Roberts Calvin W, Nelson Peter L
Department of Ophthalmology, Weill Medical College of Cornell University, New York, NY 10021, USA.
J Ocul Pharmacol Ther. 2007 Apr;23(2):182-7. doi: 10.1089/jop.2006.0070.
The aim of this study was to determine differences in particle size between three prednisolone acetate suspensions: Pred Forte, EconoPred Plus, and generic prednisolone acetate 1%.
This study employed the setting of a laboratory evaluation.
Qualitative assessment of sedimentation rate as a function of particle size was the method employed for this study. Samples of the three products were taken from the top of the suspensions at 0 and 6 h and then at 12-h intervals from 12 to 72 h. At 72 h, a sample was pulled from the bottom of each suspension.
Particle size in aliquots removed from the top of the suspensions steadily decreased over time. In the Pred Forte sample, results for 72 h (bottom) were consistent with T = 0 h results. In the generic and EconoPred Plus lots, the T = 72 h (bottom) results exceeded the T = 0 h results, suggesting a tendency for these particles to agglomerate more readily.
The prednisolone particles in Pred Forte were smaller and more uniform at all time points, allowing them to stay in suspension longer. This may result in greater homogeneity between doses and increased ocular bioavailability.
本研究旨在确定三种醋酸泼尼松龙混悬液（Pred Forte、EconoPred Plus和普通1%醋酸泼尼松龙）之间的粒径差异。
本研究采用实验室评估的背景。
本研究采用将沉降速率作为粒径函数的定性评估方法。三种产品的样品在0小时和6小时时从混悬液顶部采集，然后在12至72小时内每隔12小时采集一次。在72小时时，从每个混悬液底部抽取一个样品。
从混悬液顶部取出的等分试样中的粒径随时间稳步减小。在Pred Forte样品中，72小时（底部）的结果与0小时的结果一致。在普通产品和EconoPred Plus批次中，72小时（底部）的结果超过了0小时的结果，表明这些颗粒更容易团聚。
Pred Forte中的醋酸泼尼松龙颗粒在所有时间点都更小且更均匀，使其能够在混悬液中停留更长时间。这可能导致剂量之间更大的均匀性并提高眼部生物利用度。
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