Probiotic nasal spray development by spray drying

Eur J Pharm Biopharm. 2021 Feb:159:211-220. doi: 10.1016/j.ejpb.2020.11.008. Epub 2020 Nov 22.

Abstract

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 >109 (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.

Keywords: Adhesion; Antimicrobial activity; Lacticaseibacillus; Nasal spray; Shelf-life; Spray drying.

MeSH terms

  • Administration, Intranasal
  • Cell Line, Tumor
  • Humans
  • Lacticaseibacillus rhamnosus*
  • Microbial Sensitivity Tests
  • Microbial Viability
  • Nasal Sprays
  • Powders
  • Probiotics / administration & dosage*
  • Respiratory Tract Infections / diet therapy*
  • Respiratory Tract Infections / microbiology
  • Spray Drying*

Substances

  • Nasal Sprays
  • Powders