Joint Laboratory of Advanced Biomedical Technology (NFU-UGent), College of Chemical Engineering, Nanjing Forestry University, 210037, Nanjing, P. R. China.
Laboratory of General Biochemistry and Physical Pharmacy, Faculty of Pharmaceutical Sciences, Ghent University, 9000, Ghent, Belgium.
Adv Mater. 2020 Mar;32(11):e1905486. doi: 10.1002/adma.201905486. Epub 2020 Feb 3.
The globalization of drug trade leads to the expansion of pharmaceutical counterfeiting. The immense threat of low quality drugs to millions of patients is considered to be an under-addressed global health challenge. Analytical authentication technologies are the most effective methods to identify active pharmaceutical ingredients and impurities. However, most of these analytical testing techniques are expensive and need skilled personnel. To combat counterfeiting of drugs, the package of an increasing number of drugs is being protected through advanced package labeling technologies. Though, package labeling is only effective if the drugs are not repackaged. Therefore "in-drug labeling," instead of "drug package labeling," may become powerful tools to protect drugs. This review aims to overview how advanced micro- and nanomaterials might become interesting markers for the labeling of tablets and capsules. Clearly, how well such identifiers can be integrated into "solid drugs" without compromising drug safety and efficacy remains a challenge. Also, incorporation of tags has so far only been reported for the protection of solid drug dosage forms. No doubts that in-drug labeling technologies for "liquid drugs," like injectables which contain expensive peptides, monoclonal antibodies, vaccines, dermal fillers, could help to protect them from counterfeiting as well.
药物贸易全球化导致了药品伪造的扩张。大量劣质药物对数百万患者构成的巨大威胁被认为是一个尚未得到充分解决的全球健康挑战。分析鉴定技术是识别原料药和杂质的最有效方法。然而,这些分析测试技术大多昂贵且需要熟练的人员。为了打击药品伪造,越来越多的药品包装采用了先进的包装标签技术来进行保护。尽管如此,如果药品不被重新包装,包装标签才是有效的。因此,“药品内标签”而非“药品包装标签”可能成为保护药品的有力工具。本文旨在综述先进的微纳材料如何可能成为片剂和胶囊标签的有趣标记物。显然,在不影响药物安全性和疗效的情况下,这些标识符在“固体制剂”中的整合效果如何仍然是一个挑战。此外,标签的加入迄今为止仅被报道用于保护固体制剂的药物。毫无疑问,对于“液体制剂”,如含有昂贵的多肽、单克隆抗体、疫苗、真皮填充剂的注射剂,药品内标签技术也可以帮助保护它们免受伪造。