Development and clinical evaluation of clotrimazole-β-cyclodextrin eyedrops for the treatment of fungal keratitis
| Autor: | Hiba M. Salmo, Bazigha K. Abdul Rasool |
|---|---|
| Rok vydání: | 2012 |
| Předmět: |
Adult
Male Preservative Pharmaceutical Science Aquatic Science Pharmacology Keratitis Amphotericin B Drug Discovery Medicine Animals Humans Fungal keratitis Clotrimazole Ecology Evolution Behavior and Systematics Retrospective Studies chemistry.chemical_classification Cyclodextrins Ecology Cyclodextrin business.industry General Medicine Eye infection Middle Aged medicine.disease Clinical trial Drug Combinations Treatment Outcome chemistry Female Rabbits Ophthalmic Solutions business Agronomy and Crop Science Eye Infections Fungal medicine.drug Research Article |
| Zdroj: | AAPS PharmSciTech. 13(3) |
| ISSN: | 1530-9932 |
| Popis: | Fungal keratitis is a serious corneal disease that may result in loss of vision. There are limited treatment options available in Iraqi eye hospitals which might be the main reason behind the poor prognosis of many cases. The purpose of this study was to prepare and pharmaceutically evaluate clotrimazole–β-cyclodextrin (CTZ–β-CD) eyedrops then clinically assess its therapeutic efficacy on fungal keratitis compared with extemporaneous amphotericin B eyedrops (0.5% w/v). A CTZ–β-CD ophthalmic solution was prepared and evaluated by various physicochemical, microbiological, and biological tests. The prepared formula was stable in 0.05 M phosphate buffer pH 7.0 at 40 ± 2°C and 75 ± 5% RH for a period of 6 months. Light has no significant effect on the formula’s stability. The CTZ–β-CD eyedrops efficiently complied with the isotonicity, sterility, and antimicrobiological preservative effectiveness tests. Results of the clinical study revealed that 20 (80%) patients showed a favorable response to the CTZ–β-CD eyedrops, while 16 patients (64%) exhibited a favorable response to amphotericin B (P > 0.05). The mean course of treatment was significantly (P < 0.05) less in the CTZ treatment group than in the amphotericin group (21.5 ± 5.2 vs. 28.3 ± 6.4 days, respectively). The CTZ formulation was significantly (P < 0.05) more effective in the management of severe cases and also against Candida sp. than amphotericin B. There was no significant difference (P < 0.05) between both therapies against filamentous fungi. The CTZ–β-CD formulation can be used alternatively to other ophthalmic antimycotic treatment options in developing countries where stability, cost, or efficacy is a limiting factor. |
| Databáze: | OpenAIRE |
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