Preview

Drug development & registration

Advanced search

THREE-DIMENSIONAL PRINTING TECHNOLOGY FOR THE PRODUCTION OF DOSAGE FORMS

Abstract

The development of personalized medicine requires new approaches to the development of dosage forms (DF), one such approach is rapid prototyping or in a different way the three-dimensional printing of tablets, plasters and other DF. Since the principle of individual dosing, the exact spatial arrangement of the pharmaceutical substance (PS), the possibility of using various geometric tablet forms to adjust the release rate, depending on the patient's need, is also possible in this approach, moreover, when creating a DF for the presented technology, it is possible to create and Quickly adjust the release profile according to the patient's requirements. A special impetus to the development of this technology was the recognition of the scalability of rapid prototyping and the release in 2016 in the US: with the approval of the FDA (Food and Drug Administration) 3D-printed orodispersible tablet Spritam® (levetiracetam). In this review we present methods of production of DF by the method of three-dimensional printing, such as the Theriform® process, stereolithography, extrusion, continuous inkjet printing, impregnated thread printing, microprojection, etc., classification of 3D printing types and features of each type of printing and equipment, on which the main technological process is produced. For the sake of clarity of the processes, the compositions and auxiliary substances used (AS), for example biodegradable polymers such as PLA, PLGA, etc., compositions of «ink» and powder substrates required for each type of process are given, as well as experimental data obtained from literature sources, curves release and technological properties of model samples. The possibilities demonstrated by the 3D printing of drugs to researchers and developers of the DF, in particular the rapid development and production of combinations of several PS with pulsatile, controlled, immediate or any other type of sequential release of the present FS in one DF are demonstrated. The evaluation of design features, advantages and disadvantages is carried out and the main components of the equipment for 3D DF printing are shown, the main attention is paid to such elements as printheads. it is their speed, mechanism of action and device that determines the type of rapid prototyping and the properties of the received DF. Conclusions about the prospects of this direction, in general, and of each technology separately, are evaluated, the advantages and disadvantages of the presented methods of DF production are estimated.

About the Authors

E. V. Blynskaya
«Scientific Research Institute of Pharmacology named after. V. V. Zakusov»
Russian Federation


S. V. Tishkov
«Scientific Research Institute of Pharmacology named after. V. V. Zakusov»
Russian Federation


K. V. Alekseev
Medical University «REAVIZ»
Russian Federation


References

1. Terent’eva O. A., Flisyuk E. V. About the possibilities of using 3D printing technologies to create personalized medicines // Science and humanity. The role of technology and science in the modern world. Materialy mezhdunarodnoi nauchno-prakticheskoi koferentsii. 2016. P. 15–18.

2. Aho J., Boetker J. P., Baldursdottir S. et al. Rheology as a tool for evaluation of melt processability of innovative dosage forms // International journal of pharmaceutics. 2015. V. 494. № 2. P. 623–642.

3. Alomari M., Mohamed, F. H., Basit, A. W. et al. Personalised dosing: printing a dose of one’s own medicine // International journal of pharmaceutics. 2015. V. 494. № 2. P. 568–577.

4. Badgujar B., Mundada A. The technologies used for developing orally disintegrating tablets: a review // Acta pharmaceutica. 2011. V. 61. № 2. P. 117–139.

5. Chua C. K., Leong K. F., An J. Introduction to rapid prototyping of biomaterials // Rapid prototyping of biomaterials. 2014. P. 1–15.

6. Chia H. N., Wu B. M. Recent advances in 3D printing of biomaterials // Journal of biological engineering. 2015. V. 9. № 1. P. 4.

7. De Groot N. L., Spiegel B. M. R., van Haalen H. G. M. et al. Gastroprotective strategies in chronic NSAID users: a costeffectiveness analysis comparing singletablet formulations with individual components // Value in Health. 2013. V 16. № 5. P. 769–777.

8. Dimitrov D., Schreve K., De Beer N. Advances in three dimensional printing– state of the art and future perspectives // Rapid Prototyping Journal. 2006. V. 12. № 3. P. 136–147.

9. Daly R., Harrington T. S., Martin G. D. et al. Inkjet printing for pharmaceutics – a review of research and manufacturing // International journal of pharmaceutics. 2015. V. 494. № 2. P. 554–567.

10. Elele E., Shen, Y., Susarla, R. et al. Electrodeless electrohydrodynamic drop-on-demand encapsulation of drugs into porous polymer films for fabrication of personalized dosage units // Journal of pharmaceutical sciences. 2012. V. 101. № 7. P. 2523–2533.

