Stability of phenytoin sodium suspensions for the treatment of open wounds

Int J Pharm Compd. 2006 Jan-Feb:10:74-8.

Abstract

The objective of this study was to evaluate the stability of two phenytoin sodium suspensions in 0.9% sodium chloride solution for use in noninstitutional settings (where pharmacies are not present) to dispense phenytoin on a daily basis. A generic extended phenytoin sodium (Mylan) and a name brand phenytoin sodium (Dilantin) in suspension form were evaluated. Both suspensions were first assessed for degradation during frozen storage at designated time intervals. Frozen samples were compared with freshly prepared samples. The chemical stability of phenytoin concentration in the samples was assessed by using a high-performance liquid chromatography analytical technique. During the course of the experiment, the samples showed no crystallization and the pH remained in a range of 10.6 to 10.73. The suspensions were tested for contamination. The results show that Dilantin and Mylan suspensions remained stable and free of contamination. Suspensions of phenytoin sodium in 0.9% sodium chloride solution are stable at room temperature for at least 2 weeks.