Development of Personalised Immediate-Release Gel-Based Formulations Using Semi-Solid Extrusion.

Abstract

Precision in dosing is crucial for optimizing therapeutic outcomes and preventing overdosing, especially in preterm infants. Traditional manual adjustments to adapt the dose often lead to inaccuracies, contamination risks, and reduced precision. To overcome these challenges, semi-solid extrusion 3D printing was used to create personalised gel-based caffeine dosage forms. The hydrogels, made from agar and hydroxypropyl methylcellulose, demonstrated excellent rheological properties, ensuring uniform extrusion and accurate shape retention during and after printing. This gel formulation allowed for precise adjustments of caffeine volume and content tailored to a neonate weighing 1.36 kg, achieving a recovery of 103.46%, well within acceptable limits. Additionally, three production batches confirmed the process's reproducibility with minimal variability. Forced degradation studies showed that both pure caffeine and caffeine in the gel matrix exhibited similar stability profiles, confirming the drug's chemical integrity. The printed gel dosage forms also displayed immediate-release characteristics, with over 80% of caffeine released within 45 min, highlighting their suitability for rapid therapeutic action. These findings emphasise the potential of SSE 3DP and gel-based formulations to produce personalised drug delivery systems with high precision, reproducibility, and reliability.