Effect of pH, ionic strength and agitation rate on dissolution behaviour of 3D-printed tablets, tablets prepared from ground hot-melt extruded filaments and physical mixtures

With the current focus on 3D-printing technologies, it is essential to understand the processes involved in such printing methods and approaches to minimize the variability in dissolution behaviour to achieve better quality control outcomes. For this purpose, two formulations of theophylline tablets...

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Main Authors: Nashed, Nour, Chan, Stephanie, Lam, Matthew, Ghafourian, Taravat, Nokhodchi, Ali
Format: Article
Language:English
Published: MDPI 2023
Subjects:
Online Access:https://repository.londonmet.ac.uk/8326/1/biomedicines-11-00375-v2.pdf
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author Nashed, Nour
Chan, Stephanie
Lam, Matthew
Ghafourian, Taravat
Nokhodchi, Ali
author_facet Nashed, Nour
Chan, Stephanie
Lam, Matthew
Ghafourian, Taravat
Nokhodchi, Ali
author_sort Nashed, Nour
collection LMU
description With the current focus on 3D-printing technologies, it is essential to understand the processes involved in such printing methods and approaches to minimize the variability in dissolution behaviour to achieve better quality control outcomes. For this purpose, two formulations of theophylline tablets were prepared using hydroxypropyl cellulose (HPC) and ethyl cellulose (EC). Among the two types of tablets, three different methods (physical mixture (PM), hot-melt extrusion (HME) and 3D-printing fused deposition modelling (FDM)) were applied and their dissolution behaviours were studied under various conditions using a biodissolution tester. This was carried out at pH values of 1.2, 2.2, 5.8, 6.8, 7.2 and 7.5, mimicking the medium in the gastrointestinal tract. Dissolution tests under two dipping rates (10 dpm and 20 dpm) and two ionic strengths (0.2 M and 0.4 M) were conducted to mimic fed and fasting conditions. The dissolution efficiency (DE%), release rate, similarity factor (f2) and difference factor (f1) were calculated. When comparing the DE%, the formulation containing EC showed less sensitivity to changes in the dipping rate and ionic strength compared to the HPC formulation. As for the manufacturing method, 3D-printing FDM could improve the robustness of the dissolution behaviour of both formulations to dipping rate changes. However, for ionic strength changes, the effect of the manufacturing method was dependent on the formulation composition. For example, the 3D-printed tablets of the HPC formulation were more sensitive to changes in ionic strength compared to the EC-containing formulation. The release mechanism also changed after the thermal process, where n values in the Korsmeyer–Peppas model were much higher in the printing and HME methods compared to the PM. Based on the formulation composition, the 3D-printing method could be a good candidate method for tablets with a robust dissolution behaviour in the GI tract. Compared to HPC polymers, using hydrophobic EC polymers in printable formulations can result in a more robust dissolution behaviour in fed and fasting states.
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spelling oai:repository.londonmet.ac.uk:83262023-04-18T14:07:12Z https://repository.londonmet.ac.uk/8326/ Effect of pH, ionic strength and agitation rate on dissolution behaviour of 3D-printed tablets, tablets prepared from ground hot-melt extruded filaments and physical mixtures Nashed, Nour Chan, Stephanie Lam, Matthew Ghafourian, Taravat Nokhodchi, Ali 660 Chemical engineering With the current focus on 3D-printing technologies, it is essential to understand the processes involved in such printing methods and approaches to minimize the variability in dissolution behaviour to achieve better quality control outcomes. For this purpose, two formulations of theophylline tablets were prepared using hydroxypropyl cellulose (HPC) and ethyl cellulose (EC). Among the two types of tablets, three different methods (physical mixture (PM), hot-melt extrusion (HME) and 3D-printing fused deposition modelling (FDM)) were applied and their dissolution behaviours were studied under various conditions using a biodissolution tester. This was carried out at pH values of 1.2, 2.2, 5.8, 6.8, 7.2 and 7.5, mimicking the medium in the gastrointestinal tract. Dissolution tests under two dipping rates (10 dpm and 20 dpm) and two ionic strengths (0.2 M and 0.4 M) were conducted to mimic fed and fasting conditions. The dissolution efficiency (DE%), release rate, similarity factor (f2) and difference factor (f1) were calculated. When comparing the DE%, the formulation containing EC showed less sensitivity to changes in the dipping rate and ionic strength compared to the HPC formulation. As for the manufacturing method, 3D-printing FDM could improve the robustness of the dissolution behaviour of both formulations to dipping rate changes. However, for ionic strength changes, the effect of the manufacturing method was dependent on the formulation composition. For example, the 3D-printed tablets of the HPC formulation were more sensitive to changes in ionic strength compared to the EC-containing formulation. The release mechanism also changed after the thermal process, where n values in the Korsmeyer–Peppas model were much higher in the printing and HME methods compared to the PM. Based on the formulation composition, the 3D-printing method could be a good candidate method for tablets with a robust dissolution behaviour in the GI tract. Compared to HPC polymers, using hydrophobic EC polymers in printable formulations can result in a more robust dissolution behaviour in fed and fasting states. MDPI 2023-01-27 Article PeerReviewed text en cc_by_4 https://repository.londonmet.ac.uk/8326/1/biomedicines-11-00375-v2.pdf Nashed, Nour, Chan, Stephanie, Lam, Matthew, Ghafourian, Taravat and Nokhodchi, Ali (2023) Effect of pH, ionic strength and agitation rate on dissolution behaviour of 3D-printed tablets, tablets prepared from ground hot-melt extruded filaments and physical mixtures. Biomedicines, 11 (2) (375). pp. 1-17. ISSN 2227-9059 https://doi.org/10.3390/biomedicines11020375 10.3390/biomedicines11020375 10.3390/biomedicines11020375
spellingShingle 660 Chemical engineering
Nashed, Nour
Chan, Stephanie
Lam, Matthew
Ghafourian, Taravat
Nokhodchi, Ali
Effect of pH, ionic strength and agitation rate on dissolution behaviour of 3D-printed tablets, tablets prepared from ground hot-melt extruded filaments and physical mixtures
title Effect of pH, ionic strength and agitation rate on dissolution behaviour of 3D-printed tablets, tablets prepared from ground hot-melt extruded filaments and physical mixtures
title_full Effect of pH, ionic strength and agitation rate on dissolution behaviour of 3D-printed tablets, tablets prepared from ground hot-melt extruded filaments and physical mixtures
title_fullStr Effect of pH, ionic strength and agitation rate on dissolution behaviour of 3D-printed tablets, tablets prepared from ground hot-melt extruded filaments and physical mixtures
title_full_unstemmed Effect of pH, ionic strength and agitation rate on dissolution behaviour of 3D-printed tablets, tablets prepared from ground hot-melt extruded filaments and physical mixtures
title_short Effect of pH, ionic strength and agitation rate on dissolution behaviour of 3D-printed tablets, tablets prepared from ground hot-melt extruded filaments and physical mixtures
title_sort effect of ph ionic strength and agitation rate on dissolution behaviour of 3d printed tablets tablets prepared from ground hot melt extruded filaments and physical mixtures
topic 660 Chemical engineering
url https://repository.londonmet.ac.uk/8326/1/biomedicines-11-00375-v2.pdf
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