Hot Melt Extrusion: A Viable Option for Implementing Continuous Manufacturing in the Pharmaceutical Industry

In recent years, hot melt extrusion (HME) has been most widely investigated for developing pharmaceutical medications. HME is a single-step manufacturing process and is suitable for the extrusion of drug-loaded filaments, films, or patches, and granules. The filaments can be processed as pellets or can be processed into tablets or capsules. The HME can be coupled with various downstream processing equipments and process analytical technology (PAT) tools for transforming into a continuous manufacturing line. Establishing a continuous manufacturing line will ensure product quality and will benefit both the industries and the patient population. In fact, the HME can also be paired with additive manufacturing platforms such as fused deposition modeling (FDM) for the fabrication of on-demand and patient-centric medications. Even complex medications can be easily manufactured using an additive manufacturing approach. Despite various advantages of HME, a few limitations, such as the availability of suitable materials and a more in-depth understanding of the process, is still warranted. However, compared with other manufacturing approaches, the HME-based continuous manufacturing is a viable option for the pharmaceutical industry. Keywords: hot melt extrusion, solubility enhancement, continuous manufacturing, additive manufacturing, 3D printing