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Development of a compounded propofol nanoemulsion using multiple non-invasive process analytical technologies.

T Rooimans1, M Damen2, C M A Markesteijn3

  • 1Research and Development Department, Tiofarma BV, Oud-Beijerland, The Netherlands; Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.

International Journal of Pharmaceutics
|April 15, 2023
PubMed
Summary
This summary is machine-generated.

Extemporaneous compounding of propofol emulsions using readily available lipid emulsions offers a viable solution for drug shortages. This method ensures critical quality attributes are met for emergency propofol supply.

Keywords:
COVID-19CompoundingDrug shortageParenteral lipid nano-emulsionPropofol

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Critical Care Medicine

Background:

  • Propofol is essential for sedation in COVID-19 patients but faced global shortages during the pandemic.
  • Existing supply chains were overwhelmed by the increased demand for propofol.
  • The standard oil-in-water emulsion formulation of propofol requires specialized manufacturing.

Purpose of the Study:

  • To explore extemporaneous preparation of propofol emulsions without specialized equipment.
  • To address temporary propofol shortages by developing an alternative preparation method.
  • To assess the feasibility of using a commercially available lipid emulsion for propofol formulation.

Main Methods:

  • Utilized a commercially available 20% lipid emulsion (SMOFlipid) and liquid propofol drug substance.
  • Employed Spatially Resolved Dynamic Light Scattering for in situ droplet size monitoring.
  • Used Near Infrared Spectroscopy for non-destructive monitoring of propofol distribution.
  • Applied response surface methodology to optimize formulation parameters.

Main Results:

  • An optimal formulation was identified: 4% w/v propofol, mixed for ~15 minutes at a 40° shaking angle.
  • Mean droplet size and percentage of large droplets (>5µm) were critical quality attributes studied.
  • In situ and non-destructive monitoring maintained sterility throughout the process.
  • The optimized method demonstrated successful extemporaneous preparation of a propofol nanoemulsion.

Conclusions:

  • Extemporaneous compounding of propofol emulsions is a viable strategy for emergency drug supply.
  • This method can temporarily alleviate propofol shortages during global crises.
  • The developed technique ensures critical quality attributes for safe administration.