As the drug security landscape broadens, many manufacturers are looking beyond packaging-level security features for ways to mark, and verify, the actual drug product or materials. Advances in on- and in-dosage technologies have made them feasible complements to tamper-resistant packaging, RFID and barcoding, field inspections, and other essential elements of a holistic anticounterfeiting program.
Another wrinkle on dosage-level drug product security is rapid field scanning and product analysis. Current field testing solutions involve either sending samples to testing labs, which can take days, weeks or months. A crude field test kit, the Global Pharma Health Fund (GPHF) Minilab is also available, but it can only test 43 drugs, weighs over 100 pounds, requires purchase of reagents and other consumables, trained operators, power and clean water, says Julien Bradley, product manager at Ahura Scientific. For this reason, spectrometry and imaging manufacturers have been releasing smaller, handheld testing devices.
Ultimately, testing raw materials will be key to ensuring public safety, explains Bradley. Ahura’s TruScan Raman devices allow materials to be tested, as is, in the package. “Without requiring changes to manufacturing, packaging or support, governments could [use technologies like this to] curb significantly the volume of counterfeit drugs in circulation,” Bradley says, adding that Raman should be one element in any modern anticounterfeiting toolkit.
Bruker Optics has worked with Chinese regulators to provide a range of NIR, Raman, and NMR analyzers for their anticounterfeiting field efforts. The company recently introduced a portable FT-IR spectrometer for organic and inorganic materials.
Analytical Spectral Devices (ASD) will debut its RxSpec 700Z portable near-infrared drug anti-counterfeiting device at the IFPAC 2009 show in Baltimore at the end of this month.
Ceram Surface and Materials Analysis (CSMA), with GlaxoSmithKline, has developed a method of identifying counterfeit tablets by x-ray photoelectron spectroscopy and ToF-SIMS.
Polychromix, Inc.’s Phazir RX is a handheld NIR solution that offers qualitative and quantitative material analysis, including both identification and concentration level measurements, within a few seconds.
Near-infrared (NIR) chemical imaging — distinct from NIR spectroscopy — is being used in the field to provide a “real/fake” detection of tablets and capsules, as well as more detailed information about chemical composition. GSK and Malvern Instruments have used the devices to verify anti-malarial tablets. (For more information on these efforts, visit http://www.pharmamanufacturing.com/articles/2008/067.html.)
In 2008, Applied DNA Sciences began marketing a forensic anticounterfeiting system based upon plant-derived DNA sequences. Botanical DNA can be encrypted into inks and paper for packaging, but also coating inks, then read with a proprietary detection pen.
Authentix, Inc. has used molecular recognition markers (MRMs) for nearly a decade to create trace markers and a matching recognition molecule in the product — the specific binding pair enables sensitive and specific detection of the marker. The ingestible markers, typically inserted at parts-per-billion levels, are inert, odorless, colorless and tasteless to ensure that the finished product is not impaired in any way.
Microtrace Solutions, Inc. develops increasingly smaller microtaggants for packaging plastics and films, but it has also added laser etching to its repertoire. While the taggants are not edible, tablets and capsules can be marked by etched barcodes or logos as a security means, says VP of Marketing Brian Brogger.
NanoInk, Inc. has been at the forefront of the on-dosage movement in its work with Northwestern University on dip pen nanolithography, or DPN. Through its NanoGuardian technology, NanoInk manipulates coatings of tablets and capsules (and vial caps) to encrypt “nanocodes” containing whatever information the manufacturer desires. Pharmaceutical Manufacturing recently spoke with Dean Hart, the company’s executive vice president, about current challenges and market opportunities.
Editor’s Note: For our full interview with Hart, click here.
PhM: Explain what nanoencryption technology is and what it actually means to put a nanocode on a tablet or capsule.
D.H.: First and foremost, we add nothing to the dosage. We add no chemicals, we add no additional product, if you will, to the particular medications that we’re encrypting. We have perfected a manner by which we make manipulations in the coatings of those tablets and capsules and vial caps, and by doing so, we’re able to, at a very high throughput — over a million encryptions per eight-hour period — place our multilayered security features actually on the dosage.
PhM: How does the encryption happen?
D.H.: Our nanoencrypter machine ... typically sits within the manufacturing line right before packaging. So the product is complete, it goes through our nanoencrypting, we place the nanoencryption codes and the other security features on the dosages, and then they go into the appropriate packaging.
PhM: And then how is the data read?
D.H.: Because it is at that nanoscale level, there’s really nothing, from a handheld perspective, that can be used to read that. And that’s seen by our organization as well as my clients as a good thing. And where we do that is at our Authentication Center, the first of which has been established here in Skokie, Illinois, in our home office.
PhM: So the product would have to go through your center?
D.H.: Yes. And within hours of being able to receive it, not only can we quickly authenticate it ... but we would be able to read the nanocodes, report back those nanocodes, and we do that in a nondestructive fashion. So comparatively to, say, HPLC authentication methodologies and other chemical authentication technologies, ours is nondestructive. And not only does it authenticate, but it tells all of the distribution and manufacturing data for that particular dosage.
PhM: It sounds like a lot of data.
D.H.: The key to any security feature is layering. We believe our technology is very complementary to what’s being done on-package, if you will. And I think the nice thing is that our nanocode is just that: it’s a code. And that code is associated with an unlimited amount of data, as defined by the manufacturer. And every piece of this information, including whatever the e-pedigree initiative that they might be implementing for their on-package technology, can be included in this nanocode.
PhM: It also sounds expensive, which is a concern for all manufacturers.
D.H.: It actually is not. We’re fractions of a penny per tablet ... But the key is, what are you paying for? And I think you have to look at it not only as the raw expense, but also the benefit. I mean, you have a technology which can not only authenticate at the field level, but can also trace back every single dosage that is manufactured by that particular organization.