Predicting probiotic viability during tabletting using the finite element method integrated with a thermal tolerance model

IF 5.2 2区 医学 Q1 PHARMACOLOGY & PHARMACY International Journal of Pharmaceutics Pub Date : 2025-03-15 Epub Date: 2025-02-11 DOI:10.1016/j.ijpharm.2025.125341
Bide Wang , Oleksiy V. Klymenko , Rachael Gibson , Andrew Middleton , Sam Elvin , Vishal Shinde , I. Csaba Sinka , Chuan-Yu Wu
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Abstract

Tablet is an effective system for delivering probiotics into the gastrointestinal tract. However, the mechanical stress, combined with the local heating generated during compaction, pose challenges to maintaining probiotic viability. Evaluating probiotic viability under various compression conditions is necessary to optimise the tabletting process. However, testing each scenario individually significantly increases development time and costs. Hence, it is of scientific and industrial importance to develop predictive models for assessing probiotic viability during compaction. In this study, a finite element (FE) model integrating the modified Drucker-Prager Cap (DPC) model with a thermal tolerance model was developed for the first time to predict the probiotic viability during powder compaction. The capability of the model in predicting mechanical behaviour, thermal response, and probiotic viability was demonstrated through comparison with experimental measurements. FE analysis revealed that the viability of the probiotic Lactobacillus gasseri (L. gasseri KS-13) decreases as the compression pressure increases, as observed experimentally. Furthermore, it is also found that pre-compression is an effective method to enhance the viability of probiotics during compaction.

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利用结合热耐受性模型的有限元法预测压片过程中益生菌的活力。
片剂是将益生菌输送到胃肠道的有效系统。然而,机械应力加上压实过程中产生的局部加热,对维持益生菌的生存能力构成了挑战。评估不同压缩条件下益生菌的活力是优化压片工艺的必要条件。然而,单独测试每个场景会显著增加开发时间和成本。因此,开发预测模型来评估压实过程中益生菌的活力具有重要的科学和工业意义。本研究首次建立了将改进的Drucker-Prager Cap (DPC)模型与耐热性模型相结合的有限元模型,用于预测粉末压实过程中益生菌的活力。通过与实验测量的比较,证明了该模型在预测机械行为、热响应和益生菌活力方面的能力。实验结果表明,随着压缩压力的增加,益生菌气态乳杆菌(L. gasseri KS-13)的活力降低。此外,还发现预压缩是一种有效的方法,以提高益生菌在压实过程中的活力。
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来源期刊
CiteScore
10.70
自引率
8.60%
发文量
951
审稿时长
72 days
期刊介绍: The International Journal of Pharmaceutics is the third most cited journal in the "Pharmacy & Pharmacology" category out of 366 journals, being the true home for pharmaceutical scientists concerned with the physical, chemical and biological properties of devices and delivery systems for drugs, vaccines and biologicals, including their design, manufacture and evaluation. This includes evaluation of the properties of drugs, excipients such as surfactants and polymers and novel materials. The journal has special sections on pharmaceutical nanotechnology and personalized medicines, and publishes research papers, reviews, commentaries and letters to the editor as well as special issues.
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