Troy Wanandy PhD , Simon A. Handley PhD , Thanh-Thao Adriana Le MBBS, FRACP , Wun Yee Lau MBBS, FRACP , Malcolm E. Turner MBBS, FRACP , Michael D. Wiese PhD
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Wiese PhD","doi":"10.1016/j.jaip.2024.10.040","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Limited information is available regarding the physicochemical stability of penicillin-based preparations for skin testing purposes, and no information is currently available for other classes of antibiotics.</div></div><div><h3>Objective</h3><div>To perform chemical and physical stability studies on 16 parenteral antibiotics for skin testing purposes, with an overall aim to provide practical recommendations to clinicians on suitable components, storage, and optimal shelf-life of such preparations.</div></div><div><h3>Methods</h3><div>Chemical stability was assessed via validated stability-indicating high performance liquid chromatography with ultraviolet detection assays, while absence of precipitations or haziness, significant pH shift, and color change were used to determine physical stability.</div></div><div><h3>Results</h3><div>Other than amoxicillin/clavulanic acid, all of the parenteral antibiotics were found to have adequate physicochemical stability between 2 and 7 days. Amoxicillin in water for injection BP retained more than 90% stability, whereas amoxicillin/clavulanic acid dropped to less than 80%. Ampicillin remained more than 90% stable for 2 days, and benzylpenicillin, flucloxacillin, and piperacillin/tazobactam were stable for 2 days or more at approximately 95%. Cephalosporins were stable for 2 days, except ceftazidime, which increased to more than 110%. Aztreonam, ciprofloxacin, and vancomycin retained more than 95% stability for 7 days, whereas meropenem was stable for 2 days. Sulfamethoxazole/trimethoprim in plastic syringe lost 15% but stabilized at approximately 85% for 7 days. No precipitation occurred, but amoxicillin/clavulanic acid changed color by day 2. pH decreases of 1.0 unit or less were observed in penicillins, whereas cefepime dropped below acceptable pH limits by day 7. Absorbance shifts of more than 100 units were seen in several antibiotics by day 7.</div></div><div><h3>Conclusions</h3><div>This study has generated practical stability information for clinicians, allowing 15 parenteral antibiotics from 7 different classes to be aseptically prepared in advance for use in the testing of drug allergy reactions.</div></div>","PeriodicalId":51323,"journal":{"name":"Journal of Allergy and Clinical Immunology-In Practice","volume":"13 2","pages":"Pages 343-352"},"PeriodicalIF":8.2000,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Stability of Antibiotics for Use in the Testing of Immediate Drug Allergy Reactions\",\"authors\":\"Troy Wanandy PhD , Simon A. Handley PhD , Thanh-Thao Adriana Le MBBS, FRACP , Wun Yee Lau MBBS, FRACP , Malcolm E. Turner MBBS, FRACP , Michael D. Wiese PhD\",\"doi\":\"10.1016/j.jaip.2024.10.040\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Limited information is available regarding the physicochemical stability of penicillin-based preparations for skin testing purposes, and no information is currently available for other classes of antibiotics.</div></div><div><h3>Objective</h3><div>To perform chemical and physical stability studies on 16 parenteral antibiotics for skin testing purposes, with an overall aim to provide practical recommendations to clinicians on suitable components, storage, and optimal shelf-life of such preparations.</div></div><div><h3>Methods</h3><div>Chemical stability was assessed via validated stability-indicating high performance liquid chromatography with ultraviolet detection assays, while absence of precipitations or haziness, significant pH shift, and color change were used to determine physical stability.</div></div><div><h3>Results</h3><div>Other than amoxicillin/clavulanic acid, all of the parenteral antibiotics were found to have adequate physicochemical stability between 2 and 7 days. Amoxicillin in water for injection BP retained more than 90% stability, whereas amoxicillin/clavulanic acid dropped to less than 80%. Ampicillin remained more than 90% stable for 2 days, and benzylpenicillin, flucloxacillin, and piperacillin/tazobactam were stable for 2 days or more at approximately 95%. Cephalosporins were stable for 2 days, except ceftazidime, which increased to more than 110%. Aztreonam, ciprofloxacin, and vancomycin retained more than 95% stability for 7 days, whereas meropenem was stable for 2 days. Sulfamethoxazole/trimethoprim in plastic syringe lost 15% but stabilized at approximately 85% for 7 days. No precipitation occurred, but amoxicillin/clavulanic acid changed color by day 2. pH decreases of 1.0 unit or less were observed in penicillins, whereas cefepime dropped below acceptable pH limits by day 7. 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Stability of Antibiotics for Use in the Testing of Immediate Drug Allergy Reactions
Background
Limited information is available regarding the physicochemical stability of penicillin-based preparations for skin testing purposes, and no information is currently available for other classes of antibiotics.
Objective
To perform chemical and physical stability studies on 16 parenteral antibiotics for skin testing purposes, with an overall aim to provide practical recommendations to clinicians on suitable components, storage, and optimal shelf-life of such preparations.
Methods
Chemical stability was assessed via validated stability-indicating high performance liquid chromatography with ultraviolet detection assays, while absence of precipitations or haziness, significant pH shift, and color change were used to determine physical stability.
Results
Other than amoxicillin/clavulanic acid, all of the parenteral antibiotics were found to have adequate physicochemical stability between 2 and 7 days. Amoxicillin in water for injection BP retained more than 90% stability, whereas amoxicillin/clavulanic acid dropped to less than 80%. Ampicillin remained more than 90% stable for 2 days, and benzylpenicillin, flucloxacillin, and piperacillin/tazobactam were stable for 2 days or more at approximately 95%. Cephalosporins were stable for 2 days, except ceftazidime, which increased to more than 110%. Aztreonam, ciprofloxacin, and vancomycin retained more than 95% stability for 7 days, whereas meropenem was stable for 2 days. Sulfamethoxazole/trimethoprim in plastic syringe lost 15% but stabilized at approximately 85% for 7 days. No precipitation occurred, but amoxicillin/clavulanic acid changed color by day 2. pH decreases of 1.0 unit or less were observed in penicillins, whereas cefepime dropped below acceptable pH limits by day 7. Absorbance shifts of more than 100 units were seen in several antibiotics by day 7.
Conclusions
This study has generated practical stability information for clinicians, allowing 15 parenteral antibiotics from 7 different classes to be aseptically prepared in advance for use in the testing of drug allergy reactions.
期刊介绍：
JACI: In Practice is an official publication of the American Academy of Allergy, Asthma & Immunology (AAAAI). It is a companion title to The Journal of Allergy and Clinical Immunology, and it aims to provide timely clinical papers, case reports, and management recommendations to clinical allergists and other physicians dealing with allergic and immunologic diseases in their practice. The mission of JACI: In Practice is to offer valid and impactful information that supports evidence-based clinical decisions in the diagnosis and management of asthma, allergies, immunologic conditions, and related diseases.
This journal publishes articles on various conditions treated by allergist-immunologists, including food allergy, respiratory disorders (such as asthma, rhinitis, nasal polyps, sinusitis, cough, ABPA, and hypersensitivity pneumonitis), drug allergy, insect sting allergy, anaphylaxis, dermatologic disorders (such as atopic dermatitis, contact dermatitis, urticaria, angioedema, and HAE), immunodeficiency, autoinflammatory syndromes, eosinophilic disorders, and mast cell disorders.
The focus of the journal is on providing cutting-edge clinical information that practitioners can use in their everyday practice or to acquire new knowledge and skills for the benefit of their patients. However, mechanistic or translational studies without immediate or near future clinical relevance, as well as animal studies, are not within the scope of the journal.
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