Hemanth KG, Hemamanjushree S, Abhinaya N, Raveendra Pai, Girish Pai K
Hemanth KG1, Hemamanjushree S1, Abhinaya N1, Raveendra Pai2, Girish Pai K1*
1Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka-576104, India.
2Formulation Development, Glenmark Pharmaceuticals Limited, Taloja, Maharashtra-410208, India.
Volume - 14,
Issue - 1,
Year - 2021
The existence of 3D printing (3DP) ways back to 1992, and its sound presence in the pharmaceutical industry was made in 2015 by the launch of 1st 3D printed drug, Spritam was manufactured by Aprecia Pharmaceuticals. Implementation of 3DP is escalating in the number of industries, including the pharmaceutical industry. The purpose of this review paper is to briefly discuss types of 3DP and their role in formulating novel dosage forms. Binder jet printing, VAT polymerization, powder bed fusion, and material extrusion are briefly explained along with an example of their implementation in the formulation of the dosage form. A few novel dosage forms which can bypass the first-pass metabolism and how 3D printing is useful in formulating them as been discussed. It also includes a comparison of the process of 3D printed tablets and conventional methods of manufacturing. The significance of 3D printing in novel dosage form and augmenting 3DP with hot-melt extrusion (HME) method is discussed. The regulatory concerns in adopting this technology on a large-scale are addressed. 3DP technology could rapidly print transdermal needles, buccal patches, and different shapes of vaginal rings and proved it can be a versatile tool in formulation technology. As the pharmaceutical industry involves stringent regulations, certain aspects need to be considered by regulatory authorities before implementing this tool into commercial-scale manufacturing.
Cite this article:
Hemanth KG, Hemamanjushree S, Abhinaya N, Raveendra Pai, Girish Pai K. 3D Printing: A Review on Technology, Role in Novel Dosage Forms and Regulatory Perspective. Research J. Pharm. and Tech. 2021; 14(1):562-572. doi: 10.5958/0974-360X.2021.00102.5
Hemanth KG, Hemamanjushree S, Abhinaya N, Raveendra Pai, Girish Pai K. 3D Printing: A Review on Technology, Role in Novel Dosage Forms and Regulatory Perspective. Research J. Pharm. and Tech. 2021; 14(1):562-572. doi: 10.5958/0974-360X.2021.00102.5 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2021-14-1-102
1. Christopher B. 3D Printing - The Next Industrial Revolution [Internet]. 2013 [cited 2020 Apr 24]. Available from: https://www.explainingthefuture.com/3dp_book.html
2. Basit AW, Gaisford S, editors. 3D Printing of Pharmaceuticals [Internet]. 1st ed. Springer International Publishing; 2018 [cited 2020 Mar 21]. (AAPS Advances in the Pharmaceutical Sciences Series; vol. 31). Available from: http://link.springer.com/ 10.1007/978-3-319-90755-0
3. Gross BC, Erkal JL, Lockwood SY, Chen C, Spence DM. Evaluation of 3D Printing and Its Potential Impact on Biotechnology and the Chemical Sciences. Anal Chem [Internet]. 2014 Apr [cited 2020 Mar 21];86(7):3240–53. Available from: https://pubs.acs.org/doi/10.1021/ac403397r
4. Hull CW. Method for production of three-dimensional objects by stereolithography [Internet]. US5762856A, 1998 [cited 2020 Apr 24]. Available from: https://patents.google.com/patent/ US5762856A/en
5. Yu DG, Zhu L-M, Branford-White CJ, Yang XL. Three-Dimensional Printing in Pharmaceutics: Promises and Problems. J Pharm Sci [Internet]. 2008 Sep [cited 2020 Mar 21];97(9):3666–90. Available from: https://l inkinghub.elsevier.com/retrieve/pii/S0022354916326909
