Department of Micro- and Nanotechnology, Technical University of Denmark, Oersteds Plads 345C, 2800 Kgs. Lyngby, Denmark.
Department of Micro- and Nanotechnology, Technical University of Denmark, Oersteds Plads 345C, 2800 Kgs. Lyngby, Denmark; Department of Applied Mathematics and Computer Science, Technical University of Denmark, Richard Petersens Plads 321, 2800 Kgs. Lyngby, Denmark.
Eur J Pharm Biopharm. 2019 Feb;135:44-48. doi: 10.1016/j.ejpb.2018.12.008. Epub 2018 Dec 18.
Vaccines provide great benefit for global health, but are insufficiently distributed in developing countries due to high costs of manufacturing and limited storage stability. Spray drying formulations of peptide-based vaccines offer a promising strategy to reduce production costs and improve unrefrigerated storage stability. This design of experiments investigated how adjusting spray drying parameters (inlet temperature, atomization pressure, feed rate and aspiration rate) affects residual moisture and reconstitution properties of the powder product, and morphology and size of the rehydrated particles. An emulsion capable of forming cubosomes with the protein ovalbumin as model antigen was used as vaccine formulation and spray dried. The produced powders had low residual moisture content, independent of the spray drying parameters within the range investigated. Cryogenic transmission electron microscopy revealed that cubosomes were produced after rehydration regardless of the spray drying parameters. Furthermore, dynamic light scattering showed that the average diameter of the rehydrated particles consistently was close to 230 nm at any combination of spray drying parameters as long as the outlet temperature was kept below a threshold of 115 °C. The process thus appears to be robust allowing optimization to be focused on yield, dry particle engineering or outlet temperature considerations.
疫苗为全球健康带来了巨大的益处，但由于制造成本高和储存稳定性有限，在发展中国家的分布不足。基于肽的疫苗喷雾干燥制剂提供了一种有前途的策略，可以降低生产成本并提高非冷藏储存稳定性。本实验设计研究了调整喷雾干燥参数（入口温度、雾化压力、进料速率和抽吸速率）如何影响粉末产品的残余水分和再配制性能，以及再水合颗粒的形态和大小。一种能够形成具有卵清蛋白作为模型抗原的立方相的乳液被用作疫苗制剂并进行喷雾干燥。所生产的粉末具有低残余水分含量，与所研究的喷雾干燥参数无关。低温传输电子显微镜显示，立方相在再水合后形成，无论喷雾干燥参数如何。此外，动态光散射表明，只要出口温度保持在 115°C 以下的阈值以下，再水合颗粒的平均直径始终接近 230nm，无论喷雾干燥参数的组合如何。因此，该工艺似乎具有很强的鲁棒性，可以集中优化产量、干颗粒工程或出口温度的考虑因素。
