Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, St. John's University, 8000 Utopia Parkway, Queens, New York 11439.
Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, St. John's University, 8000 Utopia Parkway, Queens, New York 11439.
J Pharm Sci. 2018 May;107(5):1263-1268. doi: 10.1016/j.xphs.2017.12.021. Epub 2017 Dec 26.
Gluten is found in food containing wheat, rye, and barley, and it may be introduced into medicines through the use of starch or any modified form of starch derived from these grains. The ingestion of gluten poses serious health hazards to people with celiac disease and non-celiac gluten sensitivity, and they must avoid the oral ingestion of gluten. In 2011, the Food and Drug Administration solicited information and public comments on 'gluten in drug products.' However, the 'final rule' that the Agency issued in 2013 involved only the voluntary 'gluten-free' labeling of food, and it did not include drug products. In this commentary, we are proposing that all drug products can and should be made gluten free. This is especially important since there is currently a global trade in medicines, and patients and health care providers do not know whether a product is gluten free or not unless they are labeled as such. All drug products can be made gluten free as there are many alternatives to gluten-containing starch that can be used as excipients during their formulation. Global collaborative efforts of regulatory agencies, pharmaceutical companies, and excipient manufacturers will be needed to implement a gluten-free medication policy and new regulatory guidelines.
麸质存在于含有小麦、黑麦和大麦的食物中，它可能通过使用淀粉或这些谷物来源的任何改性淀粉形式引入药物中。麸质的摄入对乳糜泻和非乳糜泻麸质敏感的人造成严重的健康危害，他们必须避免口服摄入麸质。2011 年，食品和药物管理局就“药物中的麸质”征求信息和公众意见。然而，该机构在 2013 年发布的“最终规则”仅涉及食品的自愿“无麸质”标签，并不包括药物。在这篇评论中，我们建议所有药物都可以而且应该做到无麸质。这一点尤为重要，因为目前存在着全球药品贸易，而且患者和医疗保健提供者只有在标签上注明无麸质时才知道产品是否无麸质。所有药物都可以做到无麸质，因为在药物配方中可以使用许多替代含麸质淀粉的辅料。监管机构、制药公司和辅料制造商需要开展全球合作，以实施无麸质药物政策和新的监管指南。
