Pharmaceuticals
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
By Vajda P, Bartus G, Csapó M and 4 others.
Abstract
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
Five injectable concentrates were characterised for pH, and one was titrated with 0.1 N hydrochloric acid in a preservative-free ophthalmic vehicle to pH 7.30-7.60. Three 10 mL batches were prepared aseptically and release-tested; drop volume and delivered dose were determined on one batch, which was also followed for 28 days at 15-25 °C and 2-8 °C by inspection, pH, sterility and comparative HPLC-UV assay (single determinations).