Temperature profiles of antibiotic-containing elastomeric infusion devices used by ambulatory care patients

Docherty, Toni; Montalto, Michael; Leslie, Joni; King, Katrina; Niblett, Suzanne; Garrett, Tim

doi:10.2146/ajhp151071

Cited by 12 publications

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References 10 publications

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“…The final concentration of drug recovered in the device can potentially be altered by temperature, pH changes and associated buffers, altering the starting drug concentration of the solution, degradant rate, formation of toxic impurities, and altered flow rates of devices. 75,80,88,[93][94][95] These variables are particularly important if infusions are going to be utilized outside of an inpatient setting and not for immediate use. These variables can impact the logistics of manufacturing and delivery of infusions, particularly when the shelf life of the product could be days or even weeks.…”

Section: Evidence Summarymentioning

confidence: 99%

“…In addition, there is further evidence to suggest in an outpatient setting that temperature (due to the device being worn close to the body) can potentially accelerate the degradation of antimicrobials. 93 Stability data for agents such as flucloxacillin, piperacillintazobactam, and cefepime have been evaluated recently. Buffered flucloxacillin, 73,86 buffered piperacillin-tazobacatam, 73,87 and cefepime 81 PIs appear to be supported by reproducible stability data at 24 h or more, depending on temperature storage conditions.…”

Section: Evidence Summarymentioning

confidence: 99%

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International consensus recommendations for the use of prolonged‐infusion beta‐lactam antibiotics: Endorsed by the American College of Clinical Pharmacy, British Society for Antimicrobial Chemotherapy, Cystic Fibrosis Foundation, European Society of Clinical Microbiology and Infectious Diseases, Infectious Diseases Society of America, Society of Critical Care Medicine, and Society of Infectious Diseases Pharmacists

Hong,

Downes,

FakhriRavari

et al. 2023

Pharmacotherapy

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Intravenous β‐lactam antibiotics remain a cornerstone in the management of bacterial infections due to their broad spectrum of activity and excellent tolerability. β‐lactams are well established to display time‐dependent bactericidal activity, where reductions in bacterial burden are directly associated with the time that free drug concentrations remain above the minimum inhibitory concentration (MIC) of the pathogen during the dosing interval. In an effort to take advantage of these bactericidal characteristics, prolonged (extended and continuous) infusions (PIs) can be applied during the administration of intravenous β‐lactams to increase time above the MIC. PI dosing regimens have been implemented worldwide, but implementation is inconsistent. We report consensus therapeutic recommendations for the use of PI β‐lactams developed by an expert international panel with representation from clinical pharmacy and medicine. This consensus guideline provides recommendations regarding pharmacokinetic and pharmacodynamic targets, therapeutic drug‐monitoring considerations, and the use of PI β‐lactam therapy in the following patient populations: severely ill and nonseverely ill adult patients, pediatric patients, and obese patients. These recommendations provide the first consensus guidance for the use of β‐lactam therapy administered as PIs and have been reviewed and endorsed by the American College of Clinical Pharmacy (ACCP), the British Society for Antimicrobial Chemotherapy (BSAC), the Cystic Fibrosis Foundation (CFF), the European Society of Clinical Microbiology and Infectious Diseases (ESCMID), the Infectious Diseases Society of America (IDSA), the Society of Critical Care Medicine (SCCM), and the Society of Infectious Diseases Pharmacists (SIDP).

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Section: Evidence Summarymentioning

confidence: 99%

Section: Evidence Summarymentioning

confidence: 99%

International consensus recommendations for the use of prolonged‐infusion beta‐lactam antibiotics: Endorsed by the American College of Clinical Pharmacy, British Society for Antimicrobial Chemotherapy, Cystic Fibrosis Foundation, European Society of Clinical Microbiology and Infectious Diseases, Infectious Diseases Society of America, Society of Critical Care Medicine, and Society of Infectious Diseases Pharmacists

Hong,

Downes,

FakhriRavari

et al. 2023

Pharmacotherapy

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“…The present study has evidenced that AC combined in elastomeric devices could be included in OPAT programs, although the external temperature needs to be controlled: in warmer environments, where 37 °C can be reached, the combination of both drugs should not be used, since its concentration drops below 90% in the first 12 h after its preparation. Nonetheless, temperatures between 25 °C and 30 °C are more common in elastomeric infusion devices, and we have demonstrated the stability of AC at both conditions until 24 h of storage [ 20 ]. Additionally, both drugs attained the stability criterion of >90% of the original concentration for 48 h at refrigerated temperatures.…”

