Stability and compatibility of drug mixtures in an implantable infusion system

Summary This study evaluated the stability and the compatibility of mixtures of morphine sulphate, bupivacaine, and clonidine hydrochloride and of hydromorphone, bupivacaine, and clonidine hydrochloride, when used in constant flow implantable pumps under simulated clinical use conditions. The pumps were filled with drug mixtures and incubated at 37 °C for a period of 90 days. Aliquots were sampled monthly from the reservoir and catheter outlet and the drug concentrations analysed using validated chromatography methods. Individual materials from the infusion system were immersed in the drug mixtures and stored at 37 °C for 60 weeks and evaluated for mechanical performance for compatibility testing. Both drug mixtures were found to be stable over 90 days in the pump at 37 °C. All device materials retained acceptable mechanical performance following exposure. These results demonstrate that both drug mixtures are stable when maintained at simulated body temperature in an implantable infusion system for 90 days.