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Extrusion 3D Printing of Paracetamol Tablets from a Single Formulation with Tunable Release Profiles Through Control of Tablet Geometry.
AAPS PharmSciTech. 2018 Nov; 19(8):3403-3413.AP

Abstract

An extrusion-based 3D printer was used to fabricate paracetamol tablets with different geometries (mesh, ring and solid) from a single paste-based formulation formed from standard pharmaceutical ingredients. The tablets demonstrate that tunable drug release profiles can be achieved from this single formulation even with high drug loading (> 80% w/w). The tablets were evaluated for drug release using a USP dissolution testing type I apparatus. The tablets showed well-defined release profiles (from immediate to sustained release) controlled by their different geometries. The dissolution results showed dependency of drug release on the surface area/volume (SA/V) ratio and the SA of the different tablets. The tablets with larger SA/V ratios and SA had faster drug release. The 3D printed tablets were also evaluated for physical and mechanical properties including tablet dimension, drug content, weight variation and breaking force and were within acceptable range as defined by the international standards stated in the US Pharmacopoeia. X-ray powder diffraction, differential scanning calorimetry and attenuated total reflectance Fourier transform infrared spectroscopy were used to identify the physical form of the active and to assess possible drug-excipient interactions. These data again showed that the tablets meet USP requirement. These results clearly demonstrate the potential of 3D printing to create unique pharmaceutical manufacturing, and potentially clinical, opportunities. The ability to use a single unmodified formulation to achieve defined release profiles could allow, for example, relatively straightforward personalization of medicines for individuals with different metabolism rates for certain drugs and hence could offer significant development and clinical opportunities.

Authors+Show Affiliations

Advanced Materials and Healthcare Technologies, School of Pharmacy, University of Nottingham, University Park, Nottingham, NG7 2RD, UK.Advanced Materials and Healthcare Technologies, School of Pharmacy, University of Nottingham, University Park, Nottingham, NG7 2RD, UK.Faculty of Engineering, University of Nottingham, University Park, Nottingham, NG7 2RD, UK.Faculty of Engineering, University of Nottingham, University Park, Nottingham, NG7 2RD, UK.Advanced Manufacturing Technology, GlaxoSmithKline (Ireland), 12 Riverwalk, Citywest, Business Campus, Dublin, 24, Ireland.Advanced Manufacturing Technology, GlaxoSmithKline, 709 Swedeland Rd, King of Prussia, Pennsylvania, 19406-0939, USA.Advanced Manufacturing Technology, GlaxoSmithKline, 709 Swedeland Rd, King of Prussia, Pennsylvania, 19406-0939, USA.Advanced Materials and Healthcare Technologies, School of Pharmacy, University of Nottingham, University Park, Nottingham, NG7 2RD, UK. clive.roberts@nottingham.ac.uk.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

30097806

Citation

Khaled, Shaban A., et al. "Extrusion 3D Printing of Paracetamol Tablets From a Single Formulation With Tunable Release Profiles Through Control of Tablet Geometry." AAPS PharmSciTech, vol. 19, no. 8, 2018, pp. 3403-3413.
Khaled SA, Alexander MR, Irvine DJ, et al. Extrusion 3D Printing of Paracetamol Tablets from a Single Formulation with Tunable Release Profiles Through Control of Tablet Geometry. AAPS PharmSciTech. 2018;19(8):3403-3413.
Khaled, S. A., Alexander, M. R., Irvine, D. J., Wildman, R. D., Wallace, M. J., Sharpe, S., Yoo, J., & Roberts, C. J. (2018). Extrusion 3D Printing of Paracetamol Tablets from a Single Formulation with Tunable Release Profiles Through Control of Tablet Geometry. AAPS PharmSciTech, 19(8), 3403-3413. https://doi.org/10.1208/s12249-018-1107-z
Khaled SA, et al. Extrusion 3D Printing of Paracetamol Tablets From a Single Formulation With Tunable Release Profiles Through Control of Tablet Geometry. AAPS PharmSciTech. 2018;19(8):3403-3413. PubMed PMID: 30097806.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Extrusion 3D Printing of Paracetamol Tablets from a Single Formulation with Tunable Release Profiles Through Control of Tablet Geometry. AU - Khaled,Shaban A, AU - Alexander,Morgan R, AU - Irvine,Derek J, AU - Wildman,Ricky D, AU - Wallace,Martin J, AU - Sharpe,Sonja, AU - Yoo,Jae, AU - Roberts,Clive J, Y1 - 2018/08/10/ PY - 2018/01/22/received PY - 2018/06/12/accepted PY - 2018/8/12/pubmed PY - 2019/1/22/medline PY - 2018/8/12/entrez KW - 3D printing KW - geometry KW - immediate release KW - paracetamol KW - personalised medicine KW - sustained release SP - 3403 EP - 3413 JF - AAPS PharmSciTech JO - AAPS PharmSciTech VL - 19 IS - 8 N2 - An extrusion-based 3D printer was used to fabricate paracetamol tablets with different geometries (mesh, ring and solid) from a single paste-based formulation formed from standard pharmaceutical ingredients. The tablets demonstrate that tunable drug release profiles can be achieved from this single formulation even with high drug loading (> 80% w/w). The tablets were evaluated for drug release using a USP dissolution testing type I apparatus. The tablets showed well-defined release profiles (from immediate to sustained release) controlled by their different geometries. The dissolution results showed dependency of drug release on the surface area/volume (SA/V) ratio and the SA of the different tablets. The tablets with larger SA/V ratios and SA had faster drug release. The 3D printed tablets were also evaluated for physical and mechanical properties including tablet dimension, drug content, weight variation and breaking force and were within acceptable range as defined by the international standards stated in the US Pharmacopoeia. X-ray powder diffraction, differential scanning calorimetry and attenuated total reflectance Fourier transform infrared spectroscopy were used to identify the physical form of the active and to assess possible drug-excipient interactions. These data again showed that the tablets meet USP requirement. These results clearly demonstrate the potential of 3D printing to create unique pharmaceutical manufacturing, and potentially clinical, opportunities. The ability to use a single unmodified formulation to achieve defined release profiles could allow, for example, relatively straightforward personalization of medicines for individuals with different metabolism rates for certain drugs and hence could offer significant development and clinical opportunities. SN - 1530-9932 UR - https://www.unboundmedicine.com/medline/citation/30097806/Extrusion_3D_Printing_of_Paracetamol_Tablets_from_a_Single_Formulation_with_Tunable_Release_Profiles_Through_Control_of_Tablet_Geometry_ L2 - https://dx.doi.org/10.1208/s12249-018-1107-z DB - PRIME DP - Unbound Medicine ER -