Spray-dried anti-Campylobacter bacteriophage CP30A powder suitable for global distribution without cold chain infrastructure

Int J Pharm. 2019 Oct 5:569:118601. doi: 10.1016/j.ijpharm.2019.118601. Epub 2019 Aug 5.

Abstract

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.

Keywords: Campylobacter jejuni; Global health; Particle engineering; Phage CP20; Phage CP30A; Shipping stability.

MeSH terms

  • Bacteriophages*
  • Campylobacter / virology*
  • Chemistry, Pharmaceutical
  • Desiccation
  • Excipients / chemistry
  • Leucine / chemistry
  • Powders
  • Trehalose / chemistry

Substances

  • Excipients
  • Powders
  • Trehalose
  • Leucine