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P.L. Nelson, C. Roberts; Comparative Analysis of Prednisolone Acetate Suspensions . Invest. Ophthalmol. Vis. Sci. 2005;46(13):1750.
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Purpose: To determine differences in particle size between 3 marketed prednisolone acetate suspensions: PredForte (Allergan); EconoPred Plus (Alcon) and generic prednisolone acetate 1% (Falcon). Methods: Testing performed on the 3 products qualitatively assessed sedimentation rate as a function of particle size. 3 bottles of each product were combined, and analyzed using a Malvern Mastersizer–S laser diffraction particle size analyzer equipped with a 300RF lens and a MS–1 small volume sample presentation unit., A single sample of each product was taken at time 0. The sample tubes were then capped and allowed to stand undisturbed at room temperature. Additional samples were taken from the top of the suspensions at 6 hours, and then at 12 hour intervals 12–72 hours. At 72 hours, a final sample was pulled from the bottom of each suspension. Results: At every timepoint, particles of Predforte were substantially smaller than those of the other 2 products. All three samples demonstrated a trend towards decreasing particle size over time. This demonstrates that larger particles settled out of suspension more readily than smaller particles, as expected. In the PredForte sample, results for 72 hrs (bottom) were consistent with T = 0 hr results. In the generic and EconoPred Plus lots, the T = 72 hour (bottom) results exceeded the T = 0 results, suggesting a tendency for these particles to agglomerate more readily. Conclusions:The prednisolone particles in PredForte were smaller and more uniform at all timepoints, allowing them to stay in suspension longer than EconoPred Plus or generic prednisolone acetate particles. This smaller particle size and lesser tendency of agglomeration is likely to result in greater homogeneity between doses and increased bioavailability of the drug in the eye.
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