Stability of fluconazole solution as an ophthalmic preparation / Mari Addylaine M. Reyes, Jonah Jane R. Sedano, Klarisse Pauline M. Taaca, Ruby Jean R. Tumala and Jimrouse Clarisse C. Vinluan.

Includes appendices and bibliographical references.

Abstract: Fungal keratitis is an infection of the cornea. It can cause blindness if not treated and in some cases, treatment cannot restore vision. In these cases, permanent vision impairment or blindness may occur. One treatment for fungal keratitis is fluconazole. In the market, fluconazole is available in oral and intravenous preparations only and there is no ophthalmic preparation available yet. Natamycin 5% w/v is the only ophthalmic preparation registered to the FDA. In some countries in the United States of America, fluconazole is extemporaneously prepared. And there are studies stating the intra-corneal penetration of fluconazole making it a possible formulation for an ophthalmic solution. This led the researchers to study its stability for 30-day period under 40°C ± 2°C. As in-use stability testing (14-day stability)was also performed simulating the usage of the patient in his home under room temperature. Fluconazole (Diflucan) 2 mg/ml was used and was transferred into different vials containing 10 ml each. The purity, pH and viscosity of the solution were determined on day 0 and day 30 of storage for the 30-day stability test. And for the in-use stability test, the purity and pH was determined on day 0, 1, 5, 9 and 14 while the viscosity was determined on day 0, 5, 9 and 14 storage. The researchers therefore conclude that both for the 30-day and 14-stability test, the pH of the solution was within the acceptable range of 4.5 to 11.5, while the assay and viscosity results showed a decreasing value over time because of the solution being subjected to high temperature which enhanced the degradation of the preparation,

Thesis - School of Pharmacy