Warfarin Chemical Stability Not Affected by Repackaging Into Dose Administration Aids
When stored at accelerated and controlled room temperature conditions there was a significant increase in tablet hardness.
HealthDay News — The chemical stability of warfarin sodium tablets is not affected by repackaging into dose administration aids (DAAs), according to a study published in the Journal of Pharmacy Practice and Research.
Caynan Mendes Rugno, BPharm, from RMIT University in Bundoora, Australia, and colleagues examined the stability of warfarin sodium tablets stored in DAAs and original packaging over an 8-week period. Tablets were removed from the original packaging and repackaged into DAAs; DAAs and original packages were stored at controlled room temperature (25 degrees Celsius; 60% relative humidity [RH]), accelerated (40 degrees Celsius/75% RH), and uncontrolled room temperature conditions (19 to 21 degrees Celsius/38 to 50% RH). A validated high-performance liquid chromatography method was used to assess the chemical stability.
The researchers found that at 8 weeks there was no significant change in warfarin content. When stored at accelerated and controlled room temperature conditions there was a significant increase in tablet hardness. At eight weeks, hardness of tablets stored in original packaging was comparable to that of those stored in DAAs. Compared with baseline, there was a significant difference in the dissolution profile of tablets stored in original containers at accelerated conditions for 8 weeks.
"Repackaging of warfarin sodium tablets into DAAs does not affect the chemical stability," the authors write. "However, tablets should be stored in a cool, dry place to minimize the effects on physical properties."
Mendes Rugno C, Graan J, Hanna P, et al. Stability of warfarin sodium tablets repackaged in dose administration aids [published online November 16, 2017]. J Pharm Pract Res. doi: 10.1002/jppr.1332