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Pharmaceutical Manufacturing and Packing Sourcer

Flexible Pharma

The pharmaceutical industry has been interested in 'smart packaging' for a number of years. Giving packaging intelligence and the ability to communicate with the outside world brings many advantages. For example, it allows medication to be tracked from production to patient, reducing the chances of counterfeit products entering the supply chain, giving manufacturers more brand protection and users peace of mind that they are taking safe, effective medicines. Creating that intelligence means adding electronic circuits to the packaging. Traditionally, electronic circuits are made on bulky and inflexible printed circuit boards and involve thick, rigid silicon chips. Integrating these into pharmaceutical packaging on an item level is not straightforward. Existing package solutions like blister packages or vials would need to be completely redesigned to accommodate their inclusion.

But now a new approach to electronics is set to change things. Flexible electronics is an emerging technology in which sensors and other electronic circuits are made directly onto thin, pliable plastic films. This brings a number of benefits that are particularly relevant to building intelligence into pharmaceutical packaging. Firstly, and most obviously, the resulting electronic systems are flexible and extremely slim. They can also be produced in any shape required. Together, these properties mean that flexible electronics could be easily added to existing pharmaceutical packaging solutions without having to redesign them.

Moreover, flexible electronics can be produced using low-cost printing processes like those used in any household printer. And because the circuits can be printed directly onto flexible films, they can be produced in a roll-to-roll setup, allowing electronic systems to be produced by the metre and thereby greatly reducing production costs.

Flexible electronics are already starting to be applied in pharmaceutical packaging. For example, some pharmaceutical companies are currently looking at using a concept known as the Smart Blister to improve patient adherence to medication regimens.

Addressing Non-Adherence

Long-term medication regimens are important in the management of many chronic illnesses. In some cases, regimens can be very complex, with patients having to take tablets at specific times of the day. However, half of all patients prescribed a long-term regimen do not keep to it, making their therapy less effective. For the patient, this can lead to acute episodes of relapse, lower quality of life and, ultimately, an earlier death. Meanwhile, healthcare systems are put under increased economic pressure due to the cost of extra hospital days needed per patient.

Attempts to improve adherence have so far focused either on ways to remind patients to take their medication, or monitoring how well they stick to their prescribed regimen. The first approach typically uses specially designed medication dispensers. For the second approach, the simplest methodology is to check how often the patient refills their prescription - but this has been found to be unreliable. To combat this issue, a number of smart packaging solutions have been investigated; however, most tried so far have had to be custom manufactured for each medication type, making them difficult to roll-out more widely.

By contrast, the Smart Blister is a low-cost electronic sticker that can be attached to the foil-side of any blister pack to monitor adherence without having to modify the package in any way. When the patient pushes a tablet out of the blister pack, it breaks a conductive line in the Smart Blister and the integrated electronics record the time and date. The patient can then transfer this data onto a suitably equipped smartphone at regular intervals simply by tapping it against the blister pack.

From the phone, the data is transmitted via mobile phone networks or the Internet to the patient's doctor, who can monitor the patient's adherence to their regimen. If the doctor sees that the patient is not taking their medication, is not taking it at the right time or simply is not sending through their data, they can arrange an appointment with the patient to discuss the reasons why.

Developed by Holst Centre and Dutch life sciences firm DSM, the Smart Blister concept has already been tested in a small-scale clinical trial (1). This showed the concept's reliability as a tool to monitor adherence, and suggested that it was accepted by patients and pharmacists. The technology is now being commercialised by Dutch pharmaceutical packaging specialist Qolpac, and could be widely available on the market within a year.

Currently, adding Smart Blister technology to a standard blister does bring some added cost. As a result, it is likely that the technology will initially be applied to more expensive drugs for chronic illnesses. However, this is also typically the type of medication that needs to be taken to a precise timetable, and so is most likely to cause non-adherence issues.

