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Visualizing disintegration of 3D printed tablets in humans using MRI and comparison with in vitro data
Iria Seoane-Viaño1, Tania Pérez-Ramos2, Jiaqi Liu3
1Department of Pharmaceutics, UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK; Department of Pharmacology, Pharmacy and Pharmaceutical Technology, Paraquasil Group (GI-2109), Faculty of Pharmacy, iMATUS and Health Research Institute of Santiago de Compostela (IDIS), University of Santiago de Compostela (USC), Santiago de Compostela 15782, Spain.
Three-dimensional (3D) printing of medications shows promise for personalized medicine. However, current in vitro tests do not accurately predict the in vivo intestinal behavior of 3D printed drug products in humans.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- 3D Printing in Medicine
Background:
- Three-dimensional (3D) printing offers personalized medicine manufacturing potential.
- Limited in vivo data exists for 3D printed dosage forms, especially human intestinal behavior.
- Predictive accuracy of in vitro tests for 3D printed drug performance in vivo is unknown.
Purpose of the Study:
- To investigate the in vivo intestinal behavior of 3D printed tablets (printlets) in humans.
- To compare in vitro disintegration times with in vivo disintegration using magnetic resonance imaging (MRI).
- To evaluate the predictive capability of standard and alternative in vitro disintegration methods for 3D printed formulations.
Main Methods:
- Selective laser sintering (SLS) 3D printing used to create placebo torus-shaped printlets at two laser scanning speeds (90 mm/s and 130 mm/s).
- In vivo disintegration times assessed in 6 human volunteers using MRI.
- In vitro disintegration tests performed using a standard USP apparatus and an alternative reduced-volume, low-agitation method.
Main Results:
- Printlets manufactured at 90 mm/s had in vitro disintegration times of 7.2 ± 1 min (USP) and 25.5 ± 4.1 min (alternative method).
- Printlets manufactured at 130 mm/s had in vitro disintegration times of 2.8 ± 0.8 min (USP) and 18.8 ± 1.9 min (alternative method).
- In vivo disintegration times were 17.3 ± 7.2 min (90 mm/s) and 12.7 ± 6.8 min (130 mm/s). The alternative in vitro method showed closer resemblance to in vivo results, but no clear correlation was established.
Conclusions:
- In vivo intestinal disintegration of 3D printed tablets varies with manufacturing parameters (laser scanning speed).
- Current in vitro disintegration tests, including an alternative method, do not accurately predict in vivo performance of these 3D printed drug products.
- Development of improved in vitro methodologies is crucial for the clinical translation of 3D printed medications.
