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3D-Printed Drugs for Children—Are We Ready Yet?

Abstract

The first medicine manufactured by three-dimensional (3D) printing was recently approved by the Food and Drug Administration (FDA). The advantages of printing as a manufacturing route enabling more flexibility regarding the dose, and enlarging individual treatment options, have been demonstrated. There is a particular need for flexible drug delivery solutions when it comes to children. Printing as a new pharmaceutical manufacturing technology brings manufacturing closer to the patient and can easily be adjusted to the required dosing scheme, offering more flexibility for treatments. Printing of medicine may therefore become the manufacturing route of choice to provide tailored and potentially on-demand treatments for patients with individual needs. This paper intends to summarize and discuss the state of the art, the crucial aspects which should be taken into account, and the still-open questions, in order to make 3D printing a suitable manufacturing route for pediatric drugs.

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References

  1. 1.

    United States Food and Drug Administration. Paving the way for personalized medicine. 2013.

  2. 2.

    Norman J, et al.. A new chapter in pharmaceutical manufacturing: 3D-printed drug products. Adv Drug Delivery Rev. 2016. In press. doi: 10.1016/j.addr.2016.03.001.

  3. 3.

    Kolakovic R, et al. Printing technologies in fabrication of drug delivery systems. Expert Opin Drug Deliv. 2013;10(12):1711–23.

    CAS  Article  PubMed  Google Scholar 

  4. 4.

    Gross BC, et al. Evaluation of 3D printing and its potential impact on biotechnology and the chemical sciences. Anal Chem. 2014;86(7):3240–53.

    CAS  Article  PubMed  Google Scholar 

  5. 5.

    Jonathan G, Karim A. 3D printing in pharmaceutics: a new tool for designing customized drug delivery systems. Int J Pharm. 2016;499:376–94.

    CAS  Article  PubMed  Google Scholar 

  6. 6.

    Melocchi A, et al. Hot-melt extruded filaments based on pharmaceutical grade polymers for 3D printing by fused deposition modeling. Int J Pharm. 2016;509(1–2):255–63.

    CAS  Article  PubMed  Google Scholar 

  7. 7.

    Aprecia Pharmaceuticals. 3D Printing/ZipDose technology. 2016. Available at: https://www.aprecia.com/zipdose-platform/3d-printing.php

  8. 8.

    European parliament. Open innovation in industry, including 3D printing. 2015. Available at: http://www.europarl.europa.eu/RegData/etudes/STUD/2015/563445/IPOL_STU(2015)563445_EN.pdf.

  9. 9.

    United States Food and Drug Administration. Medical applications of 3D printing. 2016.

  10. 10.

    Wang JZ, Li ZY, Guo XH. Could personalized bio-3D printing rescue the cardiovascular system? Int J Cardiol. 2016;223:561–3.

    Article  PubMed  Google Scholar 

  11. 11.

    Genina N, et al. Ethylene vinyl acetate (EVA) as a new drug carrier for 3D printed medical drug delivery devices. Eur J Pharm Sci. 2016;90:53–63.

    CAS  Article  PubMed  Google Scholar 

  12. 12.

    Sandler N, Preis M. Printed drug-delivery systems for improved patient treatment. Trends Pharmacol Sci. 2016; doi:10.1016/j.tips.2016.10.002.

    PubMed  Google Scholar 

  13. 13.

    Genina N, et al. Tailoring controlled-release oral dosage forms by combining inkjet and flexographic printing techniques. Eur J Pharm Sci. 2012;47(3):615–23.

    CAS  Article  PubMed  Google Scholar 

  14. 14.

    Sandler N, et al. Inkjet printing of drug substances and use of porous substrates-towards individualized dosing. J Pharm Sci. 2011;100(8):3386–95.

    CAS  Article  PubMed  Google Scholar 

  15. 15.

    Preis M, Breitkreutz J, Sandler N. Perspective: concepts of printing technologies for oral film formulations. Int J Pharm. 2015;494(2):578–84.

    CAS  Article  PubMed  Google Scholar 

  16. 16.

    Içten E, et al. Drop-on-demand system for manufacturing of melt-based solid oral dosage: effect of critical process parameters on product quality. AAPS PharmSciTech. 2016;17(2):284–93.

    Article  PubMed  Google Scholar 

  17. 17.

    Preis M. Orally disintegrating films and mini-tablets—innovative dosage forms of choice for pediatric use. AAPS PharmSciTech. 2015;16(2):234–41.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  18. 18.

