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Article Title

Effect of container on the physicochemical stability of propofol injectable emulsion after being diluted with 0.9% NaCl for intravenous infusion

Abstract

Effects of glass and plastic containers on the physicochemical properties of propofol injectable emulsion consisting of medium-chain triglycerides (MCTs) and long-chain triglycerides (LCTs) after being diluted with 0.9% NaCl were evaluated. Propofol MCT/LCT reconstituted with normal saline to 2.0 mg/mL, 2.5 mg/mL, 3.0 mg/mL, 4.0 mg/mL, and 5.0 mg/mL were packaged into glass (type II soda-lime-silica), polyvinyl chloride (PVC) soft bag, and non-PVC soft bag (Cryovac®polyolefin soft bag container), and then stored at ambient temperature/humidity (25 ± 2 °C/50 ± 5% RH) for 3 days to test its stability. We found that the pH and osmolarity of propofol injectable emulsions were consistent among different formulations. All formulations packaged in glass and plastic containers were stable for 6 hours; the globule size distribution of these emulsions met the requirements described in Chapter 729 of the United States Pharmacopeia. However, propofol formulations of higher concentrations (3.0 mg/mL, 4.0 mg/mL, and 5.0 mg/mL) stored in plastic containers were found to have abnormal globule size distribution profiles compared with those stored in glass containers after 24 hours. We therefore recommend that the propofol MCT/LCT emulsions should be packaged into glass containers and used within 6 hours after reconstitution with diluents. © 2013, Food and Drug Administration, Taiwan. Published by Elsevier Taiwan LLC. All rights reserved.

ScienceDirect Link

10.1016/j.jfda.2013.09.006

Creative Commons License

Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.

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