Stability of latanoprost in an ophthalmic lipid emulsion using polyvinyl alcohol.
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.
Sakai
Yusuke
Y
Senju Pharmaceutical Co. Ltd., 1-5-4 Murotani, Nishi-ku, Kobe, Hyogo 651-2241, Japan. yusuke@senju.co.jp
Yasueda
Shin-Ichi
S
Ohtori
Akira
A
D004355:Drug Stability; D004356:Drug Storage / Q000379:methods; D045703:Emulsifying Agents / Q000737:chemistry*; D004655:Emulsions; D005227:Fatty Acids / Q000737:chemistry; D006863:Hydrogen-Ion Concentration; D000077338:Latanoprost; D009821:Oils / Q000737:chemistry; D009883:Ophthalmic Solutions / Q000737:chemistry; D011142:Polyvinyl Alcohol / Q000737:chemistry*; D011461:Prostaglandins F, Synthetic / Q000737:chemistry*; D013696:Temperature; D013997:Time Factors; D014280:Triglycerides / Q000737:chemistry
D045703:Emulsifying Agents; D004655:Emulsions; D005227:Fatty Acids; D009821:Oils; D009883:Ophthalmic Solutions; D011461:Prostaglandins F, Synthetic; D014280:Triglycerides; D000077338:Latanoprost; D011142:Polyvinyl Alcohol