Andrew J.L. McArthur1, Victoria L. Oliver2, Pete Lambert1, Eddie French1, Jacob Harker1
& Michelle P. McIntosh1
1Drug Delivery, Disposition and Dynamics, Monash Institute of Pharmacy and Pharmaceutical Science, Monash University, Melbourne, VIC 3052, Australia.
2Melbourne University School of Population and Global Health, Melbourne University, Melbourne,
VIC 3052, Australia.
Summary
Pharmaceutical products developed for low-income markets may face greater challenges in covering manufacturing costs while meeting affordable costs of goods in these settings. Inhaled products for these markets must address the cost of manufacture and how this impacts the affordability of the product to the end-user in order to improve chances of long-term sustainable healthcare outcomes. In this example of an inhaled powder product designed for use in low-income markets, addressing the cost of manufacture require optimisation of the raw yield and speed of production spray drying process by increasing process parameters such as the concentration of feed solution and feed solution pumping speed. However, increasing powder production in this way may influence the carefully engineered powder particle characteristics which in turn will affect dose delivery. To address this issue, the complex nature of the relationships between spray drying processing parameters and physical powder attributes critical to product performance were characterised using a Design of Experiments (DoE) approach. Response Surface Methodology (RSM) was then employed to construct a predictive model and carefully optimise the processing parameters for maximal powder yield and spray drying efficiency while maintaining tight limits on particle size, moisture content, and glass transition temperature.
Key message
A DoE (24-CCD) approach was used to increase spray drying yield and powder production efficiency while maintaining critical quality attributes of trehalose powder particle for deep lung penetration,
in order to better address inhaled product affordability challenges experienced by low-income countries.