Systematic Literature Review on Methodology and Manufacturing Process of Personalized Tablet using Selective Laser Sintering Technology
Abstract
3-dimensional printing (3DP) technology has garnered interests as a novel candidate for future pharmaceutical manufacturing. Since the first drug product (Spritam®) has been approved for commercialization by the Food and Drug Administration (FDA), there has been an enormous opportunity for printing custom drugs using 3DP. Many 3DP methods have been documented for pharmaceutical applications in the literature. However, selective laser sintering (SLS) printing remains the least studied for pharmaceutical applications. There are many advantages and challenges in adopting an SLS method to fabricate personalized medicines, such as accurate, cheaper, and simpler ways to configure dosing for certain patient groups. In this study, we systematically reviewed all available literature investigating the technique of personalized printlets using SLS printing, and further discussed the method used in its process. A systematic searching strategy was performed in Scopus, PubMed, and Google Scholar databases using predetermined search strings. Of the 122 articles, only eight articles completely met the inclusion criteria, and they were subsequently used for data synthesis. The results showed that the printing process, spectrophotometry analysis, thermal analysis, X-ray powder diffraction and characterization of the printlet were the vital parameters in the printing method, leading to potential pharmaceutical applications in personalized medicine.
References
ASTM F2792 - 12a Standard Terminology for Additive Manufacturing Technologies, (Withdrawn 2015). (n.d.). Retrieved March 17, 2021, from https://www.astm.org/DATABASE.CART/WITHDRAWN/F2792.htm
Awad, A., Fina, F., Goyanes, A., Gaisford, S., & Basit, A. W. (2020). 3D printing: Principles and pharmaceutical applications of selective laser sintering. International Journal of Pharmaceutics, 586, 119594. https://doi.org/10.1016/j.ijpharm.2020.119594
Awad, A., Fina, F., Trenfield, S. J., Patel, P., Goyanes, A., Gaisford, S., & Basit, A. W. (2019). 3D printed pellets (Miniprintlets): A novel, multi-drug, controlled release platform technology. Pharmaceutics, 11(4). https://doi.org/10.3390/pharmaceutics11040148
Barakh Ali, S. F., Mohamed, E. M., Ozkan, T., Kuttolamadom, M. A., Khan, M. A., Asadi, A., & Rahman, Z. (2019). Understanding the effects of formulation and process variables on the printlets quality manufactured by selective laser sintering 3D printing. International Journal of Pharmaceutics, 570(May), 118651. https://doi.org/10.1016/j.ijpharm.2019.118651
Beaman, J. J., & Deckard, C. R. (1990). Selective Laser Sinterng With Assisted Powder Handlng (Patent No. US4938816A). In Google Patents (No. US4938816A). United States Patent.
Fina, F., Goyanes, A., Gaisford, S., & Basit, A. W. (2017). Selective laser sintering (SLS) 3D printing of medicines. International Journal of Pharmaceutics, 529(1–2), 285–293. https://doi.org/10.1016/j.ijpharm.2017.06.082
Fina, F., Goyanes, A., Madla, C. M., Awad, A., Trenfield, S. J., Kuek, J. M., Patel, P., Gaisford, S., & Basit, A. W. (2018). 3D printing of drug-loaded gyroid lattices using selective laser sintering. International Journal of Pharmaceutics, 547(1–2), 44–52. https://doi.org/10.1016/j.ijpharm.2018.05.044
Fina, F., Madla, C. M., Goyanes, A., Zhang, J., Gaisford, S., & Basit, A. W. (2018). Fabricating 3D printed orally disintegrating printlets using selective laser sintering. International Journal of Pharmaceutics, 541(1–2), 101–107. https://doi.org/10.1016/j.ijpharm.2018.02.015
Goodridge, R. D., Tuck, C. J., & Hague, R. J. M. (2012). Laser sintering of polyamides and other polymers. Progress in Materials Science, 57(2), 229–267. https://doi.org/10.1016/j.pmatsci.2011.04.001
Haris, M. S., Azlan, N. H. M., Taher, M., Rus, S. M., & Chatterjee, B. (2020). 3D-printed drugs: A fabrication of pharmaceuticals towards personalized medicine. Indian Journal of Pharmaceutical Education and Research, 54(3), S411–S422. https://doi.org/10.5530/ijper.54.3s.139
Hinojosa-Torres, J., Aceves-Hernández, J. M., Hinojosa-Torres, J., Paz, M., Castaño, V. M., & Agacino-Valdés, E. (2008). Degradation of lisinopril: A physico-chemical study. Journal of Molecular Structure, 886(1–3), 51–58. https://doi.org/10.1016/j.molstruc.2007.03.064
