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Does Uniformity of Topical Corticosteroid Ophthalmic Medications: Flourometholone Acetate 0.1 Suspension and Loteprednol Etabonate 0.5 gel
Journal Article - Embargoed Full-Text
59th Medical Wing San Antonio United States
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Purpose The purpose of the study was to determine the concentrations of Flarexregistered and Lotemaxregistered when shaken and not shaken. Many patients fail to shake or inappropriately shake suspensions of corticosteroids prior to instillation as directed. This study was designed to help determine what concentration of corticosteroid these patients are receiving. In addition, independent confirmation of loteprednol etabonate ophthalmic geldose uniformity was determined and compared as a possible alternative. Methods Drug concentrations of shaken versus unshaken Flarexregistered and Lotemaxregistered were determined over a 20 day simulated tapered course in our institutional laboratory. Collected samples were analyzed by reversed phase high performance liquid chromatography HPLC with photodiode array detection at 240 nm. Results Flarexregistered had a mean concentration of 93.7 of the declared concentration when shaken and 7.25 when not shaken. The difference between these groups was statistically significant p0.0001 . Lotemaxregistered had a mean concentration of 96.74 of the declared concentration when shaken and a mean concentration of 98.97 when not shaken. The difference between these groups was not statistically significant p0.194. Conclusions Flarexregistered maintains dose uniformity when shaken. When not shaken it has poor dose uniformity. Lotemaxregistered was consistent whether shaken or not in our study and can be considered to eliminate the variability of poor patient compliance with shaking.
APPROVED FOR PUBLIC RELEASE