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Solvent-free temperature-facilitated direct extrusion 3D printing for pharmaceuticals

Kuźmińska, M, Pereira, BC, Habashy, R, Peak, M, Isreb, M, Gough, TD, Isreb, A and Alhnan, MA (2021) Solvent-free temperature-facilitated direct extrusion 3D printing for pharmaceuticals. International Journal of Pharmaceutics, 598. p. 120305. ISSN 0378-5173

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In an era moving towards digital health, 3D printing has successfully proven its applicability in providing personalised medicine through a technology-based approach. Among the different 3D printing techniques, direct extrusion 3D printing has been demonstrated as a promising approach for on demand manufacturing of solid dosage forms. However, it usually requires the use of elevated temperatures and/or the incorporation of an evaporable solvent (usually water). This can implicate the addition of a drying step, which may compromise the integrity of moisture- or temperature-sensitive drugs, and open the door for additional quality control challenges. Here, we demonstrate a new approach that simplifies direct extrusion 3D printing process with the elimination of the post-printing drying step, by merely adding a fatty glyceride, glyceryl monostearate (GMS), to a model drug (theophylline) and permeable water insoluble methacrylate polymers (Eudragit RL and RS). Indeed, rheological studies indicated that the addition of a combination of a plasticiser, (triethyl citrate), and GMS to theophylline: methacrylate polymer blends significantly reduced the extensional viscosity (to <2.5 kPa·Sec) at 90 °C. Interestingly, GMS demonstrated a dual temperature-dependant behaviour by acting both as a plasticiser and a lubricant at printing temperature (90–110 °C), while aiding solidification at room temperature. X-ray powder diffraction indicated incomplete miscibility of GMS within the polymeric matrix at room temperature with the presence of a subtle diffraction peak, at 2(Θ) = 20°. The 3D printed tablets showed acceptable compendial weight and content uniformity as well as sufficient mechanical resistance. In vitro theophylline release from 3D printed tablets was dependant on Eudragit RL:RS ratio. All in all, this work contributes to the efforts of developing a simplified, facile and low-cost 3D printing for small batch manufacturing of bespoke tablets that circumvents the use of high temperature and post-manufacturing drying step.

Item Type: Article
Uncontrolled Keywords: Tablets; Solvents; Temperature; Drug Liberation; Printing, Three-Dimensional; Direct ink writing; Early phase clinical trials; Material extrusion; Patient-specific; Personalized; Small batch; Drug Liberation; Printing, Three-Dimensional; Solvents; Tablets; Temperature; Pharmacology & Pharmacy; 1115 Pharmacology and Pharmaceutical Sciences
Subjects: R Medicine > RM Therapeutics. Pharmacology
Divisions: Pharmacy & Biomolecular Sciences
Publisher: Elsevier BV
SWORD Depositor: A Symplectic
Date Deposited: 20 May 2022 09:36
Last Modified: 20 May 2022 09:45
DOI or ID number: 10.1016/j.ijpharm.2021.120305
URI: https://researchonline.ljmu.ac.uk/id/eprint/16878
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