Department of Mechanical Engineering, University of Alberta, Edmonton, Canada.
School of Biosciences, University of Nottingham, Loughborough, UK.
Int J Pharm. 2019 Oct 5;569:118601. doi: 10.1016/j.ijpharm.2019.118601. Epub 2019 Aug 5.
Campylobacter jejuni is a leading cause of foodborne illness globally. In this study, a spray drying and packaging process was developed to produce a thermally-stable dry powder containing bacteriophages that retains biological activity against C. jejuni after long distance shipping at ambient temperature. Spray drying using a twin-fluid atomizer resulted in significantly less (p < 0.05) titer reduction than spray drying using a vibrating mesh nebulizer. The use of centrifugation and dilution of filtered bacteriophage lysate in the formulation step resulted in a significantly greater (p < 0.05) proportion of bacteriophages remaining active relative to use of no centrifugation and dilution. The spray-dried bacteriophage powder generated using leucine and trehalose as excipients was flowable, non-cohesive, and exhibited a high manufacturing yield. The powder retained its titer with no significant differences (p > 0.05) in biological activity after storage in suitable packaging for at least 3 weeks at room temperature and after ambient temperature shipping a total distance of approximately 19,800 km, including with a 38 °C temperature excursion. The bacteriophage powder therefore appears suitable for global distribution without the need for cold chain infrastructure.
空肠弯曲菌是全球食源性疾病的主要致病菌。本研究开发了喷雾干燥和包装工艺，生产出一种热稳定的干粉，其中含有在常温下长途运输后仍能保持对空肠弯曲菌生物活性的噬菌体。使用双流体雾化器进行喷雾干燥比使用振动筛式雾化器导致的效价降低显著更少（p<0.05）。在配方步骤中使用离心和过滤噬菌体裂解物的稀释，相对于不使用离心和稀释，显著增加了保持活性的噬菌体的比例（p<0.05）。使用亮氨酸和海藻糖作为赋形剂产生的喷雾干燥噬菌体粉末是可流动的、非粘性的，并且表现出高的制造收率。该粉末在室温下合适的包装中储存至少 3 周，以及在常温下运输约 19,800 公里，包括 38°C 的温度波动后，其效价保持不变，生物活性没有显著差异（p>0.05）。因此，噬菌体粉末似乎无需冷链基础设施即可在全球范围内分发。
