Journal
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS
Volume 127, Issue -, Pages 213-222Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.ejpb.2018.02.033
Keywords
Phage; PEV2; PEV40; Pulmonary infections; Phage dry powder; Antibiotic resistance
Categories
Funding
- Australian Research Council [DP150103953]
- National Institute of Allergy and Infectious Diseases of the National Institutes of Health [R21AI121627]
- University of Sydney
- National Health and Medical Research Council Centre of Research Excellence in Tuberculosis Control [APP1043225]
- NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES [R33AI121627, R21AI121627] Funding Source: NIH RePORTER
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This study aimed to assess the robustness of using a spray drying approach and formulation design in producing inhalable phage powders. Two types of Pseudomonas phages, PEV2 (Podovirus) and PEV40 (Myovirus) in two formulations containing different amounts of trehalose (70% and 60%) and leucine (30% and 40%) were studied. Most of the surface of the produced powders was found to be covered in crystalline leucine. The powders were stored at 4 degrees C and 20 degrees C under vacuum. The phage stability and in vitro aerosol performance of the phage powders were examined on the day of production and after 1, 3 and 12 months of storage. A minor titer loss during production was observed for both phages (0.2-0.8 log(10) pfu/ml). The storage stability of the produced phage powders was found to be phage and formulation dependent. No further reduction in titer occurred for PEV2 powders stored at 4 degrees C across the study. The formulation containing 30% leucine maintained the viability of PEV2 at 20 degrees C, while the formulation containing 40% leucine gradually lost titer over time with a storage reduction of similar to 0.9 log(10) pfu/ml measured after 12 months. In comparison, the PEV40 phage powders generally had a similar to 0.5 log(10) pfu/ml loss upon storage regardless of temperature. When aerosolized, the total in vitro lung doses of PEV2 were of the order of 10(7) pfu, except the formulation containing 40% leucine stored at 20 degrees C which had a lower lung dose. The PEV40 powders also had lung doses of 10(6)-10(7) pfu. The results demonstrate that spray dried Myoviridae and Podoviridae phage in a simple formulation of leucine and trehalose can be successfully stored for one year at 4 degrees C and 20 degrees C with vacuum packaging.
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