3D PRINTING OF PHARMACEUTICALS – A POTENTIAL TECHNOLOGY IN DEVELOPING PERSONALIZED MEDICINE
DOI:
https://doi.org/10.22270/ajprd.v6i3.375Keywords:
Three dimensional printing, personalized medicine, novel drug deliveryAbstract
The 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. Even though this technology exists for a long time it is of public interest highly now due to the approval of 3-D printed tablet and other medical devices and also with the advent of USFDA’s guidance on technical considerations specific to devices using additive manufacturing which encompasses 3-dimensional (3D) printing has triggered many thoughts about this technology which needs to be considered for successful delivery of intended product. This paper presents regulatory agencies expectations, limitations, problems in establishing such setups for production of drug products, advantages, disadvantages, applications, methods and associated risks involved in manufacturing. It also provides the comprehensive review of the current status of research and development on this platform.
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References
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26. FDA SPRITAM (Levetiracetam) Tablets. Available online: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207958Orig1s000TOC.cfm
27. Pharmaceuticals, A. 3D Printing. Available online: https://www.aprecia.com/zipdose-platform/3dprinting.php
28. Khaled SA, Burley JC, Alexander MR, Yang J, Roberts CJ. 3D printing of five-in-one dose combination polypill with defined immediate and sustained release profiles. Journal of Controlled Release. 2015; 217: 308–14
29. Khaled SA, Burley JC, Alexander MR, Yang J, Roberts CJ. 3D printing of tablets containing multiple drugs with defined release profiles. International Journal of Pharmaceutics. 2015; 494(2): 643-50
30. 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. Journal of Pharmaceutical Sciences. 2008; 97 (7): 2619–36.
31. Lee BK, Yun YH, Choi JS, Choi YC, Kim JD, Cho YW. Fabrication of drug-loaded polymer microparticles with arbitrary geometries using a piezoelectric inkjet printing system. International Journal of Pharmaceutics. 2012; 427 (2): 305–10.
32. Goole J; Amighi K. 3D printing in pharmaceutics: A new tool for designing customized drug delivery systems. International Journal of Pharmaceutics. 2016; 499, 376–94
33. Melchels FPW, Feijen J, Grijpma DW. A review on stereolithography and its applications in biomedical engineering. Biomaterials. 2010; 31(24): 6121–30.
34. Schmidt M, Pohle D, Rechtenwald T. Selective laser sintering of PEEK. CIRP Annals Manufacturing Technology. 2007; 56(1): 205–8.
35. Katstra WE, Palazzolo RD, Rowe CW, Giritlioglu B, Teung P, Cima MJ. Oral dosage forms fabricated by three dimensional printing™. Journal of Controlled Release. 2000; 66(1):1–9.
36. Goyanes A, Wang J, Buanz A, Martínez-Pacheco R, Telford R, Gaisford S, Basit AW. 3D Printing of Medicines: Engineering Novel Oral Devices with Unique Design and Drug Release Characteristics. 2015; 12(11):4077-84
37. Chai X, Chai H, Wang X, Yang J, Li J, Zhao Y, Cai W, Tao T, Xiang X. Fused Deposition Modeling (FDM)3D Printed Tablets for Intragastric Floating Delivery of Domperidone. Scientific Reports. 2017; 7: 2829.
38. Skowyra J, Pietrzak K, Alhnan MA. Fabrication of extended release patient-tailored prednisolone tablets via fused deposition modelling (FDM) 3D printing. European Journal of Pharmaceutical Sciences. 2015; 68:11–7
39. 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. 2014; 89: 157–62
40. Pietrzak K, Isreb A, Alhnan MA. A flexible-dose dispenser for immediate and extended release 3D printed tablets. European Journal of Pharmaceutics and Biopharmaceutics. 2015; 96:380–7.
41. Khaled SA, Burley JC, Alexander MR, Roberts CJ. Desktop 3D printing of controlled release pharmaceutical bilayer tablets. International Journal of Pharmaceutics. 2014; 461 (1–2): 105–11.
42. Khaled SA, Burley JC, Alexander MR, Yang J, Roberts CJ. 3D printing of tablets containing multiple drugs with defined release profiles. International Journal of Pharmaceutics. 2015; 494(2): 643–50.
43. Okwuosa TC, Stefaniak D, Arafat B, Isreb A, Ka-Wai W, Alhnan MA. A Lower Temperature FDM 3D Printing for the Manufacture of Patient-Specific Immediate Release Tablets, Pharmaceutical Research. 2016; 33:2704–12
44. Yu DG, Zhu L-M, Branford-White CJ, Yang XL. Threedimensional printing in pharmaceutics: promises and problems. Journal of Pharmaceutical Sciences. 2008; 97(9): 3666–90.