11. Goyanes A. Buanz A. B., Basit A. W. et al. Fused-filament 3D printing (3DP) for fabrication of tablets // International journal of pharmaceutics. 2014. V. 476. № 1–2. P. 88–92.

12. Goyanes A., Buanz A. B., Hatton G. B. et al. 3D printing of modified-release aminosalicylate (4-ASA and 5-ASA) tablets // European Journal of Pharmaceutics and Biopharmaceutics. 2015. V. 89. P. 157–162.

13. Gittard S. D., Narayan R. J. Laser direct writing of micro-and nano-scale medical devices // Expert review of medical devices. 2010. V. 7. № 3. P. 343–356.

14. Günther D., Heymel B., Franz J. et al. Continuous 3D-printing for additive manufacturing // Rapid Prototyping Journal. 2014. V. 20. № 4. P. 320–327.

15. Khaled S. A. Burley, J. C., Alexander, M. R. et al. Desktop 3D printing of controlled release pharmaceutical bilayer tablets // International journal of pharmaceutics. 2014. V. 461. № 1–2. P. 105–111.

16. Kuang M., Wang L., Song Y. Controllable printing droplets for high‐resolution patterns // Advanced materials. 2014. V. 26. № 40. Р. 6950–6958.

17. Katstra W. E., Palazzolo R. D., Rowe C. W. et al. Oral dosage forms fabricated by Three Dimensional Printing™ // Journal of controlled release. 2000. V. 66. № 1. P. 1–9.

18. Lee J. Y., Choi B., Wu B. et al. Customized biomimetic scaffolds created by indirect three-dimensional printing for tissue engineering // Biofabrication. 2013. V. 5. № 4. P. 45.

19. Lewis J. A., Gratson G. M. Direct writing in three dimensions // Materials today. 2004. V. 7. № 7. P. 32–39.

20. Moulton S. E., Wallace G. G. 3-dimensional (3D) fabricated polymer based drug delivery systems // Journal of Controlled Release. 2014. V. 193. P. 27–34.

21. Mohanty S., Larsen L. B., Trifol J. et al. Fabrication of scalable and structured tissue engineering scaffolds using water dissolvable sacrificial 3D printed moulds // Materials Science and Engineering: 2015. V. 55. P. 569–578.

22. Melchels F. P. W., Feijen J., Grijpma D. W. A review on stereolithography and its applications in biomedical engineering // Biomaterials. 2010. V. 31. № 24. P. 6121–6130.

23. Pietrzak K., Isreb A., Alhnan M. A. A flexible-dose dispenser for immediate and extended release 3D printed tablets // European Journal of Pharmaceutics and Biopharmaceutics. 2015. V. 96. P. 380–387.

24. Siegel R. A., Rathbone M. J. Overview of controlled release mechanisms // Fundamentals and applications of controlled release drug delivery. Springer US, 2012. P. 19–43.

25. Patent USA 5204055. Three-dimensional printing techniques / Sachs E. M. et al. 1993.

26. Sandler N., Määttänen A., Ihalainen P et al. Inkjet printing of drug substances and use of porous substrates‐towards individualized dosing // Journal of pharmaceutical sciences. 2011. V. 100. № 8. P. 3386–3395.

27. Skowyra J., Pietrzak K., Alhnan M. A. Fabrication of extended-release patienttailored prednisolone tablets via fused deposition modelling (FDM) 3D printing // European Journal of Pharmaceutical Sciences. 2015. V. 68. P. 11–17.

28. Thakral S., Thakral N. K., Majumdar D. K. Eudragit®: a technology evaluation // Expert opinion on drug delivery. 2013. V. 10. № 1. P. 131–149.

29. Rowe C. W., Katstra W. E., Palazzolo R. D. et al. Multimechanism oral dosage forms fabricated by three dimensional printing™ // Journal of controlled release. 2000. V. 66. № 1. P. 11–17.

30. Yu D. G., Zhu L. M., Branford-White C. J. et al. Three-dimensional printing in pharmaceutics: promises and problems // Journal of pharmaceutical sciences. 2008. V. 97. № 9. P. 3666–3690.

31. Yun Y. H., Kim J. D., Lee B. K. et al. Polymer inkjet printing: Construction of three-dimensional structures at microscale by repeated lamination // Macromolecular research. 2009. V. 17. № 3. P. 197–202.


Review

For citations:


Blynskaya E.V., Tishkov S.V., Alekseev K.V. THREE-DIMENSIONAL PRINTING TECHNOLOGY FOR THE PRODUCTION OF DOSAGE FORMS. Drug development & registration. 2018;(3):10-19. (In Russ.)

Views: 1014


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2305-2066 (Print)
ISSN 2658-5049 (Online)