Accession Number : AD1036352

Title :   Does Uniformity of Topical Corticosteroid Ophthalmic Medications: Flourometholone Acetate 0.1 Suspension and Loteprednol Etabonate 0.5 gel

Descriptive Note : Journal Article - Embargoed Full-Text

Corporate Author : 59th Medical Wing San Antonio United States

Personal Author(s) : Bennion, John

Full Text :

Report Date : 03 Jan 2017

Pagination or Media Count : 22

Abstract : Purpose: The purpose of the study was to determine the concentrations of Flarex(registered) and Lotemax(registered) 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 Flarex(registered) and Lotemax(registered) 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: Flarex(registered) 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 (p=0.0001 ). Lotemax(registered) 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 (p=0.194). Conclusions: Flarex(registered) maintains dose uniformity when shaken. When not shaken it has poor dose uniformity. Lotemax(registered) was consistent whether shaken or not in our study and can be considered to eliminate the variability of poor patient compliance with shaking.

Descriptors :   dosage , therapeutics , biomedical research , corticosteroid agents , medical research , simulation , patients , ophthalmology , eye

Subject Categories : Medicine and Medical Research

Distribution Statement : APPROVED FOR PUBLIC RELEASE