Pharmaceutical 3D Printing: A Promising Technology for creating customized Medications
Abstract
Three-dimensional printing (3DP) enables the development of diverse geometries through computer aided design using different techniques and materials for desired applications such as pharmaceutical drug delivery system. Now a days 3D PRINTING technology has caught the attention of medical devices industry and pharmaceutical industry due to its applications on various platform in health care industry. Although this technology has been around for quite some time, it is currently of significant public interest, especially following the approval of 3-D printed tablets and other medical devices. Additionally, the introduction of the USFDA’s guidance on technical aspects related to devices utilizing additive manufacturing, which includes 3-dimensional (3D) printing, has sparked numerous considerations about this technology that are essential for the effective delivery of the intended product. It emerges as one of the most influential and impactful tools utilized for the accurate production of advanced dosage forms, tissue engineering, and disease modeling.
Conclusion: 3D printing is emerging as a transformative technology in the pharmaceutical and medical device industries, enabling precise fabrication of advanced drug delivery systems, tissue engineering solutions, and disease models. With growing regulatory support and proven applications, it holds significant potential to shape the future of personalized healthcare.
Keywords:
3D printing, computer-aided design, manufacturing process, Novel drug delivery, Customized Medications
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References
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2. Jose PA, GV PC. 3D printing of pharmaceuticals–a potential technology in developing personalized medicine. Asian journal of pharmaceutical research and development. 2018 Jul 10;6(3):46-54.Alhnam MA, Okwuosa TC, Sadia M, Wan K-W, Ahmed W; Emergence of 3D Printed Dosage Forms: Opportunities and Challenges. Pharm Res, 2016; 33(8): 1817-1832 DOI:10.22270/ajprd.v6i3.375.
3. Lee KJ, Kang A, Delfino JJ, West TG, Chetty D, Monkhouse DC, Yoo J. Evaluation of critical formulation factors in the development of a rapidly dispersing captopril oral dosage form. Drug development and industrial pharmacy. 2003; 1;29 (9):967-79.DOI:
10.1081/ddc-120025454.
4. Waleed H, Almalki Malik A ;3D printing for drug delivery and biomedical applications Sarwar Drug Discovery Today .2020; 25 (9): 1668-1681 DOI:10.1016 j.drudis. 2020.07.007.
5. Healy AV, Fuenmayor E, Doran P, Geever LM, Higginbotham CL, Lyons JG. Additive manufacturing of personalized pharmaceutical dosage forms via stereolithography. Pharmaceutics. 2019; 3;11(12):645.DOI: 10.3390/ pharmaceutics11120645
6. Ngo TD, Kashani A, Imbalzano G, Nguyen KT, Hui D. Additive manufacturing (3D printing): A review of materials, methods, applications and challenges. Composites Part B:Engineering.2018;15;143:17296.DOI:https://doi.org/10.1016/j.compositesb.2018.02.012.
7. Jose PA, GV PC. 3D printing of pharmaceuticals–a potential technology in developing personalized medicine. Asi j. pharma Res & devel; 2018; 10;6(3):46-54. DOI:10.22270/ajprd.v6i3.375.
8. Ali A, Ahmad U, Akhtar J. 3D Printing in Pharmaceutical. Pharmaceutical Formulation Design: Recent Practices. 2020 5:139.DOI: 10.37285/ ijpsn.2022.15.2.11
9. Snehal G, Nagesh A, Suresh S. A decisive overview on three dimensional printing in pharmaceuticals. Journal of Drug Delivery & Therapeutics. 2019 May 1;9(3):591-8.DOI: https://doi.org/10.22270/jddt.v9i3.2837.
10. Meléndez PA, Kane KM, Ashvar CS, Albrecht M, Smith PA. Thermal inkjet application in the preparation of oral dosage forms: dispensing of prednisolone solutions and polymorphic characterization by solid-state spectroscopic techniques.J.pharma.scie. 2008; 97(7):2619-36.DOI: 10.1002/jps. 21189.
11. Katakam P, Dey B, Assaleh FH, Hwisa NT, Adiki SK, Chandu BR, Mitra A. Top-down and bottom-up approaches in 3D printing technologies for drug delivery challenges. Critical Reviews™ in Therapeutic Drug Carrier Systems. 2015;32(1).DOI: 10.1615/critrevtherdrugcarriersyst.201401115.
12. Ziaee M, Crane NB. Binder jetting: A review of process, materials, and methods. Additive Manufacturing. 2019; 1; 28:781-801.DOI: 28:781-801.
13. Miyanaji H, Yang L. Equilibrium saturation in binder jetting additive manufacturing processes: theoretical model vs experimental observations. 2016; (1) :1945–1959 DOI:2152/49742.
