Counterfeit drugs: why on-dose authentication offers the most viable solution (part II)

Leading excipient and film coating manufacturer Colorcon has developed a solution to help in the fight against fake drugs through the inclusion of taggants embedded onto individual pills … and the use of smart readers to track and verify branded/authentic products

Further to our discussion in part I, I open the second half of the meeting with Colorcon’s Chief Scientific Officer, Dr Ali Rajabi-Siahboomi, and Global Product Authentication Lead, Gary Pond, about the robustness of the detection technology.

ARS: We’ve been hearing a lot recently about the constraints of PCR (polymerase chain reaction) detection, which is used to detect the taggants, although this has probably been overplayed by the press.

DNA is robust and there's no doubt about the identity of a tablet that’s tagged; it’s impossible to get a positive signal if you don’t have the DNA taggant and the corresponding reagent for that specific taggant.

You need to use PCR to detect it … but the latest machines are automated, portable and reliable, and a single molecule is all that’s needed to identify the tag.

But the game doesn't stop there! Our goal is to go all the way to ensure that the patient has complete confidence that they are taking an authentic drug. That's partly why we started looking at other technologies.

We have shown that it’s possible to detect the silica taggants using a mobile laboratory based reader and a smartphone app.

Now in the final stages of development, this app enables field use across the entire distribution network, including the supply chain, enforcement agencies as well as by patients or caregivers.

KSR: How does the incorporation of the taggants affect the cost of the coating?

GFP: The cost per tablet is a fraction of a cent. These taggants are advanced, complex technologies, so there will be a slight increase in product cost, but the film coating process doesn’t change.

As such, it’s extremely cost-effective to apply. Compared with product costs and the detrimental impact of counterfeit drugs, the overall cost to the producer of the finished dosage form is negligible.

KSR: Is the global pharmaceutical supply chain secure enough to handle pills, tablets and capsules with your coating?

Dr Ali Rajabi-Siahboomi

ARS: Fortunately, most diversion doesn’t involve the raw materials … because this is of low value to the criminals. Pharma companies have security built into manufacturing plant and centres of distribution, but there will always be a risk during transportation.

The chain of custody and the distribution network is something that the manufacturers must make as watertight as possible.

Similarly, Colorcon has developed processes to ensure security during the shipment of the taggants as well as the manufacture and supply of the tagged Opadry.

Also, the reagent for DNA tag detection and the supporting codes for silica taggants are never shipped or stored together. It is almost impossible to detect the taggants — either alone or in the Opadry film coating — and the codes or algorithms within the taggants are virtually impossible to successfully reverse engineer.

KSR: Can you tailor the coatings to specific requirements and/or quantities according to individual customer needs?

GFP: The products and services we offer through SoteriaRx are backed by advanced technology and significant investment made by Colorcon to develop a viable solution.

For both taggant types, we’ve done extensive work to create solutions that work effectively with our film coatings and inks. Our position as a film coating leader and our reputation as a valued and trusted partner to the pharma industry is critical to success.

Our customers rely on us to bring them proven solutions that effectively meet their needs. We work closely with our clients to understand their wishes and follow through with exemplary service and support from development to commercial manufacture.

We thoroughly test our new offerings to ensure that we can provide the right solution for our customers with confidence. At this time, we have ongoing stability and proof of concept studies to ensure our recommended solutions are reliable and robust in use.

KSR: We are now operating in a “new normal” world in which technology such as this is going to become increasingly important. Is this the future of managing the global supply chain for drugs?

ARS: The most exciting part of this technology is when we look at the mobile phone app and its potential applications; in addition to authenticating the product, we can think about what types of information it could be linked to.

Through proof of concept, we’ve shown how you could track a product around the globe, leveraging the currently available serialisation technology and applying similar principles in terms of gathering the information to a central location.

Gary Pond

But you can also look at it from another angle: how can this medicine-related information directly impact the patient? The mobile phone app can utilise the data to set up an alarm system to remind patients to take the right medication at the right time, improving medication regime adherence.

An unexpected impact of the pandemic is its effect on clinical trials; participants have struggled to access testing centres. How can study units ensure that people who take clinical trial medication at home follow the correct medication regime?

Failure to comply will give rise to misleading results, which can be enormously costly to pharma companies and significantly delay trial outcomes.

It may soon be possible to authenticate the tablet using a smartphone, video the volunteer taking the medication and use a smartwatch to monitor vital signs. There’s currently lots of interest in the clinical trial aspect of the technology.

We're not quite there yet, but this exciting future is close and COVID has accelerated a lot of technology. Where and when there is a need, the rate of innovation will increase.

KSR: You mentioned that this research and development has been ongoing for many years. You’ve reached a point now where it all sounds very promising and functional. Is there a next stage? Is there somewhere else you want to get to?

ARS: Right now, it's the beginning of the commercialisation process. We're in discussion with several companies, sharing concepts and talking about practicality and values.

As with any new technology, it will take time for people to understand the platform and think about how it integrates and supports their current multilayered security strategy.

This also holds true for those in the commercial and patient-centric arena. It presents an innovative way to engage with their patients when dosing their medication. On-dose authentication is complementary to serialisation, but we believe that this technology safeguards the patient and brand to a new level by securing the actual product.

As it’s a new technology, cross-functional teams are being brought together within pharma to discuss its impact.

We’re working with companies to help them explore how this offering integrates with their current product security strategies, understand their challenges, then collaborate to develop and implement an effective solution.

There are many new exciting options that companies need to think about, though, such as the role that patients play in authenticating their medication (overt versus covert) and how best to leverage the smartphone app to support patient engagement and build stronger brand loyalty.

Typically, when Colorcon develops a new product, our goal is that it is applied consistently to every tablet across a variety of conditions. In this case, the approach differs, as every product is different and each client has its own needs and different levels of security.

For some companies, it may be important that each batch is identifiable at each location; others may just want one product with one tag around the globe. So, we’re spending a lot of time together with our clients to understand their requirements.

It’s not simple … and launching this type of technology is more complex than bringing a new film coating system to market. As we learn more and understand the objectives and practices that clients wish to apply, we continue to innovate.

On the product security side, the primary questions we’re being asked to answer are whether this product is real or fake, and what’s its provenance. When you get to the commercial side, patient safety is paramount.

Companies are keen to better engage the patient and help them to manage their disease and improve outcomes. So, there are two distinct areas wherein we can integrate product security with patient safety and brand awareness.

We’ve come a long way and removed major technology hurdles to implementation; plus, we can share data to show the robustness of the solutions. We don't have to look into the future — it’s already here.

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