Hybrid Manufacturing of Oral Solid Dosage Forms via Overprinting of Injection-Molded Tablet Substrates
Abstract
:1. Introduction
2. Materials and Methods
2.1. Materials
2.2. Hot-Melt Extrusion
2.3. Injection Molding
2.4. 3D Printing and Overprinting
2.5. Melt Flow Indexing
2.6. Attenuated Total Reflectance Fourier Transform Infrared Spectroscopy
2.7. Differential Scanning Calorimetry
2.8. Filament Brittleness
2.9. Tablet Hardness
2.10. Tablet Friability
2.11. Tablet Layer Adhesion Test
2.12. Scanning Electron Microscopy
2.13. Drug Release Studies
2.14. Statistical Analysis
3. Results and Discussion
3.1. Hot-Melt Extrusion for Drug-Polymer Blend and Filament Production by Filament Maker
3.2. Overprinting Tablet Production and Testing
3.3. Drug Dissolution Study
4. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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PVP-VA (%) | PCL (%) | Theophylline (%) |
---|---|---|
40 | 60 | - |
36 | 54 | 10 |
IM Processing Parameters | |
---|---|
Shot Size (mm) | 15 |
Cooling Time (s) | 70 |
1st Injection Pressure (bar) | 30/60/120 |
2nd injection pressure (bar) | 20/40/100 |
1st Pressure Time (s) | 2 |
2nd Pressure time (s) | 6 |
2nd Pressure setting (mm) | 6 |
Decompression (mm) | 4 |
Injection Speed (%) | 75% |
2nd Injection Speed (%) | 40% |
2nd Speed Point (mm) | 4 |
Batch Number | 3DP Infill Percentage (%) | 3DP Raster Angle (°) | IM Injection Pressure (Bar) |
---|---|---|---|
1 | 25 | 45/−45 | 30 |
2 | 25 | 60/−60 | 30 |
3 | 25 | 75/−75 | 30 |
4 | 25 | 45/−45 | 60 |
5 | 25 | 45/−45 | 120 |
6 | 50 | 45/−45 | 30 |
7 | 100 | 45/−45 | 30 |
8 | 25 | 45/−45 | - |
9 | 50 | 45/−45 | - |
10 | 100 | 45/−45 | - |
11 | - | - | 30 |
12 | - | - | 60 |
13 | - | - | 120 |
Sample | Glass Transition (°C) | Melting (°C) | Crystallization (°C) |
---|---|---|---|
PVP-VA | 104.6 | - | - |
PCL | - | 57.3 | 23.0 |
PCL-FM | - | 57.1 | 30.1 |
Theophylline | - | 274.5 | 253.9 |
Placebo-HME | 103.8 | 57.4 | 32.2 |
Placebo-FM | 103.8 | 56.7 | 29.9 |
Drug-loaded-HME | - | 53.4 | 28.9 |
Drug-loaded-FM | - | 53.5 | 31.3 |
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Xu, H.; Ebrahimi, F.; Gong, K.; Cao, Z.; Fuenmayor, E.; Major, I. Hybrid Manufacturing of Oral Solid Dosage Forms via Overprinting of Injection-Molded Tablet Substrates. Pharmaceutics 2023, 15, 507. https://doi.org/10.3390/pharmaceutics15020507
Xu H, Ebrahimi F, Gong K, Cao Z, Fuenmayor E, Major I. Hybrid Manufacturing of Oral Solid Dosage Forms via Overprinting of Injection-Molded Tablet Substrates. Pharmaceutics. 2023; 15(2):507. https://doi.org/10.3390/pharmaceutics15020507
Chicago/Turabian StyleXu, Han, Farnoosh Ebrahimi, Ke Gong, Zhi Cao, Evert Fuenmayor, and Ian Major. 2023. "Hybrid Manufacturing of Oral Solid Dosage Forms via Overprinting of Injection-Molded Tablet Substrates" Pharmaceutics 15, no. 2: 507. https://doi.org/10.3390/pharmaceutics15020507