Formulation Development of a pH-Adjusted, Preservative-Free 1% 5-Fluorouracil Eye Drop Compounded from Injectable Concentrate: A Risk-Assessed Magistral Formulation and 28-Day Stability Case Study

Background

No licensed ophthalmic 5-fluorouracil (5-FU) product is available in Hungary, and published compounded 5-FU eye drops are alkaline dilutions of the injectable concentrate. We report a formulation development and 28-day storage-stability case study of a pH-adjusted, preservative-free 1% 5-FU eye drop prepared under Council of Europe Resolution CM/Res(2016)1.

Methods