Stability of Russell's viper venom toxoid (lyophilized form) on storage.

A previously developed Russell's viper venom toxoid in Myanmar is in a liquid form that shows reversion in the form of a reduced number of formaldehyde linkages and toxicity during storage at 37 degrees C and at room temperature. In order to have a safe, potent and stable toxoid, a lyophilized form was prepared in the present study from the liquid toxoid through the use of a freeze dryer. Both the liquid and lyophilized forms were then stored at 4 degrees C and at room temperature, and in addition to safety and immunogenicity tests, biochemical parameters such as the protein content, the activity of venom enzymes (proteinase, phospholipase A, phosphodiesterase, and arginine esterase), and the released free formalin amounts were assessed at 3-month intervals over a period of 1 year. The results indicate that under both conditions, the lyophilized toxoid shows minimum changes in enzyme activity, a reduced tendency toward formaldehyde linkage, no toxicity, and more immunogenicity in comparison with the respective liquid toxoids. It could therefore be hypothesized that Russell's viper venom toxoid in a lyophilized form is more promising in terms of efficacy and stability for prophylactic use in human immunization than the conventional toxoid in a liquid form.