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Investigation of the Fused Deposition Modeling Additive Manufacturing I: Influence of Process Temperature on the Quality and Crystallinity of the Dosage Forms

  • Research Article
  • Theme: Pharmaceutical Thermal Processing - An Update
  • Published:
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Abstract

With the advancements in cutting-edge technologies and rapid development of medical sciences, patient-focused drug development (PFDD) through additive manufacturing (AM) processes is gathering more interest in the pharmaceutical area than ever. Hence, there is an urgent need for researchers to comprehensively understand the influence of three-dimensional design on the development of novel drug delivery systems (DDSs). For this research, fused deposition modeling (FDM) 3D printing was investigated, and phenytoin (PHT) was selected as the model drug. The primary purpose of the current investigation was to understand the influence of AM process on the pharmaceutical products’ quality. A series of comparative studies, including morphology, solid-state analysis, and in vitro drug release studies between additive manufactured filaments (printlets) and extruded filaments, were conducted. The FDM-based AM showed adequate reproducibility by manufacturing printlets with consistent qualities; however, the model slicing orientation significantly affected the print qualities. The texture analysis studies showed that the mechanical properties (breaking behavior) of additive manufactured printlets were varied from the extruded filaments. Additionally, the higher printing temperature also influenced the solid state of the drug where the process assisted in PHT’s amorphization in the printed products, which further affected their mechanical properties and in vitro drug release performances. The current investigation illustrated that the AM process would change the printed objects’ macrostructure over the conventional products, and the printing temperature and slicing will significantly affect the printing process and product qualities.

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Funding

The research work reported herein was supported by Dr. Mo Maniruzzaman’s start-up funds at The University of Texas at Austin and the Faculty Science and Technology Acquisition and Retention (STARs) Award. The authors and specifically Dr. Jiaxiang Zhang and Rishi Thakkar would also like to acknowledge the financial support from CoM3D Ltd., under an existing Master Sponsored Research Agreement (UTA19-000358) with The University of Texas at Austin.

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Authors and Affiliations

  1. Pharmaceutical Engineering and 3D Printing (PharmE3D) Lab, Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, Austin, TX, 78712, USA

    Jiaxiang Zhang, Rishi Thakkar, Vineet R. Kulkarni, Yu Zhang, Anqi Lu & Mohammed Maniruzzaman

Authors
  1. Jiaxiang Zhang
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  2. Rishi Thakkar
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  3. Vineet R. Kulkarni
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  4. Yu Zhang
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  6. Mohammed Maniruzzaman
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Correspondence to Mohammed Maniruzzaman.

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Guest Editors: Feng Zhang, Michael Repka and Suresh Bandari

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Zhang, J., Thakkar, R., Kulkarni, V.R. et al. Investigation of the Fused Deposition Modeling Additive Manufacturing I: Influence of Process Temperature on the Quality and Crystallinity of the Dosage Forms. AAPS PharmSciTech 22, 258 (2021). https://doi.org/10.1208/s12249-021-02094-8

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