IOVS Genetics
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(Investigative Ophthalmology and Visual Science. 2004;45:3229-3233.)
© 2004 by The Association for Research in Vision and Ophthalmology, Inc.
DOI:  10.1167/iovs.04-0206
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Ocular Bioerodible Minitablets as Strategy for the Management of Microbial Keratitis

Wim Weyenberg,1 An Vermeire,2 Marijke M. M. Dhondt,2 Els Adriaens,2 Philippe Kestelyn,3 Jean Paul Remon,2 and Annick Ludwig1

1From the Laboratory of Pharmaceutical Technology and Biopharmacy, University of Antwerp, Antwerp, Belgium; the 2Laboratory of Pharmaceutical Technology, Ghent University, Ghent, Belgium; and the 3Department of Ophthalmology, Ghent University Hospital, Ghent, Belgium.

PURPOSE. Evaluation in volunteers of ciprofloxacin-containing ocular gelling minitablets with prolonged release properties.

METHODS. The irritation potential of ciprofloxacin-containing bioadhesive powder mixtures, used to prepare ocular bioerodible minitablets, was evaluated with a slug mucosal-irritation test. The tear pharmacokinetic profiles of ciprofloxacin were determined in six healthy volunteers after topical administration of a minitablet and a single eye drop in the lower fornix. The drug concentrations in the tear samples collected were measured by using a validated HPLC method. Each volunteer was asked to give an evaluation of the preparations applied by answering a standard questionnaire.

RESULTS. The results of the mucosal-irritation test demonstrated the nonirritating properties of the bioadhesive powder mixtures. The ocular minitablet, applied in the fornix was in general well tolerated by the healthy volunteers. The mean tear concentration of ciprofloxacin was 33.0, 135.2, and 33.7 µg/g at 30, 300, and 480 minutes after application of the minitablet. Mean tear levels of 84.7, 45.6, and 8.4 µg/g were obtained at 5, 30, and 60 minutes after application of an eye drop.

CONCLUSIONS. Due to their prolonged drug release properties, the ocular minitablets containing ciprofloxacin can be considered as a promising drug delivery system to be used in the treatment of ulcerative bacterial keratitis.






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Copyright © 2004 by the Association for Research in Vision and Ophthalmology