New sterilized parenteral formulation

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/08 (2006.01) A61K 31/4184 (2006.01) A61K 31/4439 (2006.01) A61K 31/444 (2006.01) A61L 2/08 (2006.01) A61P 1/04 (2006.01)

Patent

CA 2649946

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.

La présente invention concerne une formulation parentérale stérilisée stable comprenant un inhibiteur de la pompe à protons sensible aux acides. La formulation, une formulation solide comprenant l'inhibiteur de la pompe à protons sensible aux acides et éventuellement des excipients acceptables du point de vue pharmaceutique, a été stérilisée dans son récipient final par un rayonnement ionisant. Le récipient peut être constitué de plusieurs compartiments et contenir séparément un solvant approprié, qui est stérilisé, c'est-à-dire irradié, en même temps que la formulation solide. Autrement, le solvant approprié est stérilisé séparément ou fabriqué aseptiquement. La formulation solide est dissoute dans un solvant approprié avant d'être administrée au patient, c'est-à-dire qu'elle est préparée de façon extemporanée. La présente invention concerne également la formulation parentérale stérilisée préparée, la formulation solide stable, des procédés servant à obtenir ladite formulation parentérale et la formulation solide ainsi que des utilisations thérapeutiques de celle-ci.

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