Veering to a Continuous Platform of Fused Deposition Modeling Based 3D Printing for Pharmaceutical Dosage Forms: Understanding the Effect of Layer Orientation on Formulation Performance
Abstract
:1. Introduction
2. Materials and Methods
2.1. Materials
2.2. Solid-State Analysis (Pre-Printing Process)
2.2.1. Thermogravimetric Analysis (TGA)
2.2.2. Differential Scanning Calorimetry (DSC) Analysis
2.2.3. Powder X-Ray Diffraction (XRD) Analysis
2.2.4. Polarized Light Microscopy (PLM)
2.2.5. Fourier Transform Infrared Spectroscopy (FTIR)
2.3. Hot-Melt Extrusion (HME)
2.4. Designing and FDM 3D Printing of Formulations
2.5. Assessment of Printed Tablets
2.6. Evaluation of Dosage Form Breaking Force
2.7. In Vitro Release Performance Testing
2.8. Analytical Method
2.9. Statistics
3. Results
3.1. Pre-Formulation Characterization and Thermal Assessment
3.2. Processing FNB-Loaded Drug Filaments Using the HME Process
3.3. Characterization of FNB-Loaded Extruded Filaments
3.4. Print Quality Comparison between the Two Processes
3.5. Effect of Layer Orientation on Printlet Strength
- Testing when the printlets are placed horizontally: At both a 25% and 50% infill density, the print differences proved to be statistically significant as compared to the 75% infill density prints, where the difference in the force required to break them was not significant. In addition, as the infill density increased, the force required to break the printed tablet increased, which correlated to an increased strength due to reduced void spaces in the prints (Figure 6c). The printlets formulated using the continuous method broke with the print splitting in two pieces and with the split occurring along the axis of printing (45°), across all infill densities tested for the study. The reason for this split along the axis can be attributed to the fact that, when a force is applied at a 45° angle, it becomes resolved into two components, one that acts in line and the other along the axis of the printed angle. This split in the applied force prevents the crushing of the tablet and in turn, ends up splitting it along its printed axis. Comparatively, when printed using the conventionally used pharmaceutical FDM printing process, the tablets when tested in the horizontal orientation were crushed into small fragments.
- Testing when the printlets are placed vertically: As compared to the horizontal orientation for testing, the force required to break the printlet was significantly different across all the infill densities tested in this study. The force required to break a printlet with layers printed at 45° axes is greater as compared to the force required to break a printlet with layers printed at a 0° axis. This was the case for both the 50% and 75% infill printlets (Figure 6c). The printlets printed using both printers, when tested after being placed vertically, collapsed on their structure without showing any breakage post removal and had their height reduced due to compression because of the applied force (Figure 6b). For both prints, breakages or crushing of the printlets was seen for 4 and 5 units for the continuous and batch processes, respectively. This can be attributed to the large void spaces and weak internal structural strength of the print at low infill densities.
3.6. Performance Comparison Using In Vitro Release Study
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Process | Diameter (mm) | Height (mm) |
---|---|---|
Batch printing | 7.843 ± 0.294 | 4.967 ± 0.199 |
Continuous printing | 8.007 ± 0.055 | 5.004 ± 0.018 |
Reference | Test | Difference Factor (f1) | Similarity Factor (f2) |
---|---|---|---|
25B | 25C | 20.862 | 36.982 |
50B | 50C | 5.815 | 65.517 |
75B | 75C | 13.437 | 54.846 |
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Kulkarni, V.R.; Chakka, J.; Alkadi, F.; Maniruzzaman, M. Veering to a Continuous Platform of Fused Deposition Modeling Based 3D Printing for Pharmaceutical Dosage Forms: Understanding the Effect of Layer Orientation on Formulation Performance. Pharmaceutics 2023, 15, 1324. https://doi.org/10.3390/pharmaceutics15051324
Kulkarni VR, Chakka J, Alkadi F, Maniruzzaman M. Veering to a Continuous Platform of Fused Deposition Modeling Based 3D Printing for Pharmaceutical Dosage Forms: Understanding the Effect of Layer Orientation on Formulation Performance. Pharmaceutics. 2023; 15(5):1324. https://doi.org/10.3390/pharmaceutics15051324
Chicago/Turabian StyleKulkarni, Vineet R., Jaidev Chakka, Faez Alkadi, and Mohammed Maniruzzaman. 2023. "Veering to a Continuous Platform of Fused Deposition Modeling Based 3D Printing for Pharmaceutical Dosage Forms: Understanding the Effect of Layer Orientation on Formulation Performance" Pharmaceutics 15, no. 5: 1324. https://doi.org/10.3390/pharmaceutics15051324
APA StyleKulkarni, V. R., Chakka, J., Alkadi, F., & Maniruzzaman, M. (2023). Veering to a Continuous Platform of Fused Deposition Modeling Based 3D Printing for Pharmaceutical Dosage Forms: Understanding the Effect of Layer Orientation on Formulation Performance. Pharmaceutics, 15(5), 1324. https://doi.org/10.3390/pharmaceutics15051324