Aina Morenikeji, Baillon Fabien, Sescousse Romain, Sanchez-Ballester Noelia M, Begu Sylvie, Soulairol Ian, Sauceau Martial
RAPSODEE, IMT Mines Albi, CNRS, University of Toulouse, 81013 Albi, France.
ICGM, University of Montpellier, CNRS, ENSCM, 34293 Montpellier, France.
Gels. 2024 Oct 17;10(10):665. doi: 10.3390/gels10100665.
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.
给药精准度对于优化治疗效果及预防用药过量至关重要，尤其是在早产儿中。传统的手动调整剂量方式往往会导致不准确、有污染风险以及精准度降低。为克服这些挑战，采用了半固体挤出3D打印技术来制造个性化的基于凝胶的咖啡因剂型。由琼脂和羟丙基甲基纤维素制成的水凝胶表现出优异的流变学特性，确保了打印过程中及打印后均匀挤出并准确保持形状。这种凝胶配方能够根据一名体重1.36千克的新生儿精确调整咖啡因的体积和含量，回收率达到103.46%，完全在可接受范围内。此外，三个生产批次证实了该工艺具有最小变异性的可重复性。强制降解研究表明，纯咖啡因和凝胶基质中的咖啡因表现出相似的稳定性特征，证实了药物的化学完整性。打印出的凝胶剂型还具有速释特性，45分钟内超过80%的咖啡因释放出来，突出了它们适用于快速治疗作用。这些发现强调了半固体挤出3D打印技术和基于凝胶的配方在生产具有高精度、可重复性和可靠性的个性化药物递送系统方面的潜力。
