Stability of latanoprost in an ophthalmic lipid emulsion using polyvinyl alcohol

Abstract

Latanoprost in water is not stable against heat stress due to hydrolysis of the isopropyl ester in the latanoprost molecule. Therefore, the storage condition of latanoprost ophthalmic solution, Xalatan brand, was in a low temperature (2-8 degrees C). We formulated a favorable ophthalmic lipid emulsion of latanoprost using polyvinyl alcohol as emulsifier which showed a good heat stability. The assays of the latanoprost ophthalmic lipid emulsions adjusted to pH 5.0, 6.0 and 7.0 were 100.4%, 100.7% and 99.2% after storage for 4 weeks at 60 degrees C, respectively. The possibility of room temperature storage for the latanoprost ophthalmic lipid emulsion was demonstrated.