Rapidly dissolving extrudates prepared by a warm extrusion process

In this study, the suitability as rapid release dosage forms for ibuprofen of cylindrically shaped extrudates based on Gelucire 50/13 and Polyethylene glycol 4000 was investigated. Several drug to carrier weight ratios were processed in a small-scale ram extruder at a temperature much lower than the melting point of the binders. Cylindrical extrudates, regular in shape and with a smooth surface were obtained. In the Gelucire 50/13/ibuprofen extrudates, only a slight reduction of drug crystallinity compared to the relative physical blends was found, which in any case, did not affect the stability of the systems. While in the Gelucire case the ibuprofen dissolution was improved even by a little percentage of carrier in the formulation, with Polyethylene glycol 4000 the introduction of additional hydrophilic excipients was found to be necessary to achieve a dissolution rate and extent of dissolution of the drug comparable to those of Gelucire/ibuprofen systems.