    Klingmann V, et al. Favorable acceptance of mini-tablets compared with syrup: a randomized controlled trial in infants and preschool children. J Pediatr. 2013;163(6):1728–32.

    Article  PubMed  Google Scholar 

  19. 19.

    Cella M, et al. Dosing rationale for fixed-dose combinations in children: shooting from the hip. Clin Pharmacol Ther. 2012;91(4):718–25.

    CAS  Article  PubMed  Google Scholar 

  20. 20.

    Ernest TB, et al. Preparation of medicines for children—a hierarchy of classification. Int J Pharm. 2012;435(2):124–30.

    CAS  Article  PubMed  Google Scholar 

  21. 21.

    Stoltenberg I, Winzenburg G, Breitkreutz J. Solid oral dosage forms for children—formulations, excipients and acceptance issues. J Appl Ther Res. 2010;7(4):141–6.

    CAS  Google Scholar 

  22. 22.

    Davies EH, Tuleu C. Medicines for children: a matter of taste. J Pediatr. 2008;153(5):599–604.

    Article  PubMed  Google Scholar 

  23. 23.

    Mennella JA, Beauchamp GK. Optimizing oral medications for children. Clin Ther. 2008;30(11):2120–32.

    Article  PubMed  PubMed Central  Google Scholar 

  24. 24.

    Khaled SA, et al. 3D printing of five-in-one dose combination polypill with defined immediate and sustained release profiles. J Control Release. 2015;217:308–14.

    CAS  Article  PubMed  Google Scholar 

  25. 25.

    Khaled SA, et al. 3D printing of tablets containing multiple drugs with defined release profiles. Int J Pharm. 2015;494:643–50.

    CAS  Article  PubMed  Google Scholar 

  26. 26.

    Sanderson K. 3D printing: the future of manufacturing medicine? Pharm J. 2015;294(7865):598–600.

    Google Scholar 

  27. 27.

    Preis M, Sandler N. Printing technologies and tailored dosing. Hospital Pharmacy Europe. http://www.hospitalhealthcare.com. 2016.

  28. 28.

    Öblom H, Berg J, Alanko I, Preis M, Sandler N. Thin substrates manufactured by means of 3D printing for tailor-made drug delivery systems. Int J Pharm. 2016;511(2):1134–5.

    Article  Google Scholar 

  29. 29.

    Goyanes A, et al. Effect of geometry on drug release from 3D printed tablets. Int J Pharm. 2015;494:657–63.

    CAS  Article  PubMed  Google Scholar 

  30. 30.

    Fillekes Q, Mulenga V, Kabamba D, Kankasa C, Thomason MJ, Cook A, et al. Pharmacokinetics of nevirapine in HIV-infected infants weighing 3 kg to less than 6 kg taking paediatric fixed dose combination tablets. AIDS. 2012;26(14):1795–800.

    CAS  Article  PubMed  Google Scholar 

  31. 31.

    U.S. Department of Health and Human Services. Technical considerations for additive manufactured devices—draft guidance for industry and food and drug administration staff. 2016.

  32. 32.

    Khairuzzaman A. Before you click “print”: regulatory considerations for 3D-printed drug products. United States Food and Drug Administration. Proceedings of the AAPS Annual Meeting. 2016, Denver.

  33. 33.

    Christensen A. Pre-printing considerations. FDA Additive Manufacturing Workshop. 2014.

  34. 34.

    Rayna T, Striukova L. From rapid prototyping to home fabrication: how 3D printing is changing business model innovation. Technol Forecast Soc Chang. 2016;102:214–24.

    Article  Google Scholar 

  35. 35.

    Eisenberg M. 3D printing for children: what to build next? Int J Child-Comput Interact. 2013;1:7–13.

    Article  Google Scholar 

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Acknowledgments

We would like to thank the Finnish Cultural Foundation (00161140) and the Academy of Finland ( 297293) for their support.

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Correspondence to Maren Preis.

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Communicated by: Maren Preis and Jörg Breitkreutz

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Preis, M., Öblom, H. 3D-Printed Drugs for Children—Are We Ready Yet?. AAPS PharmSciTech 18, 303–308 (2017). https://doi.org/10.1208/s12249-016-0704-y

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KEY WORDS

  • 3D printing
  • children
  • drug delivery
  • pediatrics