Abstract
Purpose
The fabrication of ready-to-use immediate release tablets via 3D printing provides a powerful tool to on-demand individualization of dosage form. This work aims to adapt a widely used pharmaceutical grade polymer, polyvinylpyrrolidone (PVP), for instant on-demand production of immediate release tablets via FDM 3D printing.
Methods
Dipyridamole or theophylline loaded filaments were produced via processing a physical mixture of API (10%) and PVP in the presence of plasticizer through hot-melt extrusion (HME). Computer software was utilized to design a caplet-shaped tablet. The surface morphology of the printed tablet was assessed using scanning electron microscopy (SEM). The physical form of the drugs and its integrity following an FDM 3D printing were assessed using x-ray powder diffractometry (XRPD), thermal analysis and HPLC. In vitro drug release studies for all 3D printed tablets were conducted in a USP II dissolution apparatus.
Results
Bridging 3D printing process with HME in the presence of a thermostable filler, talc, enabled the fabrication of immediate release tablets at temperatures as low as 110°C. The integrity of two model drugs was maintained following HME and FDM 3D printing. XRPD indicated that a portion of the loaded theophylline remained crystalline in the tablet. The fabricated tablets demonstrated excellent mechanical properties, acceptable in-batch variability and an immediate in vitro release pattern.
Conclusions
Combining the advantages of PVP as an impeding polymer with FDM 3D printing at low temperatures, this approach holds a potential in expanding the spectrum of drugs that could be used in FDM 3D printing for on demand manufacturing of individualised dosage forms.
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Abbreviations
- API:
-
Active pharmaceutical ingredient
- CAD:
-
Computer aided design
- DSC:
-
Differential scanning calorimetry
- FDM:
-
Fused deposition modelling
- HME:
-
Hot melt extrusion
- HPLC:
-
High performance liquid chromatography
- PLA:
-
Polylactic acid
- PVA:
-
Poly(vinyl alcohol)
- PVP:
-
Polyvinylpyrrolidone
- SEM:
-
Scanning electron microscopy
- Tg:
-
Glass transition temperature
- TGA:
-
Thermal gravimetric analysis
- Tm:
-
Melting point
- XRPD:
-
X-ray powder diffractometry
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The authors would like to thank UCLAN Innovation Team for their support and Mrs Rim Arafat for her help with graphics design.
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Okwuosa, T.C., Stefaniak, D., Arafat, B. et al. A Lower Temperature FDM 3D Printing for the Manufacture of Patient-Specific Immediate Release Tablets. Pharm Res 33, 2704–2712 (2016). https://doi.org/10.1007/s11095-016-1995-0
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DOI: https://doi.org/10.1007/s11095-016-1995-0