University of Antwerp, Department of Pharmaceutical, Biomedical and Veterinary Sciences, Laboratory of Pharmaceutical Technology and Biopharmacy, Universiteitsplein 1, 2610 Wilrijk, Belgium.
University of Antwerp, Department of Bioscience Engineering, Research Group Environmental Ecology and Applied Microbiology, Groenenborgerlaan 171, 2020 Antwerp, Belgium.
Eur J Pharm Biopharm. 2021 Feb;159:211-220. doi: 10.1016/j.ejpb.2020.11.008. Epub 2020 Nov 22.
The upper respiratory tract (URT) is the main entrance point for many viral and bacterial pathogens, and URT infections are among the most common infections in the world. Recent evidences by our own group and others imply the importance of lactobacilli as gatekeepers of a healthy URT. However, the benefits of putting health-promoting microbes or potential probiotics, such as these URT lactobacilli, in function of URT disease control and prevention is underestimated, among others because of the absence of adequate formulation modalities. Therefore, this study entails important aspects in probiotic nasal spray development with a novel URT-derived probiotic strain by spray drying. We report quantitative and qualitative analysis of several spray-dried formulations, i.e. powders for reconstitution, based on disaccharide or sugar alcohol combinations with a polymer, including their long-term stability. Four formulations with the highest survival of >10 (Colony Forming Units) CFU/g after 28 weeks were further examined upon reconstitution which confirmed sufficiency of one bottle/dosage form during 7 days and rheological properties of shear-thinning. Tests also demonstrated maintained viability and cell morphology overall upon spraying through a nasal spray bottle in all 4 formulations. Lastly, application suitability in terms of high adherence to Calu-3 cells and antimicrobial activity against common URT pathogens was demonstrated and was not impacted neither by powder production process nor by spraying of reconstituted powder through a nasal spray device.
上呼吸道（URT）是许多病毒和细菌病原体的主要入口，URT 感染是世界上最常见的感染之一。我们自己的研究小组和其他研究小组的最新证据表明，乳杆菌作为健康 URT 的守门员的重要性。然而，将促进健康的微生物或潜在的益生菌（如这些 URT 乳杆菌）用于 URT 疾病控制和预防的功能的好处被低估了，部分原因是缺乏足够的配方模式。因此，这项研究涉及到通过喷雾干燥开发新型 URT 衍生益生菌菌株的益生菌鼻喷雾剂的重要方面。我们报告了几种喷雾干燥制剂的定量和定性分析，即基于二糖或糖醇与聚合物组合的再配制粉末，包括它们的长期稳定性。在 28 周后，有 4 种制剂的存活率超过 10（菌落形成单位）CFU/g，进一步对其进行了再配制后的检查，这证实了在 7 天内一瓶/剂量形式的充分性，并且具有剪切稀化的流变学特性。测试还表明，在所有 4 种制剂中，通过鼻喷雾剂瓶喷雾，均可保持整体的生存能力和细胞形态。最后，证明了在高粘附性方面适用于 Calu-3 细胞和针对常见 URT 病原体的抗菌活性，并且粉末生产过程和通过鼻喷雾装置喷雾再配制粉末都不会影响其适用性。
