Stability and in vitro activity of voriconazole eyedrops at a concentration of 3 microg/mL

• Published in: Farmacia hospitalaria 2005-09, Vol.29 (5), p.331-334
• Main Authors: Isla Tejera, B, Garzas Martín de Almagro, C, Cárdenas Aranzana, M, Pérez Rodrigo, I, Aumente Rubio, M D, Gordillo Sánchez, R
• Format: Article
• Language: Spanish
• Subjects: Antifungal Agents - administration & dosage; Antifungal Agents - pharmacology; Drug Stability; Ophthalmic Solutions; Pyrimidines - administration & dosage; Pyrimidines - pharmacology; Triazoles - administration & dosage; Triazoles - pharmacology; Voriconazole
• ISSN: 1130-6343

To assess the stability and activity of voriconazole 3 microg/mL eyedrops as prepared for use against amphotericin B- and fluconazole-resistant fungal endophthalmitis. Stability (concentration using UV-spectrophotometry; pH, osmolarity, and particle formation) and sterility were analyzed under various preservation conditions--room temperature (22-24 degrees C) or refrigerated (2-8 degrees C). The preparation's in vitro efficacy was analyzed using the standard National Committee for Clinical Laboratory Standards method for 30 days. Voriconazole concentrations were found to be within limits allowed by the United Stated Pharmacopeia (90-115%). pH (room temperature: 6.96-7.60; refrigerated: 6.84-7.21) and osmolarity (room temperature: 265-284 mOsm/l; refrigerated: 270-285 mOsm/l) remained within eye physiological ranges throughout the study under the analyzed conditions. The preparation s antifungal activity remained stable during the first three weeks. The voriconazole 3 microg/mL eyewash preparation remained stable, sterile and with full antifungal activity for 21 days when stored both at room temperature and under refrigeration conditions.