4.8 Review

Fused Deposition Modeling (FDM), the new asset for the production of tailored medicines

Journal

JOURNAL OF CONTROLLED RELEASE
Volume 330, Issue -, Pages 821-841

Publisher

ELSEVIER
DOI: 10.1016/j.jconrel.2020.10.056

Keywords

Fused deposition modeling; Precision medicine; Solid oral forms; Quality by design; Hot melt extrusion; 3D printed drugs

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The shift towards precision medicine in conventional medicine has led to a focus on customizing oral drug delivery using 3D printing technology, particularly Fused Deposition Modeling (FDM). Various FDM methods have been reported in the production of pharmaceutical solid oral forms, with challenges such as high printing temperatures for thermosensitive ingredients and moisture sensitivity in storage studies. FDM appears to be well-suited for treating rare diseases and populations requiring tailored doses or release kinetics.
Over the last few years, conventional medicine has been increasingly moving towards precision medicine. Today, the production of oral pharmaceutical forms tailored to patients is not achievable by traditional industrial means. A promising solution to customize oral drug delivery has been found in the utilization of 3D Printing and in particular Fused Deposition Modeling (FDM). Thus, the aim of this systematic literature review is to provide a synthesis on the production of pharmaceutical solid oral forms using FDM technology. In total, 72 relevant articles have been identified via two well-known scientific databases (PubMed and ScienceDirect). Overall, three different FDM methods have been reported: Impregnation-FDM, Hot Melt Extrusion coupled with FDM and Print-fill, which yielded to the formulation of thermoplastic polymers used as main component, five families of other excipients playing different functional roles and 47 active ingredients. Solutions are underway to overcome the high printing temperatures, which was the initial brake on to use thermosensitive ingredients with this technology. Also, the moisture sensitivity shown by a large number of prints in preliminary storage studies is highlighted. FDM seems to be especially fitted for the treatment of rare diseases, and particular populations requiring tailored doses or release kinetics. For future use of FDM in clinical trials, an implication of health regulatory agencies would be necessary. Hence, further efforts would likely be oriented to the use of a quality approach such as Quality by Design which could facilitate its approval by the authorities, and also be an aid to the development of this technology for manufacturers.

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