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Importance of pressure plasticity during compression of probiotic tablet formulations
European Journal of Pharmaceutics and Biopharmaceutics ( IF 4.9 ) Pub Date : 2019-10-09 , DOI: 10.1016/j.ejpb.2019.10.001
Eline Byl , Piet Bladt , Sarah Lebeer , Filip Kiekens

The usefulness, the high production rate and the cost effectiveness make tablets the dosage form of choice for oral probiotics. Nevertheless, probiotic bacteria undergo a lot of mechanical stress during tableting which causes damage to their cell wall and membrane and other bio-active components. This can lead to an inactivation of the probiotic bacteria and therefore in a failure of the probiotic therapy. To obtain a tablet with a sufficient amount of viable cells, research on the influence of formulation and process parameters on bacterial survival is essential. This study aimed to decipher tableting properties of the probiotic powder blends that have a major impact on survival rates. The powder blends consisted of the prototype probiotic strain Lactobacillus rhamnosus GG, a filler-binder and a suitable amount of lubricant. They were manufactured by direct compression at different compression pressures and tableting speeds. The tableting properties were analysed in detail by a 3-D modelling technique, which characterized normalized time, pressure and displacement simultaneously. The results of the 3-D modelling demonstrated the significant effect of the pressure plasticity (e) and the angle of rotation (ω) on the viability of L. rhamnosus GG during direct compression.



中文翻译:

益生菌片剂压缩过程中压力可塑性的重要性

实用性,高生产率和成本效益使片剂成为口服益生菌的首选剂型。然而,益生菌在压片过程中会承受很大的机械应力,这会对它们的细胞壁和膜以及其他生物活性成分造成损害。这可能导致益生菌失活,从而导致益生菌治疗失败。为了获得具有足够数量活细胞的片剂,研究制剂和工艺参数对细菌存活的影响至关重要。这项研究旨在破译对存活率有重大影响的益生菌粉末混合物的压片特性。粉末混合物由益生菌原型鼠李糖乳杆菌组成GG,填充剂和适量的润滑剂。它们是通过在不同的压缩压力和压片速度下直接压缩制成的。通过3-D建模技术对压片特性进行了详细分析,该技术同时对归一化的时间,压力和位移进行了表征。3-D建模的结果表明,在直接压缩过程中,压力可塑性(e)和旋转角度(ω)对鼠李糖乳杆菌GG的生存能力具有显着影响。

更新日期:2019-10-09
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