Abstract

3D-printing technology offers a flexible manufacturing platform with the potential to address the need of personalized dosage forms. However, quality aspects of such small-scale, on-demand production of pharmaceutical products intended for personalization is still limited. The aim of this study was therefore to study critical quality control attributes of lipid tablets produced by semi-solid extrusion (SSE) 3D printing from emulsion gels incorporating a poorly water-soluble drug. Quality attributes for both the printable emulsion gel and the printed dosage forms were assessed. The emulsion gel was shown to be printable with accurate dosing for at least one month of storage at 4 degrees C. Tablets were 3D printed in different sizes and a correlation, R2 value of 0.99, was found between the weight and the drug content. The 3D-printed tablets complied with the mass and drug content uniformity requirements described in the European Pharmacopoeia.. Solid-state characterization of the tablets during short-term storage revealed no signs of crystallinity of the drug. Lastly, the lipid digestion and drug release were unchanged after short-term storage of the tablets. This study demonstrates the potential of SSE 3D printing for personalized dosing of a lipid-based formulation strategy and discusses central quality attributes for the printable formulation and the 3D-printed dosage form.

Keywords

Poorly water-soluble drug; Emulsion gel; Semi-solid extrusion; 3D printing; Quality control; Personalized dosage form

Published in

International Journal of Pharmaceutics
2023, Volume: 646, article number: 123413

SLU Authors

• Johansson, Mathias

  • Department of Molecular Sciences, Swedish University of Agricultural Sciences
    

UKÄ Subject classification

Pharmaceutical Sciences


Publication identifier

DOI: https://doi.org/10.1016/j.ijpharm.2023.123413

Permanent link to this page (URI)

https://res.slu.se/id/publ/126524