6. Dumitrescu I-B. The age of Pharmaceutical 3D printing. Technological and therapeuticcal implications of additive manufacturing. FARMACIA [Internet]. 2018 Jun 30 [cited 2020 Apr 5];66(3):365–89. Available from: http://farmaciajournal.com/ issue-articles/the-age-of-pharmaceutical-3d-printing-technological-and-therapeutical-implications-of-additive-manufacturing/
7. Rolls-Royce to 3D print aerospace parts with SLM 500 [Internet]. 3D Printing Industry. 2019 [cited 2020 Aug 10]. Available from: https://3dprintingindustry.com/news/rolls-royce-to-3d-print-aerospace-parts-with-slm-500-157331/
8. Sirringhaus H, Kawase T, Friend RH, Shimoda T, Inbasekaran M, Wu W, et al. High-Resolution Inkjet Printing of All-Polymer Transistor Circuits. Science [Internet]. 2000 Dec 15 [cited 2020 Mar 21];290(5499):2123–6. Available from: https:// www.sciencemag.org/lookup/doi/10.1126/science.290.5499.2123
9. Boland T, Mironov V, Gutowska A, Roth ElisabethA, Markwald RR. Cell and organ printing 2: Fusion of cell aggregates in three-dimensional gels. Anat Rec [Internet]. 2003 Jun [cited 2020 Mar 21];272A (2):497–502. Available from: http://doi.wiley.com/ 10.1002/ar.a.10059
10. Economidou SN, Pere CPP, Reid A, Uddin MdJ, Windmill JFC, Lamprou DA, et al. 3D printed microneedle patches using stereolithography (SLA) for intradermal insulin delivery. Mater Sci Eng C [Internet]. 2019 Sep [cited 2020 Mar 21];102: 743–55. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0928493118330704
11. Hager I, Golonka A, Putanowicz R. 3D Printing of Buildings and Building Components as the Future of Sustainable Construction? Procedia Eng [Internet]. 2016 [cited 2020 Mar 21];151: 292–9. Available from: https://linkinghub.elsevier.com/retrieve/pii/S1877705816317453
12. Yang F, Zhang M, Bhandari B. Recent development in 3D food printing. Crit Rev Food Sci Nutr [Internet]. 2017 Sep 22 [cited 2020 Apr 24];57(14):3145–53. Available from: https://doi.org/ 10.1080/10408398.2015.1094732
13. Michael M. Food 3D Printing: What Happened to 3D-Printed Food for the Elderly? [Internet]. 3DPrint.com | The Voice of 3D Printing / Additive Manufacturing. 2020 [cited 2020 Jun 6]. Available from: https://3dprint.com/267312/food-3d-printing-what-happened-to-3d-printed-food-for-the-elderly/
14. PTI. 3D Printed Artificial Corneas May Work in Place of Eye Donations [Internet]. TheQuint. 2019 [cited 2020 Aug 10]. Available from: https://fit.thequint.com/health-news/scientists-3d-printed-artificial-corneas-mimic-human-eyes
15. Trenfield SJ, Awad A, Goyanes A, Gaisford S, Basit AW. 3D Printing Pharmaceuticals: Drug Development to Frontline Care. Trends Pharmacol Sci [Internet]. 2018 May [cited 2020 Mar 21];39(5):440–51. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0165614718300440
16. Rantanen J, Sandler N. Printing and Additive Manufacturing. AAPS PharmSciTech [Internet]. 2019 Oct [cited 2020 Mar 21];20(7):261, s12249-019-1427–7. Available from: http://link.springer.com/10.1208/s12249-019-1427-7
17. How can 3D printed orphan drugs improve life of patients? - The point of view of Antonio Benedetti, CEO of Cycle Pharmaceuticals [Internet]. 3D ADEPT MEDIA. 2018 [cited 2020 Jun 6]. Available from: https://3dadept.com/how-can-3d-printed-orphan-drugs-improve-life-of-patients-the-point-of-view-of-antonio-benedetti-ceo-of-cycle-pharmaceuticals/
18. Khrystyna O. 5 Differences Between Open Source and Closed Source Software - API2Cart [Internet]. API2Cart - Unified Shopping Cart Data Interface. 2019 [cited 2020 Apr 24]. Available from: https://api2cart.com/business/5-differences-between-open-source-and-closed-source-software/
19. A List of CAD Software Programs, Both Paid and Free - Core77 [Internet]. 2017 [cited 2020 Apr 24]. Available from: https://www.core77.com/posts/67714/A-List-of-CAD-Software-Programs-Both-Paid-and-Free.