45. Huang SH, Liu P, Mokasdar A, Hou L. Additive manufacturing and its societal impact: a literature review. International Journal of Advanced Manufacturing Technology. 2013; 67(5–8):1191–203.
46. Gaylo CM, Pryor TJ, Fairweather JA, Weitzel DE. Apparatus, systems and methods for use in three-dimensional printing. In.:Google Patents. Available online: https://patents.google.com/patent/WO2004005014A2/en?inventor=Chistopher+M+Gaylo
2. Diogo JH. 3D Printing of Pharmaceutical Drug Delivery Systems. Archives of Organic and Inorganic Chemical Sciences. 2018; 1(2). AOICS.MS.ID.000109.
3. Andrea AK, Marta GP, Dolores RS. Personalised 3D Printed Medicines: Which Techniques and Polymers Are More Successful?. Bioengineering. 2017; 4(79) , 1-16
4. Alhnan MA, Okwuosa TC, Muzna S, WaiWan K, Ahmed W, Arafat B. Emergence of 3D Printed Dosage Forms: Opportunities and Challenges. Pharmaceutical Research. 2016);33:1817–32
5. Available online: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/3DPrintingofMedicalDevices/default.htm
6. Available online: http://cbm.msoe.edu/markMyweb/printResources/documents/historyOf3DPrinting.pdf
7. Wang, J, Goyanes A, Gaisford S, Basit AW. Stereolithographic (SLA) 3D printing of oral modified-release dosage forms. International Journal of Pharmaceutics. 2016; 503, 207–212.
8. Prasad LK, Smyth H. 3D printing technologies for drug delivery: A review. Drug Development and Industrial Pharmacy. 2016, 42, 1019–31.
9. Food and Drug Administration, 2017. Guidance for Industry: Technical Considerations for Additive Manufactured Medical Devices. Center for Devices and Radiological Health Center for Biologics Evaluation and Research, U.S. Department of Health and Human Services. Available online: https://www.fda.gov/
downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM499809.pdf
10. Food and Drug Administration, 2002, General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, U.S. Department Of Health and Human Services. Available online: https://www.fda.gov/downloads/medicaldevices/.../ucm085371.pdf
11. Deciding When to Submit a 510(k) for a Change to an Existing Device. Available online: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm)
12. 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes. Available online: www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080194.pdf
13. Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process. Available online: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm089360.pdf
14. Changes or Modifications During the Conduct of a Clinical Investigation. Available online: www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm082158.pdf
15. Outterson K. Regulating compounding pharmacies after NECC. The New England Journal of Medicine. 2012; 367(21):1969–72.
16. Drues M. The case of the New England Compounding Center. Healthcare packaging. 8/11/15. Available from: http://www.healthcarepackaging.com/case-new-england-compoundingcenter.
17. Sun L. FDA finds widespread safety issues at compounding pharmacies. In.Washington Post: Health & Science. 2013.
18. 21 CFR 200, Food and Drug Administration, https://www.gpo.gov/fdsys/granule/CFR-2012-title21-vol4/CFR-2012-title21-vol4-part200
19. CFR 300, Food and Drug Administration, https://www.gpo.gov/fdsys/granule/CFR-2009-title21-vol5/CFR-2009-title21-vol5-part300
20. Colleen D, Lisa B, Matthew J, Farah T, James B, Gail D, Celeste L, MadaganKevin, MaidenTodd, Tracy Q, John S. 3D printing of medical devices: when a novel technology meets traditional legal principles. Reedsmith. 9/12/15. Available from: http://www.reedsmith.com/3D-Printing-of-Medical-Devices–When-a-Novel-Technology-Meets-Traditional-Legal-Principles-09-09-2015/.
21. Drues M. Printing medical devices at home is just the beginning: Part II. 8/12/15. Available from: http://www.healthcarepackaging.com/trends-and-issues/3d-printingadditivemanufacturing/printing-medical-devices-home-just-beginning.
22. Sparrow N. FDA tackles opportunities, challenges of 3D-printed medical devices. In.Plastics today: Medicine; 2014. Available online: https://www.plasticstoday.com/content/fda-tackles-opportunities-challenges-3d-printed-medical-devices/13081585320639
23. Pollack S, Coburn J. FDA goes 3-D. 30/11/15. Available from: http://blogs.fda.gov/fdavoice/index.php/tag/osel/.
24. Aprecia Zipdose® technology. 12/3/2015. Available from: https://aprecia.com/zipdose-platform/zipdose-technology.php
25. Jassim-Jaboori AH, Oyewumi MO. 3D Printing Technology in Pharmaceutical Drug Delivery: Prospects and Challenges. Journal of Biomolecular Research & Therapeutics; 2015; 4(4): 1-3.
