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Ocular distribution and safety of pazufloxacin 0.6% ophthalmic solution in rabbits

Poster Details

First Author: O.Olvera MEXICO

Co Author(s):    Y. Contreras   L. Baiza   P. Marquez   J. Bonilla           

Abstract Details

Purpose:

To evaluate ocular distribution and safety of pazufloxacin ophthalmic solution 0.6% after instillation to New Zealand White rabbits eyes.

Setting:

Medical Research Department Laboratorios Sophia S.A. de C.V., Zapopan, Mexico.

Methods:

64 eyes were used in the ocular distribution study.Pazufloxacin 0.6% was instilled 30 μL in both eyes. Were measured in conjunctiva, cornea and aqueous humor, at the following time points: 0.25,1,3,4,6,8,12,24h.After euthanasia,tissues were collected and analyzed by high performance liquid chromatography. 60 eyes were used for the safety study. Group 1 were instilled pazufloxacin 0.6%;Group 2 moxifloxacin 0.5% and group 3 gatifloxacin 0.5%, in both eyes.Doses were given 7 times daily for 30 days. On day 31 rabbits were euthanized and eyes enucleated for histopathologic assessment.Conjunctival hyperemia,chemosis, corneal staining and conjunctival discharge were assessed as clinical toxicity and safety criteria.

Results:

After a single instillation the highest maximum concentration was found in conjunctiva (21659 ng/g), followed by cornea (11651 ng/g) and aqueous humor (1707 ng/g). Cmax in all tissues were higher than the minimal inhibition concentration for pseudomonas aeuriginosa (422 ng/g) No statistically significant differences between groups were found. In the histopathologic report no differences were encountered between groups and there were no signs of cellular toxicity.

Conclusions:

Pazufloxacin ocular distribution and safety profile, make it a viable option for topical treatment of ocular infections. Further studies are granted to assess and compare efficacy of pazufloxacino and other quinolones.

Financial Disclosure:

One or more of the authors is employed by a for-profit company with an interest in the subject of the presentation

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