Abstract
Treatment of ocular mycosis is based on painful instillation of Fungizone ® eye drops. The purpose of the study was to develop and to evaluate an Amphotericin B eye drop (AmB) as a better tolerated lipidic emulsion. A concentrated alkaline solution of AmB was mixed with Intralipid ® 20%, then neutralized and buffered. The eye drop tolerance and pharmacokinetics were evaluated compared with eye drops in Fungizone ® aqueous solution. The tolerance of the AmB lipidic emulsion was better than those observed with a magistral preparation of Fungizone ® eye drops ( P < 0.0005). The average corneal concentrations obtained with the Fungizone ® and emulsion eye drops were 501 ± 208 and 274 ± 106 ng/g, repsectively ( P = 0.039). The average AmB concentrations in the aqueous humour were 490 ± 180 and 300 ± 260 ng/ml, respectively, for the Fungizone ® and emulsion eye drops (NS). The plasmatic concentrations measured, lower than 20 ng/ml, were too weak to be toxic.
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