Physicochemical Stability Study of Polymyxin B in Various Infusion Solutions for Administration to Critically Ill Patients

Lim, Tze-Peng; Hee, Daryl Kim-Hor; Lee, Winnie; Teo, Jin Yao; Cai, Yiying; Chia, Shannon Yu-Hng; Leaw, Johannesen Yee-Kiat; Lee, Shannon Jing-Yi; Lee, Lawrence Soon-U; Kwa, Andrea Lay-Hoon

doi:10.1177/1060028016649598

Cited by 5 publications

(7 citation statements)

References 10 publications

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“…No statistical differences were evidenced in these pH values during 72 hs. The results obtained in this work are in agreement with reported by Lim et al (2016) who evidenced no statistical differences in pH and osmolarity values of polymyxin B solutions over time.…”

Section: Lc-ms/ms Analysessupporting

confidence: 93%

“…The results obtained in this work are similar to those reported by Lim et al (2016) 106.9 a ± 5.4 100.4 a ± 3.9 90.7 a ± 2.3 90.7 b ± 4.2 86.9 b ± 1.1 ab Averages in the same line followed by the same character do not differ significantly (p>0.05) based on Tukey test note that analyses were not performed at 40 °C as in the present study. The temperature of 40 °C is suggested for international guidelines to provide information's during accelerated storage conditions (WHO, 2009).…”

Section: Lc-ms/ms Analysessupporting

confidence: 92%

“…However, such a volume may be excessively high for some critically ill patients who have either risk of developing fluid overload states or have restriction of fluid infusion due to several conditions. Therefore, stability of polymyxin B in lower volume solutions is of paramount importance and for which the administration should be performed slowly (Lim et al, 2016).…”

Section: Introductionmentioning

confidence: 99%

“…The stability of polymyxin B was evaluated also in 0.9% saline solutions stored at room temperature and under refrigeration using a microbiological assay (He et al, 2010). In a more recent study the stability of polymyxin B was evaluated in various reduced infusion volumes of 0.045%, 0.225% and 0.9% saline, and 5% dextrose stored at 4, 25 and 30 °C (Lim et al, 2016).…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of the stability of Polymyxin B in saline and glucose solutions using LC-MS/MS

Castilhos

Dillenburg

Antunes

et al. 2020

Braz. J. Pharm. Sci.

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Polymyxins are a group of antibacterial substances and have remained the drugs of choice for treatment of resistant Gram-negative bacilli. Polymyxin B is administered by intravenous infusion and requires the reconstitution of lyophilized powder with 0.9% saline or 5% glucose solutions. To date, there is little information about polymyxin stability in different infusions solutions, especially at 40 ºC, a temperature that is recommended to study drug stability as it accelerates degradation reactions. Therefore, in this work an analytical method using LC-MS/MS was developed, validated and applied to determine the stability of polymyxin B diluted in 0.9% saline or 5% glucose solutions at 25 ºC and 40 ºC. The stability of polymyxin B solutions was evaluated during 72 hours. Polymyxin B1 and B2 were stable for 24 hours in saline (0.9%) and glucose solution (5%), however a significant degradation of polymyxin B1 and B2 was observed after 48 hours and 72 hours of assay. The reduction of polymyxin content was evidenced in both saline and glucose media, at room temperature as well as at 40 °C. No significant differences in pH of polymyxin solutions (glucose or saline) were evidenced during stability assay.

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Section: Lc-ms/ms Analysessupporting

confidence: 93%

Section: Lc-ms/ms Analysessupporting

confidence: 92%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Evaluation of the stability of Polymyxin B in saline and glucose solutions using LC-MS/MS

Castilhos

Dillenburg

Antunes

et al. 2020

Braz. J. Pharm. Sci.

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“…Study drug was reconstituted and diluted with normal saline (NS) for injection. Unused portions were properly discarded to minimize loss of potency in subsequent experiments (32). Colistin sulfate (Sigma-Aldrich Chemical Company, Milwaukee, WI, USA) and creatinine-d3 (Cayman Chemicals, Ann Arbor, MI, USA) were used as internal standards for the LC-MS/MS assay (Agilent Technologies).…”

Section: Methodsmentioning

confidence: 99%

Evaluation of Dose Fractionated Polymyxin B on Acute Kidney Injury: A Translational In Vivo Model

Liu

Pais

Avedissian

et al. 2019

Preprint

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2 0 injury, biomarker, KIM1 2 1 2 2 Acknowledgements: None 2 3 Polymyxin B dose fractionation Abstract 2 4The polymyxins are last-line defense for highly resistant infections. Nephrotoxicity, however, is a dose-limiting 2 5factor. Yet, approaches to mitigate nephrotoxicity are poorly defined. This study aimed to investigate the impact of 2 6 dose fractionated (once, twice and thrice daily) polymyxin B (PB) on acute kidney injury (AKI) in a pre-clinical 2 7model. Secondarily, we aimed to describe the pharmacokinetic (PK) profile of PB. Sprague-Dawley rats were 2 8 assigned to experimental groups with different dosing intervals but constant total daily exposure (12 mg/kg/day into 2 9 single, twice daily, and thrice daily doses) and controls received normal saline subcutaneously over 3 days. Blood 3 0 and urine samples were collected, and kidneys were harvested at necropsy. A three-compartment model best 3 1 described the data and Bayesian observed vs. predicted concentration demonstrated bias, imprecision, and R 2 of 3 2 0.129 mg/L, 0.729 mg 2 /L 2 and 0.652, respectively. PB exposure (i.e. AUC 24h ) were similar across treatment groups 3 3 over time (p=0.87). As a representative, urinary KIM-1 were elevated on days 1 and 2 for experimental groups 3 4 compared to controls, and thrice daily group experienced the most KIM-1 increase [mean increase (95% CI) day 1 3 5 from day -1, 4.44 (0.89, 8.00) ng/mL; p=0.018] as compared to control [mean increase (95% CI) day 1 from day -1, 3 6 0.03 (-0.42, 0.49) ng/mL; p=0.99]. Correspondingly, significant histopathological damage was observed with the 3 7same group (p=0.013) (controls as a referent). Our findings suggested that fractionating the PB dose thrice daily 3 8 resulted in the most injury in a rat model.

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High-concentration polymyxin B infusion: is it safe to give?

Xin

Winnie

Lim

et al. 2023

International Journal of Antimicrobial Agents

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Physicochemical Stability Study of Polymyxin B in Various Infusion Solutions for Administration to Critically Ill Patients

Cited by 5 publications

References 10 publications

Evaluation of the stability of Polymyxin B in saline and glucose solutions using LC-MS/MS

Evaluation of the stability of Polymyxin B in saline and glucose solutions using LC-MS/MS

Evaluation of Dose Fractionated Polymyxin B on Acute Kidney Injury: A Translational In Vivo Model

High-concentration polymyxin B infusion: is it safe to give?

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