Purpose

Proper taste-masking formulation design is a critical issue for instant-dissolving tablets (IDTs). The purpose of this study is to use the electronic tongue to design the additives of the 3D printed IDTs to improve palatability.

Methods

A binder jet 3D printer was used to prepare IDTs of levetiracetam. A texture analyzer and dissolution apparatus were used to predict the oral dispersion time and in vitro drug release of IDTs, respectively. The palatability of different formulations was investigated using the ASTREE electronic tongue in combination with the design of experiment and a model for masking bitter taste. Human gustatory sensation tests were conducted to further evaluate the credibility of the results.

Results

The 3D printed tablets exhibited rapid dispersion (<30 s) and drug release (2.5 min > 90%). The electronic tongue had an excellent ability of taste discrimination, and levetiracetam had a good linear sensing performance based on a partial least square regression analysis. The principal component analysis was used to analyze the signal intensities of different formulations and showed that 2% sucralose and 0.5% spearmint flavoring masked the bitterness well and resembled the taste of corresponding placebo. The results of human gustatory sensation test were consistent with the trend of the electronic tongue evaluation.

Conclusions

Owing to its objectivity and reproducibility, this technique is suitable for the design and evaluation of palatability in 3D printed IDT development.

中文翻译：

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基于电子舌的掩味研究：3D打印左乙拉西坦速溶片的配方设计

目的

正确的掩味配方设计是速溶片 (IDT) 的一个关键问题。本研究的目的是利用电子舌设计 3D 打印 IDT 的添加剂以提高适口性。

方法

使用粘合剂喷射 3D 打印机制备左乙拉西坦的 IDT。质地分析仪和溶出度仪分别用于预测IDT的口服分散时间和体外药物释放。使用ASTREE电子舌结合实验设计和苦味掩蔽模型研究了不同配方的适口性。进行了人类味觉测试以进一步评估结果的可信度。

结果

3D 打印的片剂表现出快速分散（<30 秒）和药物释放（2.5 分钟 > 90%）。基于偏最小二乘回归分析，电子舌具有优异的味觉辨别能力，左乙拉西坦具有良好的线性感知性能。主成分分析用于分析不同配方的信号强度，结果表明2%的三氯蔗糖和0.5%的留兰香调味剂很好地掩盖了苦味，并类似于相应安慰剂的味道。人体味觉测试结果与电子舌评价趋势一致。

结论

由于其客观性和可重复性，该技术适用于 3D 打印 IDT 开发中的适口性设计和评估。