Effects of storage conditions on the stability of spray dried, inhalable bacteriophage powders

[Display omitted] This study aimed to develop inhalable powders containing phages active against antibiotic-resistant Pseudomonas aeruginosa for pulmonary delivery. A Pseudomonas phage, PEV2, was spray dried into powder matrices comprising of trehalose (0–80%), mannitol (0–80%) and l-leucine (20%)....

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Bibliographic Details
Published in:International journal of pharmaceutics 2017-04, Vol.521 (1-2), p.141-149
Main Authors: Leung, Sharon S.Y., Parumasivam, Thaigarajan, Gao, Fiona G., Carter, Elizabeth A., Carrigy, Nicholas B., Vehring, Reinhard, Finlay, Warren H., Morales, Sandra, Britton, Warwick J., Kutter, Elizabeth, Chan, Hak-Kim
Format: Article
Language:English
Subjects:
Administration, Inhalation
Bacteriophages - chemistry
Crystallization
Desiccation - methods
Drug Stability
Drug Storage - methods
Humidity - adverse effects
MDR
Multi-drug resistance
Particle Size
PEV2
Phage
Powders
Pseudomonas aeruginosa - chemistry
Pseudomonas aeruginosa - physiology
Pulmonary infection
Spray drying
X-Ray Diffraction
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Summary:[Display omitted] This study aimed to develop inhalable powders containing phages active against antibiotic-resistant Pseudomonas aeruginosa for pulmonary delivery. A Pseudomonas phage, PEV2, was spray dried into powder matrices comprising of trehalose (0–80%), mannitol (0–80%) and l-leucine (20%). The resulting powders were stored at various relative humidity (RH) conditions (0, 22 and 60% RH) at 4°C. The phage stability and in vitro aerosol performance of the phage powders were examined at the time of production and after 1, 3 and 12 months storage. After spray drying, a total of 1.3 log titer reduction in phage was observed in the formulations containing 40%, 60% and 80% trehalose, whereas 2.4 and 5.1 log reductions were noted in the formulations containing 20% and no trehalose, respectively. No further reduction in titer occurred for powders stored at 0 and 22% RH even after 12 months, except the formulation containing no trehalose. The 60% RH storage condition had a destructive effect such that no viable phages were detected after 3 and 12 months. When aerosolised, the total lung doses for formulations containing 40%, 60% and 80% trehalose were similar (in the order of 105 pfu). The results demonstrated that spray drying is a suitable method to produce stable phage powders for pulmonary delivery. A powder matrix containing ≥40% trehalose provided good phage preservation and aerosol performances after storage at 0 and 22% RH at 4°C for 12 months.
ISSN:0378-5173
1873-3476
DOI:10.1016/j.ijpharm.2017.01.060