Patent ID: 8617467

Claim:
A method for sterilizing a dynamic dispersion system having a stable state and an unstable state comprising the steps of: pressurizing the dynamic dispersion system to a pressure in excess of 0.25 MPa to increase the temperature of the dynamic dispersion system to a temperature in excess of 120Â° C. for a period of time sufficient to achieve a sterile system, the dynamic dispersion system having micro- or nano-dispersions of small particles or droplets, the small particles or droplets having a stable state and an unstable state; and withdrawing pressure from the dynamic dispersion system of small particles or droplets before the small particles or droplets reach the unstable state, wherein the small particles or droplets comprise (i) a therapeutically active compound and (ii) an excipient, the excipient being associated with the therapeutically active compound, wherein the excipient comprises a surfactant, wherein the temperature of the dynamic dispersion system is raised above 120Â° C. for a time period in excess of 1 minute.