, triclinic, displaying a thermal event at 98-112.degree. C. and melting with decomposition at about 400.degree. C. (DSC). Andolast disodium Form A is a not hygroscopic solid, surprisingly stable to several humidity conditions in a temperature range acceptable for ordinary storage conditions. In addition its stability allows both chemical manufacturing and pharmaceutical manufacturing process consistency and reproducibility under conditions more viable and less expensive when compared to those used for highly hygroscopic solids.

Inventors: Giordani; Antonio (Pavia, IT), Santoro; Antonino (Monza, IT), Senin; Paolo (Monza, IT), Ghirri; Matteo (Milan, IT), Makovec; Francesco (Lesmo, IT), Gilotta; Paola (Monza, IT), Peris; Walter (Milan, IT), Rovati; Lucio Claudio (Monza, IT)

Assignee: Rottapharm S.p.A.

International Classification: A61K 9/14 (20060101); A61K 31/41 (20060101); C07D 207/00 (20060101)

Expiration Date: 2019-11-02 0:00:00