Fabrication of Polypill Pharmaceutical Dosage Forms Using Fused Deposition Modeling 3D Printing: A Systematic Review.

Abstract

Background/objectives: The pharmacy profession has undergone significant changes driven by advancements in patient care and healthcare systems. The FDA approval of Spritam^® (levetiracetam), the first 3D-printed drug, has sparked increased interest in the use of Fused Deposition Modeling (FDM) 3D printing for pharmaceutical applications, particularly in the production of polypills.

Methods: This review provides an overview of FDM 3D printing in the development of pharmaceutical dosage forms, focusing on its operation, printing parameters, materials, additives, advantages, and limitations. Key aspects, such as the ability to personalize medication and the challenges associated with the technique, including drug stability at high temperatures, are discussed.

Results: Fourteen studies relevant to FDM 3D-printed polypills were analyzed from an initial pool of 60. The increasing number of publications highlights the growing global interest in this technology, with the UK contributing the highest number of studies.

Conclusions: FDM 3D printing offers significant potential for personalized medicine by enabling precise control over dosage forms and tailoring treatments to individual patient needs. However, limitations such as high printing temperatures and the lack of standardized GMP guidelines for large-scale production must be addressed to fully realize its potential in pharmaceutical manufacturing.