Issue link: https://www.e-digitaleditions.com/i/1035980
Tablets & Capsules October 2018 35 applications for both pharmaceutical SODFs and pack- aging are orders of magnitude less than the FDA and WHO guidance. Using DNA molecular taggants for tablets, capsules, and packaging As previously described, DNA molecular taggants can be added to the coating, ink printing, or ingredients of a tablet or capsule, providing traceability. The feasibility of this technology has been demonstrated through collabo- rations between taggant suppliers and some of the indus- try's largest companies, with further investment toward commercialization underway. For packaging, the DNA taggant can differentiate a real product from a fake by covert addition to the ink used to print barcodes or to the varnish on the package. For example, Videojet Technologies offers a continuous inkjet molecular ink solution to pharmaceutical, biotech, and medical-device companies. Linking the identifiers of the SODF and the package together and incorporating this information and subsequent authentication transac- tions to a digital record provides a strong archive for pro- active and reactive audits. Imagine a scenario in which a company would like to use DNA molecular taggants to allow authentication of both the dosage ingredients and the packaging for an SODF product. After a formulation and validation period with the specific application and ingredient, the molecu- scale PCR processes and are chemically indistinguishable from the DNA in humans, plants, animals, food, or bacte- ria. Consequently, after routine pharmaceutical purifica- tion, the resulting molecular taggant is chemically identi- cal to the DNA complement of food. Although synthesized from standard DNA building blocks, DNA molecular taggants are designed to be sim- ple product identifiers with small sequence structures and no biological function or information coding. As a result, the taggants have no capacity for gene function and are more stable with respect to extreme heat, UV light, and absolute dryness than standard DNA. A well-known third-party food and drug safety con- sulting firm assesses DNA molecular taggants as Generally Recognized as Safe (GRAS) "through experi- ence based on common use in food prior to January 1, 1958" per 21 CFR 170.30 [4]. The FDA's "Statement of Policy—Food Derived from New Plant Varieties" (57 FR 22984, May 29, 1992) offers the agency's view that [DNA] nucleic acids omnipresent in food are presumed to be GRAS, and by following FDA guidance related to the introduction of other nucleic acid material, no serious question of GRAS status would be expected [5]. In the area of orally delivered vaccines and other orally delivered biologics, the FDA and World Health Organization (WHO) have determined that intact gene- sized human DNA may be safely included in oral dosage formulations at levels as high as 100 micrograms per dose [6, 7]. In the FDA guidance, the agency notes that this allowance is conservative and that if the DNA were applied as fragments that were smaller than gene size (much less than 500 base pairs, for example), then the 100-microgram standard would be seen as even more conservative than it is for long, functional human DNA. The DNA concentrations required for molecular taggant Photo 1: Before dispensing medications, pharmacists can verify tablets, capsules, or packaging printed with pre-tagged ink by swabbing the marked portion of the product and analyzing the sample using a tabletop DNA authentication device. Acid Resistant Vegetable Capsules ) ' u n. , u, ' . ' AN EXCELLENT CHOICE FOR DELIVERY OF ACID-SENSITIVE ACTIVE INGREDIENDTS . . . <> . BioCaps Enterprises, Inc. www.biocaps.net • info@biocaps.net US Patent 9452141 Visit us at SSW Booth #1347