In-vitro stability of porcine factor VIII (Hyate:C(®) )

The stability of porcine factor VIII (Hyate:C(®) ) 30 units mL(-1) , 15 units mL(-1) and 5 units mL(-1) prepared aseptically in 0.9% sodium chloride injection was studied. Solutions were stored in plastic syringes at room temperature and ambient light, and at body temperature protected from light. Samples obtained immediately after mixing and at 4, 24, 48 and 72 h were assayed for FVIII activity using a one-stage FVIII assay. Samples were considered stable if FVIII activity did not decline more than 10% compared with baseline values. Hyate:C(®) 5 units mL(-1) stored at room temperature retained FVIII activity within 90% of baseline values for at least 24 h. When stored at body temperature, FVIII activity of Hyate:C(®) 5 units mL(-1) declined to less than 90% of baseline values within 4 h. Stability of Hyate:C(®) 15 units mL(-1) and 30 units mL(-1) stored at room temperature was retained for at least 72 h. When Hyate:C(®) 15 units mL(-1) and 30 units mL(-1) were stored at body temperature, stability was retained for 24 h. Results of this study will permit further evaluation of Hyate:C(®) stability when administered by ambulatory infusion pumps.