Drugs in ambulatory infusion devices: the appropriate temperature for stability testing

Abstract

Aim: To determine the temperature of an infusion solution during simulated ambulatory infusion and recommend temperatures for stability assessment of drugs in this setting. Method: A 100 mL cassette of a Continuous Ambulatory Delivery Device (CADD) was filled with water. To simulate in situ conditions the CADD cassette, with a temperature probe, was placed in a fabric pouch and worn beside the torso. The temperature of the solution was measured every three hours over a 48- hour period. Results: The mean temperature of the contents of the CADD cassette was 28.8 degrees C, standard deviation 1.1 degrees C. The maximum and minimum temperatures were 30.9 degrees C and 27.2 degrees C, respectively. Discussion: Stability studies for ambulatory infusion devices should be performed at temperatures considerably higher than 'room temperature' and much lower than body temperature. The maximum temperature of the infusion solution is unlikely to be greater than 31 degrees C. Other climates may vary these requirements. (author abstract)