Verification of the Safety and Efficacy of Latanoprost Eye Drops with Improved Stability at Room Temperature

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  • 室温保存可能なラタノプロスト点眼液の安全性および有効性の検証

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<p>We established a formulation of latanoprost eye drops that is stable at room temperature. It was demonstrated that two additive surfactants and the preservative benzalkonium chloride form complex micelles that inhibit adsorption and hydrolysis interacting with latanoprost in this formulation. In this study, we verified the efficacy and safety of latanoprost eye drops with improved stability by a new mechanism using complex micelles.</p><p>On the rabbit ocular mucous irritation test, it was demonstrated that local irritation due to the latanoprost eye drop formulation we developed was no greater than that of the original formulation. In addition, there was no apparent incompatibility between latanoprost eye drops and 10 types of eye drops likely to be used together. Moreover, on the human bioequivalence test, it was demonstrated that the efficacy of latanoprost eye drops was equal to that of the original drug formulation by statistical analysis of maximum changes in ocular tension and area under the ocular tension-time curves.</p><p>The efficacy and safety of latanoprost eye drops showing improved stability using complex micelles were verified as equal to those of the original drug formulation. It was considered that the latanoprost eye drop formulation that we developed would be useful in clinical practice.</p>

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