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[Azone-induced changes on corneal endothelium in rabbits]
Objective:
To investigate ocular toxic effect of azone at low concentrations in rabbits to determine whether this penetration enhancer has any value for ocular use.
Methods:
0.3%, 0.6%, 0.9% concentrations of azone in an ocular emulsion vehicle were studied. Rabbits in three experimental groups received topical 30 microl of 0.3%, 0.6%, 0.9% azone respectively three times daily for 4 weeks. Rabbits in control group 1 received 30 microl of vehicle without azone as negative control and rabbits in control group 2 received nothing as normal control. Clinical and histopathological examinations of rabbit cornea endothelial cells were made by slit-lamp biomicroscopy, light microscopy and scanning electron microscopy.
Results:
No clinical and histopathological evidence of ocular toxicity occurred in all treated and control eyes. The concentration of azone used in this study was 3-9 times higher than that (at 0.1%) at which corneal penetration of hydrophilic compounds can be enhanced enormously.
Conclusion:
Azone has value for incorporation into ocular formulations to increase therapeutic action of many hydrophilic drugs.