Comparison of Syrian generic ceftriaxone sodium preparations for injection: BHT content and its implications.

IF 1.9 4区医学 Q3 INFECTIOUS DISEASES

Journal of Chemotherapy Pub Date : 2025-02-21 DOI:10.1080/1120009X.2025.2468046

Abeer Srour, Khawla Alamere, Ghassan Abo Chameh, Basima Arous, Mohammad Amer Al-Mardini

{"title":"Comparison of Syrian generic ceftriaxone sodium preparations for injection: BHT content and its implications.","authors":"Abeer Srour, Khawla Alamere, Ghassan Abo Chameh, Basima Arous, Mohammad Amer Al-Mardini","doi":"10.1080/1120009X.2025.2468046","DOIUrl":null,"url":null,"abstract":"<p><p>This study aimed to evaluate the compatibility of generic ceftriaxone sodium preparations with various rubber closures used in pharmaceutical packaging, focusing on the release of butylated hydroxytoluene (BHT), an antioxidant present in rubber closures that may migrate into drug products. BHT levels were quantified using gas chromatography-mass spectrometry (GC-MS) to assess stability and safety. Results showed that all samples contained BHT, with concentrations ranging from below the quantification limit to a maximum of 5.65 ppm. Notably, 47.62% of the samples exceeded the threshold of toxicological concern (TTC) of 1.5 µg/day, raising significant safety concerns. Older samples exhibited higher BHT levels, and products from pharmacies generally had greater concentrations than those obtained from manufacturers. These findings underscore the critical importance of assessing interactions between drug formulations and packaging materials, emphasizing the need for rigorous quality control in injectable pharmaceuticals. Future research should explore strategies to mitigate BHT accumulation in these preparations.</p>","PeriodicalId":15338,"journal":{"name":"Journal of Chemotherapy","volume":" ","pages":"1-6"},"PeriodicalIF":1.9000,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Chemotherapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/1120009X.2025.2468046","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}

引用次数: 0

Abstract

This study aimed to evaluate the compatibility of generic ceftriaxone sodium preparations with various rubber closures used in pharmaceutical packaging, focusing on the release of butylated hydroxytoluene (BHT), an antioxidant present in rubber closures that may migrate into drug products. BHT levels were quantified using gas chromatography-mass spectrometry (GC-MS) to assess stability and safety. Results showed that all samples contained BHT, with concentrations ranging from below the quantification limit to a maximum of 5.65 ppm. Notably, 47.62% of the samples exceeded the threshold of toxicological concern (TTC) of 1.5 µg/day, raising significant safety concerns. Older samples exhibited higher BHT levels, and products from pharmacies generally had greater concentrations than those obtained from manufacturers. These findings underscore the critical importance of assessing interactions between drug formulations and packaging materials, emphasizing the need for rigorous quality control in injectable pharmaceuticals. Future research should explore strategies to mitigate BHT accumulation in these preparations.

查看原文本刊更多论文

叙利亚普通注射用头孢曲松钠制剂的比较：BHT含量及其意义。

本研究旨在评估通用头孢曲松钠制剂与用于药品包装的各种橡胶密封件的相容性，重点关注橡胶密封件中可能迁移到药品中的抗氧化剂丁基羟基甲苯（BHT）的释放。采用气相色谱-质谱（GC-MS）定量测定BHT水平，以评估其稳定性和安全性。结果表明，所有样品均含有BHT，其浓度范围从低于定量限值到最高5.65 ppm。值得注意的是，47.62%的样品超过了1.5µg/天的毒理学关注阈值（TTC），引起了重大的安全问题。较旧的样品显示出较高的BHT水平，药店产品的浓度通常高于制造商产品的浓度。这些发现强调了评估药物配方和包装材料之间相互作用的关键重要性，强调了注射药物严格质量控制的必要性。未来的研究应探索减轻BHT在这些制剂中的积累的策略。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Journal of Chemotherapy 医学-药学

CiteScore

3.70

自引率

0.00%

发文量

144

审稿时长

6-12 weeks

期刊介绍： The Journal of Chemotherapy is an international multidisciplinary journal committed to the rapid publication of high quality, peer-reviewed, original research on all aspects of antimicrobial and antitumor chemotherapy. The Journal publishes original experimental and clinical research articles, state-of-the-art reviews, brief communications and letters on all aspects of chemotherapy, providing coverage of the pathogenesis, diagnosis, treatment, and control of infection, as well as the use of anticancer and immunomodulating drugs. Specific areas of focus include, but are not limited to: · Antibacterial, antiviral, antifungal, antiparasitic, and antiprotozoal agents; · Anticancer classical and targeted chemotherapeutic agents, biological agents, hormonal drugs, immunomodulatory drugs, cell therapy and gene therapy; · Pharmacokinetic and pharmacodynamic properties of antimicrobial and anticancer agents; · The efficacy, safety and toxicology profiles of antimicrobial and anticancer drugs; · Drug interactions in single or combined applications; · Drug resistance to antimicrobial and anticancer drugs; · Research and development of novel antimicrobial and anticancer drugs, including preclinical, translational and clinical research; · Biomarkers of sensitivity and/or resistance for antimicrobial and anticancer drugs; · Pharmacogenetics and pharmacogenomics; · Precision medicine in infectious disease therapy and in cancer therapy; · Pharmacoeconomics of antimicrobial and anticancer therapies and the implications to patients, health services, and the pharmaceutical industry.