OCULAR TOLERANCE OF SERTACONAZOLE GEL

The in vitro and in vivo tolerance of sertaconazole gel, a new topical azole antifungal, was studied. Ketoconazole gel (Panfungol(R)) was us ed as a reference substance. The methods applied for tolerance assessm ent were the bovine corneal opacity and permeability test for the in v itro assay and a modified Draize test for the in vivo assay. The resul ts obtained show that both substances can be classified as slightly ir ritant and with acceptable tolerance. However, unlike ketoconazole gel , sertaconazole gel did not cause a positive lesion index in vivo. Ket oconazole was 5.25 times more irritant in vitro than sertaconazole gel , whose effect was similar to that of saline solution. Consequently, t he negligible irritant effect of sertaconazole gel on a type of epithe lium that is extremely sensitive, i.e. the cornea, confirms the tolera nce of this new antifungal gel on other structures such as the skin an d mucous membranes.