Method of stabilizing lansoprazole
AssigneeTeva Pharmaceutical Industries Ltd.
InventorsClaude Singer, Anita Liberman, Irena Veinberg
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Abstract
The present invention provides a stable 2-(2-pyridylmethyl)sulfinyl-1H-benzimidazole (lansoprazole) and a method for stabilizing lansoprazole by use of a weakly basic material. The present invention also provides a method for the preparation of a stable lansoprazole.
Claims8
A chemically stable lansoprazole, having less than about 0.1% (wt/wt) 2-[[3-methyl-4-(2,2,2-trifluorethoxy)-2-pyridinil]sulfonyl]-1H benzimidazole and less than about 0.1% (wt/wt) 2-[[3-methyl-4-(2,2,2-trifluorethoxy)-2-pyridinil]thio]-1H benzimidazole, upon exposure to a relative humidity of 75% at 40° C. for a period of at least about three months.
A chemically stable lansoprazole, having less than about 0.1% (wt/wt) 2-[[3-methyl-4-(2,2,2-trifluorethoxy)-2-pyridinil]sulfonyl]-1H benzimidazole and less than about 0.1% (wt/wt) 2-[[3-methyl-4-(2,2,2-trifluorethoxy)-2-pyridinil]thio]-1H benzimidazole, upon exposure to a relative humidity of 75% at 40° C. for a period of at least about six months.
A chemically stable lansoprazole, which does not change color upon exposure to a relative humidity of 75% at 40° C. for a period of at least six months.
Dependencies are inferred from the claim text.