Crystalline and stable form of andolast

Details Crystalline and stable form of andolast Crystalline and stable form of andolast

2007-02-23

2010-11-02

Chung, Susannah (Department: 1626)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Particulate form

C514S381000, C548S250000

Reexamination Certificate

active

07824710

ABSTRACT:
Described is a new crystalline Form A of Andolast disodium salt, triclinic, displaying a thermal event at 98-112° C. and melting with decomposition at about 400° 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.

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