Stable formulation of phenobarbital sodium injection
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United States of America Patent
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Feb 27, 2018
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app pub date -
Nov 18, 2016
filing date -
Nov 20, 2015
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Abstract
Stable phenobarbital sodium solutions for injection that do not generate impurities during extended storage. These solutions include phenobarbital sodium in an amount of 15 to 200 mg/mL; a C1-C4 alcohol such as ethanol in an amount of 105 to 160 mg/mL; and a glycol such as propylene glycol in an amount of between 620 and 830 mg/mL and have a pH of between 9 and 12 which is adjusted to that range by adding acid or base, as required. No more than 50 mg/mL water is present including any water introduced by the acid or base. The solutions contain no more than 0.8% of phenyl ethyl acetyl urea impurity as well as no detectable amount of phenyl butyric acid after two years storage at room temperature.
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