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Formulation Development Studies of Three-Dimensional Printable Filaments Containing Eudragit S100 Polymer with High-Glass Transition Temperature

Year 2022, Volume: 4 Issue: 3, 143 - 151, 31.12.2022

Abstract

The aim of this study is to examine the formulation, process, and equipment conditions to obtain printable filaments for fused-deposition modelling three-dimensional printing (FDM-3DP) using Eudragit-S100 polymer, which is widely used in the pharmaceutical field and has a high glass transition temperature (Tg).
The filaments were extruded by a modified simple single screw extruder. The influence of powder preparation processes such as pre-plastification, sieving, drying, and the formulation factors, such as types and amounts of excipients on the quality of filaments were evaluated. The mechanical properties of filaments were determined manually. Structural integrity and homogeneity of filaments and the printed tablets were demonstrated by SEM. Finally, the printability of the filaments was shown by producing the tablets using an FDM-3D Printer.
When combining triacetin and citric acid, extrudable formulations with an adequate plastification were obtained. Magnesium stearate increased the output speed of the filament through the nozzle of the extruder. Furthermore, it was seen that simple modifications on the extruder and powder preparation process improved the printability of the filaments. A higher screw speed accelerated the output of the filaments while minimizing the filament diameter variability, which is a requirement for providing uninterrupted printing.
In conclusion, the filaments containing Eudragit S100 were successfully and reproducibly printed into round-shaped tablets after modification of the extruder and improvement of the formulation development processes. 

Supporting Institution

the Scientific & Technological Research Council of Turkey (TUBITAK), Dicle University Scientific Research Projects Coordination Unit (DUBAP).

Project Number

TUBITAK (219S197), DUBAP (ECZACILIK.20.004)

