Twin-Screw Extruders Prepare High Drugload Nanosized Dispersible Amorphous Solid Dispersions

Nanosized amorphous drug delivery systems are increasingly viewed as crucial building blocks for efficacious treatments of disease conditions. However, production methods at commercially practical scales pose a significant challenge for successfully translating such technology. This talk describes a novel, anhydrous, twin-screw extrusion (TSE) platform-based technology to overcome the issues associated with developing and scaling up the production of the nanosized amorphous drug delivery systems. With polyol as the process medium, the proposed TSE platform enables the encapsulation of the drug and reduction of particle size in a single-step process, eliminating the need for organic solvents or water.

Remarkably, these resulted in nanoparticles with sizes ranging from 80 to 240 nm, achieving up to 98% drug encapsulation efficiency, and a maximum production throughput of 400 g/hour. In addition to the enhanced solubility achieved via ASD, pH-responsive drug release was also realised through the choice of polymeric carriers in the formulations. We expect this platform technology to streamline the development and scale-up production of various nanosized amorphous drug delivery systems.