Section: Discussionmentioning

confidence: 99%

Stability of Ampicillin plus Ceftriaxone Combined in Elastomeric Infusion Devices for Outpatient Parenteral Antimicrobial Therapy

et al. 2023

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Currently, ampicillin plus ceftriaxone (AC) is one of the preferred treatments for Enterococcus faecalis infective endocarditis. However, there is a lack of stability data for the combination of both drugs in elastomeric devices, so the inclusion of AC in Outpatient Parenteral Antimicrobial Therapy (OPAT) programs is challenging. The objective of the study was to determine the stability of AC in elastomeric pumps when stored at 8 ± 2 °C, 25 ± 2 °C, 30 ± 2 °C and 37 ± 2 °C using LC-MS/MS. The combination was diluted in 0.9% sodium chloride and the final concentrations were ampicillin 24 g/L plus ceftriaxone 8 g/L. Physical and chemical stability were evaluated at 12, 20, 24, 36 and 48 h after preparation. Stability was met at each time point if the percentage of intact drug was ≥90% of its respective baseline concentration and color and clearness remained unchanged. The drug combination was stable for 48 h when it was kept at 8 ± 2 °C. At 25 ± 2 °C and 30 ± 2 °C, they were stable for 24 h of storage. At 37 ± 2 °C, the stability criterion was not met at any time point. These results prove that AC could be included in OPAT programs using elastomeric infusion devices for the treatment of E. faecalis infections.

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“…However, these studies did not meet the YCD criteria for a body worn device. Importantly, in some hot tropical climates such as in Australia, in-use temperatures are often in excess of usual room temperature 23 24. De Jongh et al 14 evaluated the stability of temocillin solution in Milli-Q water at a concentration of 83.4 g/L when exposed to temperatures up to 37°C.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the stability of temocillin in elastomeric infusion devices used for outpatient parenteral antimicrobial therapy in accordance with the requirements of the UK NHS Yellow Cover Document

et al. 2022

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ObjectiveTo evaluate the stability of temocillin solution in two elastomeric infusion devices – Easypump II LT 270–27- S and Dosi-Fusor L25915-250D1 for OPAT administration during 14 days of 5°C±3°C fridge storage followed by 24 hour exposure at an in-use temperature of 32°C, when reconstituted with 0.3% citrate buffer at pH7.MethodsStability testing was conducted in accordance with standard protocols in the UK National Health Service Yellow Cover Document (YCD). A stability indicating assay method was applied using a high-performance liquid chromatography (HPLC) system with a photodiode array detector. Low (500 mg/240 mL), intermediate (4000 mg/240 mL) and high (6000 mg/240 mL) temocillin concentrations were tested in triplicate devices with duplicate samples taken at 11 time points during fridge storage and subsequent in-use temperature exposure.ResultThe percentage of temocillin remaining after 14 days of fridge storage was greater than 97% in both devices and at all concentrations tested. During subsequent in-use temperature exposure, a 95% stability limit was achieved for 12 hours except for the high concentration (25 mg/mL) in the Dosi-Fusor device. It met this criterion for only 10 hours — the percent of temocillin remaining at 12 hours was 94.5%. However, for all devices and the doses tested, the degradation of temocillin was <9% at the end of 24 hours in-use temperature exposure.ConclusionTemocillin reconstituted with 0.3% citrate buffer at pH7 in elastomeric infusion devices can be stored in a fridge (2°C–8°C) for 14 days meeting the YCD acceptance criteria. Considering <5% degradation, the current data supports twice daily dosing of temocillin within the OPAT setting. In jurisdictions where a <10% degradation limit is acceptable, once daily dosing with 24-hour continuous infusion may be considered. Temocillin is a useful alternative to other broad-spectrum anti-Gram-negative agents currently utilised in the OPAT setting and supports the wider antimicrobial stewardship agenda.

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Temperature profiles of antibiotic-containing elastomeric infusion devices used by ambulatory care patients

Cited by 12 publications

References 10 publications

Stability of Ampicillin plus Ceftriaxone Combined in Elastomeric Infusion Devices for Outpatient Parenteral Antimicrobial Therapy

Evaluation of the stability of temocillin in elastomeric infusion devices used for outpatient parenteral antimicrobial therapy in accordance with the requirements of the UK NHS Yellow Cover Document

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