Jamróz, W., Szafraniec, J., Kurek, M., & Jachowicz, R. (2018). 3D Printing in Pharmaceutical and Medical Applications – Recent Achievements and Challenges. Pharmaceutical Research, 35(9). https://doi.org/10.1007/s11095-018-2454-x
Januskaite, P., Xu, X., Ranmal, S. R., Gaisford, S., Basit, A. W., Tuleu, C., & Goyanes, A. (2020). I spy with my little eye: A paediatric visual preferences survey of 3d printed tablets. Pharmaceutics, 12(11), 1–16. https://doi.org/10.3390/pharmaceutics12111100
Khan, F. A., Narasimhan, K., Swathi, C. S. V., Mustak, S., Mustafa, G., Ahmad, M. Z., & Akhter, S. (2019). 3D Printing Technology in Customized Drug Delivery System: Current State of the Art, Prospective and the Challenges. Current Pharmaceutical Design, 24(42), 5049–5061. https://doi.org/10.2174/1381612825666190110153742
Ligon, S. C., Liska, R., Stampfl, J., Gurr, M., & Mülhaupt, R. (2017). Polymers for 3D Printing and Customized Additive Manufacturing. In Chemical Reviews (Vol. 117, Issue 15, pp. 10212–10290). American Chemical Society. https://doi.org/10.1021/acs.chemrev.7b00074
Mohamed Shaffril, H. A., Ahmad, N., Samsuddin, S. F., Samah, A. A., & Hamdan, M. E. (2020). Systematic literature review on adaptation towards climate change impacts among indigenous people in the Asia Pacific regions. Journal of Cleaner Production, 258, 120595. https://doi.org/10.1016/j.jclepro.2020.120595
Mohamed Shaffril, H. A., Samah, A. A., Samsuddin, S. F., & Ali, Z. (2019). Mirror-mirror on the wall, what climate change adaptation strategies are practiced by the Asian’s fishermen of all? Journal of Cleaner Production, 232, 104–117. https://doi.org/10.1016/j.jclepro.2019.05.262
Mohamed Shaffril, H. A., Samsuddin, S. F., & Abu Samah, A. (2020). The ABC of systematic literature review: the basic methodological guidance for beginners. Quality and Quantity, 0123456789. https://doi.org/10.1007/s11135-020-01059-6
Park, B. J., Choi, H. J., Moon, S. J., Kim, S. J., Bajracharya, R., Min, J. Y., & Han, H. K. (2019). Pharmaceutical applications of 3D printing technology: current understanding and future perspectives. Journal of Pharmaceutical Investigation, 49(6), 575–585. https://doi.org/10.1007/s40005-018-00414-y
Salmoria, G., Vieira, F., Ghizoni, G., Marques, M., & Kanis, L. (2017). 3D printing of PCL/Fluorouracil tablets by selective laser sintering: Properties of implantable drug delivery for cartilage cancer treatment. Rheumatology and Orthopedic Medicine, 2(3), 1–7. https://doi.org/10.15761/rom.1000121
Shellabear, M., & Nyrhilä, O. (2004). DMLS – Development History and State of the Art. Lane 2004, 1–12.
Shirazi, S. F. S., Gharehkhani, S., Mehrali, M., Yarmand, H., Metselaar, H. S. C., Adib Kadri, N., & Osman, N. A. A. (2015). A review on powder-based additive manufacturing for tissue engineering: Selective laser sintering and inkjet 3D printing. Science and Technology of Advanced Materials, 16(3). https://doi.org/10.1088/1468-6996/16/3/033502
Siddaway, A. P., Wood, A. M., & Hedges, L. V. (2018). How to Do a Systematic Review: A Best Practice Guide for Conducting and Reporting Narrative Reviews, Meta-Analyses, and Meta-Syntheses. Annual Review of Psychology, 70(1), 747–770. https://doi.org/https://doi.org/10.1146/annurev-psych-010418-102803
Trenfield, S. J., Tan, H. X., Goyanes, A., Wilsdon, D., Rowland, M., Gaisford, S., & Basit, A. W. (2020). Non-destructive dose verification of two drugs within 3D printed polyprintlets. International Journal of Pharmaceutics, 577(December 2019). https://doi.org/10.1016/j.ijpharm.2020.119066
Voelker, R. (2015). News from the Food and Drug Administration. JAMA -The Journal of the American Medical Association, 313, 1898. https://doi.org/10.1001/jama.2015.4799
World Heath Organization. (2011). Revision of monograph on tablets. International Pharmacopeia REVISION OF MONOGRAPH ON TABLETS Final Text for Addition to The International Pharmacopoeia, March, 1–6.
Yap, C. Y., Chua, C. K., Dong, Z. L., Liu, Z. H., Zhang, D. Q., Loh, L. E., & Sing, S. L. (2015). Review of selective laser melting: Materials and applications. In Applied Physics Reviews (Vol. 2, Issue 4, p. 041101). American Institute of Physics Inc. https://doi.org/10.1063/1.4935926