Manipulation of Naproxen Particle Morphology Via the Spherical Crystallization Technique to Achieve A Directly Compressible Raw Material

Abstract

Crystals of naproxen were modified by the spherical crystallization technique to improve the compression and flow characteristics of the drug substance. A naproxen:acetone solution was added to water, and the crystals were agglomerated with either hexanol, octanol, or toluene. The resulting agglomerates were compact spherical aggregates of plate shaped crystals, regardless of the agglomerating solvent used. The quantity of the agglomerating solvent and the temperature of the solvent system were critical process parameters, probably due to their effect on the drug solubilization. Crystal agglomeration sufficiently improved the intrinsic compressibility and flow characteristics of naproxen that the agglomerated material was directly compressible.