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J. Katz, G. R. Owen, S. M. Robertson, A. C. Brooks, O. James; A New in vivo Rabbit Model That Mimics Human Dosing to Determine the Distribution of 1.0% Prednisolone Acetate Suspensions in the Tears and Aqueous Humor. Invest. Ophthalmol. Vis. Sci. 2007;48(13):4314.
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To use a new rabbit model that simulates dosing in the human eye to predict the ocular penetration and distribution of prednisolone following topical dosing of two commercial formulations.
Anesthetised rabbits were given a single topical dose of either new OMNIPREDTM (OP) or PRED FORTE* (PF) prednisolone acetate ophthalmic suspensions (1%). A 30 minute controlled period that simulated the human eye with manual blinking (4 blinks/min) and supplemental tear flow (2 µL/min) followed. Tear samples were collected every 5 minutes, and after euthanasia, aqueous humor and tissue samples were collected at 60 minutes. Prednisolone acetate and alcohol concentrations were quantified using HPLC.
The mean concentrations of prednisolone (acetate and alcohol combined) (µg/mL or µg/g ± SE) in the tears at the 15 min time point were 280 ± 120 for OP and 170 ± 115 for PF (p > 0.05). The concentrations in the tissues at 1 hour were: in the aqueous humor 0.56 ± 0.11 for OP and 0.43 ± 0.15 for PF (p > 0.05); in the cornea 5.2 ± 1.4 for OP and 3.8 ± 1.1 for PF (p > 0.05); in the palpebral conjunctiva 4.5 ± 2.3 for OP and 4.0 ± 2.3 for PF (p > 0.05); in the bulbar conjunctiva 6.6 ± 2.4 for OP and 6.0 ± 3.9 for PF (p > 0.05).
Overall, OMNIPREDTM and PRED FORTE* prednisolone acetate ophthalmic suspensions (1%) realized similar tear, aqueous humor, corneal and conjunctival tissue concentrations.*Trademarks are the property of their respective owners
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