Evaluation of the stability of tigecycline in elastomeric infusion devices used for outpatient parenteral antimicrobial therapy.

Background: Tigecycline is increasingly being considered in outpatient parenteral antimicrobial therapy (OPAT) programmes given its spectrum of activity; however, stability data are lacking, necessitating further study. Objective: To assess tigecycline stability in elastomeric infusers under OPAT conditions, following the UK Yellow Cover Document (YCD) stability testing guidelines. Methods: Tigecycline was reconstituted with normal saline in Leventon Dosi-Fuser and Baxter-LV10 infusers at doses of 50, 100 and 200 mg in 240 mL. Additionally, a tigecycline intermittent infusion dose (50 mg/100 mL) was reconstituted in Baxter-SV100 infusers. The infusers were stored under refrigerated storage (2°C-8°C) for 7 days, followed by exposure at an in-use temperature of 32°C for 24 h, or at 25°C for 2 hours for the intermittent infusion. Stability was evaluated using a stability-indicating assay, pH measurement, subvisible particle count and visual inspection as per the YCD. Results: After 7 days of refrigeration followed by 24 h exposure to 32°C, the mean ± SD percentage of tigecycline remaining was 97.9 ± 0.6, 97.3 ± 0.6 and 95.4 ± 0.8 for the Baxter LV10 devices, and 97.2 ± 0.3, 96.9 ± 0.5 and 95.8 ± 0.8 for Dosi-Fuser devices at the low, intermediate, and high dose levels, respectively. For intermittent infusion in Baxter-SV100 devices, the mean ± SD percentage remaining after 7 days of refrigerated storage followed by 2 h at 25°C was 99.7 ± 0.2. Conclusions: Tigecycline meets the UK YCD criteria of ≤5% degradation limit, indicating its suitability for both intermittent and continuous 24-h infusion in OPAT programs.