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R. Toyos, A. Kulshreshtha, M. Cagle; A Comparison of the Settling Characteristics for NEVANACTM, AZOPT® and PRED FORTE Ophthalmic Suspensions . Invest. Ophthalmol. Vis. Sci. 2006;47(13):4384.
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To compare the settling characteristics of NEVANACTM 0.1% ophthalmic suspension (Alcon) with AZOPT® 1% (Alcon) and PRED FORTE 1% ophthalmic suspension (Allergan).
The suspension products were pooled individually. A sample was taken from the pooled products for time zero HPLC analysis. Aliquots of 40 mL of each product were poured into four sets of 50 mL graduated cylinders. One set of cylinders was used for taking photographs at intervals of 0, 1, 3 and 6 weeks to determine settling of the suspensions. The other three sets of cylinders were used for HPLC analysis at 1, 3 and 6 weeks intervals. The top 10 mL of the suspension supernate from each product cylinder was drawn at these intervals and retained for HPLC analysis. Microscopic images were taken using polarized light microscopy at a magnification of 1000X, using an oil immersion objective.
Results from the settling study demonstrated that NEVANACTM suspension is a more robust suspension than PRED FORTE. Over the study period of six weeks, NEVANACTM suspension showed about 6% settling, while PRED FORTE exhibited 90% settling and AZOPT® suspension exhibited no settling. The microscopic images also confirmed that all three suspensions had comparable particle size.
When compared with AZOPT® and PRED FORTE, NEVANACTM suspension demonstrated significantly less settling than PRED FORTE and comparable settling to AZOPT®.
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