Evaluation of the Galenic stability of a Propofol Emulsion after the Expiration date

Abstract

Objective: Propofol is an intravenous lipid emulsion indicated for the induction and maintenance of general anesthesia or sedation. Like all emulsions, propofol is thermodynamically unstable. The objective of this study was to evaluate the post expiration stability of a batch of propofol. Methods: The parameters studied to evaluate the stability of the drug were: visual appearance, ph, droplet diameter and zeta potential.For this purpose we had 20 ampoules of Propofol Fresenius with an expiration date of May 2021. The measurements started directly 1 month after the expiration of the batch and lasted 6 months. Results: Visual examination showed no abnormalities suggestive of instability. The pH varied between 6.95 and 7.15 until it decreased to a value of 5.58 at the 6th month after expiration. The diameter of the droplets ranged from 109.52nm to 125.15nm with a maximum of 169.5nm. Conclusion: The results obtained suggest a good galenic stability up to 3 months after expiry and may allow a use beyond the limit of use in case of complete stability study.