Fabrication of a Controlled-Release Core-Shell Floating Tablet of Ketamine Hydrochloride Using a 3D Printing Technique for Management of Refractory Depressions and Chronic Pain

In this study, a novel floating, controlled-release and core-shell oral tablet of ketamine hydrochloride (HCl) was produced using a dual extrusion by 3D printing method. A mixture of Soluplus<sup>®</sup> and Eudragit<sup>®</sup> RS-PO was extruded by a hot-melt extrusion (HME...

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Main Authors: Tahmineh Karami, Emad Ghobadi, Mohammad Akrami, Ismaeil Haririan
Format: Article
Language:English
Published: MDPI AG 2024-03-01
Series:Polymers
Subjects:
Online Access:https://www.mdpi.com/2073-4360/16/6/746
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author Tahmineh Karami
Emad Ghobadi
Mohammad Akrami
Ismaeil Haririan
author_facet Tahmineh Karami
Emad Ghobadi
Mohammad Akrami
Ismaeil Haririan
author_sort Tahmineh Karami
collection DOAJ
description In this study, a novel floating, controlled-release and core-shell oral tablet of ketamine hydrochloride (HCl) was produced using a dual extrusion by 3D printing method. A mixture of Soluplus<sup>®</sup> and Eudragit<sup>®</sup> RS-PO was extruded by a hot-melt extrusion (HME) nozzle at 150–160 °C to fabricate the tablet shell, while a second nozzle known as a pressure-assisted syringe (PAS) extruded the etamine HCl in carboxymethyl cellulose gel at room temperature (25 °C) inside the shell. The resulting tablets were optimized based on the United States pharmacopeia standards (USP) for solid dosage forms. Moreover, the tablet was characterized using Fourier-transform infrared (FTIR) spectrum, scanning electron microscopy (SEM), differential scanning calorimetry (DSC), and buoyancy techniques. The results showed a desired dissolution profile for a 100% infill optimized tablet with total drug release (100%) during 12 h. Weight variation and content uniformity of the tablets achieved the USP requirements. SEM micrographs showed a smooth surface with acceptable layer diameters. According to the FTIR analysis, no interference was detected among peaks. Based on DSC analysis, the crystallinity of ketamine HCl did not change during melt extrusion. In conclusion, the floating controlled-release 3D-printed tablet of ketamine HCl can be a promising candidate for management of refractory depressions and chronic pain. Additionally, the additive manufacturing method enables the production of patient-tailored dosage with tunable-release kinetics for personalized medicine in point-of care setting.
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spelling doaj.art-c9acd2840e0442d9836b8c2668ec95932024-03-27T14:01:13ZengMDPI AGPolymers2073-43602024-03-0116674610.3390/polym16060746Fabrication of a Controlled-Release Core-Shell Floating Tablet of Ketamine Hydrochloride Using a 3D Printing Technique for Management of Refractory Depressions and Chronic PainTahmineh Karami0Emad Ghobadi1Mohammad Akrami2Ismaeil Haririan3School of Engineering, University of Tehran, Tehran P.O. Box 11155-4563, IranDepartment of Pharmaceutics, Biomaterials, Medical Biomaterials Research Center, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran P.O. Box 14155-6451, IranDepartment of Pharmaceutics, Biomaterials, Medical Biomaterials Research Center, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran P.O. Box 14155-6451, IranDepartment of Pharmaceutics, Biomaterials, Medical Biomaterials Research Center, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran P.O. Box 14155-6451, IranIn this study, a novel floating, controlled-release and core-shell oral tablet of ketamine hydrochloride (HCl) was produced using a dual extrusion by 3D printing method. A mixture of Soluplus<sup>®</sup> and Eudragit<sup>®</sup> RS-PO was extruded by a hot-melt extrusion (HME) nozzle at 150–160 °C to fabricate the tablet shell, while a second nozzle known as a pressure-assisted syringe (PAS) extruded the etamine HCl in carboxymethyl cellulose gel at room temperature (25 °C) inside the shell. The resulting tablets were optimized based on the United States pharmacopeia standards (USP) for solid dosage forms. Moreover, the tablet was characterized using Fourier-transform infrared (FTIR) spectrum, scanning electron microscopy (SEM), differential scanning calorimetry (DSC), and buoyancy techniques. The results showed a desired dissolution profile for a 100% infill optimized tablet with total drug release (100%) during 12 h. Weight variation and content uniformity of the tablets achieved the USP requirements. SEM micrographs showed a smooth surface with acceptable layer diameters. According to the FTIR analysis, no interference was detected among peaks. Based on DSC analysis, the crystallinity of ketamine HCl did not change during melt extrusion. In conclusion, the floating controlled-release 3D-printed tablet of ketamine HCl can be a promising candidate for management of refractory depressions and chronic pain. Additionally, the additive manufacturing method enables the production of patient-tailored dosage with tunable-release kinetics for personalized medicine in point-of care setting.https://www.mdpi.com/2073-4360/16/6/7463D printingadditive manufacturingketaminetabletextended releasepersonalized medicine
spellingShingle Tahmineh Karami
Emad Ghobadi
Mohammad Akrami
Ismaeil Haririan
Fabrication of a Controlled-Release Core-Shell Floating Tablet of Ketamine Hydrochloride Using a 3D Printing Technique for Management of Refractory Depressions and Chronic Pain
Polymers
3D printing
additive manufacturing
ketamine
tablet
extended release
personalized medicine
title Fabrication of a Controlled-Release Core-Shell Floating Tablet of Ketamine Hydrochloride Using a 3D Printing Technique for Management of Refractory Depressions and Chronic Pain
title_full Fabrication of a Controlled-Release Core-Shell Floating Tablet of Ketamine Hydrochloride Using a 3D Printing Technique for Management of Refractory Depressions and Chronic Pain
title_fullStr Fabrication of a Controlled-Release Core-Shell Floating Tablet of Ketamine Hydrochloride Using a 3D Printing Technique for Management of Refractory Depressions and Chronic Pain
title_full_unstemmed Fabrication of a Controlled-Release Core-Shell Floating Tablet of Ketamine Hydrochloride Using a 3D Printing Technique for Management of Refractory Depressions and Chronic Pain
title_short Fabrication of a Controlled-Release Core-Shell Floating Tablet of Ketamine Hydrochloride Using a 3D Printing Technique for Management of Refractory Depressions and Chronic Pain
title_sort fabrication of a controlled release core shell floating tablet of ketamine hydrochloride using a 3d printing technique for management of refractory depressions and chronic pain
topic 3D printing
additive manufacturing
ketamine
tablet
extended release
personalized medicine
url https://www.mdpi.com/2073-4360/16/6/746
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