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W. F. Stringer, R. Bryant; Dose Uniformity of Prednisolone Acetate Ophthalmic Suspensions Compared to DurezolTM (Difluprednate Ophthalmic Emulsion), 0.05%. Invest. Ophthalmol. Vis. Sci. 2009;50(13):1461.
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Compare the dose uniformity of two prednisolone acetate suspensions (generic [Falcon Pharmaceuticals, Ltd., Fort Worth, TX] and Pred Forte® [Allergan, Inc., Irvine, CA]) to DurezolTM (difluprednate ophthalmic emulsion), 0.05%.
Bottles of prednisolone acetate suspension, 1% (Falcon), Pred Forte® (prednisolone acetate suspension 1%), and Durezol were stored either upright or inverted for 12 hours. After storage, the bottles were either shaken (mechanical wrist action shaker for 5 seconds) or not to simulate actual patient usage and 2 drops from each were dispensed. To simulate QID dosing, this process was repeated 3 times at 4-hour intervals each day, followed by 12 hour re-storage. The dispensed drops were analyzed for drug content by high-performance liquid chromatography (HPLC).
The dose uniformity of Durezol was excellent regardless of storage orientation or shaking before use. Generic prednisolone acetate suspension exhibited very poor dose uniformity regardless of orientation or shaking (Figure 1). Pred Forte also exhibited poor dose uniformity, although the scatter drop to drop was not as marked compared to the generic prednisolone acetate formulation (Figure 2).
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