Spherical agglomeration has the potential to improve the handling of unfavourably shaped crystals. A large number of process parameters must be adjusted to carry out spherical agglomeration, which is a challenging task, especially for complex organic molecules. The possibility of preparing spherical crystals in different solvent systems for two active pharmaceutical ingredients is examined.

Abstract

The possibility of spherical agglomeration was investigated for two active pharmaceutical ingredients from different classes of the Biopharmaceutics Classification System. The effects of different batch crystallization solvent systems on the granulometric properties and structures of dronedarone hydrochloride and ceritinib were investigated. Light and stereomicroscopy were used to determine the size and shape of the agglomerates, while X-ray powder diffraction was applied to assess the changes in polymorphic form. Since the change in the solvent system had no effect on the crystal structure but did alter the size and shape of the crystals, dissolution experiments were carried out to determine drug release profiles.