Department of Bioengineering, University of California, Riverside, USA.
Sci Rep. 2022 May 6;12(1):7452. doi: 10.1038/s41598-022-11234-4.
Counterfeit or substandard medicines adversely affect the health of millions of people and cost an estimated $200 billion USD annually. Their burden is greatest in developing countries, where the World Health Organization estimates that one in ten medical products are fake. In this work, I describe a simple addition to the existing drug manufacturing process that imparts an edible universally unique physical identifier to each pill, tablet, capsule, caplet, etc. This technique uses nonpareils (also called sprinkles and "hundreds and thousands"), tiny inexpensive multicolor candy spheres that are normally added to other candies or desserts as decorations. If nonpareils are applied at random to a pill immediately after manufacture, the specific pattern they form is unlikely to ever be repeated by random chance; this means that the pattern (or "CandyCode") can be used to uniquely identify the pill and distinguish it from all other pills. By taking a photograph of each CandyCoded pill after manufacture and recording the location and color of each nonpareil, a manufacturer can construct a database containing the CandyCodes of all known-authentic pills they produce. A consumer can then simply use a cellphone to photograph a pill and transfer its image to the manufacturer's server, which determines whether the pill's CandyCode matches a known-good CandyCode in their database (meaning that the pill is authentic) or does not have a match in the database (in which case the consumer is warned that the pill may be counterfeit and should not be consumed). To demonstrate the feasibility of using random particles as universal identifiers, I performed a series of experiments using both real CandyCodes (on commercially produced chocolate candies) and simulated CandyCodes (generated by software). I also developed a simple method for converting a CandyCode photo to a set of strings for convenient storage and retrieval in a database. Even after subjecting CandyCodes to rough handling to simulate shipping conditions, the CandyCodes were still easily verifiable using a cellphone camera. A manufacturer could produce at least [Formula: see text] CandyCoded pills-41 million for each person on Earth-and still be able to uniquely identify each CandyCode. By providing universally-unique IDs that are easy to manufacture but hard to counterfeit, require no alteration of the existing drug formulation and minimal alteration of the manufacturing process, and need only a cameraphone for verification, CandyCodes could play an important role in the fight against fraud in pharmaceuticals and many other products.
假冒伪劣药品严重影响数百万人的健康，每年造成的损失估计达 2000 亿美元。发展中国家受其影响最大，世界卫生组织估计，这些国家十分之一的医疗产品都是假药。在这项工作中，我描述了一种简单的方法，即在现有的药物制造过程中添加一种可食用的、普遍唯一的物理标识符到每个药丸、片剂、胶囊、糖衣片等。该技术使用小糖粒（也称为糖霜和“成百上千”），这是一种微小而廉价的多色糖果球，通常用于装饰其他糖果或甜点。如果小糖粒在药丸制造后立即随机应用于药丸，它们形成的特定图案不太可能通过随机机会再次重复；这意味着该图案（或“糖果码”）可用于唯一识别药丸并将其与其他所有药丸区分开来。制造商可以通过在制造后拍摄每个加了糖果码的药丸的照片，并记录每个小糖粒的位置和颜色，来构建一个包含他们生产的所有已知正品药丸的糖果码数据库。消费者只需使用手机拍摄药丸的照片并将其图像传输到制造商的服务器，服务器就可以确定该药丸的糖果码是否与数据库中已知的好糖果码匹配（这意味着药丸是正品），或者在数据库中没有匹配（在这种情况下，消费者会收到警告，表明药丸可能是假冒的，不应服用）。为了证明使用随机粒子作为通用标识符的可行性，我使用真实的糖果码（商业生产的巧克力糖果上的）和模拟的糖果码（软件生成的）进行了一系列实验。我还开发了一种简单的方法，可将糖果码照片转换为一组字符串，以便于在数据库中存储和检索。即使将糖果码经过粗暴的处理来模拟运输条件，仍然可以使用手机摄像头轻松验证糖果码。制造商可以生产至少[公式：见正文]个加了糖果码的药丸-地球上每个人 4100 万粒-仍然能够唯一识别每个糖果码。通过提供易于制造但难以伪造、无需改变现有药物配方和制造工艺、仅需摄像头即可验证的通用唯一 ID，糖果码可以在打击药品和许多其他产品的欺诈行为中发挥重要作用。