20. Gundeti SR. A Comparison Study of 3D Scanners for Diagnosing Deviations in Their Outputs Using Reverse Engineering Technique. IOSR J Mech Civ Eng. 2017;14(03):26–32.
21. Pierre-Antoine A. 3D scanners categories - guide on the different types of 3D scanners [Internet]. Aniwaa. 2020 [cited 2020 Apr 24]. Available from: https://www.aniwaa.com/guide/3d-scanners/3d-scanners-categories/
22. Farahani N, Braun A, Jutt D, Huffman T, Reder N, Liu Z, et al. Three-dimensional Imaging and Scanning: Current and Future Applications for Pathology. J Pathol Inf [Internet]. 2017/10/03 ed. 2017; 8:36. Available from: https://www.ncbi.nlm.nih.gov/ pubmed/28966836
23. Vanderploeg A, Lee S-E, Mamp M. The application of 3D printing technology in the fashion industry. Int J Fash Des Technol Educ. 2016;10(2):170–9.
24. Hemamanjushree S, Tippavajhala VK. Simulation of Unit Operations in Formulation Development of Tablets Using Computational Fluid Dynamics. AAPS PharmSciTech. 2020 Mar 12;21(3):103.
25. Rapp BE. Computational Fluid Dynamics. In: Microfluidics: Modelling, Mechanics and Mathematics [Internet]. Elsevier; 2017 [cited 2020 Mar 21]. p. 609–22. Available from: https://linkinghub.elsevier.com/retrieve/pii/B9781455731411500290
26. Comminal R, Serdeczny MP, Pedersen DB, Spangenberg J. Numerical Modeling of the Material Deposition and Contouring Precision in Fused Deposition Modeling. undefined [Internet]. 2018 [cited 2020 Apr 24]; Available from: https://www.semanticscholar.org/paper/Numerical-Modeling-of-the-Material-Deposition-and-Comminal-Serdeczny/f0defcf37f8cd057885c8b5e8d1b9cdb024fbae8
27. Alhnan MA, Okwuosa TC, Sadia M, Wan K-W, Ahmed W, Arafat B. Emergence of 3D Printed Dosage Forms: Opportunities and Challenges. Pharm Res [Internet]. 2016 Aug [cited 2020 Mar 21];33(8):1817–32. Available from: http://link.springer.com/10.1007/s11095-016-1933-1
28. Vuddanda PR, Alomari M, Dodoo CC, Trenfield SJ, Velaga S, Basit AW, et al. Personalisation of warfarin therapy using thermal ink-jet printing. Eur J Pharm Sci [Internet]. 2018 May [cited 2020 Mar 21]; 117:80–7. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0928098718300642
29. Cooley P, Wallace D, Antohe B. Applicatons of Ink-Jet Printing Technology to BioMEMS and Microfluidic Systems. :7.
30. Yu DG, Branford-White C, Yang Y-C, Zhu L-M, Welbeck EW, Yang X-L. A novel fast disintegrating tablet fabricated by three-dimensional printing. Drug Dev Ind Pharm [Internet]. 2009 Dec [cited 2020 Mar 21];35(12):1530–6. Available from: http://www.tandfonline.com/doi/full/10.3109/03639040903059359
31. Vithani K, Goyanes A, Jannin V, Basit AW, Gaisford S, Boyd BJ. An Overview of 3D Printing Technologies for Soft Materials and Potential Opportunities for Lipid-based Drug Delivery Systems. Pharm Res [Internet]. 2019 Jan [cited 2020 Mar 21];36(1):4. Available from: http://link.springer.com/ 10.1007/s11095-018-2531-1
32. Melchels FPW, Feijen J, Grijpma DW. A review on stereolithography and its applications in biomedical engineering. Biomaterials [Internet]. 2010 Aug [cited 2020 Mar 21];31(24):6121–30. Available from: https://l inkinghub.elsevier.com/retrieve/pii/S0142961210005661
33. Fina F, Goyanes A, Madla CM, Awad A, Trenfield SJ, Kuek JM, et al. 3D printing of drug-loaded gyroid lattices using selective laser sintering. Int J Pharm [Internet]. 2018 Aug [cited 2020 Mar 21];547(1–2):44–52. Available from: https://linkinghub.elsevier. com/retrieve/pii/S0378517318303545
34. Jingjunjiao Longa HG Jun Lua, Craig Buntd and Ali Seyfoddin. Application of Fused Deposition Modelling (FDM) Method of 3D Printing in Drug Delivery. Curr Pharm Des. 2017; 23:433–9.