26. FDA SPRITAM (Levetiracetam) Tablets. Available online: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207958Orig1s000TOC.cfm
27. Pharmaceuticals, A. 3D Printing. Available online: https://www.aprecia.com/zipdose-platform/3dprinting.php
28. Khaled SA, Burley JC, Alexander MR, Yang J, Roberts CJ. 3D printing of five-in-one dose combination polypill with defined immediate and sustained release profiles. Journal of Controlled Release. 2015; 217: 308–14
29. Khaled SA, Burley JC, Alexander MR, Yang J, Roberts CJ. 3D printing of tablets containing multiple drugs with defined release profiles. International Journal of Pharmaceutics. 2015; 494(2): 643-50
30. 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. Journal of Pharmaceutical Sciences. 2008; 97 (7): 2619–36.
31. Lee BK, Yun YH, Choi JS, Choi YC, Kim JD, Cho YW. Fabrication of drug-loaded polymer microparticles with arbitrary geometries using a piezoelectric inkjet printing system. International Journal of Pharmaceutics. 2012; 427 (2): 305–10.
32. Goole J; Amighi K. 3D printing in pharmaceutics: A new tool for designing customized drug delivery systems. International Journal of Pharmaceutics. 2016; 499, 376–94
33. Melchels FPW, Feijen J, Grijpma DW. A review on stereolithography and its applications in biomedical engineering. Biomaterials. 2010; 31(24): 6121–30.
34. Schmidt M, Pohle D, Rechtenwald T. Selective laser sintering of PEEK. CIRP Annals Manufacturing Technology. 2007; 56(1): 205–8.
35. Katstra WE, Palazzolo RD, Rowe CW, Giritlioglu B, Teung P, Cima MJ. Oral dosage forms fabricated by three dimensional printing™. Journal of Controlled Release. 2000; 66(1):1–9.
36. Goyanes A, Wang J, Buanz A, Martínez-Pacheco R, Telford R, Gaisford S, Basit AW. 3D Printing of Medicines: Engineering Novel Oral Devices with Unique Design and Drug Release Characteristics. 2015; 12(11):4077-84
37. Chai X, Chai H, Wang X, Yang J, Li J, Zhao Y, Cai W, Tao T, Xiang X. Fused Deposition Modeling (FDM)3D Printed Tablets for Intragastric Floating Delivery of Domperidone. Scientific Reports. 2017; 7: 2829.
38. Skowyra J, Pietrzak K, Alhnan MA. Fabrication of extended release patient-tailored prednisolone tablets via fused deposition modelling (FDM) 3D printing. European Journal of Pharmaceutical Sciences. 2015; 68:11–7
39. 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. 2014; 89: 157–62
40. Pietrzak K, Isreb A, Alhnan MA. A flexible-dose dispenser for immediate and extended release 3D printed tablets. European Journal of Pharmaceutics and Biopharmaceutics. 2015; 96:380–7.
41. Khaled SA, Burley JC, Alexander MR, Roberts CJ. Desktop 3D printing of controlled release pharmaceutical bilayer tablets. International Journal of Pharmaceutics. 2014; 461 (1–2): 105–11.
42. Khaled SA, Burley JC, Alexander MR, Yang J, Roberts CJ. 3D printing of tablets containing multiple drugs with defined release profiles. International Journal of Pharmaceutics. 2015; 494(2): 643–50.
43. Okwuosa TC, Stefaniak D, Arafat B, Isreb A, Ka-Wai W, Alhnan MA. A Lower Temperature FDM 3D Printing for the Manufacture of Patient-Specific Immediate Release Tablets, Pharmaceutical Research. 2016; 33:2704–12
44. Yu DG, Zhu L-M, Branford-White CJ, Yang XL. Threedimensional printing in pharmaceutics: promises and problems. Journal of Pharmaceutical Sciences. 2008; 97(9): 3666–90.
45. Huang SH, Liu P, Mokasdar A, Hou L. Additive manufacturing and its societal impact: a literature review. International Journal of Advanced Manufacturing Technology. 2013; 67(5–8):1191–203.
46. Gaylo CM, Pryor TJ, Fairweather JA, Weitzel DE. Apparatus, systems and methods for use in three-dimensional printing. In.:Google Patents. Available online: https://patents.google.com/patent/WO2004005014A2/en?inventor=Chistopher+M+Gaylo
Published
2018-07-10
How to Cite
Jose, P. A., & GV, P. C. (2018). 3D PRINTING OF PHARMACEUTICALS – A POTENTIAL TECHNOLOGY IN DEVELOPING PERSONALIZED MEDICINE. Asian Journal of Pharmaceutical Research and Development, 6(3), 46–54. https://doi.org/10.22270/ajprd.v6i3.375
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Review Articles
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