Hot-Melt Extrusion Paired Fused Deposition Modeling 3D Printing: Development of Pharmaceutical Medications

In recent years much research has been conducted exploring the suitability of various additive manufacturing (AM) techniques for developing pharmaceuticals. In 2015 the approval of the first 3D-printed product SPRITRAM® (levetiracetam) by the US Food and Drug Administration (USFDA) attracted researchers from various avenues of the pharmaceutical sector. The orally disintegrating levetiracetam tablets are manufactured by Aprecia Pharmaceuticals (Ohio, USA) utilizing a novel zip dose technology platform. Developing pharmaceuticals by AM process allows physicians to control the dose of the medications rather than prescribing the dose determined by pharmaceutical industries. Depending on age, sex, race, state of disease, and biological factors, a single dose of medication might not be suitable for the entire patient population. The AM techniques enable the fabrication of on-demand medications for different doses and geometries. In addition, AM also provides the flexibility of controlling the release profiles by adjusting the infill densities of the medications. Complex medications such as polypills can also be fabricated, making it easier for geriatric patients experiencing dysphagia. The AM has various advantages when compared with conventional manufacturing techniques. This chapter mainly focuses on the fused deposition modeling (FDM) 3D printing technique along with the hot-melt extrusion (HME) platform, which is needed for developing the feedstock (drug-loaded polymeric filaments) material. Various critical parameters concerning the process, formulation, and instrument are discussed in detail, with a small note on the advantages and limitations.