Pharmaceutical formulation comprising glycine as a stabilizer
OwnerJames McShane, Ray Wood +3inventors
InventorsJames McShane, Ray Wood, Sumio Watanabe, Kiyoshi Iwamoto, Katsumi Onai
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OwnerJames McShane, Ray Wood +3inventors
InventorsJames McShane, Ray Wood, Sumio Watanabe, Kiyoshi Iwamoto, Katsumi Onai
Estimating the term…
The present invention provides pharmaceutical formulations suitable for intravenous injection comprising a lyophilized anti-ulcerative agent reconstituted in isotonic solutions suitable for intravenous administration, such as 5% dextrose or 0.9% sodium chloride. The solutions are brought to a pH of between about 9 and about 12, preferably between about pH 10 and 11, by a glycine-sodium hydroxide buffer. Such formulations are chemically and physically stable, and do not significantly change color, for at least between about 6 and about 12 hours at room temperature, and are stable to color change for from between about 24 and 48 hours if kept at 5° C.
A method for preventing or treating a peptic ulcer in a person requiring the same comprising intravenously administering to the person an effective amount of a pharmaceutical formulation having a pH between about 10 and about 11;
A method for preventing or treating a disorder associated with the secretion of gastric acid in a person requiring the same comprising administering to the person an aqueous pharmaceutical formulation suitable for intravenous injection comprising glycine and a compound of formula (I) or a pharmaceutically acceptable salt thereof, in a pharmaceutically acceptable carrier;
Dependencies are inferred from the claim text.