Published Paper Details:

Extrusion technology is well known that has been developed over the last century and spans many diverse industrial fields. The main application of extrusion technology in the pharma field is of hot-melt extrusion. Hot-melt extrusion technique is utilized by much pharmaceutical industry for manufacturing various dosage forms. Many formulations developed using HME are introduced in the market. The twin-screw extrusion technology is used widely in hot melt processing. Various processing factors in twin-screw extruders impacts product quality. During the development of the HME process, one must consider drug and excipient's thermal profiles, barrel temperature, screw speed, and feed rate. Scaling up the extruder process is a critical task that requires an understanding of screw geometry, volumetric dimensions of the screw, the power required, and heat transfer and generation. Nowadays, simulation software like Ludovic and Polyflow have developed, which can mimic the product movement and heat distribution in extruder and help in scaling the process. The regulatory authority is these days enforcing quality by design approach, which applied to HME. As it is continuous, process monitoring at each step is an important part, and therefore process analytical tool as part of QbD are developed. NIR, RAMAN, UV spectrometry methods generally used. Many novel formulations have been developed using extruders. Therefore the proper understanding of scale-up and process design will provide insights to solve various formulation problems