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A Lower Temperature FDM 3D Printing for the Manufacture of Patient-Specific Immediate Release Tablets

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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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ACKNOWLEDGMENTS AND DISCLOSURES

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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Correspondence to Mohamed A. Alhnan.

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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

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