Comparative stability study of unit-dose repackaged furosemide tablets

Abstract

The stability of a 40 mg furosemide tablet drug product repackaged in a unit-dose USP class A blister pack and the identical product in its original container made of HDPE material was studied under ICH long-term conditions of 25°C and relative humidity (RH) of 60% and accelerated stressed conditions of 40°C and 75% RH. Samples from original and repackaged drug products were periodically removed from storage conditions and subjected to pharmaceutical and spectroscopic analysis. Results indicate the potency 91.5 ± 0.9% of the tablet strength for the original packaging drug product vs 91.6 ± 4.0% for the repackaged product are statistically similar for long-term and accelerated stress conditions. Tablet hardness (6.0 ± 0.3 KP) and loss on drying (3.2%) was the same for original and repackaged drug products under both stressed conditions indicating similar moisture sorption behavior. Non-invasive spectroscopic techniques did not show any differences in moisture content. Dissolution and TGA results were similar for all study samples. In conclusion, contrary to a previous FDA repackaging study for tablets with hygroscopic excipients, the product quality attributes of furosemide tablets formulated with low sorption excipients were not affected by repackaging, under the specific stress conditions of this study.