Room Temperature Stable, Lyophilized Natriuretic Peptide Formulations
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United States of America Patent
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Issued Date -
Jun 25, 2009
app pub date -
Dec 19, 2008
filing date -
Dec 19, 2007
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Abandoned
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Abstract
Lyophilized pharmaceutical compositions comprise a natriuretic peptide, a buffer and a bulking agent that are stable at room temperature. Preferably, for a fill volume of 1 mL (pre-lyophilization), the total cake mass, post-lyophilization, is 30-175 mg. Preferably, the natriuretic peptide is ularitide or a pharmaceutically acceptable salt thereof. Various embodiments of the compositions may further comprise at least one of an acid and a base. In some embodiments, the pH of the compositions is between 4.0 and 6.0. In addition, various embodiments of the compositions may further comprise a stabilizing agent. In some embodiments, the compositions are isotonic. Preferably, the compositions are used for the treatment of cardiac conditions. The invention also relates to methods for preparing such compositions.
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