Label Free Pharmaceutical Anticounterfeiting Technology

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DESCRIPTION (provided by applicant): The counterfeiting of consumer goods, documents and other valuable objects has always been a perpetual and widespread problem for humankind. Perhaps the most costly and morally reprehensible form of counterfeiting is the manufacture of counterfeit pharmaceutical products. Imitations range from expensive drugs prescribed in affluent countries to increase the quality of life to the entire supply chain in Africa where it is estimated that >80% of all pharmaceutical products are counterfeit. However, an anticounterfeiting method to protect pharmaceutical preparations directly at the pill level presents a singularly stringent set of requirements in terms of employing a method that would satisfy the FDA. A method is proposed here which is very inexpensive, impossible to reverse engineer or replicate, can label the pharmaceutical directly at the pill level at a speed commensurate with manufacturing rates and with no FDA approval as the technique is "label free" meaning that no chemical was added to the pharmaceutical. The technology is based on a series of micromachined embossing stamps with hierarchical micron to nanometer features that emboss encoded information directly onto the thin film coating pharmaceutical preparations. The embossing stamps are prepared by writing a series of features of decreasing size, from 50 ¿m to around 50 nm, onto an Si wafer with an electron beam. After etching these features to ~100-5000 nm using Deep Reactive Ion Etching (DRIE), a negative mold is made by electroplating (i.e. electroforming) a Ni-Co alloy onto the silicon master. This negative metal stamp is then used to emboss the polymer film encapsulating the pill transferring features as small as 20nm. The embossed features will comprise a hierarchy of features with sizes of 100¿m, 5¿m, 500nm and 50nm. The 100¿m features can be visualized by the consumer with a magnifying glass, the 5¿m features at a pharmacy with an optical microscope, the 500nm features at the wholesale distribution level with an SEM, and the 50nm scale during manufacture with an SEM or AFM. The stamp cannot be replicated, as the technology used to fabricate the smallest features is operated slightly below its optimum resolution range, thereby generating many impossible to duplicate unique and random defects. The "LFAT" technology developed in this proposal represents a system in which pharmaceutical products can be labeled and detected by the manufacturer, distributor or consumer. The identifying features are impossible to replicate and easy to apply, without any need for FDA approval. This technology can be rapidly deployed to prevent the illnesses and suffering caused by consumption of counterfeit products.