Title: Stability of Anidulafungin in Concentrated Pharmaceutical Solution
Abstract: Abstract Background Currently, the reconstitution instructions in the package insert indicate that 100 mg of anidulafungin powder is to be dissolved in 30 ml of sterile water for injection and this reconstituted solution is to be further mixed with 100 ml of either normal saline (NS) or dextrose 5% (w/v) (D5) to give a final infusion solution of concentration 0.77 mg/mL. The compatibility of the reconstituted solution with diluents other than NS or D5 has not been established and there is no literature to support the the use of a more concentrated infusion solution. Thus, the infusion solution prepared strictly according to the method described by the manufacturer may pose a problem clinically in patients who are indicated for treatment with anidulafungin but require fluid restriction. In order to meet the needs of the abovementioned patient populations in the clinical setting, it is imperative to establish the stability of suitable anidulafungin infusion solutions prepared in diluents that are appropriate to the patients but differ from that set forth by the manufacturer Methods After an initial validation of the HPLC-MS/MS method, the concentration of the anidulafungin solutions was determined over 48/72 hours. Other parameters assessed were pH, osmolality and particulate matter. Results 100 mg of anidulafungin powder was soluble in 15 ml of sterile water and this reconstituted solution was stable for at least 24 hours at 25. Anidulafungin infusion solutions of concentration 2 mg/mL prepared using diluents like NS, D5, half normal saline (HNS) and NSD5 were stable for at least 72 hours at 25. If the diluent was HNSD5, the infusion solution of concentration 2 mg/mL was stable for at least 48 hours at 25. All of the anidulafungin solutions tested were of acceptable standard for an injection in terms of pH, osmolality and particulate matter Conclusion The method of preparation employed yielded anidulafungin solutions of suitable stability for clinical use and can be adopted should there be a need to differ from the manufacturer’s recommended preparation method. We may use these concentrated preparations for patient with central line like in ICU or OPAT setting Disclosures All authors: No reported disclosures.