Evaluation of Benzene Presence and Formation in Benzoyl Peroxide Drug Products.

Kaury Kucera, Nicola Zenzola, Amber Hudspeth, Mara Dubnicka, Wolfgang Hinz, Christopher G Bunick, Michael Girardi, Arash Dabestani, David Y Light
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Abstract

The potent carcinogen, benzene, is a known degradation product of benzoyl peroxide (BPO) and was recently reported to form when BPO drug products, used for acne and rosacea treatment, are incubated at body temperature and elevated temperatures expected during storage and transportation. This study provides evidence for a wide range of benzene concentrations (0.16 ppm to 35.30 ppm) detected by GC-MS in 111 over-the-counter BPO drug products tested and maintained at room temperature. A prescription encapsulated BPO drug product was stability tested at cold (2°C) and elevated temperature (50°C), resulting in no apparent benzene formation at 2°C, and high levels of benzene formation at 50°C, suggesting that encapsulation technology may not stabilize BPO drug products but cold storage may greatly reduce benzene formation. Face model experiments where BPO drug product was applied to PolyMethyl MethAcrylate (PMMA) photoprotection test skin plates and benzene was detected in surrounding air by SIFT-MS, showed detectable benzene through evaporation and substantial benzene formation when exposed to UV light at levels below peak sunlight. Results suggest that potential benzene exposure from formation during BPO drug product use poses significant risks independent of the starting benzene concentration.

评估过氧化苯甲酰药物产品中苯的存在和形成。
苯是一种已知的过氧化苯甲酰(BPO)降解产物,最近有报告称,当用于治疗痤疮和红斑痤疮的 BPO 药物产品在体温以及储存和运输过程中的预期高温下孵育时,会产生苯。本研究提供的证据表明,在室温下测试和保存的 111 种非处方药 BPO 产品中,通过气相色谱-质谱仪检测到的苯浓度范围很广(0.16 ppm 至 35.30 ppm)。在低温(2°C)和高温(50°C)条件下对处方封装的 BPO 药物产品进行了稳定性测试,结果表明在 2°C 条件下没有明显的苯形成,而在 50°C 条件下苯的形成水平较高,这表明封装技术可能无法稳定 BPO 药物产品,但低温储存可能会大大减少苯的形成。在脸部模型实验中,将 BPO 药物产品涂抹在聚甲基丙烯酸甲酯(PMMA)光保护测试皮肤板上,并通过 SIFT-MS 检测周围空气中的苯,结果表明通过蒸发可检测到苯,当暴露在低于日照峰值水平的紫外线下时,会有大量苯形成。结果表明,在使用 BPO 药物产品的过程中,潜在的苯暴露会造成重大风险,与起始苯浓度无关。
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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