14. Tofail SA, Koumoulos EP, Bandyopadhyay A, Bose S, O’Donoghue L, Charitidis C. Additive manufacturing: scientific and technological challenges, market uptake and opportunities. Materials today. 2018; 21(1):22-37.DOI: 10.1016/j.mattod.2017.07.001
15. Ngo TD, Kashani A, Imbalzano G, Nguyen KT, Hui D. Additive manufacturing (3D printing): A review of materials, methods, applications and challenges. Composites Part B: Engineering; 2018 (15);143:172-96. DOI: 10.1016/j. compositesb.2018.02.012
16. Małek E, Miedzińska D, Popławski A, Szymczyk W. Application of 3D printing technology for mechanical properties study of the photopolymer resin used to print porous structures. Technical Sciences. 2019; 22(2):183-94.DOI: https://doi.org/10.31648/ts.4584.
17. Lamichhane S, Bashyal S, Keum T, Noh G, Seo JE, Bastola R, Choi J, Sohn DH, Lee S. Complex formulations, simple techniques: Can 3D printing technology be the Midas touch in pharmaceutical industry. Asian journal of pharmaceutical sciences. 2019; 14(5):465-79.DOI: 10.1016/j.ajps.2018.11.008.
18. Caballero-Aguilar LM, Silva SM, Moulton SE. Three-dimensional printed drug delivery systems. InEngineering drug delivery systems 2020 :147-162.DOI: 10.1016/B978-0-08-102548-2.00006-8.
19. Konta, A.A., Pina, M.G., & Serrano, D.RPersonalised 3D printed medicines: which techniques and polymers are more successful. Bioengineering, 2017; 4 (4):79.DOI: 10.3390/bioengineering4040079.
20. Kadry H, Wadnap S, Xu C, Ahsan F. Digital light processing (DLP) 3D-printing technology and photoreactive polymers in fabrication of modified-release tablets. European Journal of Pharmaceutical Sciences. 2019 ;135:60-67;DOI: 10.1016/j.ejps. 2019.05.008.
21. Norman J, Madurawe RD, Moore CM, Khan MA, Khairuzzaman A. A new chapter in pharmaceutical manufacturing: 3D-printed drug products. Advanced drug delivery reviews. 2017;108:39-50;DOI: 10.1016/j.addr. 2016.03.001.
22. Genina N, Holländer J, Jukarainen H, Mäkilä E, Salonen J, Sandler N. Ethylene vinyl acetate (EVA) as a new drug carrier for 3D printed medical drug delivery devices. European Journal of Pharmaceutical Sciences. 2016; (90):53-63;DOI:10.1016/j.ejps.2015.11.005
23. Melocchi A, Parietti F, Maroni A, Foppoli A, Gazzaniga A, Zema L. Hot-melt extruded filaments based on pharmaceutical grade polymers for 3D printing by fused deposition modeling. International journal of pharmaceutics. 2016 Jul 25;509(1-2):255-6;.DOI; 10.1016/j.ijpharm.2016.05.036
24. Goyanes A, Buanz AB, Basit AW, Gaisford S. Fused-filament 3D printing (3DP) for fabrication of tablets. International journal of pharmaceutics. 2014 D;476(1-2):88-92;DOI: 10.1016/j.ijpharm.2014.09.044.
25. Khaled SA, Alexander MR, Irvine DJ, Wildman RD, Wallace MJ, Sharpe S, Yoo J, Roberts CJ. Extrusion 3D printing of paracetamol tablets from a single formulation with tunable release profiles through control of tablet geometry. Aaps Pharmscitech. 2018;19(8):3403-13;DOI: 10.1208/s12249-018-1107-z.
26. Dores F, Kuźmińska M, Soares C, Bohus M, Shervington LA, Habashy R, Pereira BC, Peak M, Isreb A, Alhnan MA. Temperature and solvent facilitated extrusion based 3D printing for pharmaceuticals. European Journal of Pharmaceutical Sciences.2020 ;152:105-110; DOI: 10.1016/j.ejps.2020. 105430.
27. Wu Y, Woodbine L, Carr AM, Pillai AR, Nokhodchi A, Maniruzzaman M. 3D printed calcium phosphate cement (CPC) scaffolds for anti-cancer drug delivery. Pharmaceutics. 2020 Nov 11;12(11):1077;DOI: 10.3390/pharmaceutics12111077.
28. Goyanes A, Buanz AB, Hatton GB, Gaisford S, Basit AW. 3D printing of modified-release aminosalicylate (4-ASA and 5-ASA) tablets. European journal of pharmaceutics and biopharmaceutics. 2015; 89:157-62;DOI:10.1016/j.ejpb2014.12.003.
29. El Aita I, Breitkreutz J, Quodbach J. Investigation of semi-solid formulations for 3D printing of drugs after prolonged storage to mimic real-life applications. Europ J. Pharma. Sci; 2020;146:105266;DOI: 10.1016/j.ejps.2020.105266.
30. Cui M, Li Y, Wang S, Chai Y, Lou J, Chen F, Li Q, Pan W, Ding P. Exploration and preparation of a dose-flexible regulation system for levetiracetam tablets via novel semi-solid extrusion three-dimensional printing. J. Pharma.Sci. 2019 ;108(2):977-86;DOI: 10.1016/j.xphs.2018. 10.001.