References

  • Beck, R.C.R., Chaves, P.S., Goyanes, A., Vukosavljevic, B., Buanz, A., Windbergs, M., et al. (2017) 3D printed tablets loaded with polymeric nanocapsules: An innovative approach to produce customized drug delivery systems. International Journal of Pharmaceutics, 528(1-2),268-79.
  • Bruce, L.D., Shah, N.H., Malick, A.W., Infeld, M.H., McGinity, J.W. (2005). Properties of hot-melt extruded tablet formulations for the colonic delivery of 5-aminosalicylic acid. European Journal of Pharmaceutics and Biopharmaceutics, 59(1),85-97.
  • Carlier, E., Marquette, S., Peerboom, C., Denis, L., Benali, S., Raquez, J.M. et al. (2019). Investigation of the parameters used in fused deposition modelling of poly (lactic acid) to optimize 3D printing sessions. International Journal of Pharmaceutics, 565,367-77.
  • Chai, X.Y., Chai, H.Y., Wang, X.Y., Yang, J.J., Li, J., Zhao, Y., et al. (2017) Fused Deposition Modelling (FDM) 3D Printed Tablets for Intragastric Floating Delivery of Domperidone. Scientific Reports,7.
  • Elkasabgy, N.A., Mahmoud, A.A., Maged, A. (2020). 3D printing: An appealing route for customized drug delivery systems. International Journal of Pharmaceutics, 588.
  • Genina, N., Hollander, J., Jukarainen, H., Makila, E., Salonen, J., Sandler, N. (2016). Ethylene vinyl acetate (EVA) as a new drug carrier for 3D printed medical drug delivery devices. European Journal of Pharmaceutical Sciences, 90,53-63.
  • Gioumouxouzis, C.I., Chatzitaki, A.T., Karavasili, C., Katsamenis, O.L., Tzetzis, D., Mystiridou, E. et al. (2018). Controlled Release of 5-Fluorouracil from Alginate Beads Encapsulated in 3D Printed pH-Responsive Solid Dosage Forms. AAPS PharmSciTech, 19(8),3362-75.
  • Goyanes, A., Martinez, P.R., Buanz, A., Basit, A.W., Gaisford, S. (2015) Effect of geometry on drug release from 3D printed tablets. International Journal of Pharmaceutics, 494(2),657-63.
  • Goyanes, A., Fina, F., Martorana, A., Sedough, D., Gaisford, S., Basit, A.W. (2017) Development of modified release 3D printed tablets (printlets) with pharmaceutical excipients using additive manufacturing. International Journal of Pharmaceutics, 527(1-2),21-30.
  • Kollamaram, G., Croker, D.M., Walker, G.M., Goyanes, A., Basit, A.W., Gaisford, S. (2018) Low temperature fused deposition modelling (FDM) 3D printing of thermolabile drugs. International Journal of Pharmaceutics, 545(1-2),144-52.
  • Okwuosa, T.C., Stefaniak, D., Arafat, B., Isreb, A., Wan, K.W., Alhnan, M.A. (2016) A Lower Temperature FDM 3D Printing for the Manufacture of Patient-Specific Immediate Release Tablets. Pharmaceutical Research, 33(11),2704-12.
  • Okwuosa, T.C., Sadia, M., Isreb, A., Habashy, R., Peak, M., Alhnan, M.A. (2021) Can filaments be stored as a shelf-item for on-demand manufacturing of oral 3D printed tablets? An initial stability assessment. International Journal of Pharmaceutics, 600.
  • Pereira, G.G., Figueiredo, S., Fernandes, A.I., Pinto, J.F. (2020). Polymer Selection for Hot-Melt Extrusion Coupled to Fused Deposition Modelling in Pharmaceutics. Pharmaceutics. 12(9).
  • Pietrzak, K., Isreb, A., Alhnan, M.A. (2015) A flexible-dose dispenser for immediate and extended release 3D printed tablets. European Journal of Pharmaceutics and Biopharmaceutics, 96,380-7.
  • Roulon, S., Soulairol, I., Lavastre, V., Payre, N., Cazes, M., Delbreilh, L. et al. (2021). Production of Reproducible Filament Batches for the Fabrication of 3D Printed Oral Forms. Pharmaceutics. 13(4).
  • Sadia, M., Sosnicka, A., Arafat, B., Isreb, A., Ahmed, W., Kelarakis, A. (2016). Adaptation of pharmaceutical excipients to FDM 3D printing for the fabrication of patient-tailored immediate release tablets. International Journal of Pharmaceutics, 513(1-2), 659-68.
Year 2022, Volume: 4 Issue: 3, 143 - 151, 31.12.2022

Abstract

Project Number

TUBITAK (219S197), DUBAP (ECZACILIK.20.004)

