Stability of antibiotics for use in the testing of immediate drug allergy reactions.

IF 8.2 1区医学 Q1 ALLERGY Journal of Allergy and Clinical Immunology-In Practice Pub Date : 2024-11-06 DOI:10.1016/j.jaip.2024.10.040

Troy Wanandy, Simon A Handley, Thanh-Thao Adriana Le, Wun Yee Lau, Malcolm E Turner, Michael D Wiese

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Abstract

Background: Limited information is available regarding the physicochemical stability of penicillins-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 colour 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 to 7 days. Amoxicillin in Water for Injection BP retained >90% stability, while amoxicillin/clavulanic acid dropped to <80%. Ampicillin remained >90% stable for 2 days, and benzylpenicillin, flucloxacillin, and piperacillin/tazobactam were stable for ≥2 days at ∼95%. Cephalosporins were stable for 2 days, except ceftazidime, which increased to >110%. Aztreonam, ciprofloxacin, and vancomycin retained >95% stability for 7 days, while meropenem was stable for 2 days. Sulfamethoxazole/trimethoprim lost 15% but stabilized at ∼85% for 7 days. No precipitation occurred, but amoxicillin/clavulanic acid changed colour by day 7. pH decreases of ≤1.0 unit were observed in penicillins, while cefepime dropped below acceptable pH limits by day 7. Absorbance shifts >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.

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抗生素的稳定性，用于测试药物过敏的即时反应。

背景：有关用于皮试的青霉素类制剂理化稳定性的资料有限，目前尚无其他类别抗生素的相关资料：对 16 种用于皮试的肠外抗生素进行化学和物理稳定性研究，旨在就此类制剂的合适成分、储存和最佳保质期向临床医生提供实用建议：方法：通过有效的稳定性指示高效液相色谱法和紫外线检测法评估化学稳定性，而无沉淀或混浊、明显的 pH 值变化和颜色变化则用于确定物理稳定性：结果：除阿莫西林/克拉维酸外，所有肠外抗生素在 2 至 7 天内都具有足够的理化稳定性。注射用水中阿莫西林的稳定性大于 90%，而阿莫西林/克拉维酸在 2 天内的稳定性降至 90%，苄青霉素、氟氯西林和哌拉西林/他唑巴坦在≥2 天内的稳定性为 95%。头孢菌素类药物在 2 天内保持稳定，但头孢唑肟除外，其稳定度上升至 >110%。阿奇霉素、环丙沙星和万古霉素在 7 天内的稳定性>95%，美罗培南在 2 天内的稳定性>95%。磺胺甲噁唑/三甲氧苄啶的稳定性下降了 15%，但在 7 天内稳定在 85%。青霉素类药物的 pH 值下降≤1.0 个单位，而头孢吡肟在第 7 天降至可接受的 pH 值限度以下。到第 7 天时，几种抗生素的吸光度变化大于 100 单位：这项研究为临床医生提供了实用的稳定性信息，可将 7 个不同类别的 15 种肠道外抗生素提前无菌制备，用于药物过敏反应测试。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Allergy and Clinical Immunology-In Practice ALLERGYIMMUNOLOGY-IMMUNOLOGY

CiteScore

11.10

自引率

9.60%

发文量

683

审稿时长

50 days

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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