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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.

作者信息

Nashed Nour, Chan Stephanie, Lam Matthew, Ghafourian Taravat, Nokhodchi Ali

机构信息

Pharmaceutics Research Laboratory, Arundel Building, School of Life Sciences, University of Sussex, Brighton BN1 9QJ, UK.

Department of Chemical and Pharmaceutical Sciences, School of Human Sciences, London Metropolitan University, 166-220 Holloway Road, London N7 8DB, UK.

出版信息

Biomedicines. 2023 Jan 27;11(2):375. doi: 10.3390/biomedicines11020375.


DOI:10.3390/biomedicines11020375
PMID:36830914
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9953207/
Abstract

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 () and difference factor () 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 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.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6824/9953207/94b6528298de/biomedicines-11-00375-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6824/9953207/072999ec5e84/biomedicines-11-00375-g001a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6824/9953207/838f57764f6e/biomedicines-11-00375-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6824/9953207/cd9e54d085f4/biomedicines-11-00375-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6824/9953207/f5d89f47f74f/biomedicines-11-00375-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6824/9953207/94b6528298de/biomedicines-11-00375-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6824/9953207/072999ec5e84/biomedicines-11-00375-g001a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6824/9953207/838f57764f6e/biomedicines-11-00375-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6824/9953207/cd9e54d085f4/biomedicines-11-00375-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6824/9953207/f5d89f47f74f/biomedicines-11-00375-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6824/9953207/94b6528298de/biomedicines-11-00375-g005.jpg

相似文献

[1]
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. 2023-1-27

[2]
An Insight into the Impact of Thermal Process on Dissolution Profile and Physical Characteristics of Theophylline Tablets Made through 3D Printing Compared to Conventional Methods.

Biomedicines. 2022-6-6

[3]
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[4]
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[6]
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[9]
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[10]
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引用本文的文献

[1]
Fabricating Oral Disintegrating Tablets Without Disintegrant Using Powder-Based 3D Printing.

Pharmaceutics. 2025-3-28

[2]
Enhancing Patient-Centric Drug Development: Coupling Hot Melt Extrusion with Fused Deposition Modeling and Pressure-Assisted Microsyringe Additive Manufacturing Platforms with Quality by Design.

Pharmaceutics. 2024-12-25

[3]
Enabling a novel solvent method on Albendazole solid dispersion to improve the in vivo bioavailability.

Eur J Pharm Sci. 2024-5-1

[4]
Engineering the Morphostructural Properties and Drug Loading Degree of Organic-Inorganic Fluorouracil-MgAl LDH Nanohybrids by Rational Control of Hydrothermal Treatment.

ACS Omega. 2023-7-12

本文引用的文献

[1]
An Insight into the Impact of Thermal Process on Dissolution Profile and Physical Characteristics of Theophylline Tablets Made through 3D Printing Compared to Conventional Methods.

Biomedicines. 2022-6-6

[2]
Impact of gastrointestinal tract variability on oral drug absorption and pharmacokinetics: An UNGAP review.

Eur J Pharm Sci. 2021-7-1

[3]
Role of release modifiers to modulate drug release from fused deposition modelling (FDM) 3D printed tablets.

Int J Pharm. 2021-3-15

[4]
Influence of Buffers, Ionic Strength, and pH on the Volume Phase Transition Behavior of Acrylamide-Based Nanogels.

Polymers (Basel). 2020-11-4

[5]
Power of the Dissolution Test in Distinguishing a Change in Dosage Form Critical Quality Attributes.

AAPS PharmSciTech. 2018-10-22

[6]
Physiological parameters of the gastrointestinal fluid impact the dissolution behavior of the BCS class IIa drug valsartan.

Pharm Dev Technol. 2018-12

[7]
The effect of pH, buffer capacity and ionic strength on quetiapine fumarate release from matrix tablets prepared using two different polymeric blends.

Drug Dev Ind Pharm. 2017-8

[8]
Coupling 3D printing with hot-melt extrusion to produce controlled-release tablets.

Int J Pharm. 2017-3-15

[9]
1. Commentary on an exponential model for the analysis of drug delivery: Original research article: a simple equation for description of solute release: I II. Fickian and non-Fickian release from non-swellable devices in the form of slabs, spheres, cylinders or discs, 1987.

J Control Release. 2014-9-28

[10]
The effect of pH and ionic strength of dissolution media on in-vitro release of two model drugs of different solubilities from HPMC matrices.

Colloids Surf B Biointerfaces. 2013-6-25

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