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3D extrusion printing of high drug loading immediate release paracetamol tablets

Khaled, Shaban A.; Alexander, Morgan R.; Wildman, Ricky D.; Wallace, Martin J.; Sharpe, Sonja; Yoo, Jae; Roberts, Clive J.

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Authors

Shaban A. Khaled

Profile image of MORGAN ALEXANDER

MORGAN ALEXANDER MORGAN.ALEXANDER@NOTTINGHAM.AC.UK
Professor of Biomedical Surfaces

RICKY WILDMAN RICKY.WILDMAN@NOTTINGHAM.AC.UK
Professor of Multiphase Flow and Mechanics

Martin J. Wallace

Sonja Sharpe

Jae Yoo



Abstract

The manufacture of immediate release high drug loading paracetamol oral tablets was achieved using an extrusion based 3D printer from a premixed water based paste formulation. The 3D printed tablets demonstrate that a very high drug (paracetamol) loading formulation (80% w/w) can be printed as an acceptable tablet using a method suitable for personalisation and distributed manufacture. Paracetamol is an example of a drug whose physical form can present challenges to traditional powder compression tableting. Printing avoids these issues and facilitates the relatively high drug loading. The 3D printed tablets were evaluated for physical and mechanical properties including weight variation, friability, breaking force, disintegration time, and dimensions and were within acceptable range as defined by the international standards stated in the United States Pharmacopoeia (USP). X-Ray Powder Diffraction (XRPD) was used to identify the physical form of the active. Additionally, XRPD, Attenuated Total Reflectance Fourier Transform Infrared spectroscopy (ATR-FTIR) and differential scanning calorimetry (DSC) were used to assess possible drug-excipient interactions. The 3D printed tablets were evaluated for drug release using a USP dissolution testing type I apparatus. The tablets showed a profile characteristic of the immediate release profile as intended based upon the active/excipient ratio used with disintegration in less than 60 seconds and release of most of the drug within 5 minutes. The results demonstrate the capability of 3D extrusion based printing to produce acceptable high-drug loading tablets from approved materials that comply with current USP standards.

Citation

Khaled, S. A., Alexander, M. R., Wildman, R. D., Wallace, M. J., Sharpe, S., Yoo, J., & Roberts, C. J. (2018). 3D extrusion printing of high drug loading immediate release paracetamol tablets. International Journal of Pharmaceutics, 538(1-2), 223-230. https://doi.org/10.1016/j.ijpharm.2018.01.024

Journal Article Type Article
Acceptance Date Jan 13, 2018
Online Publication Date Jan 17, 2018
Publication Date Mar 1, 2018
Deposit Date Jan 29, 2018
Publicly Available Date Jan 18, 2019
Journal International Journal of Pharmaceutics
Print ISSN 0378-5173
Electronic ISSN 1873-3476
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 538
Issue 1-2
Pages 223-230
DOI https://doi.org/10.1016/j.ijpharm.2018.01.024
Public URL https://nottingham-repository.worktribe.com/output/918265
Publisher URL https://www.sciencedirect.com/science/article/pii/S037851731830036X
Contract Date Jan 29, 2018

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