STUDY OF KETOPROFEN'S DISSOLUTION IN POLYETHYLENE OXIDE FORMULATIONS PREPARED BY HOT MELT EXTRUSION

摘要

Solubility parameters have been used as an approach to predict active pharmaceutical ingredients solubility in a polymeric excipient. The solubility is important because it dictates the processing window for hot melt extrusion and the stability of the formulation during storage. Nevertheless, it is challenging and complicated to predict the solubility and there is very few published studies in the field. In this study Film Casting Technique, Differential Scanning Calorimetry, Thermal Gravimetric Analysis, and Hot Melt Extrusion process were used to study and analyze the solubility of ketoprofen in polyethylene oxide (PolyoxTM N10). The outcomes from the different method and techniques implemented were consistent and the best results were obtained with the maximum concentration of ketoprofen. The suggested processing temperature was 70°C and 70 rpm for the rotor rotation speed. The stability of the samples were monitored by two months. The methodology used in this study can be applied to analyze and investigate other drug-polymer pairs.