High-pressure sterilization to terminally sterilize pharmaceutical preparations and medical products
AssigneesBaxter International Inc., Baxter Healthcare S.A.
InventorsAlfredo Rodriguez, Barrett E. Rabinow, Mark Doty, Jamie Konkel
Life of this patent
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Abstract
The present invention provides a process for sterilizing a system, preferably a pharmaceutical preparation such as a dispersion of small particles or droplets of a pharmaceutically active compound using high pressure terminal sterilization techniques and products therefrom.
Claims21
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 120° 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 120° C. for a time period in excess of 1 minute.
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 120° 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 step of pressurizing the system is pulsed.
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 120° 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, and the small particles or droplets transform from a first thermodynamic phase into a second thermodynamic phase following the withdrawing of pressure.
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 120° 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 therapeutically active compound is poorly water-soluble.
Dependencies are inferred from the claim text.