Storage stability of inhalable phage powders containing lactose at ambient conditions

Storage stability of inhalable phage powders containing lactose at ambient conditions.

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Item Type: Article
Status: Published
Official URL:
Journal or Publication Title: International Journal of Pharmaceutics
Volume: 560
Page Range: pp. 11-18
Date: 2019
Divisions: Tuberculosis
Depositing User: General Admin
Identification Number: 10.1016/j.ijpharm.2019.01.050
ISSN: 03785173
Date Deposited: 21 Dec 2020 06:01

The aim of this study was to evaluate the storage stability of inhalable phage powders containing lactose and leucine as excipient. As an FDA-approved excipient for inhalation, lactose is preferred over other sugars. PEV phages active against antibiotic-resistant Pseudomonas aeruginosa was spray dried with lactose (55-90%) and leucine (45-10%). Produced powders were heat-sealed in an aluminium pouch at 15% relative humidity (RH) with subsequent storage at 20 °C/60% RH for 12 months. Lactose concentration in the powder positively influenced the phage stability over time. Formulation containing 90% lactose maintained the viability of PEV61 across the study, while ∼1.2 log10 titer reduction was observed in formulations with less lactose. PEV20 was more prone to inactivation (1.7 log10 titer loss at 12-month) when lactose concentration in the particle was below 80%. The fine particle fraction (% wt. particles <5 μm in aerosol) of phage powders was 52-61% and remained the same after 12-month storage. The results demonstrate that spray dried PEV phage powders containing lactose and leucine are biologically and physically stable over long-term storage at ambient temperature. Furthermore, these spray dried phage powders were shown to be non-toxic to lung alveolar macrophage and epithelial cells in vitro.

Keywords: Bacteriophage (Phage); Inhalation aerosol; Lactose; Spray dried powders; Storage stability.

Copyright © 2019 Elsevier B.V. All rights reserved.

Chang, Rachel Yoon Kyung
Wallin, Martin
Kutter, Elizabeth
Morales, Sandra
Britton, Warwick
Li, Jian
Chan, Hak-Kim
Last Modified: 21 Dec 2020 06:01

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