35. 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. Int J Pharm [Internet]. 2016 Jul [cited 2020 Mar 21];509(1–2):255–63. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0378517316304161
36. Fu J, Yu X, Jin Y. 3D printing of vaginal rings with personalized shapes for controlled release of progesterone. Int J Pharm [Internet]. 2018 Mar [cited 2020 Mar 21];539(1–2):75–82. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0378517318300553
37. Tagami T, Hayashi N, Sakai N, Ozeki T. 3D printing of unique water-soluble polymer-based suppository shell for controlled drug release. Int J Pharm [Internet]. 2019 Sep [cited 2020 Mar 21];568:118494. Available from: https://linkinghub.elsevier.com/ retrieve/pii/S0378517319305368
38. Öblom H, Zhang J, Pimparade M, Speer I, Preis M, Repka M, et al. 3D-Printed Isoniazid Tablets for the Treatment and Prevention of Tuberculosis—Personalized Dosing and Drug Release. AAPS PharmSciTech [Internet]. 2019 Feb [cited 2020 Mar 21];20(2):52. Available from: http://link.springer.com/10.1208/s12249-018-1233-7
39. Chai X, Chai H, Wang X, Yang J, Li J, Zhao Y, et al. Fused Deposition Modeling (FDM) 3D Printed Tablets for Intragastric Floating Delivery of Domperidone. Sci Rep [Internet]. 2017 Dec [cited 2020 Mar 21];7(1):2829. Available from: http://www.nature.com/articles/s41598-017-03097-x
40. Arafat B, Wojsz M, Isreb A, Forbes RT, Isreb M, Ahmed W, et al. Tablet fragmentation without a disintegrant: A novel design approach for accelerating disintegration and drug release from 3D printed cellulosic tablets. Eur J Pharm Sci Off J Eur Fed Pharm Sci. 2018 Jun 15; 118:191–9.
41. Prausnitz MR, Langer R. Transdermal drug delivery. Nat Biotechnol [Internet]. 2008 Nov [cited 2020 Mar 21];26(11):1261–8. Available from: http://www.nature.com/articles/nbt.1504
42. Caudill CL, Perry JL, Tian S, Luft JC, DeSimone JM. Spatially controlled coating of continuous liquid interface production microneedles for transdermal protein delivery. J Control Release Off J Control Release Soc. 2018 28; 284:122–32.
43. Chinna Reddy P, Chaitanya KSC, Madhusudan Rao Y. A review on bioadhesive buccal drug delivery systems: current status of formulation and evaluation methods. DARU J Pharm Sci [Internet]. 2011 [cited 2020 Jun 6];19(6):385–403. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3436075/
44. Eleftheriadis GK, Ritzoulis C, Bouropoulos N, Tzetzis D, Andreadis DA, Boetker J, et al. Unidirectional drug release from 3D printed mucoadhesive buccal films using FDM technology: In vitro and ex vivo evaluation. Eur J Pharm Biopharm Off J Arbeitsgemeinschaft Pharm Verfahrenstechnik EV. 2019 Nov; 144:180–92.
