« INSIDER INSIGHT
The development of small, highly accurate, and affordable spectroscopic devices has made worldwide authentication by non-experts a real possibility. One way to take advantage of these devices is to create taggant recipes that can be detected spectroscopically. The taggant is not a single substance (which might be more vulnerable both to reverse-engineering and to its own supply disruptions). Instead, it is a chemical code, which is more versatile in that it offers combinatoric possibilities yielding innumerable options. More to the point, spectrometers for field use by non-specialists give yes/no, match/no-match answers without providing any evidence of the underlying algorithms or computations.
Covert chemical taggants provide a weapon in the fight against fake medicine by enabling authentication throughout the supply chain. Until now the use of covert taggants in anti- counterfeiting has involved rare or crafted molecules paired with highly complicated and cumbersome detection techniques. This approach is based upon the assumption that if the anti-counterfeiting measures employed are sufficiently complicated and expensive, the protections they offer will remain beyond the reach of those attempting to replicate them. Today that assumption appears faulty. The level of technical ability demonstrated by counterfeiters has risen dramatically in recent years and shows no sign of abating. Fakes can no longer be identified by misspellings on packaging. Many illicit manufacturers have moved beyond the “quick score” and now aim to sell mock versions that are good enough to garner repeat customers. These sophisticated operations are capable of producing something akin to a generic copy of a legitimate product—but with no cGMP procedures: no quality control, no clean rooms, no accountability. In addition, these same counterfeiters have become impressively skilled at mimicking a wide array of packaging-based brand protection measures by deploying their own holograms, their own UV ink, and their own fluorophore taggants.
Simply elevating the complexity
and expense of a brand protection measure is no longer a reliable obstacle to duplication.
The approach described here addresses protection needs across the marketplace without the need to escalate costs and complexity. This spectroscopy-based brand
protection returns the anti-counterfeiting advantage to legitimate manufacturers, packagers, and distributors using inexpensive, instantly verifiable chemical taggants.
Methods The
system relies on a set of commodity chemicals arrayed in a code. The code is employed to tag products and packaging so that these items can be quickly and easily authenticated in the field without disclosing the underlying components of the coding scheme. The system is compatible with many types of drug packaging including paperboard and labels, borosilicate glass vials, polypropylene caps and bottles, syringes, shrink wrap, lacquer, aluminum shells, and plastic vial buttons. Code-based spectroscopic tagging can create a vast array of unique chemical codes, many of which may be applied to the surface of or embedded directly into the packaging.
The work described here uses commodity chemical compounds shown to meet rigorous specifications for spreading capacity, color fastness, temperature, humidity, and many other user requirements dictated by regulatory, as well as manufacturer, needs. The ability of UV-cured commodity chemicals to apply and adhere to a wide range of materials and remain undetectable in the visible spectral region is a key enabler of the technology. The NIR region of the electromagnetic spectrum has been shown to be useful for distinguishing specific regions of absorption of compounds not present in an authentic substrate.1
Likewise, the use of
taggants purposely used to label a substrate can be used for authentication. This property is what makes the selected compounds particularly effective as covert taggants: the potential counterfeiter is unaware of their presence, and does not even know to search for them. They are undetectable to the naked eye, but detectable to the spectrometer.
We describe a brand protection system employing a 3-step process: develop suitable formulation(s) from commodity chemicals, apply the selected formulation, and verify that chemical code contained in the applied formulation exhibits the desired spectral absorption attributes.
This experiment demonstrated the efficacy of the chemical tagging process on paperboard using techniques similar to those previously validated with plastic stick-on labels, parenteral vials, and steel electronic components. Application was performed by mixing the taggants into materials used in paperboard manufacture.
Note that other
spectroscopies may be used, such as mid- infrared or Raman, but in this work we report specifically on the application of diffuse reflectance NIR to detect applied taggants.
The authors use chemicals generally recognized as safe (GRAS) for pharma- ceutical applications.
Results
The results of this work show that there are specific and easily discernible differences between untagged and tagged packaging and products when seen in the near-infrared spectrum (780 nm to 2500 nm). However, these differences were entirely undetectable to the naked eye in the visible spectrum (400 nm to 800 nm). These differences between tagged and untagged subjects are evidenced in the resultant formulation spectra by the presence of specific absorption bands in the NIR region.
These absorption
bands are not present in untagged packaging and products, thereby demonstrating the utility of the methods for discriminating between packaging and products that have taggant material versus those that do not.
Benefits No Reverse Engineering.
The most
effective anti-counterfeiting solutions deny security personnel access to the coding employed to protect the product being examined.
That is, brand protection best
practice is to separate what is needed to detect counterfeits from what is needed to create counterfeits.
Spectroscopy is ideal
here: a handheld spectrometer can provide an instant “Yes/No, Green/Red, Match/No- match” answer.
For the advanced user, it
www.americanpharmaceuticalreview.com | | 51
»
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76