Accurate low-temperature direct granule extrusion 3D printing of personalised paediatric minitablets

Abdillah Akbar, BVEB, Seluk, M ORCID: 0009-0000-6783-9570, Isreb, A ORCID: 0000-0001-9939-6161, da Silva, M, Dreiss, CA ORCID: 0000-0002-0578-8090, Royall, PG, Gill, A ORCID: 0000-0002-8198-1028, Bracken, L ORCID: 0000-0002-9632-2252, Tomlin, S, Giebułtowicz, J, Jones, SA and Alhnan, MA (2026) Accurate low-temperature direct granule extrusion 3D printing of personalised paediatric minitablets. International Journal of Pharmaceutics, 697. p. 126871. ISSN 0378-5173

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Abstract

Medicine individualisation remains constrained by the limited availability of age-appropriate strengths and by extemporaneous practices that can compromise dose consistency. Direct extrusion 3D printing offers an alternative manufacturing method for personalised medicine, without introducing solvents, complex preparation, or post-processing that challenge the adoption in pharmacy. However, achieving uniform weight and drug content in small objects (e.g., paediatric-friendly minitablets) and lowering the preparation temperature remain challenges for direct extrusion-based 3D printing technologies. In this work, we introduce a facile low-temperature direct granules extrusion 3D printing strategy to manufacture carvedilol minitablets, starting from carvedilol powder or crushed licensed tablets as starting materials, using a high-precision pharmaceutical-grade 3D printer. Methacrylate-based polymers, polyethylene glycol, and glyceryl monostearate were used to enable extrusion at 70–75°C. When the 3D printer was challenged with minute-dimensional designs, it was possible to manufacture batches of minitablets up to 2 mm in diameter with 0.8 mm in thickness. The lowest minitablet weight variation was 1.48%, achieved with an optimal diameter of 3.6 mm and a thickness of 1.6 mm; this was also reflected in the drug content uniformity (within ± 5%). The batches also met British Pharmacopoeia requirements for dissolution (>80% in 45 min). These findings extend direct extrusion 3D printing to a viable manufacturing platform for accurate, low-dose small solid units, such as minitablets. By coupling a GMP-compliant 3D printer with a simplified preparation workflow, this work provides a realistic blueprint for integrating direct extrusion-enabled personalised minitablets into hospital pharmacy and point-of-care settings.

Item Type:	Article
Uncontrolled Keywords:	Additive manufacturing; Individualised therapy; Paediatric-friendly; Precision medicine; Robust production; 3214 Pharmacology and Pharmaceutical Sciences; 32 Biomedical and Clinical Sciences; Generic health relevance; 3 Good Health and Well Being; 1115 Pharmacology and Pharmaceutical Sciences; Pharmacology & Pharmacy; 3214 Pharmacology and pharmaceutical sciences
Subjects:	R Medicine > RM Therapeutics. Pharmacology
Divisions:	Pharmacy and Biomolecular Sciences
Publisher:	Elsevier BV
Date of acceptance:	11 April 2026
Date of first compliant Open Access:	1 May 2026
Date Deposited:	01 May 2026 12:17
Last Modified:	01 May 2026 12:17
DOI or ID number:	10.1016/j.ijpharm.2026.126871
URI:	https://researchonline.ljmu.ac.uk/id/eprint/28501

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