IN-PROCESS MONITORING OF DRUG LOADING DURING TWIN SCREW EXTRUSION OF PHARMACEUTICAL POLYMER COMPOUNDS

摘要

Near infrared spectroscopy has been used to characterize a solid dispersion of the poorly soluble antidiabetic drug glipizide in a polyethylene oxide (PEO) matrix during twin screw extrusion. A range of drug loadings and extrusion temperatures were examined. Differential scanning calorimetry (DSC) and powder X-ray diffraction (PXRD) showed that the drug was in an amorphous state within the extruded compound, indicating the suitability of PEO as a carrier for glipizide at these conditions. All compounds exhibited a significantly improved rate and extent of drug dissolution compared to the pure drug and physical mixtures. NIR spectroscopy was found to provide a clear indication of drug loadings, highlighting the potential to incorporate the technique into a real-time quality control system.