PROCESS FOR MODIFYING DRUG CRYSTAL FORMATION OF MYCOPHENOLATE SODIUM SALT

摘要

Process for modifying the crystal habit of an acicular drug crystal wherein the acicular drug substance is a mycophenolate sodium salt, comprising suspending said crystalline drug substance in a methanol/water solvent and subjecting said suspension to a temperature oscillation, wherein the crystal habit is modified in that the mean aspect ratio of the processed crystals is smaller than 10:1 and the bulk density is above 200 kg/m 3 .