Abstract:

Polyvinyl-chloride (PVC) with plasticizers of di(2-ethylhexyl) phthalate (DEHP) and tris(2-ethylhexyl) trimellitate (TOTM) is widely used in medical and paramedical appliances. However, such plasticizers can leach from PVC products into contact solutions. The aim of this study is to investigate the release behaviors of DEHP and TOTM from the PVC intravenous infusion set into various pharmaceutical solutions under the simulated clinical conditions, such as the lipophilic substances (paclitaxel), parenteral nutrition (fat emulsion injection), acid and alkali pharmaceutical solution (levofloxacin hydrochloride injection, pH 3.0-5.0 and furosemide, pH 8.0-9.0). A simple and rapid high-performance liquid chromatographic method with UV detection (HPLC-UV) for the determination of DEHP or TOTM released from PVC medical devices into the above intravenous preparations was developed. The cumulative amounts of DEHP or TOTM released in 24 h were in the same following order: paclitaxel>fat emulsion injection>levofloxacin hydrochloride> furosemide solution. From a comparison of the cumulative amounts of released DEHP and TOTM from the above solutions, we found that the cumulative amount of TOTM is far less than that of DEHP, under the same conditions. The cumulative amount of the DEHP released in 24 h in the paclitaxel solution was 21.14 mg, while under the same conditions, the cumulative amount of TOTM was only 0.078 mg. The cumulative amount of DEHP is assumed to be about 270 times that of the released TOTM. Thus TOTM could be a superior alternative to DEHP for use in medical devices because of its potential lower leachability.

Key words: di(2-ethylhexyl) phthalate (DEHP), high-performance liquid chromatographic method-ultraviolet detection (HPLC-UV), pharmaceutical solution, polyvinyl-chloride (PVC), release behavior, tris(2-ethylhexyl) trimellitate (TOTM)