Stable iansoprazole containing more than 500 ppm, up to about 3,000 ppm water and more than 200 ppm, up to about 5,000 ppm alcohol
AssigneeTeva Pharmaceutical Industries Ltd.
InventorsAnita Liberman, Claude Singer, Irena Veinberg
Life of this patent
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Abstract
The present invention provides a stable 2-(2-pyridylmethyl) sulfinyl-1H-benzimidazole (lansoprazole) comprising either greater than 500 ppm and not more than about 3,000 ppm water or greater than 200 ppm and not more than about 5,000 ppm alcohol, or both. The present invention provides a method of preparing a stable lansoprozole as well as a pharmaceutical composition containing same. The present invention further provides a method of purifying lansoprazole that is substantially free of sulfone and sulfide derivatives.
Claims18
Chemically stable lansoprazole comprising greater than 500 ppm and not more than about 3,000 ppm water, wherein lansoprazole is stable at a temperature of from 2° C. to 8° C. or at 25° C. at a relative humidity of up to 60% for a period of up to about 6 months.
Chemically stable lansoprazole comprising greater than 200 ppm and not more than about 5,000 ppm alcohol, wherein lansoprazole is stable at a temperature of from 2° C. to 8° C. or at 25° C. at a relative humidity of up to 60% for a period of up to about 6 months.
Chemically stable lansoprazole comprising greater than 500 ppm and not more than about 3,000 ppm water, and greater than 200 ppm and not more than about 5,000 ppm alcohol, wherein lansoprazole is stable at a temperature of from 2° C. to 8° C. or at 25° C. at a relative humidity of up to 60% for a period of up to about 6 months.
A pharmaceutical composition, comprising chemically stable lansoprazole and a pharmaceutically acceptable excipient, wherein the chemically stable lansoprazole comprises greater than 500 ppm and not more than about 3,000 ppm water and is stable at a temperature of from 2° C. to 8° C. or at 25° C. at a relative humidity of up to 60% for a period of up to about 6 months.
A pharmaceutical composition comprising chemically stable lansoprazole and a pharmaceutically acceptable excipient, wherein the chemically stable lansoprazole comprises greater than 200 ppm and not more than about 5,000 ppm alcohol and is stable at a temperature of from 2° C. to 8° C. or at 25° C. at a relative humidity of up to 60% for a period of up to about 6 months.
A pharmaceutical composition comprising chemically stable lansoprazole and a pharmaceutically acceptable excipient, wherein the chemically stable lansoprazole comprises greater than 500 ppm and not more than about 3,000 ppm water and greater than 200 ppm and not more than about 5,000 ppm alcohol and is stable at a temperature of from 2° C. to 8° C. or at 25° C. at a relative humidity of up to 60% for a period of up to about 6 months.
Dependencies are inferred from the claim text.