Compritol 888 ATO Lipid Matrices for Sustained Release Processed by Hot-Melt Extrusion

In the current study we explored the efficiency of Compritol® 888 ATO, a lipid excipient, for the manufacture of Na-Diclofenac (DfNa)sustained release matrices by using Hot Melt Extrusion (HME) processing. The extrudates were processed with a twin screw Eurolab 16 extruder and the obtained pellets were further milled to produce granules. Different HME processing approaches were used including “cold” extrusion where drug/lipid binary blends at different ratios were processed at temperatures below the lipid’s melting point. The blends were also extruded at temperatures above the lipids’ melting point and subsequently the extruded granules were incorporated in tablet formulations following direct compression at different compaction forces. In addition pre-blended tablet formulations were extruded to investigate the effect on the drug release patterns. Furthermore, the extrudates characterized by X-ray powder diffraction (XRPD), differential scanning calorimetry (DSC) and hot stage microscopy (HSM) in order to identify the state of the active substance within the lipid matrix.