Stability of frozen 1% voriconazole ophthalmic solution

American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists
Patricia Amorós-ReboredoCarmen López-Cabezas

Abstract

The physicochemical stability of frozen 1% voriconazole ophthalmic solution was evaluated. Multiple batches of voriconazole 10-mg/mL eye drops were aseptically prepared in a laminar-airflow cabinet. One batch was analyzed immediately after preparation, and the rest were stored at -20 °C and analyzed using high-performance liquid chromatography at 30, 60, and 90 days to test their physicochemical stability and sterility. All samples were analyzed in triplicate. Additional analyses were performed to determine the solution's in vitro activity once thawed. The sterility of the 1% voriconazole solution was evaluated using blood-agar media and thioglycollate broth. Samples were incubated for 14 days and checked daily for signs of growth. Stability was defined as the absence of particles, color variation, or changes in pH and a remaining antifungal concentration of 90-110% of the initial concentration. All solutions remained clear and colorless throughout the study, and no precipitation or turbidity was observed in any of the batches, regardless of solution temperature. The pH and osmolarity of all batches remained essentially unchanged during storage at -20 °C and after thawing. No significant differences in concentration were observ...Continue Reading

References

Jun 14, 2006·Archives of Ophthalmology·Eduardo C AlfonsoYunhee Lee
Nov 13, 2008·Antimicrobial Agents and Chemotherapy·Antoine DupuisNicolas Venisse
Jul 28, 2009·Journal of Pharmaceutical and Biomedical Analysis·N V V S S RamanK Ramakrishna
Aug 12, 2009·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·Daoud Al-BadriyehRobert Fullinfaw
May 27, 2010·Indian Journal of Pharmaceutical Sciences·A B KhetreR Mehendre
Oct 21, 2010·Current Eye Research·Srinivasan SenthilkumariThirumurthy Velpandian

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Citations

Oct 30, 2020·International Journal of Nanomedicine·Ghada Ahmed El-EmamAbd El Gawad H Abd El Gawad
Oct 28, 2019·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Marine RochePascal Odou

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