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Dose Titration of Solid Dosage Forms via FDM 3D-Printed Mini-Tablets
Guluzar Gorkem Buyukgoz1,2, Christopher G Kossor1,2, Shen Ji2
1New Jersey Center for Engineered Particulates (NJCEP), New Jersey Institute of Technology, Newark, NJ 07102, USA.
Pharmaceutics
|November 11, 2022
Summary
3D-printed mini-tablets offer accurate milligram-dose administration for age-specific therapy. This 3D printing method ensures consistent drug release and content uniformity, eliminating the need for tablet splitting.
Area of Science:
- Pharmaceutical Technology
- Additive Manufacturing
- Drug Delivery Systems
Background:
- Traditional tablet splitting for pediatric or age-specific dosing leads to inaccuracies and inconsistent drug release.
- Developing precise, low-dose formulations requires advanced manufacturing techniques to ensure content uniformity and predictable pharmacokinetics.
Purpose of the Study:
- To investigate the feasibility of 3D-printed mini-tablets for accurate milligram-dose administration.
- To evaluate the robustness of 3D printing for maintaining consistent drug release profiles across different dosages.
- To compare the performance of 3D-printed mini-tablets with conventionally split tablets.
Main Methods:
- Filaments containing griseofulvin (a poorly water-soluble drug) and polymers (hydroxypropyl cellulose, Kollicoat Protect) were prepared using hot-melt extrusion (HME) at 1-20% drug concentrations.
- Composite unit (multi-unit) mini-tablets were fabricated via 3D printing.
- Dose accuracy, content uniformity, and drug release profiles were assessed for mini-tablets containing doses ranging from 0.19 mg to 3.91 mg.
Main Results:
- A highly accurate dose titration (R² = 0.999) was achieved with 3D-printed mini-tablets, demonstrating precise control over milligram dosages.
- Excellent content uniformity was observed even at low drug doses (0.19 mg), confirming the efficacy of HME and 3D printing.
- 3D-printed mini-tablets exhibited similar drug release profiles to single units and superior consistency compared to split tablets.
Conclusions:
- 3D-printed mini-tablets provide a robust platform for accurate, age-specific milligram-dose administration without tablet splitting.
- The hot-melt extrusion and 3D printing process ensures excellent content uniformity and dose flexibility.
- This advanced manufacturing approach offers a viable alternative to traditional dosing methods, ensuring consistent drug release and therapeutic efficacy.
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