3PC-023 Formulation and characterisation of fluorescein sodium solution for injection for diagnostic angiography

<h3>Background and Importance</h3> Fluorescein sodium as diagnostic contrast agent belongs to the World Health Organization’s List of Essential Medicines. In our hospital fluorescein sodium injection is used in diagnostic fluorescein angiography to diagnose and monitor various eye diseases. After intravenous injection, dye quickly circulates through the blood vessels of the eye and illuminates them, thus enabling photographs to be taken with a special camera. However, due to shortage of fluorescein sodium injection on our market during the past year, a formulation had to be developed. <h3>Aim and Objectives</h3> The aim of this work was to formulate and characterise fluorescein sodium solution for injection and determine the stability at room temperature (25 ± 2°C) during its shelf life period. <h3>Material and Methods</h3> Fluorescein sodium solution for injection is prepared in laminar flow cabinet. Fluorescein sodium is completely dissolved in water for injection, then filtered through membrane filter with 0.22 μm pore size and packed into glass container. Obtained product was autoclaved at 120°C for 20 minutes, in its final container. Characterisation in terms of determination of drug content, sterility testing and test for pyrogens was carried out after sterilisation and during a 6 month period. Drug content analysis was performed using spectrophotometric method according to USP by our control laboratory. Sterility (Ph. Eur., general chapter 2.6.1) and pyrogen testing (Ph. Eur., general chapter 2.6.8) were conducted by an external lab. <h3>Results</h3> A brownish and homogenous solution of fluorescein sodium was obtained. No visual changes were observed during 6 month period. Obtained fluorescein sodium concentration after sterilisation was 98.58% of the defined concentration and it increased slightly from 99.20% (after 3 months) to 100.22% (after 6 months). Final product maintained to be sterile and pyrogen-free after 6 months. Therefore, shelf life period was proven to be 6 months at room temperature (25 ± 2°C). <h3>Conclusion and Relevance</h3> Fluorescein sodium injection is an indispensable diagnostic medicine in ophthalmology. The formulation of fluorescein sodium solution for injection (500 mg/2.5 mL) was successfully developed in our hospital pharmacy service. The solution has been prepared since August 2023 and remained stable and active for at least 6 months. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest