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    This study developed a stable propofol nano-emulsion to reduce pain during intravenous injection. The new formulation demonstrated excellent stability and quality over time, offering a promising alternative for patient comfort.

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    Area of Science:

    • Pharmaceutical Sciences
    • Nanotechnology
    • Anesthesiology

    Background:

    • Intravenous propofol injection commonly causes pain, impacting patient experience.
    • Existing propofol formulations require improvements for better tolerability.
    • Minimizing injection pain is crucial for patient compliance and satisfaction.

    Purpose of the Study:

    • To develop a stable, multi-dose propofol nano-emulsion.
    • To create a formulation associated with reduced pain upon intravenous administration.
    • To optimize nano-emulsion characteristics using a factorial design approach.

    Main Methods:

    • A 32 full factorial design was employed for formulation development.
    • Propofol was incorporated into a lipid-based nano-emulsion system.
    • High-pressure homogenization was performed at a controlled temperature (20 °C).

    Main Results:

    • The nano-emulsion exhibited a particle size of 174 nm and a zeta potential of -53.6 mV, indicating good stability.
    • No significant changes were observed in physical, chemical, or microbiological parameters after 6 months at 40 °C.
    • Key quality attributes including pH, osmolality, and HPLC stability remained consistent.

    Conclusions:

    • A stable, multi-dose propofol nano-emulsion was successfully developed.
    • The nano-emulsion formulation shows potential for reducing injection pain.
    • The optimized formulation meets stability and quality standards for pharmaceutical use.