Toward a harmonized regulatory framework for 3D-printed pharmaceutical products: the role of critical feedstock materials and process parameters

Woodcock J. The concept of pharmaceutical quality. Am Pharm Rev. 2004;7(6):10–5.

Google Scholar 

Sangshetti JN, Deshpande M, Zaheer Z, Shinde DB, Arote R. Quality by design approach: regulatory need. Arab J Chem. 2017;10:S3412–25.

Article  Google Scholar 

Simões A, Veiga F, Vitorino C. Question-based review for pharmaceutical development: an enhanced quality approach. Eur J Pharm Biopharm. 2023:114174.

Zagalo DM, Sousa J, Simões S. Quality by design (QbD) approach in marketing authorization procedures of non-biological complex drugs: a critical evaluation. Eur J Pharm Biopharm. 2022;178:1–24.

Article  PubMed  Google Scholar 

Yu LX, Amidon G, Khan MA, Hoag SW, Polli J, Raju G, et al. Understanding pharmaceutical quality by design. AAPS J. 2014;16:771–83.

Article  PubMed  PubMed Central  Google Scholar 

Hock SC, Siang TK, Wah CL. Continuous manufacturing versus batch manufacturing: benefits, opportunities and challenges for manufacturers and regulators. Generics Biosimilars Initiative J. 2021;10(1):1–14.

Article  Google Scholar 

Krueger L, Awad A, Basit AW, Goyanes A, Miles JA, Popat A. Clinical translation of 3D printed pharmaceuticals. Nat Reviews Bioeng. 2024:1–3.

Khorasani M, Ghasemi A, Rolfe B, Gibson I. Additive manufacturing a powerful tool for the aerospace industry. Rapid Prototyp J. 2022;28(1):87–100.

Article  Google Scholar 

Sainz V, Conniot J, Matos AI, Peres C, Zupanǒiǒ E, Moura L, et al. Regulatory aspects on nanomedicines. Biochem Biophys Res Commun. 2015;468(3):504–10.

Article  PubMed  Google Scholar 

Shin W, Kim M-G, Kim A. Comparison of international guidelines for early-phase clinical trials of cellular and gene therapy products. Translational Clin Pharmacol. 2022;30(1):13.

Article  Google Scholar 

Magers K. Addressing challenges in meeting chemistry, manufacturing and control regulatory requirements for gene therapy products. Cell Gene Ther Insights. 2019;5:1–16.

Google Scholar 

McKee M, Wouters OJ. The challenges of regulating artificial intelligence in healthcare: comment on clinical decision support and new regulatory frameworks for medical devices: are we ready for It?-A viewpoint paper. Int J Health Policy Manage. 2022;12:7261.

Google Scholar 

Kumar Gupta D, Ali MH, Ali A, Jain P, Anwer MK, Iqbal Z, et al. 3D printing technology in healthcare: applications, regulatory understanding, IP repository and clinical trial status. J Drug Target. 2022;30(2):131–50.

Article  PubMed  Google Scholar 

Trenfield SJ, Madla CM, Basit AW, Gaisford S. The shape of things to come: Emerging applications of 3D printing in healthcare. 3D printing of pharmaceuticals. 2018:1–19.

Andreadis II, Gioumouxouzis CI, Eleftheriadis GK, Fatouros DG. The advent of a new era in digital healthcare: a role for 3D printing technologies in drug manufacturing? Pharmaceutics. 2022;14(3):609.

Article  PubMed  PubMed Central  Google Scholar 

West TG, Bradbury TJ. 3D Printing: A Case of ZipDose® Technology–World’s First 3D Printing Platform to Obtain FDA Approval for a Pharmaceutical Product. 3D and 4D Printing in Biomedical Applications: Process Engineering and Additive Manufacturing. 2019:53–79.

Parhi R. A review of three-dimensional printing for pharmaceutical applications: quality control, risk assessment and future perspectives. J Drug Deliv Sci Technol. 2021;64:102571.

Article  Google Scholar 

Emerging Technology Program (ETP). 2023 [Available from: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/emerging-technology-program-etp

Eglovitch JS, FDA official offers insights on Emerging Technology Program. 2022 [Available from: https://www.raps.org/News-and-Articles/News-Articles/2022/11/FDA-official-offers-insights-on-Emerging-Technolog

Li P, Faulkner A, Medcalf N. 3D Bioprinting in a 2D regulatory landscape: gaps, uncertainties, and problems. Law Innov Technol. 2020;12(1):1–29.

Article  Google Scholar 

Lafeber I, Tichem J, Ouwerkerk N, Van Unen A, Van Uitert J, Bijleveld-Olierook H, et al. 3D printed Furosemide and sildenafil tablets: innovative production and quality control. Int J Pharm. 2021;603:120694.

Article  PubMed  Google Scholar 

Johannesson J, Wu M, Johansson M, Bergström CA. Quality attributes for printable emulsion gels and 3D-printed tablets: towards production of personalized dosage forms. Int J Pharm. 2023;646:123413.

Article  PubMed  Google Scholar 

Khairuzzaman A. Regulatory perspectives on 3D printing in pharmaceuticals. 3D Printing of Pharmaceuticals. 2018:215 – 36.

CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative. 2025 [Available from: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cders-framework-regulatory-advanced-manufacturing-evaluation-frame-initiative

Conformity assessment procedures. for 3D printing and 3D printed products to be used in a medical context for COVID-19 2020 [Available from: https://ec.europa.eu/docsroom/documents/40562

(EMA) EMA. Supporting Innovations 2025 [Available from: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/supporting-innovation#ema’s-innovation-task-force-(itf)-section

Muehlenfeld C, Duffy P, Yang F, Zermeño Pérez D, El-Saleh F, Durig T. Excipients in pharmaceutical additive manufacturing: A comprehensive exploration of polymeric material selection for enhanced 3D printing. Pharmaceutics. 2024;16(3):317.

Article  PubMed  PubMed Central  Google Scholar 

Kayalar C, Charoo NA, Nutan MT, Kuttolamadom M, Khan MA, Rahman Z. Quality control and regulatory landscape of 3D-Printed drug products. 3D printing: emerging technologies and functionality of polymeric excipients in drug product development. Springer; 2023. pp. 57–75.

Norman J, Madurawe RD, Moore CM, Khan MA, Khairuzzaman A. A new chapter in pharmaceutical manufacturing: 3D-printed drug products. Adv Drug Deliv Rev. 2017;108:39–50.

Article  PubMed  Google Scholar 

Seoane-Viaño I, Trenfield SJ, Basit AW, Goyanes A. Translating 3D printed pharmaceuticals: from hype to real-world clinical applications. Adv Drug Deliv Rev. 2021;174:553–75.

Article  PubMed  Google Scholar 

Tracy T, Wu L, Liu X, Cheng S, Li X. 3D printing: innovative solutions for patients and pharmaceutical industry. Int J Pharm. 2023;631:122480.

Article  PubMed  Google Scholar 

Pawar R, Pawar A. 3D printing of pharmaceuticals: approach from bench scale to commercial development. Future J Pharm Sci. 2022;8(1):1–17.

Google Scholar 

Pérez M, Carou D, Rubio EM, Teti R. Current advances in additive manufacturing. Procedia Cirp. 2020;88:439–44.

Article  Google Scholar 

Kotta S, Nair A, Alsabeelah N. 3D printing technology in drug delivery: recent progress and application. Curr Pharm Design. 2018;24(42):5039–48.

Article  Google Scholar 

Tan DK, Maniruzzaman M, Nokhodchi A. Development and optimisation of novel polymeric compositions for sustained release Theophylline caplets (PrintCap) via FDM 3D printing. Polymers. 2019;12(1):27.

Article  PubMed  PubMed Central  Google Scholar 

Li Q, Guan X, Cui M, Zhu Z, Chen K, Wen H, et al. Preparation and investigation of novel gastro-floating tablets with 3D extrusion-based printing. Int J Pharm. 2018;535(1–2):325–32.

Article  PubMed  Google Scholar 

Beitler BG, Abraham PF, Glennon AR, Tommasini SM, Lattanza LL, Morris JM, et al. Interpretation of regulatory factors for 3D printing at hospitals and medical centers, or at the point of care. 3D Print Med. 2022;8(1):7.

Article  PubMed  PubMed Central  Google Scholar 

Huanbutta K, Burapapadh K, Sriamornsak P, Sangnim T. Practical application of 3D printing for pharmaceuticals in hospitals and pharmacies. Pharmaceutics. 2023;15(7):1877.

Article  PubMed  PubMed Central  Google Scholar 

Wang J, Zhang Y, Aghda NH, Pillai AR, Thakkar R, Nokhodchi A, et al. Emerging 3D printing technologies for drug delivery devices: current status and future perspective. Adv Drug Deliv Rev. 2021;174:294–316.

Article  PubMed  Google Scholar 

Okwuosa TC, Pereira BC, Arafat B, Cieszynska M, Isreb A, Alhnan MA. Fabricating a shell-core delayed release tablet using dual FDM 3D printing for patient-centred therapy. Pharm Res. 2017;34:427–37.

Article  PubMed  Google Scholar 

Sadia M, Sośnicka A, Arafat B, Isreb A, Ahmed W, Kelarakis A, et al. Adaptation of pharmaceutical excipients to FDM 3D printing for the fabrication of patient-tailored immediate release tablets. Int J Pharm. 2016;513(1–2):659–68.

Article  PubMed  Google Scholar 

Xu L, Yang Q, Qiang W, Li H, Zhong W, Pan S, et al. Hydrophilic excipient-independent drug release from SLA-printed pellets. Pharmaceutics. 2021;13(10):1717.

Article  PubMed  PubMed Central  Google Scholar 

Hoffmann L, Breitkreutz J, Quodbach J. Fused deposition modeling (FDM) 3D printing of the thermo-sensitive peptidomimetic drug Enalapril maleate. Pharmaceutics. 2022;14(11):2411.

Article  PubMed  PubMed Central  Google Scholar 

Parulski C, Jennotte O, Lechanteur A, Evrard B. Challenges of fused deposition modeling 3D printing in pharmaceutical applications: where are we now? Adv Drug Deliv Rev. 2021;175:113810.

Article  PubMed  Google Scholar 

Ponsar H, Wiedey R, Quodbach J. Hot-melt extrusion process fluctuations and their impact on critical quality attributes of filaments and 3D-printed dosage forms. Pharmaceutics. 2020;12(6):511.

Article  PubMed  PubMed Central 

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