Abstract
The aim of current investigation was to evaluate the potential of two different grades of Lutrol (R) (Lutrol (R) F 68 and Lutrol (R) F 127) as polymeric surfactants for dissolution improvement of Kollidon (R) VA64-fenofibrate (FEN) matrices. Kollidon (R) VA64-FEN matrices with or without Lutrol (R) F grades were produced by Hot Melt Extrusion (HME) technology. Poorly water-soluble drug FEN, and two different grades of Lutrol (R) F (Lutrol (R) F 68 and Lutrol (R) F 127) were added into the HME systems to study their influence on the drug-incorporated matrices. FEN was mixed with Kollidon (R) VA64, with or without Lutrol (R) F grades (alone or in combination) at predetermined amounts which resulted in 8 different formulations. Differential scanning calorimetry (DSC) and powder X-ray diffraction (PXRD) analysis were performed to evaluate the physicochemical properties. DSC and PXRD studies indicated the formation of amorphous solid dispersion for extruded formulations of FEN. In vitro dissolution studies showed that the extrudates with Lutrol (R) F grades exhibited faster and higher release compared to formulations without Lutrol (R) F grades. Micrometrics studies revealed that when extruded at the same extrusion temperature, formulations with FEN and that contain Lutrol (R) F grades have smaller specific surface areas than formulations with no Lutrol (R) F grades. Fourier transforms infra-red (FTIR) studies indicated that FEN did not appear to interact with the polymer matrices. These studies suggested the potential of Lutrol (R) F grades in improving dissolution profile of FEN using HME technology.