Vorländer Karl, Pramann Paula, Kwade Arno, Finke Jan Henrik, Kampen Ingo
Institute for Particle Technology (iPAT), Technische Universität Braunschweig, Volkmaroder Straße 5, 38104 Braunschweig, Germany; Center of Pharmaceutical Engineering (PVZ), Technische Universität Braunschweig, Franz-Liszt-Straße 35A, 38106 Braunschweig, Germany.
Int J Pharm. 2023 Jul 25;642:123100. doi: 10.1016/j.ijpharm.2023.123100. Epub 2023 Jun 5.
Probiotic microorganisms provide health benefits to the patient when administered in a viable form and in sufficient doses. To ensure this, dry dosage forms are preferred, with tablets in particular being favored due to several advantages. However, the microorganisms must first be dried as gently as possible. Here, the model organism Saccharomyces cerevisiae was dried by spray drying. Various additives were tested for their ability to improve yeast cell survival during drying. In addition, the influence of various process parameters such as inlet temperature, outlet temperature, spray rate, spray pressure and nozzle diameter was investigated. It was possible to dry the yeast cells in such a way that a substantial proportion of living microorganisms was recovered after reconstitution. Systematic variation of formulation and process parameters showed that the use of protective additives is essential and that the outlet temperature determines the survival rate. The subsequent compression of the spray-dried yeast reduced viability and survival could hardly be improved by the addition of excipients, but the tabletability of spray-dried yeast protectant particles was quite good. For the first time, loss of viability during compaction of spray-dried microorganisms was correlated with the specific densification, allowing a deeper understanding of the mechanism of cell inactivation during tableting.
当以活的形式和足够的剂量施用时，益生菌微生物对患者有益健康。为确保这一点，首选干燥剂型，尤其是片剂，因其具有多种优点而更受青睐。然而，微生物必须首先尽可能温和地干燥。在此，通过喷雾干燥对模式生物酿酒酵母进行干燥。测试了各种添加剂在干燥过程中提高酵母细胞存活率的能力。此外，还研究了各种工艺参数，如进口温度、出口温度、喷雾速率、喷雾压力和喷嘴直径的影响。以这样一种方式干燥酵母细胞是可行的，即在复溶后可回收相当比例的活微生物。制剂和工艺参数的系统变化表明，使用保护性添加剂至关重要，且出口温度决定存活率。喷雾干燥酵母的后续压片降低了活力，添加辅料几乎无法提高存活率，但喷雾干燥酵母保护剂颗粒的可压性相当好。首次将喷雾干燥微生物压片过程中的活力损失与比压实度相关联，从而更深入地了解压片过程中细胞失活的机制。
