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.

Wolie ZT, Unwin S, Burke A, Won H, Wallis SC, Seaton RA, Gilchrist M, Roberts JA, Sime FB. Evaluation of the stability of tigecycline in elastomeric infusion devices used for outpatient parenteral antimicrobial therapy. JAC Antimicrob Resist. 2025 May 13;7(3):dlaf074. doi: 10.1093/jacamr/dlaf074. PMID: 40365447; PMCID: PMC12070266.