31. Li Q, Guan X, Cui M, Zhu Z, Chen K, Wen H, Jia D, Hou J, Xu W, Yang X, Pan W. Preparation and investigation of novel gastro-floating tablets with 3D extrusion-based printing. Int.J pharmaceutics;2018; 535(1-2):325-32;DOI: 10.1016/j.ijpharm.201710.037.
32. Musazzi UM, Selmin F, Ortenzi MA, Mohammed GK, Franzé S, Minghetti P, Cilurzo F. Personalized orodispersible films by hot melt ram extrusion 3D printing. Int.j.pharmaceutics. 2018;551(1-2):52-9; DOI: 10.1016/j.ijpharm.2018.09.013.
33. Elbl J, Gajdziok J, Kolarczyk J. 3D printing of multilayered orodispersible films with in-process drying. International Journal of Pharmaceutics. 2020 ;575:118883; DOI: 10.1016/j.ijpharm.2019. 118883
34. Vithani K, Goyanes A, Jannin V, Basit AW, Gaisford S, Boyd BJ. A proof of concept for 3D printing of solid lipid-based formulations of poorly water-soluble drugs to control formulation dispersion kinetics. Pharmaceutical research. 2019; 36(7); DOI: 10.1007/s11095-019-2639-y.
35. Rattanakit P, Moulton SE, Santiago KS, Liawruangrath S, Wallace GG. Extrusion printed polymer structures: a facile and versatile approach to tailored drug delivery platforms. Inter. J.pharmaceutics. 2012; 422(1-2):254-63; DOI: 10.1016/j.ijpharm. 2011.11.007.
36. Upadhye S;Hot melt extrusion – optimelt™ Hot Melt Extrusion Technology to Improve Bioavailability of Poorly Soluble Drugs; drug development and delivery;2015.
37. Kushwaha S. Application of hot melt extrusion in pharmaceutical 3D printing. J. Bioequiv. Availab. 2018;10:54-7;DOI: https://doi.org/10.4172/0975--0851.1000379.
38. Linares V, Casas M, Caraballo I. Printfills: 3D printed systems combining fused deposition modeling and injection volume filling. Application to colon-specific drug delivery. Euro J. Pharma & Biophar.2019;134:138-43;DOI: 10.1016/j.ejpb.2018.11.021.
39. Khairuzzaman A. Regulatory perspectives on 3D printing in pharmaceuticals. In3D printing of Pharmaceuticals Cham: Springer International Publishing.2018 : 215-236; ;DOI: 10.1007/978-3-319-90755-0_11.
40. Cerda JR, Arifi T, Ayyoubi S, Knief P, Ballesteros MP, Keeble W, Barbu E, Healy AM, Lalatsa A, Serrano DR. Personalised 3D printed medicines: Optimising material properties for successful passive diffusion loading of filaments for fused deposition modelling of solid dosage forms. Pharmaceutics. 2020 (4):345;DOI: https://doi.org/10.3390/pharmaceutics12040345.
41. Fina F, Goyanes A, Rowland M, Gaisford S, W. Basit A. 3D printing of tunable zero-order release printlets. Polymers.2020;12(8):1769;DOI:https://doi.org/10.3390/ polym12081769.
42. Korte C, Quodbach J. Formulation development and process analysis of drug-loaded filaments manufactured via hot-melt extrusion for 3D-printing of medicines. Pharmaceutical development and technology. 2018; (10):1117-27;DOI: 10.1080/10837450.2018.1433208.
43. WHO (World Health Organization). Guidelines on validation - draft for comments. 2016.
44. EMA (European Medicines Agency). Guideline on process validation for finished products - information and data to be provided in regulatory submissions. 2016.
45. FDA (Food and Drug Administration). Guidance for Industry - Process Validation: general principles and practices. 2011.
46. Agrawal A, Dudhedia M, Deng W, Shepard K, Zhong L, Povilaitis E, Zimny E. Development of tablet formulation of amorphous solid dispersions prepared by hot melt extrusion using quality by design approach. Aaps Pharmscitech. 2016; (1):214-32;DOI: 10.1208/s12249-015-0472-0.
47. Maniruzzaman M. 3D and 4D printing in Biomedical Applications. Wiley-VCH; 2019.
48. Alhijjaj M, Nasereddin J, Belton P, Qi S. Impact of processing parameters on the quality of pharmaceutical solid dosage forms produced by fused deposition modeling (FDM). Pharmaceutics. 2019; (12):633;DOI: 10.3390/pharmaceutics11120633.
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More S. Pharmaceutical 3D Printing: A Promising Technology for creating customized Medications. Int J Drug Reg Affairs [Internet]. 2025Sep.16 [cited 2025Nov.11];13(3):68-6. Available from: https://www.ijdra.com/index.php/journal/article/view/786
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