Evaluation of the stability of ceftazidime/avibactam in elastomeric infusion devices used for outpatient parenteral antimicrobial therapy utilizing a national stability protocol framework

Abstract Objectives To evaluate the stability of ceftazidime/avibactam in elastomeric infusers, utilizing the UK’s Yellow Cover Document (YCD) stability testing framework, in conditions representative of OPAT practice. Methods Ceftazidime/avibactam was reconstituted with sodium chloride 0.9% (w/v) i...

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Published in:JAC-antimicrobial resistance 2024-04, Vol.6 (2), p.dlae056-dlae056
Main Authors: Naicker, Saiyuri, Roberts, Jason A, Won, Hayoung, Wallis, Steven C, Unwin, Sean, Jamieson, Conor, Hills, Tim, Gilchrist, Mark, Santillo, Mark, Seaton, R Andrew, Drummond, Felicity, Sime, Fekade B
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container_title JAC-antimicrobial resistance
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creator Naicker, Saiyuri
Roberts, Jason A
Won, Hayoung
Wallis, Steven C
Unwin, Sean
Jamieson, Conor
Hills, Tim
Gilchrist, Mark
Santillo, Mark
Seaton, R Andrew
Drummond, Felicity
Sime, Fekade B
description Abstract Objectives To evaluate the stability of ceftazidime/avibactam in elastomeric infusers, utilizing the UK’s Yellow Cover Document (YCD) stability testing framework, in conditions representative of OPAT practice. Methods Ceftazidime/avibactam was reconstituted with sodium chloride 0.9% (w/v) in two elastomeric infusers at concentrations (dose) levels of 1500/375, 3000/750 and 6000 mg/1500 mg in 240 mL. The infusers were exposed to a fridge storage (2°C–8°C) for 14 days followed by 24 h in-use temperature (32°C). Results After 14 days of fridge storage and subsequent 24 h exposure to 32°C, mean ± SD of ceftazidime percent remaining was 75.5% ± 1.8%, 79.9% ± 1.1%, 82.4% ± 0.6%, for Easypump, and 81.7% ± 1.2%, 82.5% ± 0.5%, 85.4% ± 1.1% for Dosi-Fuser devices at the high, intermediate and low doses tested, respectively. For avibactam, mean ± SD percent remaining was 83.2% ± 1.8%, 87.4% ± 2.0%, 93.1% ± 0.9% for Easypump, and 85.1% ± 2.0%, 86.7% ± 0.1%, 92.5% ± 0.1% for Dosi-Fuser devices. The cumulative amount of pyridine generated in the devices ranged from 10.4 mg at low dose to 76.9 mg at high dose. Regression-based simulation showed that the degradation of both ceftazidime and avibactam was
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Methods Ceftazidime/avibactam was reconstituted with sodium chloride 0.9% (w/v) in two elastomeric infusers at concentrations (dose) levels of 1500/375, 3000/750 and 6000 mg/1500 mg in 240 mL. The infusers were exposed to a fridge storage (2°C–8°C) for 14 days followed by 24 h in-use temperature (32°C). Results After 14 days of fridge storage and subsequent 24 h exposure to 32°C, mean ± SD of ceftazidime percent remaining was 75.5% ± 1.8%, 79.9% ± 1.1%, 82.4% ± 0.6%, for Easypump, and 81.7% ± 1.2%, 82.5% ± 0.5%, 85.4% ± 1.1% for Dosi-Fuser devices at the high, intermediate and low doses tested, respectively. For avibactam, mean ± SD percent remaining was 83.2% ± 1.8%, 87.4% ± 2.0%, 93.1% ± 0.9% for Easypump, and 85.1% ± 2.0%, 86.7% ± 0.1%, 92.5% ± 0.1% for Dosi-Fuser devices. The cumulative amount of pyridine generated in the devices ranged from 10.4 mg at low dose to 76.9 mg at high dose. Regression-based simulation showed that the degradation of both ceftazidime and avibactam was &lt;10% for at least 12 h of the running phase, if stored in a fridge for not more than 72 h prior to in-use temperature exposure. Conclusions Whilst not meeting the strict UK YCD criteria for ≤5% degradation, ceftazidime/avibactam may be acceptable to administer as a continuous 12 hourly infusion in those territories where degradation of ≤10% is deemed acceptable.</description><identifier>ISSN: 2632-1823</identifier><identifier>EISSN: 2632-1823</identifier><identifier>DOI: 10.1093/jacamr/dlae056</identifier><identifier>PMID: 38585225</identifier><language>eng</language><publisher>UK: Oxford University Press</publisher><ispartof>JAC-antimicrobial resistance, 2024-04, Vol.6 (2), p.dlae056-dlae056</ispartof><rights>The Author(s) 2024. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy. 2024</rights><rights>The Author(s) 2024. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c324t-c3e915135bbdef4b38e74c122927cdd5060bc139c5898caf01a2062d9e49bf5b3</cites><orcidid>0000-0002-2509-0597 ; 0000-0001-6218-435X ; 0000-0002-2392-9854 ; 0000-0001-7323-245X ; 0000-0003-4061-2063</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,1604,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38585225$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Naicker, Saiyuri</creatorcontrib><creatorcontrib>Roberts, Jason A</creatorcontrib><creatorcontrib>Won, Hayoung</creatorcontrib><creatorcontrib>Wallis, Steven C</creatorcontrib><creatorcontrib>Unwin, Sean</creatorcontrib><creatorcontrib>Jamieson, Conor</creatorcontrib><creatorcontrib>Hills, Tim</creatorcontrib><creatorcontrib>Gilchrist, Mark</creatorcontrib><creatorcontrib>Santillo, Mark</creatorcontrib><creatorcontrib>Seaton, R Andrew</creatorcontrib><creatorcontrib>Drummond, Felicity</creatorcontrib><creatorcontrib>Sime, Fekade B</creatorcontrib><title>Evaluation of the stability of ceftazidime/avibactam in elastomeric infusion devices used for outpatient parenteral antimicrobial therapy utilizing a national stability protocol framework</title><title>JAC-antimicrobial resistance</title><addtitle>JAC Antimicrob Resist</addtitle><description>Abstract Objectives To evaluate the stability of ceftazidime/avibactam in elastomeric infusers, utilizing the UK’s Yellow Cover Document (YCD) stability testing framework, in conditions representative of OPAT practice. Methods Ceftazidime/avibactam was reconstituted with sodium chloride 0.9% (w/v) in two elastomeric infusers at concentrations (dose) levels of 1500/375, 3000/750 and 6000 mg/1500 mg in 240 mL. The infusers were exposed to a fridge storage (2°C–8°C) for 14 days followed by 24 h in-use temperature (32°C). Results After 14 days of fridge storage and subsequent 24 h exposure to 32°C, mean ± SD of ceftazidime percent remaining was 75.5% ± 1.8%, 79.9% ± 1.1%, 82.4% ± 0.6%, for Easypump, and 81.7% ± 1.2%, 82.5% ± 0.5%, 85.4% ± 1.1% for Dosi-Fuser devices at the high, intermediate and low doses tested, respectively. For avibactam, mean ± SD percent remaining was 83.2% ± 1.8%, 87.4% ± 2.0%, 93.1% ± 0.9% for Easypump, and 85.1% ± 2.0%, 86.7% ± 0.1%, 92.5% ± 0.1% for Dosi-Fuser devices. The cumulative amount of pyridine generated in the devices ranged from 10.4 mg at low dose to 76.9 mg at high dose. Regression-based simulation showed that the degradation of both ceftazidime and avibactam was &lt;10% for at least 12 h of the running phase, if stored in a fridge for not more than 72 h prior to in-use temperature exposure. Conclusions Whilst not meeting the strict UK YCD criteria for ≤5% degradation, ceftazidime/avibactam may be acceptable to administer as a continuous 12 hourly infusion in those territories where degradation of ≤10% is deemed acceptable.</description><issn>2632-1823</issn><issn>2632-1823</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>TOX</sourceid><recordid>eNqFkUlvFDEQhVsIRKKQK0fkIxwm46XdyxFFASJF4gLnVtkug4O73XgZNPlr_Dk8mWG5cXG57OevnvWa5iWjV4yOYnsPGua4NR6Qyu5Jc847wTds4OLpP_uz5jKle0opl7Rve_68ORODHCTn8rz5ebMDXyC7sJBgSf6KJGVQzru8PxxotBkenHEzbmHnFOgMM3ELQQ8phxmj07W1JR0IBndOYyIloSE2RBJKXiscl0xWiLVgBE9gyW52OgblaldnRlj3pOQ69cEtXwiQ5dFRvfxrZo0hBx08sRFm_BHitxfNMws-4eWpXjSf3918uv6wufv4_vb67d1GC97muuLIJBNSKYO2VWLAvtWM85H32hhJO6o0E6OWwzhosJQBpx03I7ajslKJi-b1kVstfC-Y8jS7pNF7WDCUNAkq2r4XXc-q9OoorZ9LKaKd1uhmiPuJ0emQ2XTMbDplVh-8OrGLmtH8kf9OqAreHAWhrP-D_QIXz6l4</recordid><startdate>20240401</startdate><enddate>20240401</enddate><creator>Naicker, Saiyuri</creator><creator>Roberts, Jason A</creator><creator>Won, Hayoung</creator><creator>Wallis, Steven C</creator><creator>Unwin, Sean</creator><creator>Jamieson, Conor</creator><creator>Hills, Tim</creator><creator>Gilchrist, Mark</creator><creator>Santillo, Mark</creator><creator>Seaton, R Andrew</creator><creator>Drummond, Felicity</creator><creator>Sime, Fekade B</creator><general>Oxford University Press</general><scope>TOX</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-2509-0597</orcidid><orcidid>https://orcid.org/0000-0001-6218-435X</orcidid><orcidid>https://orcid.org/0000-0002-2392-9854</orcidid><orcidid>https://orcid.org/0000-0001-7323-245X</orcidid><orcidid>https://orcid.org/0000-0003-4061-2063</orcidid></search><sort><creationdate>20240401</creationdate><title>Evaluation of the stability of ceftazidime/avibactam in elastomeric infusion devices used