Robiyanto Robiyanto1, Syed Tabish R Zaidi1, Madhur D Shastri1, Ronald L Castelino1, S Troy Wanandy2, Matthew D Jose3, Rahul P Patel4. 1. Pharmacy, School of Medicine, University of Tasmania, Hobart, Tasmania, Australia. 2. Pharmacy, School of Medicine, University of Tasmania, Hobart, Tasmania, Australia Medicine, School of Medicine, University of Tasmania, Hobart, Tasmania, Australia Department of Pharmacy, Royal Hobart Hospital, Hobart, Tasmania, Australia. 3. Medicine, School of Medicine, University of Tasmania, Hobart, Tasmania, Australia Department of Nephrology, Royal Hobart Hospital, Hobart, Tasmania, Australia. 4. Pharmacy, School of Medicine, University of Tasmania, Hobart, Tasmania, Australia Rahul.Patel@utas.edu.au.
Abstract
UNLABELLED: ♦ INTRODUCTION: Intraperitoneal tigecycline is a potential option for the treatment of peritoneal dialysis (PD)-associated peritonitis caused by microorganisms resistant to commonly used antibiotics. However, the stability of tigecycline must be assessed in the PD solution before evaluating its safety and therapeutic efficacy in PD-associated peritonitis. The objective of this study was to investigate the stability of tigecycline in 3 types of PD solutions at different temperatures for various time points. ♦ METHODS: A total of 27 PD bags (9 PD bags for each type of PD solution; 1.5% glucose, 7.5% icodextrin, and 1.5% glucose pH neutral) containing 2 μg/mL of tigecycline were prepared and stored at either 4, 25, or 37°C. An aliquot was withdrawn immediately before (0 hour) and after pre-defined time points. Each sample was analyzed in duplicate for the concentration of tigecycline using a stability-indicating high-performance liquid chromatography (HPLC) technique. Samples were also assessed for pH, color changes, and evidence of precipitation immediately after preparation and on each day of analysis. ♦ RESULTS: Tigecycline in all 3 types of PD solutions retained more than 90% of its initial concentration for at least 216, 72, and 8 hours at 4, 25, and 37°C, respectively. There was no evidence of precipitation at any time under the tested storage conditions. The pH and color of tigecycline admixed PD solutions stored at 4, 25, and 37°C remained essentially unchanged for 336, 96, and 48 hours respectively. ♦ CONCLUSION: The results obtained from the study provide a platform for future clinical studies aiming to determine the safety and therapeutic efficacy of intraperitoneally administered tigecycline for the treatment of PD-associated peritonitis.
UNLABELLED: ♦ INTRODUCTION: Intraperitoneal tigecycline is a potential option for the treatment of peritoneal dialysis (PD)-associated peritonitis caused by microorganisms resistant to commonly used antibiotics. However, the stability of tigecycline must be assessed in the PD solution before evaluating its safety and therapeutic efficacy in PD-associated peritonitis. The objective of this study was to investigate the stability of tigecycline in 3 types of PD solutions at different temperatures for various time points. ♦ METHODS: A total of 27 PD bags (9 PD bags for each type of PD solution; 1.5% glucose, 7.5% icodextrin, and 1.5% glucose pH neutral) containing 2 μg/mL of tigecycline were prepared and stored at either 4, 25, or 37°C. An aliquot was withdrawn immediately before (0 hour) and after pre-defined time points. Each sample was analyzed in duplicate for the concentration of tigecycline using a stability-indicating high-performance liquid chromatography (HPLC) technique. Samples were also assessed for pH, color changes, and evidence of precipitation immediately after preparation and on each day of analysis. ♦ RESULTS:Tigecycline in all 3 types of PD solutions retained more than 90% of its initial concentration for at least 216, 72, and 8 hours at 4, 25, and 37°C, respectively. There was no evidence of precipitation at any time under the tested storage conditions. The pH and color of tigecycline admixed PD solutions stored at 4, 25, and 37°C remained essentially unchanged for 336, 96, and 48 hours respectively. ♦ CONCLUSION: The results obtained from the study provide a platform for future clinical studies aiming to determine the safety and therapeutic efficacy of intraperitoneally administered tigecycline for the treatment of PD-associated peritonitis.
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