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.
Tahmineh Karami, Emad Ghobadi, Mohammad Akrami, Ismaeil Haririan
Polymers March 8, 2024 DOI: 10.3390/polym16060746 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Experimental study Peer reviewed |
|---|---|
| Duration | 12 h |
| Topics | Ketamine Depression Esketamine |
| Keywords | 3d printing Additive manufacturing Extended release Personalized medicine Tablet 3d-printing-technology Drug-delivery-systems Personalized-medicine Pharmaceutical-innovation Controlled-release-drugs |
| Citations | 13 |
| Key findings | A 3D-printed floating controlled-release tablet of ketamine hydrochloride achieved 100% drug release over 12 hours and met USP standards for solid dosage forms. |
Abstract
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® and Eudragit® 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.
Comparable studies
Other experimental studies on ketamine for depression, most cited first.
Citations in the library
Cites 6
- A Double-Blind, Randomized, Placebo-Controlled, Dose-Frequency Study of Intravenous Ketamine in Patients With Treatment-Resistant Depression American Journal of Psychiatry April 8, 2016
- Ketamine and depression: a narrative review Drug Design, Development and Therapy August 1, 2019
- Ascending‐Dose Study of Controlled‐Release Ketamine Tablets in Healthy Volunteers: Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability The Journal of Clinical Pharmacology February 17, 2020
- Safety and efficacy of extended release ketamine tablets in patients with treatment-resistant depression and anxiety: open label pilot study Therapeutic Advances in Psychopharmacology 2020
- Real‐world effectiveness of repeated ketamine infusions for treatment‐resistant bipolar depression Bipolar Disorders December 14, 2022
and 1 more in the library