45. Johansson EDB, Sitruk-Ware R. New delivery systems in contraception: vaginal rings. Am J Obstet Gynecol [Internet]. 2004 Apr 1 [cited 2020 Jun 6];190(4): S54–9. Available from: https://www.ajog.org/article/S0002-9378(04)00138-3/abstract
46. Tablet Formulation and Manufacturing [Internet]. Upperton Pharma Solutions. 2020 [cited 2020 Jun 7]. Available from: https://www.upperton.com/29th-april-2020-upperton-invest-500k-in-their-tablet-formulation-and-manufacturing-capabilities/
47. Hindiyeh M, Altalafha T, Al-Naerat M, Saidan H, Al-Salaymeh A, Sbeinati L, et al. Process Modification of Pharmaceutical Tablet Manufacturing Operations: An Eco-Efficiency Approach. Processes [Internet]. 2018 Feb 9 [cited 2020 Jun 6];6(2):15. Available from: http://www.mdpi.com/2227-9717/6/2/15
48. Committee for Human Medicinal Products. Guideline on Manufacture of the Finished Dosage Form. 2017;15.
49. Center for Drug Evaluation and Research. Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules Guidance for Industry. 2015 [cited 2020 Jul 6];10. Available from: https://www.fda.gov/media/87344/download
50. Patil H, Tiwari RV, Repka MA. Hot-Melt Extrusion: from Theory to Application in Pharmaceutical Formulation. AAPS PharmSciTech [Internet]. 2016 Feb [cited 2020 Mar 21];17(1):20–42. Available from: http://link.springer.com/ 10.1208/s12249-015-0360-7
51. Jonathan G. Just turn your pills into dinosaur sweets to ease the pain | Daily Mail Online [Internet]. 2015 [cited 2020 Apr 24]. Available from: https://www.dailymail.co.uk/health/article-3125396/Don-t-like-pills-Just-turn-dinosaur-sweets.html
52. Siyawamwaya M, du Toit LC, Kumar P, Choonara YE, Kondiah PPPD, Pillay V. 3D printed, controlled release, tritherapeutic tablet matrix for advanced anti-HIV-1 drug delivery. Eur J Pharm Biopharm [Internet]. 2019 May [cited 2020 Mar 21]; 138:99–110. Available from: https://linkinghub.elsevier.com/retrieve/pii/ S0939641118300493
53. Hot melt extrusion. Particle sciences drug development. 2011;3.
54. Mathew E, Pitzanti G, Larrañeta E, Lamprou DA. 3D Printing of Pharmaceuticals and Drug Delivery Devices. Pharmaceutics [Internet]. 2020 Mar 15 [cited 2020 Jun 6];12(3):266. Available from: https://www.mdpi.com/1999-4923/12/3/266
55. Park BJ, Choi HJ, Moon SJ, Kim SJ, Bajracharya R, Min JY, et al. Pharmaceutical applications of 3D printing technology: current understanding and future perspectives. J Pharm Investig [Internet]. 2018 Oct 29 [cited 2020 Mar 21]; Available from: http://link.springer.com/10.1007/s40005-018-00414-y
56. Mazzanti V, Malagutti L, Mollica F. FDM 3D printing of polymers containing natural Fillers: a review of their mechanical properties. Polymers. 2019;11(7):1094.
57. Technical Considerations for Additive Manufactured Medical Devices [Internet]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/technical-considerations-additive-manufactured-medical-devices-guidance-industry-and-food-and-drug
58. Di Prima M, Coburn J, Hwang D, Kelly J, Khairuzzaman A, Ricles L. Additively manufactured medical products – the FDA perspective. 3D Print Med [Internet]. 2016 Dec [cited 2020 Mar 21];2(1):1. Available from: https://threedmedprint. biomedcentral.com/articles/10.1186/s41205-016-0005-9
59. ZipDose® Technology [Internet]. Available from: https://www.spritam.com/#/hcp/zipdose-technology/manufactured-using-3d-printing
60. Lim SH, Kathuria H, Tan JJY, Kang L. 3D printed drug delivery and testing systems - a passing fad or the future? Adv Drug Deliv Rev [Internet]. 2018/05/21 ed. 2018 Jul; 132:139–68. Available from: https://www.ncbi.nlm.nih.gov/pubmed/29778901