Method for modification and habit recrystallization of drug substance, mycophenolate sodium crystals, the use thereof and pharmaceutical composition

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 .