Table 1

Observed change in pH of aciclovir solution in the Accufuser VAWC0100L elastomeric infusion device during storage at room temperature and subsequent exposure to in-use temperature of 32°C

Temperature conditionTime (hours)Observed mean±SD pH and change in mean pH from baseline by concentration
Low concentrationIntermediate concentrationHigh concentration
Observed pHΔ pHObserved pHΔ pHObserved pHΔ pH
Room temperature (<20°C)010.24±0.010.0011.20±0.000.0011.25±0.010.00
1210.30±0.010.0511.16±0.04−0.0411.25±0.010.00
2410.27±0.030.0311.08±0.01−0.1211.27±0.010.01
4810.17±0.03−0.0711.06±0.00−0.1411.22±0.02−0.03
9610.02±0.06−0.2310.93±0.02−0.2711.25±0.05−0.01
1209.85±0.07−0.3910.95±0.03−0.2511.15±0.04−0.11
1689.67±0.09−0.5710.70±0.04−0.5011.04±0.08−0.21
2409.47±0.11−0.7710.58±0.03−0.6210.94±0.11−0.31
3369.26±0.15−0.9910.44±0.03−0.7610.88±0.13−0.37
In-use temperature (32°C)3447.43±0.24−2.8110.45±0.04−0.7510.44±0.05−0.82
3486.91±0.02−3.3310.45±0.04−0.7510.28±0.09−0.98
3606.86±0.04−3.3810.37±0.03−0.8310.06±0.21−1.20