Shaban A. Khaled
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.
Authors
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
Professor CLIVE ROBERTS CLIVE.ROBERTS@NOTTINGHAM.AC.UK
Head of School - Life Sciences
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 |
Files
Revised Manuscript Khaled IJP 2018.pdf
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Publisher Licence URL
https://creativecommons.org/licenses/by-nc-nd/4.0/
Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by-nc-nd/4.0
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