References

  • Beck, R.C.R., Chaves, P.S., Goyanes, A., Vukosavljevic, B., Buanz, A., Windbergs, M., et al. (2017) 3D printed tablets loaded with polymeric nanocapsules: An innovative approach to produce customized drug delivery systems. International Journal of Pharmaceutics, 528(1-2),268-79.
  • Bruce, L.D., Shah, N.H., Malick, A.W., Infeld, M.H., McGinity, J.W. (2005). Properties of hot-melt extruded tablet formulations for the colonic delivery of 5-aminosalicylic acid. European Journal of Pharmaceutics and Biopharmaceutics, 59(1),85-97.
  • Carlier, E., Marquette, S., Peerboom, C., Denis, L., Benali, S., Raquez, J.M. et al. (2019). Investigation of the parameters used in fused deposition modelling of poly (lactic acid) to optimize 3D printing sessions. International Journal of Pharmaceutics, 565,367-77.
  • Chai, X.Y., Chai, H.Y., Wang, X.Y., Yang, J.J., Li, J., Zhao, Y., et al. (2017) Fused Deposition Modelling (FDM) 3D Printed Tablets for Intragastric Floating Delivery of Domperidone. Scientific Reports,7.
  • Elkasabgy, N.A., Mahmoud, A.A., Maged, A. (2020). 3D printing: An appealing route for customized drug delivery systems. International Journal of Pharmaceutics, 588.
  • Genina, N., Hollander, J., Jukarainen, H., Makila, E., Salonen, J., Sandler, N. (2016). Ethylene vinyl acetate (EVA) as a new drug carrier for 3D printed medical drug delivery devices. European Journal of Pharmaceutical Sciences, 90,53-63.
  • Gioumouxouzis, C.I., Chatzitaki, A.T., Karavasili, C., Katsamenis, O.L., Tzetzis, D., Mystiridou, E. et al. (2018). Controlled Release of 5-Fluorouracil from Alginate Beads Encapsulated in 3D Printed pH-Responsive Solid Dosage Forms. AAPS PharmSciTech, 19(8),3362-75.
  • Goyanes, A., Martinez, P.R., Buanz, A., Basit, A.W., Gaisford, S. (2015) Effect of geometry on drug release from 3D printed tablets. International Journal of Pharmaceutics, 494(2),657-63.
  • Goyanes, A., Fina, F., Martorana, A., Sedough, D., Gaisford, S., Basit, A.W. (2017) Development of modified release 3D printed tablets (printlets) with pharmaceutical excipients using additive manufacturing. International Journal of Pharmaceutics, 527(1-2),21-30.
  • Kollamaram, G., Croker, D.M., Walker, G.M., Goyanes, A., Basit, A.W., Gaisford, S. (2018) Low temperature fused deposition modelling (FDM) 3D printing of thermolabile drugs. International Journal of Pharmaceutics, 545(1-2),144-52.
  • Okwuosa, T.C., Stefaniak, D., Arafat, B., Isreb, A., Wan, K.W., Alhnan, M.A. (2016) A Lower Temperature FDM 3D Printing for the Manufacture of Patient-Specific Immediate Release Tablets. Pharmaceutical Research, 33(11),2704-12.
  • Okwuosa, T.C., Sadia, M., Isreb, A., Habashy, R., Peak, M., Alhnan, M.A. (2021) Can filaments be stored as a shelf-item for on-demand manufacturing of oral 3D printed tablets? An initial stability assessment. International Journal of Pharmaceutics, 600.
  • Pereira, G.G., Figueiredo, S., Fernandes, A.I., Pinto, J.F. (2020). Polymer Selection for Hot-Melt Extrusion Coupled to Fused Deposition Modelling in Pharmaceutics. Pharmaceutics. 12(9).
  • Pietrzak, K., Isreb, A., Alhnan, M.A. (2015) A flexible-dose dispenser for immediate and extended release 3D printed tablets. European Journal of Pharmaceutics and Biopharmaceutics, 96,380-7.
  • Roulon, S., Soulairol, I., Lavastre, V., Payre, N., Cazes, M., Delbreilh, L. et al. (2021). Production of Reproducible Filament Batches for the Fabrication of 3D Printed Oral Forms. Pharmaceutics. 13(4).
  • Sadia, M., Sosnicka, A., Arafat, B., Isreb, A., Ahmed, W., Kelarakis, A. (2016). Adaptation of pharmaceutical excipients to FDM 3D printing for the fabrication of patient-tailored immediate release tablets. International Journal of Pharmaceutics, 513(1-2), 659-68.
There are 16 citations in total.

Details

Primary Language English
Subjects Pharmacology and Pharmaceutical Sciences
Journal Section Araştırma Makalesi
Authors

Cennet Duran 0000-0002-1701-8536

Diren Sarısaltık Yaşın 0000-0001-9549-8857

Sevgi Takka 0000-0001-6451-0497

Project Number TUBITAK (219S197), DUBAP (ECZACILIK.20.004)
Publication Date December 31, 2022
Published in Issue Year 2022 Volume: 4 Issue: 3

Cite

APA Duran, C., Sarısaltık Yaşın, D., & Takka, S. (2022). Formulation Development Studies of Three-Dimensional Printable Filaments Containing Eudragit S100 Polymer with High-Glass Transition Temperature. Journal of Gazi University Health Sciences Institute, 4(3), 143-151.