PARENTERAL FORMULATION COMPRISING PROTON PUMP INHIBITOR STERILIZED IN ITS FINAL CONTAINER BY IONIZING RADIATION

摘要

The present invention relates to a stable sterilized parenteral formulation comprising an acid susceptible proton pump inhibitor. The formulation, a solid formulation comprising the acid susceptible proton pump inhibitor and optionally pharmaceutically acceptable excipients, has been sterilized in its final container by ionizing radiation. The container may consist of several compartments and separately contains a suitable solvent, which is sterilized, i.e. radiated, at the same time as the solid formulation. Alternatively, the suitable solvent is sterilized separately or aseptically manufactured. The solid formulation is dissolved in a suitable solvent before being administered to the patient, i.e. being prepared ex tempore. The present invention also relates to the prepared sterilized parenteral formulation, the stable solid formulation, processes for obtaining said parenteral formulation and the solid formulation as well as to the therapeutic uses thereof.