The Risk of Microbial Contamination in Multiple-Dose Preservative-Free Ophthalmic Preparations.
Multiple-dose ophthalmic preparations that do not contain preservatives carry high risks of microbial contamination. However, there are various types of hospital preparations, with different physicochemical properties. In the present study, we evaluated the association between physicochemical properties and microbial contamination in ophthalmic preparations. The investigated hospital preparations included ophthalmic preparations of physiological saline, 0.2% fluconazole, 0.5% vancomycin hydrochloride, and 2% cyclosporine. We investigated the microbial dynamics of each ophthalmic preparation and microbial contamination in ophthalmic preparations used by patients. Remarkable growth of Pseudomonas aeruginosa, Burkholderia cepacia, and Serratia marcescens was observed in ophthalmic preparations of physiological saline and 0.2% fluconazole. All tested microorganisms displayed decreased counts after inoculation in 0.5% vancomycin hydrochloride. In 2% cyclosporine, all investigated microorganisms were below the limit of detection after inoculation for 6 h. The microbial contamination rates of ophthalmic preparations used by patients were 16.7% (3/18 samples) for 0.5% vancomycin hydrochloride and 0% (0/30 samples) for 2% cyclosporine. All detected contaminants in 0.5% vancomycin hydrochloride were Candida spp., one of which was present at a level of 1×104colony-forming units/mL. The storage method for in-use ophthalmic preparations should be considered on the basis of their physicochemical properties.
Pharmaceutical Service, Yamaguchi University Hospital.
Atsuyuki
A
Saisyo
Rima
R
Shimono
Shigeharu
S
Oie
Kazuhiro
K
Kimura
Hiroyuki
H
Furukawa
D016956:Burkholderia cepacia / Q000302:isolation & purification; D004340:Drug Contamination / Q000517:prevention & control; D006801:Humans; D009883:Ophthalmic Solutions / Q000032:analysis*; D011310:Preservatives, Pharmaceutical / Q000032:analysis*; D011550:Pseudomonas aeruginosa / Q000302:isolation & purification; D012307:Risk Factors; D014640:Vancomycin / Q000032:analysis
D009883:Ophthalmic Solutions; D011310:Preservatives, Pharmaceutical; D014640:Vancomycin