Gonzalez Jaime R, Baiza-Duran Leopoldo, Quintana-Hau Juan, Tornero-Montaño Ruben, Castaneda-Hernandez Gilberto, Ortiz Mario, Alarcon-Oceguera Felipe, Beltran-Loustaunau Marco, Cortez-Gastelum Marco, Garcidueñas-Mejia Jorge, Gomez-Bastar Pedro, Jimenez-Roman Jesus, Korder-Ortega Vincent, Paczka-Zapata Jose, Torres-Segura Marina, Velasco-Gallegos Gustavo
Clinical Research Department, Laboratorios Sophia, S.A. de C.V., Guadalajara, Mexico.
J Clin Pharmacol. 2007 Jan;47(1):121-6. doi: 10.1177/0091270006292626.
Recently, a new latanoprost ophthalmic solution containing cyclodextrins was developed. The purpose of the present work was to compare the stability, clinical efficacy, and adverse effect profile of this formulation with the innovator product. The innovator formulation was stable at 4 degrees C but exhibited degradation at higher temperatures, whereas the cyclodextrin-containing formulation was stable at temperatures up to 40 degrees C. Formulations were assayed in a randomized double-blind clinical study in patients with primary open-angle glaucoma and/or ocular hypertension. Both latanoprost ophthalmic solutions produced comparable reduction of intraocular pressure. Conjunctival hyperemia was observed in 11.9% and 11.3% of the patients treated with the innovator and the cyclodextrin-containing formulations, respectively. There were no significant differences between the 2 ophthalmic solutions in efficacy or in the measured adverse effect. It is concluded that these 2 latanoprost ophthalmic solutions yield comparable efficacy and adverse effect outcomes. The cyclodextrin-containing formulation, however, has an improved stability.
最近，一种含有环糊精的新型拉坦前列素眼用溶液被研发出来。本研究的目的是比较该制剂与创新产品在稳定性、临床疗效和不良反应方面的情况。创新制剂在4℃时稳定，但在较高温度下会降解，而含环糊精的制剂在高达40℃的温度下仍保持稳定。在一项针对原发性开角型青光眼和/或高眼压症患者的随机双盲临床研究中对这些制剂进行了分析。两种拉坦前列素眼用溶液降低眼压的效果相当。分别有11.9%和11.3%使用创新制剂和含环糊精制剂治疗的患者出现结膜充血。这两种眼用溶液在疗效或所测不良反应方面没有显著差异。得出的结论是，这两种拉坦前列素眼用溶液产生的疗效和不良反应结果相当。然而，含环糊精的制剂具有更好的稳定性。
