Recently, hot-melt extrusion (HME) techniques have been presented as innovative platforms to produce various pharmaceuticals. HME is an emerging processing technology used primarily for the manufacture of pharmaceutical solid dispersions. It also combines the advantages of a solvent-free process with fewer production steps; HME is both simple to scale up and offers continuous manufacturing applications. A single-unit, HME-based operation, employing heat and mechanical shear, has displayed a significant potential to retain the stability of thermo-labile therapeutics, e.g., proteins. Although HME is as an effective means to manufacture, optimize, and deliver various novel macromolecules and biologics, it has recently been established from a quality by design (QbD) viewpoint as per the recent guidelines issued by the Food and Drug Administration (FDA). Moreover, HME can be coupled with modern manufacturing techniques such as 3D printing to deliver immediate potential for unit dose fabrications. As the guest editor of this special issue of Pharmaceutics, it is an honor and privilege to introduce this issue on “Pharmaceutical Applications of Hot-Melt Extrusion”. This theme issue contains 10 original research and 3 critical review papers focusing on various recent and emerging applications of HME techniques, which, I believe, will be of significant interest to readers across both industry and academia.

• University of Sussex
• University of Texas at Austin

• PAT
• Oral solid dose

1. 3D printing
2. continuous manufacturing
3. hot-melt extrusion
4. Opinion
5. oral solid dose
6. pat
7. Twin-screw granulation