Use of LC-MS/MS to determine pharmacokinetics and excipient kinetics in paediatric Dried Blood Spots

摘要

Excipients in neonates 1. Liquid pharmaceutical formulations generally contain the active pharmaceutical ingredient and excipients. Excipients are used to facilitate the manufacture of dosage forms and maintain the stability of medications. 2. Some excipients have been associated with mortality and significant morbidity in neonates and there is insufficient data for an evidence-based benefit-risk assessment. 3. The aim of the study is to predict systemic exposure to the excipient of interest (methylparaben) in the neonates, by measuring excipient blood levels and performing population excipient kinetics (EK). 4. This a part of European Study of Neonatal Exposure to Excipients (ESNEE) and Dried Blood Spots (DBS) (Fig. 1) is being used as a sampling method. 5. Samples are currently being collected opportunistically from various European centres which include UK, France and Estonia. 6. We present the development of a sensitive assay for the determination of methylparaben (Fig. 2) in DBS by LC-MS/MS.