Stability of Propofol Medium Chain Triglyceride/Long Chain Triglyceride (MCT/LCT) in 0.9% NaCl Solution with CRYOVAC® Non-PVC Soft Bag Containers
LI-JUE WEI1,2*, WEN-BANG CHANG2, CHUN-HUNG LIN2, YU-CHIEH CHEN2 AND JIN-BIN WU1
1. Department of Pharmaceutical Chemistry, College of Pharmacy, China Medical University, Taichung 404, Taiwan, R.O.C.
2. Chi Sheng Chemical Corporation, Hsin Chu 303, Taiwan, R.O.C.
(Received: April 26, 2012; Accepted: September 19, 2012)
ABSTRACT
The compatibility of propofol MCT/LCT with non-PVC soft bag was investigated in this study. Solutions of 2.0 and 2.5 mg/mL propofol MCT/LCT in 0.9% NaCl solution were filled into CRYOVAC® containers. The studied samples were grouped and stored at ambient temperature (25 ± 2°C) in the light, at ambient temperature in the dark, and at 2-8°C in the dark for 5 days. At indicated sampling time, propofol was assayed by high-performance liquid chromatography. For long-term study, propofol samples were analyzed at day 8 and at day 15. The results showed that all studied samples were stable for 5 days. Propofol contents decreased by 8-12% and 15-23% when stored in the non-PVC bag at ambient temperature in the light for 8 days and 15 days, respectively. Studied samples in non-PVC bag stored at ambient temperature in the dark showed 3-9% decrease when stored for 8 days, whereas 10-13% decrease for 15 days. Propofol concentration in non-PVC bag stored at 2-8°C in the dark showed approximately 2-8% decrease at both day 8 and day 15. In conclusion, the 2.0 and 2.5 mg/mL propofol MCT/LCT in 0.9% NaCl solution with CRYOVAC® container stored at all conditions were stable for 5 days. It is found that samples stored at ambient temperature were more labile as compared to those at 2-8°C; moreover, propofol sample was vulnerable to light exposure. In addition, DEHP additive was not detected in the CRYOVAC® soft bag container by HPLC with a quantitation limit at 5 ppm. Therefore, CRYOVAC® non-PVC soft bag is a suitable container system for propofol MCT/LCT emulsion.
Key words: compatibility, propofol MCT/LCT, non-PVC soft bag containers