Over recent decades, HME techniques have appeared as an innovative manufacturing platform for various pharmaceutical applications. HME has been successfully applied to develop multiple drug delivery systems for various applications (e.g., solubility enhancement, sustained release, taste masking, implants and films and/or strips) since the early 1970s 1, 2, 3, 4, 5. HME-based applications for pharmaceutical manufacturing date back to 1930s where HME was started mainly for its commercial exploitation in the plastics 6, 7 and food industry 8, 9. HME has emerged as a complementary pharmaceutical manufacturing technology to develop solid dispersions of challenging drug candidates to enhance their physicochemical properties [1]. In addition, it offers a solvent-free process with fewer production steps compared with conventional methods (e.g., spray drying or freeze drying) and is easy to scale-up 10, 11, 12, 13, 14. The single-unit mechanochemical approach of HME has displayed the potential to enhance the stability of thermosensitive or thermally unstable therapeutics, such as amino acids or proteins. HME also offers easy instrumentation, models, and formulae for commercial-scale manufacturing. HME can successfully be utiliszed as an effective means to manufacture, optimize, and deliver various novel macromolecules and biologics. Its use has been greatly encouraged by a quality-by-design (QbD) viewpoint steered by the US Food and Drug Administrations (FDA). In this review, we primarily focus on the foregoing subject areas.

• Tabriz University of Medical Sciences
• University of Sussex

• Regulatory
• Solid Dose

1. continuous manufacturing
2. HME
3. novel drug delivery systems
4. regulatory
5. Research Article
6. Scale-up
7. Solid Dose