PP-044 Stability of 50 and 100 [micro]g/0.1 ml intraocular solutions of voriconazole at 2-8°c

• Published in: European journal of hospital pharmacy. Science and practice 2017-03, Vol.24, p.A220
• Main Authors: Roche, M, Simon, N, Bourdon, F, D'Horne, C, Berneron, C, Lannoy, D, Odou, P
• Format: Article
• Language: English
• ISSN: 2047-9956; 2047-9964
• DOI: 10.1136/ejhpharm-2017-000640.491

Background Voriconazole is a triazole antifungal agent effective in most cases of keratitis caused by fungi. Off-label use of extemporaneously compounded intraocular (intrastromal, intracameral) voriconazole has shown promising results in deep fungal ophthalmic infections, and abscessed, recurrent or drug resistant eye infections. Stability data on voriconazole intraocular solutions (VIS) are lacking. Purpose To assess the stability of 50 and 100 µg/0.1mL VIS stocked at 2-8°C. Material and methods 2 batches of VIS (2 mL; 1 batch per concentration) were aseptically compounded from injectable Vfend (Pfizer) and Ringer's lactate solution (Baxter), stored at 2-8°C in 3 part syringes (n=66) and analysed on day 13 (D13) and after 1 (D30) and 1.5 (D44) months. Stability study was led according to the GERPAC-SFPC stability studies guidelines. At each time point, visual aspect was checked, and voriconazole relative concentration (% of initial concentration, using a stability indicating HPLC-UV-diode-array-detector method), pH and osmolality were measured. Non-visible particle counts (using light obscuration particle count test) for particle size ≥ 10 µm and ≥25 µm (Eur Pharm 2.9.19 threshold: 6000 and 600/recipient, respectively) and sterility were assessed. Statistical analysis was carried out using non-parametric tests (α