Development of a compounded propofol nanoemulsion using multiple non-invasive process analytical technologies
Propofol is the preferred anesthetic for induction and maintenance of sedation in critically ill mechanically ventilated COVID-19 patients. However, during the outbreak of the COVID-19 pandemic, regular supply chains could not keep up with the sudden increase in global demand, causing drug shortages. Propofol is formulated as an oil-in-water emulsion which is administered intravenously.
This study explores the extemporaneous preparation of a propofol emulsion without specialized manufacturing equipment to alleviate such shortages temporally. A commercially available lipid emulsion (IVLE, SMOFlipid 20 %), intended for parenteral nutrition, was used to create a propofol-loaded nanoemulsion via addition of liquid propofol drug substance and subsequent mixing. Critical quality attributes such as mean droplet size and the volume-weighted percentage of large-diameter (>5μm) droplets were studied.
The evolution of droplet size and propofol distribution was monitored in situ and non-destructively, maintaining sterility, using Spatially Resolved Dynamic Light Scattering and Near Infrared Spectroscopy, respectively. Using response surface methodology, an optimum was found for a 4 % w/v propofol formulation with a ~15 min mixing time in a flask shaker at a 40◦ shaking angle.
This study shows that extemporaneous compounding is a viable option for emergency supply of propofol drug products during global drug shortages.
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