Formulation and Quality – Chemical
2019 PharmSci 360
Hot melt extrusion (HME) is an established technology for the creation of amorphous solid dispersions aiming to enhance the bioavailability of low soluble drug substances. The identification of suitable polymers needs to be addressed at early stages to assure a successful formulation development. Several screening technologies are available; the most prominent is the solvent film casting where polymers and targeted drug substance are dissolved in a suitable solvent which is then removed. This non-thermal procedure considerably deviates from the later HME process and can lead to non-ideal polymer selections highlighting the need for alternative screening methods which more closely resemble the HME process and are easy to use.
Different thermal screening technologies were evaluated regarding their ability to predict performance and stability of targeted hot melt extruded formulations: Two methods, one based on differential scanning calorimetry (DSC) and a novel vacuum compression molding (VCM) technology are identified as suitable alternatives.