Stability Studies of F16 and JFD in Lipophilic and PBS Formulations in Different Storage Conditions

Stability Studies of F16 and JFD in Lipophilic and PBS Formulations in Different Storage Conditions

The term "Angiogenesis" implies the formation of new blood vessels. In cancer cells, angiogenesis plays a critical role in the cell growth and in the spread of cancer. F16 and JFD, two drugs patented by Dr. Appu Rathinavelu, specifically inhibit vascular endothelial growth factor receptors (VEGFRs). These drugs are going to be tested in clinical trials but first must undergo drug stability testing of the existing formulations. Therefore, the purpose of this study was to investigate the stability of F16 and JFD in order to determine the storage conditions in which the therapeutic activity of the drugs will be maintained. Two different formulations were prepared for F16, JFD and JFD-WS: solubilizing the drugs in Lipophilic and PBS. The samples were kept at 25oC and 5oC, and the degradation of the drugs was determined by drawing the samples after initial (0), 1, 7, 14, 30 and 60 days interval using the HPLC method. The results showed that the concentration of the drugs remained constant in Lipophilic formulations after sampling intervals of 60 and 14 days respectively. However, the percent content of JFD in PBS formulation was reduced at day 14 compared to initial day (0) due to the recrystallization of JFD in the buffer formulation during storage. The preliminary data of this study shows the potential of creating a stable formulation for the clinical use of both novel drugs, F16 and JFD. This project was supported by The Royal Dames of Cancer Research Inc., Fort Lauderdale, Florida.