Journal of Pharmacovigilance

Abstract

A Combined HPLC and LC-MS Approach for Evaluating Drug Stability in Elastomeric Devices: A Challenge for the Sustainability in Pharmacoeconomics

Patrizia Nardulli, Elena Capparelli, Maria Grazia Perrone, Simona Ferraiuolo, Maria Rita Laforgia, Claudia Crapolicchio and Nicola Antonio Colabufo

Objectives

A longer postoperative care, needed for patients admitted to the hospital, is expensive and associated with increased morbidity and mortality, when compared with the outpatient setting. Outpatient therapy with continuous infusion of drugs with elastomeric pumps represents an effective method to address this problem. The aim of this work is to analyse the benefits in using elastomeric devices and to test their their behaviour towards drugs to changes during storage that could influence quality, safety and efficacy of the therapy.

Methods

Several drugs belonging to different therapeutic classes, including anticancer, analgesic opioids, local anesthetics and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) have been studied using a combined HPLC/LC-MS approach. Each drug was loaded in three different brands of elastomeric devices and the samples were withdrawn over 7 days and submitted to HPLC/LC-MS analyses.

Key-Findings

All tested drugs showed high stability in each filled device, in fact only a low variability, less than 5 %, in term of percentage change in chromatographic areas, was observed. Moreover additional peaks, due to degradation of drug and/or to medical device-drug interaction, have not been detected both in HPLC and LC-MS analysis.

Conclusion

Thanks to the implementation, within clinical protocols, of the use of these infusion systems, two important goals can be achieved: a) the keeping of the quality of care also out of hospitals and b) the reduction of tangible costs as well as intangible costs in health care.