ReviewKeynoteContinuous manufacturing via hot-melt extrusion and scale up: regulatory matters

•HME can be exploited in a broad range of applications for advanced drug delivery.•Unique advantages to be utilized in a solvent free manufacturing platform.•A means to explore the potential of continuous manufacture of pharmaceuticals.•Scale-up issue considerations, from an FDA compliance point of view.•HME regulatory guidelines for the manufacture of novel drug delivery systems.

Currently, because globalization, the pharmaceutical industry is facing enormous challenges to comply with regulatory matters. Reduced patent life and overall decreased profitability of newly discovered drugs are also forcing the pharmaceutical industry to shorten the drug development time with maximum throughput. Therefore, continuous manufacturing (CM) processes via hot melt extrusion (HME) can be a promising alternative for achieving these goals. HME offers solvent-free green technology with a process that is easy to scale up. Moreover, CM provides better product quality assurance compared with batch processes, with fewer labor costs and shorter time to development. In this review, we primarily focus on various aspects of CM and the emerging application of HME to bridge the current manufacturing gap in pharmaceutical sphere.