Freeze-dried pantoprazole preparation and pantoprazole injection

  • US 6,780,881 B2
  • Filed: 07/15/2002
  • Issued: 08/24/2004
  • Est. Priority Date: 11/22/2000
  • Status: Active Grant
First Claim
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1. Process for the production of a freeze-dried preparation comprising 5-difluoromethoxy-2-[(3,4-di-methoxy-2-pyridinyl)methylsulfinyl]-1H-benzimidazole (pantoprazole), a salt thereof, a solvate of pantoprazole or a salt thereof, comprising freeze-drying of an aqueous solution of pantoprazole, a salt thereof, a solvate of pantoprazole or a salt thereof, ethylenedlamine tetraacetic acid and/or a suitable salt thereof, and sodium hydroxide and/or sodium carbonate, wherein upon dissolution in an aqueous solvent, the preparation has less than 130 subvisible particles per vial, the particles having a size equal to or greater than 10 μ

  • m, wherein the number of particles is determined according to USP 24 by light obscuration particle test count.

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