for outpatient parenteral antimicrobial therapy utilizing a national stability protocol framework</title><author>Naicker, Saiyuri ; Roberts, Jason A ; Won, Hayoung ; Wallis, Steven C ; Unwin, Sean ; Jamieson, Conor ; Hills, Tim ; Gilchrist, Mark ; Santillo, Mark ; Seaton, R Andrew ; Drummond, Felicity ; Sime, Fekade B</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c324t-c3e915135bbdef4b38e74c122927cdd5060bc139c5898caf01a2062d9e49bf5b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Naicker, Saiyuri</creatorcontrib><creatorcontrib>Roberts, Jason A</creatorcontrib><creatorcontrib>Won, Hayoung</creatorcontrib><creatorcontrib>Wallis, Steven C</creatorcontrib><creatorcontrib>Unwin, Sean</creatorcontrib><creatorcontrib>Jamieson, Conor</creatorcontrib><creatorcontrib>Hills, Tim</creatorcontrib><creatorcontrib>Gilchrist, Mark</creatorcontrib><creatorcontrib>Santillo, Mark</creatorcontrib><creatorcontrib>Seaton, R Andrew</creatorcontrib><creatorcontrib>Drummond, Felicity</creatorcontrib><creatorcontrib>Sime, Fekade B</creatorcontrib><collection>Open Access: Oxford University Press Open Journals</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>JAC-antimicrobial resistance</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Naicker, Saiyuri</au><au>Roberts, Jason A</au><au>Won, Hayoung</au><au>Wallis, Steven C</au><au>Unwin, Sean</au><au>Jamieson, Conor</au><au>Hills, Tim</au><au>Gilchrist, Mark</au><au>Santillo, Mark</au><au>Seaton, R Andrew</au><au>Drummond, Felicity</au><au>Sime, Fekade B</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of the stability of ceftazidime/avibactam in elastomeric infusion devices used for outpatient parenteral antimicrobial therapy utilizing a national stability protocol framework</atitle><jtitle>JAC-antimicrobial resistance</jtitle><addtitle>JAC Antimicrob Resist</addtitle><date>2024-04-01</date><risdate>2024</risdate><volume>6</volume><issue>2</issue><spage>dlae056</spage><epage>dlae056</epage><pages>dlae056-dlae056</pages><issn>2632-1823</issn><eissn>2632-1823</eissn><abstract>Abstract Objectives To evaluate the stability of ceftazidime/avibactam in elastomeric infusers, utilizing the UK’s Yellow Cover Document (YCD) stability testing framework, in conditions representative of OPAT practice. Methods Ceftazidime/avibactam was reconstituted with sodium chloride 0.9% (w/v) in two elastomeric infusers at concentrations (dose) levels of 1500/375, 3000/750 and 6000 mg/1500 mg in 240 mL. The infusers were exposed to a fridge storage (2°C–8°C) for 14 days followed by 24 h in-use temperature (32°C). Results After 14 days of fridge storage and subsequent 24 h exposure to 32°C, mean ± SD of ceftazidime percent remaining was 75.5% ± 1.8%, 79.9% ± 1.1%, 82.4% ± 0.6%, for Easypump, and 81.7% ± 1.2%, 82.5% ± 0.5%, 85.4% ± 1.1% for Dosi-Fuser devices at the high, intermediate and low doses tested, respectively. For avibactam, mean ± SD percent remaining was 83.2% ± 1.8%, 87.4% ± 2.0%, 93.1% ± 0.9% for Easypump, and 85.1% ± 2.0%, 86.7% ± 0.1%, 92.5% ± 0.1% for Dosi-Fuser devices. The cumulative amount of pyridine generated in the devices ranged from 10.4 mg at low dose to 76.9 mg at high dose. Regression-based simulation showed that the degradation of both ceftazidime and avibactam was &lt;10% for at least 12 h of the running phase, if stored in a fridge for not more than 72 h prior to in-use temperature exposure. Conclusions Whilst not meeting the strict UK YCD criteria for ≤5% degradation, ceftazidime/avibactam may be acceptable to administer as a continuous 12 hourly infusion in those territories where degradation of ≤10% is deemed acceptable.</abstract><cop>UK</cop><pub>Oxford University Press</pub><pmid>38585225</pmid><doi>10.1093/jacamr/dlae056</doi><orcidid>https://orcid.org/0000-0002-2509-0597</orcidid><orcidid>https://orcid.org/0000-0001-6218-435X</orcidid><orcidid>https://orcid.org/0000-0002-2392-9854</orcidid><orcidid>https://orcid.org/0000-0001-7323-245X</orcidid><orcidid>https://orcid.org/0000-0003-4061-2063</orcidid><oa>free_for_read</oa></addata></record>
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title Evaluation of the stability of ceftazidime/avibactam in elastomeric infusion devices used for outpatient parenteral antimicrobial therapy utilizing a national stability protocol framework
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