Tailoring the release of highly loaded amorphous solid dispersions via additive manufacturing
Carolina Alva1, Elisa Goetzinger1, Josip Matić2
1Research Center Pharmaceutical Engineering GmbH, Graz, Austria; Institute of Pharmaceutical Sciences, Department of Pharmaceutical Technology and Biopharmacy, University of Graz, Graz, Austria.
Summary
This study developed 3D-printed tablets with 70% itraconazole amorphous solid dispersions (ASDs) using HPMCAS. These stable ASDs prevent recrystallisation and enable tailored drug release, paving the way for personalized medicine.
Area of Science:
- Pharmaceutical Technology
- Materials Science
- Drug Delivery Systems
Background:
- Enhancing bioavailability of poorly soluble active pharmaceutical ingredients (APIs) is crucial.
- Customization of APIs is now feasible through filament-based 3D-printing (3DP).
- Highly loaded oral amorphous solid dispersions (ASDs) reduce pill burden but face recrystallisation challenges.
Purpose of the Study:
- To develop compact 3D-printed tablets containing a high-load ASD (70% itraconazole in HPMCAS).
- To investigate the processability of ASD filaments via hot-melt extrusion (HME) and 3DP.
- To assess the stability and drug release characteristics of the 3D-printed ASD tablets.
Main Methods:
- Fabrication of ASD filaments containing 70% itraconazole and HPMCAS using HME.
- Characterization of filament properties: solid-state, rheology, and mechanical behavior.
- 3D-printing of tablets and evaluation of drug release kinetics with variable infill patterns.
Main Results:
- Stable ASD filaments were successfully fabricated and processed via HME and 3DP.
- No API recrystallisation was observed in the ASDs even after six months of storage.
- Zero-order drug release was maintained, with release kinetics tunable by 3DP infill patterns.
Conclusions:
- 3D-printed ASD tablets offer a viable approach for formulating highly loaded, poorly soluble drugs.
- The developed system demonstrates excellent physical stability and controlled drug release.
- This technology holds significant potential for personalized medicine and on-demand pharmaceutical manufacturing.
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