Interactions during aqueous film coating of ibuprofen with aquacoat ECD.

During the development of a coated ibuprofen formulation a sticking tendency occurred when applying Aquacoat ECD. This interaction indicated the formation of a eutectic mixture. The compatibility of the components of Aquacoat ECD with ibuprofen was investigated by differential scanning calorimetry. Cetyl alcohol, a stabilizing excipient in Aquacoat, was found to form a eutectic system with ibuprofen. It was characterized by the construction of a phase diagram with 33 mol% ibuprofen and an onset temperature of 40.5 degrees C. Wide-angle X-ray diffraction was used to identify the polymorphic forms of cetyl alcohol. The results confirmed the amorphous state in the aqueous dispersion in contrast to the beta(0)- and gamma(4)-polymorphs of solid cetyl alcohol.