Pharmaceutical formulation comprising glycine as a stabilizer

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...

Reexamination Certificate

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Details

C514S339000, C514S340000, C514S556000, C514S557000

Reexamination Certificate

active

09549858

ABSTRACT:
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.

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Osol, A. et al., Editor-in-Chief of Remington's Pharmaceutical Sciences, 15th Edition, p. 963, Jun. 11, 1976.

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