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Trileucine and Pullulan Improve Anti- Campylobacter Bacteriophage Stability in Engineered Spray-Dried Microparticles
Annals of Biomedical Engineering ( IF 3.474 ) Pub Date : 2019-12-16 , DOI: 10.1007/s10439-019-02435-6
Nicholas B. Carrigy, Lu Liang, Hui Wang, Samuel Kariuki, Tobi E. Nagel, Ian F. Connerton, Reinhard Vehring

Abstract Spray drying biologics into a powder can increase thermal stability and shelf-life relative to liquid formulations, potentially eliminating the need for cold chain infrastructure for distribution in developing countries. In this study, process modelling, microparticle engineering, and a supplemented phase diagram were used to design physically stable fully amorphous spray-dried powder capable of stabilizing biological material. A greater proportion of anti-Campylobacter bacteriophage CP30A remained biologically active after spray drying using excipient formulations containing trehalose and a high glass transition temperature amorphous shell former, either trileucine or pullulan, as compared to the commonly used crystalline shell former, leucine, or a low glass transition temperature amorphous shell former, pluronic F-68. Particle formation models suggest that the stabilization was achieved by protecting the bacteriophages against the main inactivating stress, desiccation, at the surface. The most promising formulation contained a combination of trileucine and trehalose for which the combined effects of feedstock preparation, spray drying, and 1-month dry room temperature storage resulted in a titer reduction of only 0.6 ± 0.1 log10(PFU mL−1). The proposed high glass transition temperature amorphous formulation platform may be advantageous for stabilizing biologics in other spray drying applications in the biomedical engineering industry.
更新日期:2020-03-24

 

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