Taste Masking Study Based on an Electronic Tongue: the Formulation Design of 3D Printed Levetiracetam Instant-Dissolving Tablets

Abstract

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.

Preparation of Azithromycin Amorphous Solid Dispersion by Hot-Melt Extrusion: An Advantageous Technology with Taste Masking and Solubilization Effects

“…The selection of the polymer requires consideration of the suitability of the formulation design, mainly in terms of compatibility with API [ 5 ]. Therefore, the HSP can be calculated based on the chemical structure to predict the solid–solid miscibility of the drug and the polymer.…”

“…It is meaningless to conduct clinical trials of products with an unpleasant taste in the pediatric population. Therefore, special attention should be paid to the bitterness of drugs in the development of pediatric preparation [ 1 , 5 ].…”

Binder Jet 3D Printing of Compound LEV-PN Dispersible Tablets: An Innovative Approach for Fabricating Drug Systems with Multicompartmental Structures

“…The powder mixture was prepared according to the method in a prior article published by our team [31,32]. Briefly, LEV (API, accounting for 65% of the powder), MCC PH101 (disintegrant), mannitol (filler), PVP (binder), sucralose (sweetener), spearmint flavor (flavoring agent), and Aerosil 200 (glidant) were mixed in a Hopper Mixer (HSD15 Lab Mixer, Canaan Technology, Zhejiang, China) at 20 rpm for 20 min to obtain the final powder mixture.…”

In Vitro and In Vivo Bioequivalence Study of 3D-Printed Instant-Dissolving Levetiracetam Tablets and Subsequent Personalized Dosing for Chinese Children Based on Physiological Pharmacokinetic Modeling

“…The instant-dissolving tablets (IDTs) prepared by this technology have a highly porous internal structure, which allows them to be rapidly dispersed in water, thus solving the swallowing difficulties patients experience. In this study, the BJ-3DP technology platform, which has the ability to produce Levetiracetam (LEV) dispersible tablets by batch printing, was built independently in the early stage, and the formulations produced by using the BJ-3DP technology platform have many advantages, such as large drug loading capacity, flexible dose, and rapid release [20,21].…”

“…LEV has a low metabolic rate. In total, 93% of the administered dose is excreted after 24 h, 66% of the administered dose is unchanged in the urine, and 27% is excreted as an inactive metabolite [20].…”