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Storage stability prediction of spray dried Anti-Acinetobacter baumannii phage and phage cocktail powders
Andrew Foon Yu Cheng1, Daniel Tim Ching Choi1, Yannan Liu2
1School of Pharmacy, The Chinese University of Hong Kong, Hong Kong SAR, China.
Abstract:
Bacterial lung infections caused by Acinetobacter baumannii have traditionally been treated with oral and parental antibiotic treatments. However, the rapid emergence of multidrug-resistant (MDR) strains has led to increased mortality rates. Inhaled bacteriophage (phage) therapy, which utilizes lytic phages as therapeutic agents, has emerged as a promising alternative treatment option. However, the poor storage stability of phage products can affect their commercial viability. In this study, three anti-A. baumannii phages, including vB_AbaM-IME-AB2, vB_AbaM-IME-AB9, and vB_AbaM-IME-AB406 and their cocktail, were formulated into inhalable powders using a spray-drying technique. Two chosen excipient compositions (Formulation 1: 60% trehalose, 20% mannitol and 20% leucine, and Formulation 2: 40% trehalose, 40% mannitol and 20% leucine) were employed to stabilize phages in the powder form. The production loss of phage, particle size, particle morphology, and aerosol performance of prepared phage powders were analyzed to confirm their suitability for pulmonary delivery. Then, the feasibility of using an accelerated stability test based on the Arrhenius Equation to estimate the shelf-life of produced phage powders were demonstrated. Overall, the findings contribute to the development of inhalable phage powder formulations that can be used as a potential treatment for lung infections.
Insights
Inhalable bacteriophage (phage) powders were developed to treat multidrug-resistant Acinetobacter baumannii lung infections. Spray-drying stabilized phages, showing potential for improved storage and pulmonary delivery of phage therapy.
Area of Science:
- Microbiology
- Pharmaceutical Sciences
- Biotechnology
Background:
- Multidrug-resistant (MDR) Acinetobacter baumannii lung infections pose a significant threat due to limited treatment options.
- Bacteriophage (phage) therapy is a promising alternative, but poor storage stability hinders its clinical application.
- Developing stable, inhalable phage formulations is crucial for effective pulmonary delivery.
Purpose of the Study:
- To formulate stable, inhalable powders of anti-Acinetobacter baumannii phages using spray-drying.
- To evaluate the impact of different excipient compositions on phage stability and aerosol performance.
- To assess the feasibility of using accelerated stability testing to predict the shelf-life of phage powders.
Main Methods:
- Three specific anti-A. baumannii phages (vB_AbaM-IME-AB2, vB_AbaM-IME-AB9, vB_AbaM-IME-AB406) and their cocktail were spray-dried with two different excipient formulations.
- Analysis included phage production loss, particle size, particle morphology, and aerosol performance.
- Accelerated stability testing based on the Arrhenius Equation was employed to estimate shelf-life.
Main Results:
- Spray-drying successfully produced inhalable phage powders with acceptable particle characteristics and aerosol performance.
- Both tested excipient formulations (trehalose, mannitol, leucine) contributed to phage stabilization in powder form.
- The Arrhenius Equation provided a feasible method for estimating the shelf-life of the developed phage powders.
Conclusions:
- Inhalable bacteriophage powders are a viable formulation strategy for treating Acinetobacter baumannii lung infections.
- Spray-drying with selected excipients enhances phage stability for pulmonary delivery.
- This approach supports the commercial development of phage therapy for respiratory infections.
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