Stable injectable pharmaceutical composition of epinephrine or salts thereof
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United States of America Patent
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Issued Date -
Sep 3, 2015
app pub date -
May 3, 2013
filing date -
Oct 8, 2012
priority date (Note) -
Abandoned
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Abstract
The present invention refers to a stabilized injectable pharmaceutical composition of epinephrine or salts thereof comprising sodium metabisulfite, wherein the ratio of the amount of epinephrine or salt thereof to sodium metabisulfite in the composition ranges from about 1:0.005 to about 1:1.5 by weight. It has been observed that stable injectable epinephrine compositions with excellent storage stability and substantially free of overages can be prepared using sodium metabisulfite in said ratios. Particularly, it was found that using sodium metabisulfite in said ratios controls levels of adrenaline sulfonate impurity in said pharmaceutical compositions.
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