Anti-histamine compositions and use thereof
AssigneeTaro Pharmaceuticals North America, Inc.
InventorsSatish Asotra, Jerzy Zadykowicz, Kalpana Vanam, Shen Gao
Life of this patent
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Abstract
The present invention provides for a storage stable pharmaceutical liquid solution for oral administration having a pharmaceutically effective amount of an antihistamine and having a purity equal to or greater than about 99% by weight-based HPLC assay, residual solvents of less than about 0.5%, and a total impurity of less than about 0.2%. The storage stable solution preferably contains cetirizine. The present invention further provides a process of preparing the storage stable pharmaceutical liquid solution as well as a method of treating a mammal with a therapeutically effective amount of cetirizine in the stable pharmaceutical liquid solution.
Claims15
A stabilized pharmaceutical formulation comprising cetirizine or a salt thereof, evenly dissolved in a semi-solid spill resistant aqueous vehicle comprising glycerin in an amount of up to about 50% w/w, propylene glycol in an amount from about 3% to about 10% w/w, and carbomer in an amount of about 0.2 to about 1.0% w/w, and having a purity equal to or greater than about 99% by weight-based HPLC assay, residual solvents of less than about 0.5%, and a total impurity of less than about 0.2%.
A method of preventing formation of impurities in a pharmaceutical liquid formulation comprising mixing cetirizine or a salt thereof with a storage stabilizing semi-solid spill resistant aqueous vehicle comprising glycerin in an amount of up to about 50% w/w, propylene glycol in an amount from about 3% to about 10% w/w, and carbomer in an amount of about 0.2 to about 1.0% w/w.
A method of providing cetirizine or a salt thereof liquid formulation having an extended product shelf life, that method comprising mixing the cetirizine or salt thereof with a storage stable semi-solid spill resistant aqueous vehicle comprising glycerin in an amount of up to about 50% w/w, propylene glycol in an amount from about 3% to about 10% w/w, and carbomer in an amount of about 0.2 to about 1.0% w/w.
Dependencies are inferred from the claim text.