From Production to Patient

Another emerging smart packaging application is medication tracking. At its most basic, this involves adding a radio frequency identification (RFID) chip with a unique identifier to the packaging as a kind of electronic barcode. As the medication enters and leaves each stage of the pharmaceutical supply chain, it passes through a specially designed gateway that can read the information on the RFID chip to verify that the medication is genuine. In this way, RFID chips can prevent ineffective and potentially dangerous counterfeit medication entering the supply chain, saving patients from harm, and protecting the reputations of manufacturers and brands.

With silicon chips, this kind of application is feasible at the pallet or crate level. Flexible electronics, however, with its potential for lower costs and easier integration, makes it possible to track medication at the level of individual packets or bottles. Moreover, flexible electronics has the potential to go far beyond simple tracking and anticounterfeiting applications. For example, by integrating a variety of sensors alongside the RFID functionality, flexible electronics opens up the possibility of accurately logging the environmental conditions which medication has been exposed to during its entire lifetime.

This is an extremely useful ability as factors such as heat and humidity can dramatically affect the efficacy of many medicines. For instance, some vaccines and medicines for rheumatoid arthritis need to be kept refrigerated: in some cases, exposure to room temperatures for as little as a day or two can render a drug useless, or even potentially harmful.

To address this, a new, flexible electronic application has recently been developed, known as the Smart Label. Much like the Smart Blister, the Smart Label is a self-adhesive sticker that can be easily attached to existing pharmaceutical packaging. It combines RFID functionality with temperature and relative humidity sensors into a paper-thin label that can be put on blister packages, boxes, bottles and vials.

Before using the medicine, the patient or healthcare professional scans the Smart Label with a standard RFID reader device to see a full profile of the medication's history. This can include a product identification code to confirm the medication is genuine, plus a complete record of the conditions in which it was stored. The user can immediately see if the ambient temperature has exceeded the allowable maximum for that drug and, if so, for how long. Any medication that has been incorrectly stored can be discarded, helping to ensure effective treatment and preventing harm to the patient.

The technology behind the Smart Label is here already, and the current research effort is focused on reducing the cost of the labels. Once this is achieved, the Smart Label could be applied to mass-market temperature-sensitive medications in mature markets, as well as medicines and vaccines for developing nations where adequate refrigeration facilities may be scarce.

Tailor-Made Treatment

Smart packaging solutions like the Smart Blister and Smart Label focus on ensuring patients take the right medications in the right way to increase the chances of their therapy being effective. This helps improve quality of life for the patient and reduce unnecessary costs for healthcare systems. Moreover, healthcare insurance companies are increasingly linking reimbursement for therapies to a successful treatment outcome.

By encouraging adherence to prescribed regimens and the correct storage of medication, these solutions can improve the chances of successful treatment. And if a therapy is not successful, the Smart Blister and Smart Label can help prescribers understand why.

But this is only the start for flexible electronics in the pharmaceutical world. One day soon, we could see the technology being used to create wearable devices that can measure the actual effect of the medication we take - devices that go wherever we go without affecting our day-to-day lives. This opens the door to real-time monitoring of conditions such as diabetes and high blood pressure, allowing patients to more accurately tailor the dose they need to take to keep their condition under control, while minimising side-effects and the risk of acute episodes.

References

1. Van Onzenoort et al, Determining the feasibility of objective adherence measurement with blister packaging smart technology, Am J Health-Syst Pharm 69: pp872-879, 2012


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Jeroen van den Brand is a Program Manager at Holst Centre. He gained his PhD in Materials Science and Technology from Delft University of Technology in 2004. After three years at Fujifilm working on new product development, specifically targeting roll-to-roll processes, he joined Holst Centre in 2007. Since 2010, he has led Holst Centre's Integration Technologies Program, which develops a wide range of innovative integration and interconnect technologies to enable the realisation of low-cost, thin and flexible wireless sensors.

Stuart Cherry is a Technology Writer for Pyramidion in Antwerp, Belgium, with over ten years' experience covering topics such as semiconductors and semiconductor manufacturing, nanotechnology, healthcare and medical devices, and flexible electronics. He has a degree in Physics from the University of York and a PhD in Theoretical Physics from the University of Durham.

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Stuart Cherry
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