AMPHOTERICIN-B EYE DROPS AS A LIPIDIC EMULSION

Treatment of ocular mycosis is based on painful instillation of Fungiz one(R) eye drops. The purpose of the study was to develop and to evalu ate an Amphotericin B eye drop (AmB) as a better tolerated lipidic emu lsion. A concentrated alkaline solution of AmB was mixed with Intralip id(R) 20%, then neutralized and buffered. The eye drop tolerance and p harmacokinetics were evaluated compared with eye drops in Fungizone(R) aqueous solution. The tolerance of the AmB lipidic emulsion was bette r than those observed with a magistral preparation of Fungizone(R) eye drops (P < 0.0005). The average corneal concentrations obtained with the Fungizone(R) and emulsion eye drops were 501 +/- 208 and 274 +/- 1 06 ng/g, respectively (P = 0.039). The average AmB concentrations in t he aqueous humour were 490 +/- 180 and 300 +/- 260 ng/ml, respectively , for the Fungizone(R) and emulsion eye drops (NS). The plasmatic conc entrations measured, lower than 20 ng/ml, were too weak to be toxic.